CN113350425B

CN113350425B - Traditional Chinese medicine composition for rapidly relieving inflammatory activity of ulcerative colitis and application thereof

Info

Publication number: CN113350425B
Application number: CN202110722813.1A
Authority: CN
Inventors: 钦丹萍
Original assignee: First Affiliated Hospital of ZCMU
Current assignee: First Affiliated Hospital of ZCMU
Priority date: 2021-06-29
Filing date: 2021-06-29
Publication date: 2022-05-13
Anticipated expiration: 2041-06-29
Also published as: CN113350425A

Abstract

The invention discloses a traditional Chinese medicine composition for rapidly relieving inflammatory activity of ulcerative colitis and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20-30 parts of purslane, 10-20 parts of herba patriniae, 10-15 parts of radix sophorae flavescentis, 10-20 parts of red halloysite, 10-15 parts of cimicifugae foetidae, 10-15 parts of divaricate saposhnikovia root, 10-15 parts of salvia miltiorrhiza, 10-15 parts of pomegranate bark, 10-15 parts of dark plum charcoal, 20-30 parts of fried garden burnet, 3-6 parts of gallnut, 6-9 parts of catechu and 3-6 parts of indigo naturalis powder. The composition has definite clinical curative effect, can remarkably relieve clinical symptoms and inflammatory activities of various types of ulcerative colitis patients including rectal type, left half colon type and extensive colon type in a short time, and provides a new treatment scheme for quickly relieving the inflammatory activities for the ulcerative colitis patients, thereby being beneficial to disease control and treatment of the patients.

Description

Traditional Chinese medicine composition for rapidly relieving inflammatory activity of ulcerative colitis and application thereof

(I) technical field

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for rapidly relieving the inflammatory activity of ulcerative colitis, which is suitable for various types of ulcerative colitis including rectal type, left half colon type and extensive colon type.

(II) background of the invention

Ulcerative Colitis (UC) is one of Inflammatory Bowel Diseases (IBD), and in recent years, the incidence rate is continuously increasing in China; the clinical manifestations of ulcerative colitis are mainly persistent or recurrent diarrhea, mucopurulent bloody stool with abdominal pain, tenesmus and various systemic symptoms, the pathogenesis of which is not clear, and the clinical manifestations are mainly related to immune abnormality. Ulcerative colitis mostly starts from rectum and is distributed continuously and diffusely, so most patients with ulcerative colitis have obvious urgent defecation and anus heavy-falling feeling; some patients have anus burning or pain caused by repeated defecation wiping, and particularly have severe painful diarrhea, mucous stool, rectal bleeding, frequent defecation, urgent defecation and tenesmus as main clinical manifestations during the activity period, which seriously affects the daily life, work and study of the patients and obviously reduces the quality of life.

Therefore, there is an urgent need in clinical treatment to achieve two therapeutic outcomes, the first being efficacy in alleviating inflammatory activity and the second being speed of achieving remission. It is known that ulcerative colitis can affect rectum, left half colon and even extensive colon, and it is often difficult to quickly relieve patient symptoms and control intestinal inflammation only by taking drugs orally, and through a proper enema administration route, drugs can directly reach the pathological change part of the intestinal tract and directly contact with the mucous membrane of the pathological change to quickly exert drug effect, thereby obtaining the therapeutic target.

Traditional medicine has a long history of recording ulcerative colitis, traditional Chinese medicine considers that ulcerative colitis is located in intestines and closely related to liver, spleen and kidney, pathological factors are mainly dampness, heat, stasis and toxin, and toxin pathogen runs through the whole process of diseases.

At present, on the scheme of inducing inflammatory activity of ulcerative colitis, in order to try to relieve the disease condition as fast as possible, most domestic and foreign guidelines recommend the application of steroid hormones, but clinically aiming at the application of steroid hormones, hormone dependence or hormone resistance exists, the steroid hormones are not suitable for maintenance application, and the traditional Chinese medicine composition does not contain the steroid hormones, has shown the effect of quickly relieving the inflammatory activity of intestinal tracts clinically, and can be continuously used for maintenance treatment. Therefore, the traditional Chinese medicine composition provides a new treatment scheme for rapidly relieving inflammation activities for patients with ulcerative colitis, thereby being beneficial to disease control and treatment of patients.

Disclosure of the invention

The invention aims to provide a traditional Chinese medicine composition for rapidly relieving ulcerative colitis inflammation activities and preparation and application thereof, and provides an effective treatment scheme for ulcerative colitis patients through a proper enema administration way so as to rapidly and effectively relieve clinical symptoms and intestinal inflammation.

The technical scheme adopted by the invention is as follows:

the invention provides a traditional Chinese medicine composition for rapidly relieving inflammatory activity of ulcerative colitis, which is prepared from the following raw material medicines in parts by weight: 20-30 parts of purslane, 10-20 parts of herba patriniae, 10-15 parts of radix sophorae flavescentis, 10-20 parts of red halloysite, 10-15 parts of cimicifugae foetidae, 10-15 parts of divaricate saposhnikovia root, 10-15 parts of salvia miltiorrhiza, 10-15 parts of pomegranate bark, 10-15 parts of dark plum charcoal, 20-30 parts of fried garden burnet, 3-6 parts of gallnut, 3-9 parts of catechu and 3-6 parts of indigo naturalis powder.

The composition of the invention can also comprise 'guide' medicines in 'monarch, minister, assistant and guide' traditional Chinese medicine formulas besides the necessary components; if necessary, the patients can be modified appropriately according to the disease condition and constitution difference.

More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 30 parts of purslane, 20 parts of herba patriniae, 15 parts of radix sophorae flavescentis, 20 parts of red halloysite, 15 parts of rhizoma cimicifugae, 15 parts of divaricate saposhnikovia root, 15 parts of salvia miltiorrhiza, 15 parts of pomegranate bark, 15 parts of dark plum charcoal, 30 parts of fried garden burnet root, 6 parts of Chinese gall, 6 parts of catechu and 6 parts of indigo naturalis powder.

The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: mixing the traditional Chinese medicine components according to the formula amount, adding 2-4 times of water by weight, decocting to 1-2 times of volume, and filtering to obtain filtrate, namely the traditional Chinese medicine composition.

The invention also provides an application of the traditional Chinese medicine composition in preparing a medicine for preventing or treating ulcerative colitis, and the medicine is also used for treating rectal ulcerative colitis, left half colon ulcerative colitis or extensive colon ulcerative colitis, and the application method comprises the following steps: decocting twice for each patch, 200ml for each time, and performing enema (selecting proper enema administration route according to different types), 200ml for each time, twice daily.

The raw material medicaments adopted by the invention have the following medicinal properties, pharmacology and effects:

purslane: acid and cold; it enters liver and large intestine meridians; the main effects are as follows: clearing away heat and toxic materials, cooling blood, stopping bleeding, and relieving dysentery; it is cold in nature and slippery in nature, sour in nature and astringent, entering large intestine meridian, has the functions of clearing heat and removing toxicity, cooling blood and stopping dysentery, and can be used with Huang Lian for treating damp-heat in large intestine, abdominal pain and diarrhea, or dysentery with purulent blood, tenesmus. Herba Patriniae: pungent, bitter and slightly cold; entering stomach, large intestine and liver meridians; the main effects are as follows: clearing away heat and toxic materials, eliminating carbuncle, expelling pus, removing blood stasis, and relieving pain; it is the essential herb for treating abdominal pain due to intestinal abscess because it can clear heat and remove toxicity, resolve abscess, discharge pus, activate blood and alleviate pain. Flavescent sophora root: bitter and cold; the channels of heart, liver, stomach, large intestine and bladder; the main effects are as follows: clearing heat, eliminating dampness, killing parasites and promoting urination; can be used for treating dysentery due to damp-heat pathogen, hematochezia, and jaundice. Halloysitum rubrum: sweet, astringent and warm; entering large intestine and stomach meridians; the main effects are as follows: astringe intestines to check diarrhea, astringe to stop bleeding, heal wound and promote granulation; it is good at astringing intestine to check diarrhea and stopping bleeding, so it is a commonly used herb for chronic diarrhea and dysentery and pus and blood discharge; it is also indicated for metrorrhagia, metrostaxis, hematochezia, sores and ulcers. Cimicifugae foetidae: pungent and sweet with mild temperature; it enters bladder, liver and spleen meridians; the main effects are as follows: dispelling pathogenic wind, relieving exterior syndrome, eliminating dampness, relieving pain, and relieving spasm; because of their property of ascending and clearing dampness, they are also indicated for diarrhea due to spleen deficiency with excessive dampness and yang deficiency. Wind prevention: pungent, slightly sweet and slightly cold; it enters lung, spleen, stomach and large intestine meridians; the main effects are as follows: relieving exterior syndrome, promoting eruption, clearing away heat and toxic materials, and lifting yang qi; it enters spleen and stomach meridians and is good at directing qi of spleen and stomach to clear yang. Red sage root: bitter and slightly cold; heart meridian, pericardium and liver meridian entered; the main effects are as follows: promoting blood circulation, regulating menstruation, removing blood stasis, relieving pain, cooling blood, resolving carbuncle, relieving restlessness, and tranquilizing mind; it is indicated for abdominal pain, mass, sores, abscess and swelling. Pomegranate rind: sour, astringent and warm; entering the large intestine meridian; the main effects are as follows; astringe intestines to check diarrhea, stop bleeding and expel parasites; it is a common herb for chronic diarrhea and dysentery, and is used with sanguisorba root for hematochezia. Charring the dark plums: sour, astringent and flat; it enters liver, spleen, lung and large intestine meridians; the main effects are as follows: astringe lung, astringe intestine, promote fluid production, relieve ascaris; stir-baked into charcoal can consolidate metrorrhagia and stop bleeding. Frying the garden burnet: bitter, sour and astringent; it enters liver and large intestine meridians; the main effects are as follows: cool blood to stop bleeding, remove toxicity and heal wound; it can cool blood and astringe intestine to stop dysentery, and stir-baked into charcoal has better hemostatic effect. Gallnut: sour, astringent, cold; entering lung, large intestine and kidney meridians; the main effects are as follows; astringe intestines to check diarrhea, astringe sweat, secure essence to check nocturnal emission, stop bleeding, astringe dampness to heal wound; it can be used for chronic diarrhea and dysentery, and also for hematochezia. Catechu: bitter, astringent and slightly cold; heart and lung meridian entered; the main effects are as follows: promoting blood circulation, relieving pain, stopping bleeding, and promoting granulation; can promote healing of mucosal ulcer. Indigo naturalis powder: salty and cold; entering liver and lung meridians; the main effects are as follows: clearing away heat and toxic material, cooling blood, removing speckle, clearing liver-fire, and arresting convulsion; for epidemic febrile disease, macula, hematemesis and epistaxis; sore throat, aphtha, fire-toxin sores and ulcers; cough with chest pain, blood in the sputum; epilepsy due to summer-heat, convulsions and convulsions.

Aiming at the intestinal inflammation of ulcerative colitis, the traditional Chinese medicine theory of treatment based on syndrome differentiation is combined, the invention takes 'clearing away heat and toxic materials, healing sore and promoting tissue regeneration' as a therapeutic rule, and takes purslane, herba patriniae, radix sophorae flavescentis, red halloysite, cimicifugae foetidae, radix sileris, salvia miltiorrhiza, pomegranate rind, dark plum charcoal, fried garden burnet, gallnut, catechu and natural indigo powder as main medicines to carry out composing, wherein the natural indigo, the gallnut and the catechu are combined and applied as a medicine pair, so that the effects of clearing away heat and toxic materials, healing sore and promoting tissue regeneration are further enhanced; in terms of administration mode, the traditional Chinese medicine composition is delivered to the pathological part of the intestinal tract by different enema administration routes to exert the drug effect: patients with colorectal and sigmoid ulcerative colitis adopt a traditional retention enema form; patients with left-half colon type and extensive colon type ulcerative colitis have a TET tube retained by endoscopic intestinal canal catheterization (TET), and then the traditional Chinese medicine composition is injected into the TET tube. In clinic, the patients with UC ulcerative colitis, whether the patients have the rectum type, the sigmoid colon type, the left half colon type or the wide colon type, can quickly obtain good curative effect in a short time. Compared with western medicine enema, the traditional Chinese medicine composition enema has smaller side reaction and low price, can quickly relieve clinical symptoms of patients in a short time, controls intestinal inflammation, achieves mucosa healing and improves the life quality of the patients.

Compared with the prior art, the invention has the following beneficial effects:

the invention provides an enema traditional Chinese medicine composition for rapidly relieving inflammatory activities of various types of ulcerative colitis including rectal type, left half colon type and wide colon type through years of clinical practice and continuous exploration and improvement according to traditional Chinese medicine theory and modern pharmacology. The composition has definite clinical curative effect, can remarkably relieve clinical symptoms and intestinal inflammation activities of patients with various types of ulcerative colitis in a short time (within 2 weeks), and achieves mucosal healing. Provides a treatment scheme for patients to rapidly relieve inflammation activities, and is beneficial to the treatment of diseases and the improvement of the life quality of the patients.

(IV) description of the drawings

FIG. 1 is a comparison of the enteroscopy before and after treatment of a patient with the Chinese medicinal composition of example 1.

FIG. 2 is a graph showing the change of clinical symptom scores before and after the enema treatment of the Chinese medicine of the patient in example 1.

FIG. 3 is a comparison of the enteroscopy before and after treatment of the patient with the Chinese medicinal composition of example 2.

FIG. 4 is a graph showing the change of clinical symptom scores before and after the enema treatment of the Chinese medicine of the patient in example 2.

FIG. 5 is a comparison of the enteroscopy before and after treatment of the patient with the Chinese medicinal composition of example 3.

FIG. 6 is a curve showing the change of clinical symptom scores before and after the treatment of enema in Chinese medicine of the patient in example 3.

FIG. 7 is a comparison of the enteroscopy before and after treatment of the patient with the Chinese medicinal composition of example 4.

FIG. 8 is a graph showing the change of clinical symptom scores before and after the treatment of enema in Chinese medicine of the patient in example 4.

FIG. 9 is a comparison of the enteroscopy before and after treatment of the patient with the Chinese medicinal composition of example 5.

FIG. 10 is a graph showing the change of clinical symptom scores before and after the enema treatment of Chinese medicine in the patient of example 5.

FIG. 11 is a comparison of the enteroscopy before and after treatment of the patient with the Chinese medicinal composition of example 6.

FIG. 12 is a graph showing the change of clinical symptom scores before and after the enema treatment of Chinese medicine in the patient of example 6.

FIG. 13 is a comparison view of enteroscopy before and after treatment of the patient of comparative example 1.

FIG. 14 is a graph showing the change of clinical symptom scores before and after the treatment of enema in Chinese medicine in the patients of comparative example 1.

FIG. 15 is a comparison view of enteroscopy before and after treatment of the patient in comparative example 2.

FIG. 16 is a graph showing the change of clinical symptom scores before and after the treatment of enema in Chinese medicine in the patients of comparative example 2.

FIG. 17 is a comparison view of enteroscopy before and after treatment of the patient of comparative example 3.

FIG. 18 is a graph showing the change of clinical symptom scores before and after the treatment of enema in Chinese medicine in comparative example 3.

FIG. 19 is a comparison of before and after enteroscopy of the patient of comparative example 4.

FIG. 20 is a graph showing the change of clinical symptom scores before and after the treatment of enema in Chinese medicine in comparative example 4.

FIG. 21 is a comparison view of enteroscopy before and after treatment of the patient in comparative example 5.

FIG. 22 is a graph showing the change of clinical symptom scores before and after the treatment of enema in Chinese medicine in the patients of comparative example 5.

FIG. 23 is a comparison of before and after enteroscopy of the patient of comparative example 6.

FIG. 24 is a graph showing the change of clinical symptom scores before and after the enema treatment of Chinese medicine in patients of comparative example 6.

(V) detailed description of the preferred embodiments

The invention will be further described with reference to specific examples, but the scope of the invention is not limited thereto:

the composition can also comprise a plurality of 'guide' medicines in 'monarch, minister, assistant and guide' prescription in addition to the necessary components; if necessary, the patients can be modified appropriately according to the disease condition and constitution difference. The traditional Chinese medicine raw materials used in the embodiment of the invention are collected and prepared according to the 'Chinese pharmacopoeia' 2015 edition.

Example 1

1. Enema traditional Chinese medicine composition

(1) The formula is as follows: 30 parts of purslane, 20 parts of herba patriniae, 15 parts of radix sophorae flavescentis, 20 parts of red halloysite, 15 parts of rhizoma cimicifugae, 15 parts of divaricate saposhnikovia root, 15 parts of salvia miltiorrhiza, 15 parts of pomegranate bark, 15 parts of dark plum charcoal, 30 parts of fried garden burnet root, 6 parts of Chinese gall, 6 parts of catechu and 6 parts of indigo naturalis powder.

(2) Enema traditional Chinese medicine composition preparation: according to the formula, 30.000g of purslane, 20.000g of herba patriniae, 15.000g of radix sophorae flavescentis, 20.000g of red halloysite, 15.000g of rhizoma cimicifugae, 15.000g of divaricate saposhnikovia root, 15.000g of salvia miltiorrhiza, 15.000g of pomegranate rind, 15.000g of dark plum charcoal, 30.000g of fried garden burnet, 6.000g of Chinese gall, 6.000g of catechu and 6.000g of indigo naturalis powder are weighed, and 400ml of water is added to decoct the mixture to 200 ml.

2. Treating ulcerative colitis

(1) Basic information of the patient: chapter some, male, 32 years old; (2) and (3) clinical diagnosis: ulcerative colitis (chronic relapsing, full colon, severe, active period) (3) summary of disease: patients diagnosed with ulcerative colitis at the end of 2013 years (full colon, active, severe); sequentially treating with aminosalicylic acid preparation (mesalazine), glucocorticoid (methylprednisolone) and immunosuppressant (azathioprine), wherein the disease condition is repeated; the later patients get worse to a hospital in Zhejiang province due to symptoms such as diarrhea, abdominal pain, mucus, stool and hematochezia; after admission, the traditional Chinese medicine composition enema is used for inducing inflammation relief (specific medication and use method are described in the specification) through TET tube, the treatment course is 2 weeks, and after treatment, relevant indexes are reviewed, symptoms are perfected, endoscope evaluation is carried out, and the like.

The symptoms of diarrhea, abdominal pain, mucus and stool, hematochezia and the like of the patient are obviously improved after the next day of treatment, the inflammation of the mucous membrane under the enteroscope is obviously relieved after the traditional Chinese medicine composition is subjected to enema treatment for 2 weeks, and the results are shown in tables 4, 5, 6, 1 and 2.

(4) Enema traditional Chinese medicine composition and application method: decocting twice every plaster, each time decocting 200ml thick, and performing enema (via TET tube enema), each time 200ml, twice daily.

(5) Results

TABLE 1 ulcerative colitis endoscopic Mayo Scoring Standard (MES Scoring)

TABLE 2 improved Mayo scoring system for assessing ulcerative colitis Activity

TABLE 3 score criteria for other major clinical symptoms of ulcerative colitis

TABLE 4 modified Mayo score results

Remarking: referring to table 2, the total score 11 of the modified Mayo before enema is 2 (number of defecation) +3 (hematochezia) +3 (endoscopic evaluation) +3 (physician's overall evaluation) (the scoring criteria are detailed in table 2); the total score of improved Mayo after enema was 1 ═ 0 (number of bowel movements) +0 (hematochezia) +1 (endoscopic evaluation) +0 (physician's overall evaluation) (see table 2 for the scoring criteria).

TABLE 5 score results for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 6 relevant clinical data

Remarking: WBC for white blood cells, HB for hemoglobin, PLT for platelets, CRP for C-reactive protein, ESR for erythrocyte sedimentation rate, OB for fecal occult blood test, ALT for alanine aminotransferase, and AST for aspartate aminotransferase. Ulcerative colitis endoscopic Mayo endoscopic total score (MES) was performed according to table 1, before treatment ═ 3 and after treatment ═ 1. Physician gross assessments were made according to table 2.

FIG. 1 Pre-treatment 2019-04-15 enteroscopy diagnosis: ulcerative colitis (extensive colon, active phase). Post-treatment 2019-05-27 enteroscopy diagnosis: ulcerative colitis (extensive colon, remission).

FIG. 2 shows that the symptoms of diarrhea, hemafecia, abdominal pain, mucous stool, tenesmus and the like in patients treated by enema can be rapidly relieved, wherein the symptoms of diarrhea (scored according to the times of defecation in Table 2), hemafecia are scored according to Table 2, abdominal pain, mucous stool and tenesmus are scored according to Table 3, and the scoring standards of other embodiments are the same; (1) the diarrhea frequency is obviously reduced from the 2 nd day of enema, and the normal state is recovered from the 4 th day of enema; (2) the bloody stool condition is improved from the 1 st day of the enema, bloody stool is occasionally seen from the 3 rd day of the enema, and bloody stool is not seen from the 6 th day of the enema; (3) the abdominal pain starts to be relieved from the 1 st day of clysis, and no obvious abdominal pain attacks from the 4 th day of clysis; (4) the mucus improves from the 1 st day of enema, the mucus occasionally appears on the 3 rd day of enema, and the mucus does not appear on the 6 th day of enema; (5) the symptoms of tenesmus begin to be relieved from the day 2 of the enema, and the feeling of tenesmus is not complained from the day 8 of the enema.

Example 2

1. Traditional Chinese medicine composition formula

(1) The formula is as follows: 25 parts of purslane, 15 parts of herba patriniae, 15 parts of radix sophorae flavescentis, 20 parts of red halloysite, 15 parts of rhizoma cimicifugae, 15 parts of divaricate saposhnikovia root, 10 parts of salvia miltiorrhiza, 15 parts of pomegranate bark, 15 parts of dark plum charcoal, 25 parts of fried garden burnet, 6 parts of gallnut, 9 parts of catechu and 6 parts of indigo naturalis powder.

(2) Enema traditional Chinese medicine composition preparation: according to the formula, 25.000g of purslane, 15.000g of herba patriniae, 15.000g of radix sophorae flavescentis, 20.000g of red halloysite, 15.000g of rhizoma cimicifugae, 15.000g of divaricate saposhnikovia root, 10.000g of salvia miltiorrhiza, 15.000g of pomegranate rind, 15.000g of dark plum charcoal, 25.000g of fried garden burnet, 6.000g of Chinese gall, 9.000g of catechu and 6.000g of indigo naturalis powder are weighed, and 400ml of water is added to decoct the mixture to 200 ml.

2. Treating ulcerative colitis

(1) Basic information of the patient: one certain piece, female, 19 years old; (2) and (3) clinical diagnosis: ulcerative colitis (full colon, chronic relapsing, severe, active); (3) and (3) disease condition summarization: patients diagnosed with ulcerative colitis (full colon type, moderate active phase) in 2019, and had long-term oral administration of aminosalicylic acid preparation (mesalazine) for treatment, with the disease condition repeating; later patients have a relapse to a certain hospital in Zhejiang due to diarrhea, abdominal pain and mucous bloody stool symptoms. After admission, the traditional Chinese medicine composition enema is used for inducing inflammation relief (specific medication and use method are described in the specification) through TET tube, the treatment course is 2 weeks, and after treatment, relevant indexes are reviewed, symptoms are perfected, endoscope evaluation is carried out, and the like.

Clinical symptoms (including diarrhea, abdominal pain and mucous bloody stool) of the patient are obviously improved after the treatment is started the next day, the inflammation of mucous membrane under the enteroscope is rechecked to be obviously relieved after the traditional Chinese medicine composition is clystered for 2 weeks, the detection method is the same as that of the example 1, and the results are shown in a table 7, a table 8, a table 9, a figure 3 and a figure 4.

(5) Results

TABLE 7 modified Mayo score results

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 12 ═ 3 (number of bowel movements) +3 (hematochezia) +3 (endoscopic evaluation) +3 (physician's total evaluation); the total score of improved Mayo after enema was 0 ═ 0 (number of bowel movements) +0 (hematochezia) +0 (endoscopic evaluation) +0 (physician's overall evaluation).

TABLE 8 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 9 relevant clinical data (Normal values are as in TABLE 6)

Remarking: ulcerative colitis endoscopic Mayo endoscopic total score (MES) table 1 is referenced, before treatment 3 and after treatment 0. Physician gross evaluation is referenced in table 2.

FIG. 3 Pre-treatment 2020-12-11 enteroscopy diagnosis: ulcerative colitis (full colon, active phase). 2020-12-31 enteroscopy diagnosis after treatment: ulcerative colitis (full colon, with substantial remission).

FIG. 4 shows that the symptoms of diarrhea, hemafecia, abdominal pain, mucous stool and the like are all rapidly relieved after the enema treatment of the Chinese medicinal composition, wherein the symptoms of diarrhea (scored according to the times of defecation in Table 2), the symptoms of hemafecia are scored according to Table 2, the symptoms of abdominal pain, mucous stool and tenesmus are scored according to Table 3, and the scoring criteria of other embodiments are the same; (1) the diarrhea frequency is obviously reduced from the 1 st day of the enema, and the normal state is recovered from the 4 th day of the enema; (2) the bloody stool condition is obviously improved from the 1 st day of the enema, bloody stool is occasionally seen from the 3 rd day of the enema, and bloody stool is not seen from the 6 th day of the enema; (3) the abdominal pain starts to be relieved from the enema day 2, and no obvious abdominal pain occurs from the enema day 6; (4) the mucus obviously improves from the 1 st day of enema, and no mucus appears from the 4 th day of enema; (5) the symptom of tenesmus begins to be relieved from the enema day 2, and no obvious tenesmus appears from the enema day 8.

Example 3

1. Chinese medicinal composition preparation

(1) The formula is as follows: 20 parts of purslane, 10 parts of herba patriniae, 10 parts of radix sophorae flavescentis, 10 parts of halloysite, 12 parts of cimicifugae foetidae, 12 parts of divaricate saposhnikovia root, 15 parts of salvia miltiorrhiza, 15 parts of pomegranate bark, 10 parts of smoked plum charcoal, 20 parts of fried garden burnet root, 3 parts of gallnut, 6 parts of catechu and 6 parts of indigo naturalis powder.

(2) Enema traditional Chinese medicine composition preparation: weighing 20.000g of purslane, 10.000g of herba patriniae, 10.000g of radix sophorae flavescentis, 10.000g of red halloysite, 12.000g of rhizoma cimicifugae, 12.000g of divaricate saposhnikovia root, 15.000g of salvia miltiorrhiza, 15.000g of pomegranate rind, 10.000g of dark plum charcoal, 20.000g of fried garden burnet, 3.000g of Chinese gall, 6.000g of catechu and 6.000g of indigo naturalis powder according to the formula amount, adding 400ml of water, and decocting to 200 ml.

2. Treating ulcerative colitis

(1) Basic information of the patient: somebody in korea, male, age 61; (2) and (3) clinical diagnosis: ulcerative colitis (total colon, chronic relapsing, active, severe); (3) and (3) disease condition summarization: patients have confirmed ulcerative colitis in 2003, the disease condition is repeated in the period, the patients have a diagnosis in a hospital from 12 months in 2018 to Zhejiang province due to hematochezia and abdominal pain, the inflammation is relieved by enema induction of the TET tube traditional Chinese medicine composition after admission (the specific medication and the application method are described in the specification), the treatment course is 2 weeks, and relevant indexes, perfect symptoms, endoscopic evaluation and the like are reviewed after treatment.

The diarrhea symptoms of the patient are obviously improved after the treatment is started the next day, the inflammation of the mucous membrane under the enteroscope is rechecked after the traditional Chinese medicine composition is used for enema treatment for 2 weeks, the detection method is the same as the example 1, and the results are shown in the table 10, the table 11 and the table 12, and the figure 5 and the figure 6.

(5) Results

TABLE 10 modified Mayo score results

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 12 ═ 3 (number of bowel movements) +3 (hematochezia) +3 (endoscopic evaluation) +3 (physician's total evaluation); the total score of improved Mayo after enema 2 ═ 0 (number of bowel movements) +0 (hematochezia) +1 (endoscopic evaluation) +1 (physician's overall evaluation).

TABLE 11 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 12 relevant clinical data (Normal values are as in TABLE 6)

Remarking: ulcerative colitis endoscopic Mayo endoscopic total score (MES) table 1 is referenced, before treatment 3 and after treatment 1. Physician gross evaluation is referenced in table 2.

FIG. 5 Pre-treatment 2018-12-13 enteroscopy diagnosis: ulcerative colitis (extensive colonic). 2018-12-31 enteroscopy diagnosis after treatment: ulcerative colitis (extensive colon type, remission of inflammation of the colonic mucosa).

FIG. 6 shows that the symptoms of diarrhea, hemafecia, abdominal pain, mucous stool, tenesmus, etc. are all rapidly relieved after enema treatment, wherein the symptoms of diarrhea (scored according to the number of defecation times in Table 2), hemafecia are scored according to Table 2, abdominal pain, mucous stool, tenesmus are scored according to Table 3, and the scoring criteria of other embodiments are the same; (1) the diarrhea frequency is obviously reduced from the 1 st day of enema, the excrement is dissolved for 1-2 times from the 2 nd day of enema, and the normal state is recovered from the 6 th day of enema; (2) the bloody stool condition is obviously improved from the 2 nd day of the enema, bloody stool is occasionally seen from the 4 th day of the enema, and bloody stool is not seen from the 8 th day of the enema; (3) the abdominal pain starts to be relieved from the enema day 2, and no obvious abdominal pain occurs from the enema day 3; (4) the mucus obviously improves from the 1 st day of enema, and no mucus appears from the 4 th day of enema; (5) the symptoms of tenesmus begin to be relieved from the 3 rd day of enema, and the tenesmus is not complained from the 3 rd day of enema.

Example 4

1. Chinese medicinal composition

(1) The formula is as follows: 25 parts of purslane, 15 parts of herba patriniae, 15 parts of radix sophorae flavescentis, 20 parts of red halloysite, 15 parts of rhizoma cimicifugae, 15 parts of divaricate saposhnikovia root, 15 parts of salvia miltiorrhiza, 15 parts of pomegranate bark, 15 parts of dark plum charcoal, 30 parts of fried garden burnet, 6 parts of gallnut, 9 parts of catechu and 6 parts of indigo naturalis powder.

(2) Enema traditional Chinese medicine composition preparation: according to the formula, 25.000g of purslane, 15.000g of herba patriniae, 15.000g of radix sophorae flavescentis, 20.000g of red halloysite, 15.000g of rhizoma cimicifugae, 15.000g of divaricate saposhnikovia root, 15.000g of salvia miltiorrhiza, 15.000g of pomegranate rind, 15.000g of dark plum charcoal, 30.000g of fried garden burnet, 6.000g of Chinese gall, 9.000g of catechu and 6.000g of indigo naturalis powder are weighed, and 400ml of water is added to decoct the mixture to 200 ml.

2. Treating ulcerative colitis

(1) Basic information of the patient: some populus, male, 50 years old; (2) and (3) clinical diagnosis: ulcerative colitis (rectosigmoid, chronic relapsing, active phase); (3) disease condition summarization: patients had confirmed ulcerative colitis in 2008, and had repeated disease states during long-term oral administration of sulfasalazine. The patient is diagnosed in a hospital from 2021 year 3 month to Zhejiang province because of hematochezia and abdominal pain, and the traditional Chinese medicine composition is administered after admission to maintain enema-induced inflammation relief (the specific administration and the use method are described in the specification), the treatment course is 2 weeks, and relevant indexes, perfect symptoms, endoscopic evaluation and the like are rechecked after treatment.

The symptoms of diarrhea and hematochezia of the patient are obviously relieved after the treatment is started the next day, the inflammation of the mucous membrane under the enteroscope is rechecked to be obviously improved after the traditional Chinese medicine composition is used for enema treatment for 2 weeks, the detection method is the same as that of the example 1, and the results are shown in a table 13, a table 14, a table 15, a figure 7 and a figure 8.

(4) Enema traditional Chinese medicine composition and application method: decocting twice every plaster, 200ml each time, and performing enema (retention enema), 200ml each time, twice a day.

(5) Results

TABLE 13 modified Mayo score

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 10 ═ 2 (number of bowel movements) +3 (hematochezia) +2 (endoscopic evaluation) +3 (physician's overall evaluation); the total score of improved Mayo after enema was 0 ═ 0 (number of bowel movements) +0 (hematochezia) +0 (endoscopic evaluation) +0 (physician's overall evaluation).

TABLE 14 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 15 relevant clinical data (Normal values are as in TABLE 6)

Remarking: ulcerative colitis endoscopic Mayo endoscopic total score (MES) table 1 is referenced, 2 before treatment and 0 after treatment. Physician gross evaluation is referenced in table 2.

FIG. 7 Pre-treatment 2021-03-11 enteroscopy diagnosis: ulcerative colitis (rectosigmoid colon type, active phase). Post-treatment 2021-03-25 enteroscopy diagnosis: ulcerative colitis (rectosigmoid type, with substantial relief of inflammation).

FIG. 8 is a diagram showing that the symptoms of diarrhea, hematochezia, abdominal pain, mucous stool, tenesmus and the like in patients treated by enema are all rapidly relieved, wherein the symptoms of diarrhea (scored according to the number of defecation times in Table 2), the symptoms of hematochezia are scored according to Table 2, the symptoms of abdominal pain, mucous stool and tenesmus are scored according to Table 3, and the scoring criteria in other embodiments are the same; (1) the diarrhea frequency is obviously reduced from the 1 st day of the enema, and the normal state is recovered from the 4 th day of the enema; (2) the bloody stool condition is obviously improved from the 2 nd day of the enema, bloody stool is occasionally seen from the 3 rd day of the enema, and bloody stool is not seen from the 6 th day of the enema; (3) the abdominal pain starts to be relieved from the enema day 2, and no obvious abdominal pain occurs from the enema day 4; (4) no mucus appeared after the 4 th day of enema; (5) the symptoms of tenesmus begin to be relieved from the enema day 2, and no feeling of tenesmus is felt from the enema day 3.

Example 5

1. Chinese medicinal composition

(1) The formula is as follows: 20 parts of purslane, 10 parts of herba patriniae, 10 parts of radix sophorae flavescentis, 10 parts of halloysite, 10 parts of rhizoma cimicifugae, 10 parts of radix sileris, 15 parts of salvia miltiorrhiza, 10 parts of pomegranate bark, 10 parts of dark plum charcoal, 20 parts of fried garden burnet, 6 parts of gallnut, 6 parts of catechu and 3 parts of indigo naturalis powder.

(2) Enema traditional Chinese medicine composition preparation: weighing 20.000g of purslane, 10.000g of herba patriniae, 10.000g of radix sophorae flavescentis, 10.000g of red halloysite, 10.000g of rhizoma cimicifugae, 10.000g of divaricate saposhnikovia root, 15.000g of salvia miltiorrhiza, 10.000g of pomegranate rind, 10.000g of dark plum charcoal, 20.000g of fried garden burnet, 6.000g of Chinese gall, 6.000g of catechu and 3.000g of indigo naturalis powder according to the formula amount, adding 400ml of water, and decocting to 200 ml.

2. Treating ulcerative colitis

(1) Basic information of the patient: for certain wu, women, age 52; (2) and (3) clinical diagnosis: ulcerative colitis (rectosigmoid, chronic relapsing, moderate, active); (3) and (3) disease condition summarization: patients are diagnosed with ulcerative colitis in 2019, the patients are treated by oral administration of an aminosalicylic acid preparation (mesalazine) for a long time, the disease condition is stable in the period, the patients are diagnosed in a hospital in Zhejiang province due to diarrhea and hematochezia, the traditional Chinese medicine composition is used for maintaining enema-induced inflammation relief (the specific medicine and the use method are described in the specification), the treatment course is 2 weeks, and relevant indexes, perfect symptoms, endoscopic evaluation and the like are reviewed after treatment.

The symptoms of diarrhea and hematochezia of the patient are obviously relieved after the treatment is started the next day, the inflammation of the mucous membrane under the enteroscope is rechecked to be obviously improved after the traditional Chinese medicine composition is used for enema treatment for 2 weeks, the detection method is the same as that of the example 1, and the results are shown in a table 16, a table 17, a table 18, a figure 9 and a figure 10.

(4) Enema traditional Chinese medicine composition and application method: decocting twice every plaster, each time decocting 200ml thick, and clystering (retention clystering), each time 200ml, twice a day.

(5) Results

TABLE 16 modified Mayo score

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 9 ═ 2 (number of bowel movements) +3 (hematochezia) +2 (endoscopic assessment) +2 (physician's overall assessment); the total score of improved Mayo after enema was 0 ═ 0 (number of bowel movements) +0 (hematochezia) +0 (endoscopic evaluation) +0 (physician's overall evaluation).

TABLE 17 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 18 relevant clinical data (Normal values are as in TABLE 6)

Remarking: overall score for ulcerative colitis endoscope Mayo Endoscope (MES) table 1 is referenced, 2 before treatment and 0 after treatment. Physician gross evaluation is referenced in table 2.

Fig. 9 enteroscopy diagnosis 8 months and 31 days before treatment 2020: ulcerative colitis (rectosigmoid colon type, active phase); enteroscopy diagnosis on 9-month and 14-day 2020: ulcerative colitis (rectosigmoid type, with substantial remission).

FIG. 10 shows that the symptoms of diarrhea, hemafecia, abdominal pain, mucous stool, tenesmus, etc. are all rapidly relieved after enema treatment, wherein the symptoms of diarrhea (scored according to the number of defecation in Table 2), hemafecia are scored according to Table 2, abdominal pain, mucous stool, tenesmus are scored according to Table 3, and the scoring criteria of other embodiments are the same; (1) the diarrhea frequency is obviously reduced from the 1 st day of the enema, and the normal state of the enema is recovered from the 3 rd day of the enema; (2) the blood-carrying condition in the bowels starts to be obviously improved from the 2 nd day of the enema, and the blood-carrying condition in the bowels does not appear from the 4 th day of the enema; (3) no obvious attack of abdominal pain from the enema day 2; (4) the mucus is better on the 2 nd day of clysis, and no mucus is found on the 4 th day of clystering; (5) the symptoms of tenesmus begin to be relieved from the 1 st day of enema, and the feeling of tenesmus is not complained from the 3 rd day of enema.

Example 6

1. Chinese medicinal composition

(1) The formula is as follows: 20 parts of purslane, 10 parts of herba patriniae, 10 parts of radix sophorae flavescentis, 15 parts of halloysite, 10 parts of rhizoma cimicifugae, 10 parts of radix sileris, 10 parts of salvia miltiorrhiza, 10 parts of pomegranate bark, 15 parts of dark plum charcoal, 25 parts of fried garden burnet, 3 parts of gallnut, 3 parts of catechu and 3 parts of indigo naturalis powder.

(2) Enema traditional Chinese medicine composition preparation: weighing 20.000g of purslane, 10.000g of herba patriniae, 10.000g of radix sophorae flavescentis, 15.000g of red halloysite, 10.000g of rhizoma cimicifugae, 10.000g of radix sileris, 10.000g of radix salviae miltiorrhizae, 10.000g of pomegranate rind, 15.000g of dark plum charcoal, 25.000g of fried garden burnet, 3.000g of Chinese gall, 3.000g of catechu and 3.000g of indigo naturalis powder according to the formula amount, adding 400ml of water, and decocting to 200 ml.

2. Treating ulcerative colitis

(1) Basic information of the patient: administering a certain number of people, male, 69 years old; (2) and (3) clinical diagnosis: ulcerative colitis (sigmoid, chronic relapsing, moderate, active); (3) disease condition summarization: the patients are diagnosed as ulcerative colitis in 2019, and are treated by orally taking an aminosalicylic acid preparation (mesalazine) for a long time, and the disease condition is repeated in the period; the later patients have a relapse to a hospital in Zhejiang, and are hospitalized with the traditional Chinese medicine composition after admission, enema-induced inflammation is kept to be relieved (the specific medication and the use method are described in the specification), the treatment course is 2 weeks, and the related indexes, the symptoms, the endoscope evaluation and the like are reviewed after treatment.

The symptoms of diarrhea, abdominal pain and mucous bloody stool of the patient are obviously relieved at the beginning of the next day after the treatment, the inflammation of the mucous membrane under the enteroscope is obviously improved after the enema treatment of the traditional Chinese medicine composition is performed for 2 weeks, the detection method is the same as that of the example 1, and the results are shown in a table 19, a table 20, a table 21, a figure 11 and a figure 12.

(4) Enema traditional Chinese medicine composition and use method: decocting twice every plaster, each time decocting 200ml thick, and clystering (retention clystering), each time 200ml, twice a day.

TABLE 19 modified Mayo score

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 12 ═ 3 (number of bowel movements) +3 (hematochezia) +3 (endoscopic evaluation) +3 (physician's total evaluation); the total score of improved Mayo after enema was 1 ═ 0 (number of bowel movements) +0 (hematochezia) +1 (endoscopic evaluation) +0 (physician's overall evaluation).

TABLE 20 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 21 relevant clinical data (Normal values are as in TABLE 6)

Remarking: ulcerative colitis endoscopic Mayo endoscopic total score (MES) table 1 is referenced, before treatment 3 and after treatment 2. Physician gross evaluation is referenced in table 2.

Fig. 11 enteroscopy diagnosis at 03 months and 16 days 2021 before treatment: ulcerative colitis (left half colon, active phase with spontaneous bleeding of the mucosa). Enteroscopy diagnosis at 04 month 02 day 2021 after treatment: ulcerative colitis (rectum sigmoid colon type, mucous membrane inflammation is obviously improved after enema by traditional Chinese medicines).

FIG. 12 shows that after enema treatment, the symptoms of diarrhea, hematochezia, abdominal pain, mucous stool, tenesmus, etc. are all relieved rapidly, wherein the symptoms of diarrhea (scored according to the number of defecation times in Table 2), the symptoms of hematochezia are scored according to Table 2, the symptoms of abdominal pain, mucous stool, and tenesmus are scored according to Table 3, and the scoring criteria of other embodiments are the same; (1) the diarrhea frequency is obviously reduced from the 2 nd day of enema, and the normal state is recovered from the 4 th day of enema; (2) the blood-carrying condition in the bowels starts to be obviously improved from the 1 st day of the enema, and the blood-carrying condition in the bowels does not appear from the 3 rd day of the enema; (3) the abdominal pain starts to be relieved from the 1 st day of clysis, and no obvious abdominal pain attacks from the 3 rd day of clysis; (4) the mucus improves from the 2 nd day of enema, and no mucus is found from the 4 th day of enema; (5) the symptoms of tenesmus started to be relieved from the day 2 of enema, and the feeling of tenesmus was not complained from the day 6 of enema.

Note: the following control information of patients without enema

Compared with the patients in the embodiment, the patients who do not adopt the traditional Chinese medicine composition for enema have unobvious clinical symptom relief in a short period, have poor intestinal mucosa healing under the endoscope after recheck, or have controlled the disease condition after long-time treatment, but the disease condition relief degree is not better than that obtained by traditional Chinese medicine two-week enema, and the administration cost is high. The specific clinical data are as follows:

comparative example 1

(1) Basic information of the patient: one who is male, age 30; (2) and (3) clinical diagnosis: ulcerative colitis (full colon, chronic relapsing, moderate, active); (3) and (3) disease condition summarization: ulcerative colitis was confirmed in patient 2014; sequentially treating with aminosalicylic acid preparation (mesalazine), glucocorticoid (methylprednisolone), immunosuppressant (azathioprine), etc., with repeated symptoms; in 2019, the symptoms of abdominal pain, diarrhea and mucopurulent bloody stool of a patient are aggravated, the patient is diagnosed in a hospital in Zhejiang province, and is admitted, and then is treated by glucocorticoid (prednisone, which is taken orally 1 time a day and 40mg each time, and is continuously taken until the disease is stable, and the administration is adjusted according to the change of the disease in the period of the oral administration), immunosuppressant (azathioprine, which is taken orally 1 time a day and 100mg each time, and is continuously taken until the disease is stable, and the administration is adjusted according to the change of the disease in the period of the oral administration), thalidomide (which is taken 1 time a night and 25mg each time, and is continuously taken until the disease is stable, and the administration is adjusted according to the change of the disease in the period of the oral administration), and the patient is not treated by traditional Chinese medicine enema; clinical symptoms of the later patients were relieved earlier, and the hyperemia and edema of the partial mucous membrane under the enteroscope were also evident after review, as shown in table 22, table 23, table 24, fig. 13 and fig. 14.

(4) Results

TABLE 22 modified Mayo score

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 8 ═ 2 (number of bowel movements) +2 (hematochezia) +2 (endoscopic assessment) +2 (physician's overall assessment); the total score of improved Mayo after enema was 6 ═ 1 (number of bowel movements) +1 (hematochezia) +2 (endoscopic evaluation) +2 (physician global evaluation).

TABLE 23 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 24 relevant clinical data (Normal values are as in TABLE 6)

Remarking: ulcerative colitis endoscopic Mayo endoscopic total score (MES) table 1 is referenced, 2 before treatment and 2 after treatment. The physician overall evaluation is referred to table 2.

Fig. 13 examination time before treatment was 2019, 4 months and 9 days, enteroscopy diagnosis: ulcerative colitis (generalized, active phase). Post-treatment examination time was 8 months and 8 days in 2019, enteroscopy diagnosis: ulcerative colitis (generalized, Mayo endoscopic score 2 points).

FIG. 14 shows that symptoms such as diarrhea, hematochezia, abdominal pain, tenesmus, etc. were not rapidly relieved in a short period of time, wherein the symptoms of diarrhea (scored according to the number of defecation times in Table 2), the symptoms of hematochezia were scored according to Table 2, the symptoms of abdominal pain, mucous stool, and tenesmus were scored according to Table 3, and the scoring criteria were the same in other examples; (1) the diarrhea frequency is reduced from the treatment day 4, and the stool is carried out for 2-3 times per day; (2) the blood in the stool is improved from the 6 th day of treatment, but the stool still has blood; (3) the abdominal pain starts to be relieved from the 8 th day of treatment, and is relieved automatically after 14 days of treatment; (4) mucus improves from the 4 th day of treatment, and no mucus appears from the 14 th day of treatment; (5) the symptoms of tenesmus begin to be relieved from the 10 th day of treatment, and tenesmus is occasionally felt and can be relieved after defecation.

Comparative example 2

(1) Basic information of the patient: xu somebody, male, 18 years old; (2) and (3) clinical diagnosis: ulcerative colitis (left half colon, chronic relapsing, moderate, active); (3) and (3) disease condition summarization: patients confirmed ulcerative colitis in 2020, and the oral mesalazine has poor effect after treatment; after the patient is hospitalized by a certain hospital in Zhejiang province due to diarrhea and hematochezia, similar 300mg micropump therapy (2020.03.08, 2020.03.22) is carried out after the patient is hospitalized, aminosalicylic acid preparation (60 ml rectal administration for each time after 1 time per night of mesalazine enema liquid) and glucocorticoid (methylprednisolone and prednisone, the administration is adjusted according to the change of the state of an illness) are treated, the medicines are continuously administered until the state of the illness is stable, and the traditional Chinese medicine enema is not carried out; short-term symptom relief is not obvious after treatment, congestion and edema of mucous membrane of enteroscope part are still obvious after re-examination, and the results are shown in table 25, table 26, table 27, fig. 15 and fig. 16.

(4) Results

TABLE 25 modified Mayo score

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 10 ═ 3 (number of bowel movements) +2 (hematochezia) +2 (endoscopic evaluation) +3 (physician's overall evaluation); the total score of improved Mayo after enema was 7 ═ 2 (number of bowel movements) +2 (hematochezia) +1 (endoscopic evaluation) +2 (physician global evaluation).

TABLE 26 score for other major clinical symptoms of ulcerative colitis (see TABLE 3 for scores)

TABLE 27 relevant clinical data (Normal values as in TABLE 6)

Remarking: ulcerative colitis endoscopic Mayo endoscopic total score (MES) table 1 is referenced, 2 before treatment and 1 after treatment. Physician gross evaluation is referenced in table 2.

FIG. 15 Pre-treatment 2020-03-03 enteroscopy diagnosis: ulcerative colitis (ulcerative colitis, left half colon type). After treatment 2020-06-10 enteroscopy diagnosis: ulcerative colitis (ulcerative colitis, left half colon type).

FIG. 16 shows that symptoms such as diarrhea, hematochezia, abdominal pain, tenesmus, etc. are not rapidly relieved in a short period, wherein the symptoms are diarrhea (scored according to the number of defecation times in Table 2), the symptoms such as hematochezia are scored according to Table 2, the symptoms such as abdominal pain, mucous stool, tenesmus are scored according to Table 3, and the scoring criteria are the same in other embodiments; (1) the stool frequency is reduced from the treatment day 4, and the symptoms of the patient are repeated after 3 months of treatment; (2) the blood-carrying condition in the stool is improved from the 6 th day of treatment, but the stool still has blood, and the blood-carrying condition in the stool is repeated after the treatment; (3) the abdominal pain starts to be relieved from the 8 th day of treatment, the abdominal pain is repeated after the 12 days of treatment, and the abdominal pain symptoms of the patient are repeated after the 3 months of treatment; (4) the mucus is relieved from the 10 th day of the treatment, and the symptoms of the mucus are repeated after the patient is treated for 3 months; (5) the symptoms of tenesmus in the treatment period are not improved obviously.

Comparative example 3

(1) Basic information of the patient: certain of plum, male, age 64; (2) and (3) clinical diagnosis: ulcerative colitis (left half colon, chronic relapsing, moderate, active phase); (3) and (3) disease condition summarization: patients diagnosed with ulcerative colitis in 2009; the oral administration of aminosalicylic acid preparation (mesalazine) for more than 1 year, the patient stops taking the medicine automatically, and the hematochezia symptom is recurrent during the period, which is not considered; in 2019, after hospital visit, glucocorticoid (methylprednisolone 1 time daily, 40mg for intravenous drip for anti-inflammatory; prednisone is taken orally 1 time daily, 40mg for each time after 4 days; prednisone is taken orally 1 time daily, 35mg for each time after 7 days, and the dosage is continuously adjusted to be stable according to the change of the state of an illness), aminosalicylic acid preparation (mesalazine enema is taken rectally 1 time every night, 60ml for each time, and the dosage is continuously adjusted to be stable according to the change of the state of an illness during whichThe whole medicine) without traditional Chinese medicine enema, the patients still have hematochezia sometimes after the treatment, and the congestion and edema of partial mucous membrane can be seen after the examination of the enteroscope. The results are shown in Table 28 and Table

29Table 30, fig. 17 and fig. 18.

(4) As a result, the

TABLE 28 modified Mayo score

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 9 ═ 2 (number of bowel movements) +3 (hematochezia) +2 (endoscopic assessment) +2 (physician's overall assessment); the total score of improved Mayo after enema was 6 ═ 1 (number of bowel movements) +3 (hematochezia) +1 (endoscopic evaluation) +1 (physician's overall evaluation).

TABLE 29 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 30 relevant clinical data (Normal values are as in TABLE 6)

Remarking: overall score for ulcerative colitis endoscope Mayo Endoscope (MES) table 1 is referenced, 2 before treatment and 1 after treatment. Physician gross evaluation is referenced in table 2.

FIG. 17 Pre-treatment 2019-05-29 enteroscopy diagnosis: ulcerative colitis (left hemicolon type). 2019-10-15 enteroscopy diagnosis after treatment: follow-up for ulcerative colitis treatment (colon full, remission).

FIG. 18 shows that symptoms such as diarrhea, bloody stool, abdominal pain, mucous stool, tenesmus, etc. are not rapidly relieved in a short period of time, wherein the symptoms of diarrhea (scored according to the number of defecation times in Table 2), bloody stool are scored according to Table 2, abdominal pain, mucous stool, tenesmus are scored according to Table 3, and the scoring criteria are the same in other examples; (1) the diarrhea frequency is reduced from 8 days of treatment, and the stool is 2-3 times per day during the treatment period; (2) the blood-carrying condition in the stool is improved from the treatment day 4, but the stool still has blood, and the blood-carrying condition in the stool is repeated after the treatment; (3) the abdominal pain starts to be relieved from the 4 th day of treatment, and the abdominal pain is still repeated after the treatment; (4) mucus improves after the 6 th day after the treatment period, and the treatment is still repeated; (5) no significant relief was seen during the treatment of the symptoms of tenesmus.

Comparative example 4

(1) Basic information of the patient: some Liu, male, age 44; (2) and (3) clinical diagnosis: ulcerative colitis (chronic relapsing, left half colon, severe, active phase); (3) and (3) disease condition summarization: patients have confirmed ulcerative colitis in 2014, and are treated with glucocorticoid (methylprednisolone), aminosalicylic acid preparation (Edesar), immunosuppressant (azathioprine) and the like in sequence, and symptoms of the patients are repeated in the period; in 2019, patients are diagnosed in a hospital in Zhejiang province due to abdominal pain and diarrhea with mucopurulent bloody stool (13-20 times per day), after admission, glucocorticoid (methylprednisolone injection is administered by intravenous drip of 40mg every time 1 time every day), aminosalicylic acid preparation (Aidisia 4 times every day and oral administration of 1g every time), immunosuppressant (azathioprine 1 time every day and oral administration of 50mg every time) is treated, then biological preparation (Yinfiximab-class gram 200mg intravenous drip is administered 1 time every 2, 6 and 8 weeks after the first administration) is not treated by traditional Chinese medicine enema; the above treatment is continued until the state of illness is stable, and the medication is adjusted according to the change of the state of illness. After treatment, the symptoms of abdominal pain and diarrhea of patients are obviously relieved, but mucous bloody stool is still occasionally existed, and intestinal cavity diffuse inflammation, deep concave ulcer, pebble-like hyperplasia, crisp texture and easy bleeding caused by contact under an endoscope are rechecked. The results are shown in table 31, table 32, table 33, fig. 19 and fig. 20.

(4) Results

TABLE 31 modified Mayo score

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 12 ═ 3 (number of bowel movements) +3 (hematochezia) +3 (endoscopic evaluation) +3 (physician's total evaluation); the total score of improved Mayo after enema was 10 ═ 2 (number of bowel movements) +2 (hematochezia) +3 (endoscopic evaluation) +3 (physician's overall evaluation).

TABLE 32 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 33 relevant clinical data (Normal values are as in TABLE 6)

Remarking: ulcerative colitis endoscopic Mayo endoscopic total score (MES) table 1 is referenced, before treatment 3 and after treatment 3. Physician gross evaluation is referenced in table 2.

FIG. 19 Pre-treatment 2019-10-30 enteroscopy diagnosis: ulcerative colitis (severe). After treatment 2020-03-20 enteroscopy diagnosis: ulcerative colitis (broad, active, severe, Mayo endoscopic score 3 points).

FIG. 20 shows that symptoms such as diarrhea, bloody stool, abdominal pain, mucous stool, tenesmus, etc. are not rapidly relieved in a short period of time, wherein the symptoms of diarrhea (scored according to the number of defecation times in Table 2), bloody stool scored according to Table 2, abdominal pain, mucous stool, tenesmus, etc. are scored according to Table 3, and the scoring criteria are the same in other examples; (1) the diarrhea frequency is reduced from 8 days of treatment, and the stool is 2-3 times per day; (2) the blood-carrying condition in the stool is improved from the 6 th day of treatment, but the stool still has blood, and the blood-carrying condition in the stool is repeated after the treatment; (3) the abdominal pain is relieved earlier from the 4 th day of treatment, and the abdominal pain is still repeated after the treatment; (4) mucus got better on day 6 after the treatment period, and there are many times after the treatment; (5) the symptoms of tenesmus are relieved earlier from the day 4 of treatment, and the treatment period is still repeated.

Comparative example 5

(1) Basic information of the patient: some Wu and some female; (2) and (3) clinical diagnosis: ulcerative colitis (full colon, chronic relapsing, moderate, active); (3) and (3) disease condition summarization: patients have confirmed ulcerative colitis in 2014, and are treated by an aminosalicylic acid preparation (mesalazine enema and oral administration), glucocorticoid (detailed), thalidomide and the like in sequence, and the disease condition is repeated in the period; the patient is treated in a hospital in Zhejiang province due to symptoms of abdominal pain, diarrhea and mucous bloody stool, and is administered with biological preparation (infliximab-like 200mg intravenous drip, 1 time for each of 2, 6 and 8 weeks after the first administration) and tacrolimus (1 time per day, 3mg each time, oral treatment) after admission, and no Chinese medicine enema is used; the above treatment is continued until the state of illness is stable, and the medication is adjusted according to the change of the state of illness. After treatment, abdominal pain and mucus and bloody stool of patients are better, diarrhea occasionally occurs, and mucosa diffuse hyperemia, edema and erosion still occur under the enteroscope. The results are shown in tables 34, 35, 36, fig. 21 and 22.

(4) Results

TABLE 34 modified Mayo score

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 8 ═ 2 (number of bowel movements) +2 (hematochezia) +2 (endoscopic assessment) +2 (physician's overall assessment); the total score of improved Mayo after enema was 5 ═ 2 (number of bowel movements) +1 (hematochezia) +1 (endoscopic evaluation) +1 (physician's overall evaluation).

TABLE 35 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 36 relevant clinical data (Normal values are as in TABLE 6)

FIG. 21 Pre-treatment 2018-04-23 enteroscopy diagnosis: ulcerative colitis (chronic relapsing, active phase). Post-treatment 2018-08-28 enteroscopy diagnosis: ulcerative colitis (active, extensive colon, late involvement).

FIG. 22 shows that symptoms such as diarrhea, bloody stool, abdominal pain, mucous stool, tenesmus, etc. are not rapidly relieved in a short period of time, wherein the symptoms of diarrhea (scored according to the number of defecation times in Table 2), bloody stool are scored according to Table 2, abdominal pain, mucous stool, tenesmus are scored according to Table 3, and the scoring criteria are the same in other examples; (1) the diarrhea frequency is reduced from 8 days of treatment, and the stool is increased for 2-3 times per day; (2) the blood-carrying condition in the stool is improved from the 10 th day of treatment, but the stool still has blood, and the blood-carrying condition in the stool is repeated after the treatment; (3) the abdominal pain is relieved earlier from the 8 th day of treatment, and the abdominal pain is still repeated after the treatment; (4) no obvious improvement of mucus during the treatment period; (5) the symptoms of tenesmus are relieved earlier from the 6 th day of treatment, and the treatment period is still repeated.

Comparative example 6

(1) Basic information of the patient: xu somebody, male, 18 years old; (2) and (3) clinical diagnosis: ulcerative colitis (left half colon, chronic relapsing, moderate, active); (3) and (3) disease condition summarization: patient confirmed ulcerative colitis in 2020; followed by treatment with aminosalicylic acid preparation (mesalazine), during which the symptoms repeat; the patient is treated by a biological agent (infliximab-like 200mg intravenous drip which is administered 1 time after 2, 6 and 8 weeks after the first administration), glucocorticoid (methylprednisolone, 1 time per day, 40mg intravenous drip for 4 days, modified prednisone after 4 days, 1 time per day, 35mg oral administration each time, 5mg decrement of prednisone every 4 days, finally decrement to 25mg maintenance treatment) and aminosalicylic acid preparation (mesalazine, 4 times per day, 1g oral administration each time) after admission, wherein the patient is treated by abdominal pain, diarrhea, hematochezia and fever until a certain hospital in Zhejiang province, and is not treated by traditional Chinese medicine enema; the above treatment is continued until the state of illness is stable, and the medication is adjusted according to the change of the state of illness. After treatment, abdominal pain, hematochezia and fever symptoms are improved, sometimes diarrhea is caused, and diffuse hyperemia and erosion of local mucous membrane and changes of a sand skin sample are rechecked under a enteroscope; see tables 37, 38, 39, fig. 23 and 24 for details.

(4) Results

TABLE 37 modified Mayo score

Remarking: referring to table 2, the total score of Mayo for pre-enema improvement was 10 ═ 3 (number of bowel movements) +2 (hematochezia) +2 (endoscopic evaluation) +3 (physician's overall evaluation); the total score of improved Mayo after enema was 5 ═ 1 (number of bowel movements) +1 (hematochezia) +1 (endoscopic evaluation) +2 (physician's overall evaluation).

TABLE 38 score for other major clinical symptoms of ulcerative colitis (see Table 3 for scores)

TABLE 39 relevant clinical data (Normal values are as in TABLE 6)

FIG. 23 Pre-treatment 2020-03-03 enteroscopy diagnosis: ulcerative colitis (left half colon type, with the possibility of viral infection). After treatment 2020-06-10 enteroscopy diagnosis: ulcerative colitis (left half colon type, review).

FIG. 24 shows that symptoms of diarrhea, bloody stool, abdominal pain, mucous stool, tenesmus, etc. are not rapidly relieved in a short period of time, wherein the symptoms of diarrhea (scored according to the number of defecation times in Table 2), bloody stool are scored according to Table 2, abdominal pain, mucous stool, tenesmus are scored according to Table 3, and the scoring criteria are the same in other examples; (1) the diarrhea frequency is reduced from the 3 rd day of treatment, and the excrement is 2-3 times per day after 12 days of treatment; (2) the blood-carrying condition in the stool is improved from 8 days of treatment, but the stool still has blood, and the blood-carrying condition in the stool is repeated after the treatment; (3) the abdominal pain is relieved earlier from the 6 th day of treatment, and the abdominal pain is still repeated after the treatment; (4) on day 2 after treatment, mucus is slightly better than before, and mucus is intermittently removed; (5) the symptoms of tenesmus are relieved earlier from the 12 th day of treatment, the tenesmus are still felt, and the tenesmus can be relieved slightly after defecation.

Claims

1. A traditional Chinese medicine composition for relieving ulcerative colitis inflammation activities is characterized in that the traditional Chinese medicine composition is prepared into an enema from the following raw material medicines in parts by weight: 20-30 parts of purslane, 10-20 parts of herba patriniae, 10-15 parts of radix sophorae flavescentis, 10-20 parts of red halloysite, 10-15 parts of cimicifugae foetidae, 10-15 parts of divaricate saposhnikovia root, 10-15 parts of salvia miltiorrhiza, 10-15 parts of pomegranate bark, 10-15 parts of dark plum charcoal, 20-30 parts of fried garden burnet, 3-6 parts of gallnut, 3-9 parts of catechu and 3-6 parts of indigo naturalis powder.

2. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition is prepared into an enema from the following raw materials in parts by weight: 30 parts of purslane, 20 parts of herba patriniae, 15 parts of radix sophorae flavescentis, 20 parts of red halloysite, 15 parts of rhizoma cimicifugae, 15 parts of divaricate saposhnikovia root, 15 parts of salvia miltiorrhiza, 15 parts of pomegranate bark, 15 parts of dark plum charcoal, 30 parts of fried garden burnet root, 6 parts of Chinese gall, 6 parts of catechu and 6 parts of indigo naturalis powder.

3. The Chinese medicinal composition according to claim 1, wherein the Chinese medicinal composition is an enema prepared from aqueous extracts of the respective raw materials.

4. A method for preparing the traditional Chinese medicine composition of claim 1, which is characterized by comprising the following steps: mixing the traditional Chinese medicine components according to the formula amount, adding 2-4 times of water by weight, decocting to 1-2 times of volume, and filtering to obtain filtrate, namely the traditional Chinese medicine composition enema.

5. The use of the composition of claim 1 in the preparation of a medicament for the prevention or treatment of ulcerative colitis.

6. Use according to claim 5, characterized in that the medicament is a medicament for the treatment of inflammation in ulcerative colitis rectal form.

7. Use according to claim 5, characterized in that the medicament is a medicament for the treatment of inflammation of left-half-colon ulcerative colitis.

8. Use according to claim 5, characterized in that the medicament is a medicament for the treatment of inflammation of ulcerative colitis widespread colon.