CN115702925A - Traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof - Google Patents

Traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof Download PDF

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CN115702925A
CN115702925A CN202110913726.4A CN202110913726A CN115702925A CN 115702925 A CN115702925 A CN 115702925A CN 202110913726 A CN202110913726 A CN 202110913726A CN 115702925 A CN115702925 A CN 115702925A
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仝小林
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Guanganmen Hospital of CACMS
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Abstract

The invention discloses a traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: immature bitter orange, fried bighead atractylodes rhizome, betel nut, wine-processed rhubarb, pinellia tuber, ginger, peach kernel and dangshen. The traditional Chinese medicine composition has no obvious adverse reaction, is safe and reliable, has good medication safety, has strict formula by selecting the components of the formula and controlling the adding amount of the components of the formula, effectively treats the diabetic gastroparesis, improves the core symptoms of nausea, vomiting, postprandial satiety, early satiety, abdominal distension and the like, and has a certain regulating effect on blood sugar.

Description

Traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicine. More particularly, relates to a traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof.
Background
The Diabetic Gastroparesis (DGP) is one of the common complications of diabetes, is a symptom group which eliminates mechanical obstruction and is mainly characterized by delayed solid gastric emptying, common symptoms comprise nausea, vomiting, abdominal distension, early satiety, inappetence and frequent nausea and vomiting and easily cause electrolyte disorder, dehydration and other physical problems, the symptoms are similar to the traditional Chinese medicine 'abdominal mass syndrome', the clinical pathological bases of the traditional Chinese medicine are mainly weakness of the spleen and the stomach, weakness of transportation and transformation, dysfunction of ascending and descending, stomach disorder and descending and qi stagnation, damp turbidity or food stagnation, qi deficiency often causes qi stagnation and blood stasis, blood stasis promotes deficiency again, and malignant circulation belongs to the syndrome of deficiency and excess. In recent years, DGP has been on the rise with the rise of the incidence of diabetes, and it has been reported that the incidence of DGP is as high as 50% in these diabetic patients, and the disease not only causes great pain to the patients, but also affects the control of blood sugar, and further causes heavy burden to the society and families, and therefore attention to diabetic gastroparesis should be increased.
At present, the pharmaceutical therapy of DGP mainly adopts gastric motility promoting medicines, such as erythromycin, metoclopramide, domperidone and the like, and certain limitations may exist in the use, which is related to low bioavailability of the first-pass effect, and some patients may cause related adverse reactions, so that the control of blood sugar and the therapy of digestive tract symptoms are difficult to be considered in the therapy, and the long-term satisfactory curative effect is lacked. On the one hand, hyperglycemic states and some hypoglycemic agents themselves have the effect of destroying gastric emptying and reducing the gastric effect on gastric motility promoting drugs such as erythromycin; on the other hand, in the case of the serious disease, frequent nausea and vomiting make blood sugar difficult to control, and dangerous conditions are very likely to occur. Patterson D et al (Patterson D, abell T, rothstein R, koch K, barnett J.A double-blind multicenter compliance of domperidone and metoclopramide in the treatment of diabetes with systemic diseases, gastroparesis, am J gastroenterol.1999May, 94 (5): 1230-4.) selected 98 patients treated with domperidone and metoclopramide for diabetic gastroparesis, and studies showed that domperidone and metoclopramide were effective against the disease, but had adverse effects on the central nervous system, with the adverse effects on gastric reassurance being more severe and more common, with 49% of patients recognizing a somnolence phenomenon after 4 weeks of gastric reassurance, and 33% of patients recognizing a mental decline. For patients with severe diabetic gastroparesis, the conventional medicament has poor treatment effect, and the available other treatment modes are limited, such as electrical stimulation of the stomach, surgical treatment, injection of botulinum toxin under an endoscope and the like, but the treatment methods also have adverse surgical effects such as infection, malnutrition and the like. Abell T et al (Abell T, mcCallum R, hocking M, koch K, abrahamsson H, leblanc I, lindberg G, konturek J, nowak T, quigley EM, tougas G, starkebaum W. Gastric electrical stimulation for metabolic recovery surgery. Gastric technology. 2003 Aug;125 (2): 421-8) treated 33 patients with the gastric electrical stimulation regimen, showed better efficacy after 1 month of treatment with a significantly reduced frequency of vomiting, but 5 cases showed infection.
Therefore, how to perform effective therapeutic intervention on patients with DGP remains a medical problem to be solved.
Disclosure of Invention
The first purpose of the invention is to provide a traditional Chinese medicine composition for treating diabetic gastroparesis, which can effectively treat and relieve symptoms of diabetic gastroparesis (specific symptoms comprise nausea, vomiting, abdominal distension, early satiety and inappetence).
The second purpose of the invention is to provide application of the traditional Chinese medicine composition in preparing a medicine for treating diabetic gastroparesis.
In order to achieve the first purpose, the invention adopts the following technical scheme:
the invention provides a traditional Chinese medicine composition for treating diabetic gastroparesis, which is prepared from the following raw material medicines in parts by weight: immature bitter orange, fried bighead atractylodes rhizome, betel nut, wine-processed rhubarb, pinellia tuber, ginger, peach kernel and dangshen.
According to the invention, by selecting the formula components and controlling the adding amount of the formula components, the diabetic gastroparesis is effectively treated, and core symptoms such as nausea, vomiting, postprandial satiety, early satiety, abdominal distension and the like are improved.
Further, 10-15 parts of immature bitter orange, 10-20 parts of fried bighead atractylodes rhizome, 3-6 parts of betel nut, 3-6 parts of wine-treated rhubarb, 6-9 parts of pinellia tuber, 6-12 parts of ginger, 3-6 parts of peach kernel and 10-20 parts of codonopsis pilosula.
Further, the formula of each raw material is as follows:
12-15 parts of immature bitter orange, 12-18 parts of fried bighead atractylodes rhizome, 3-6 parts of betel nut, 3-6 parts of wine-processed rhubarb, 6-9 parts of pinellia tuber, 9-12 parts of ginger, 3-6 parts of peach kernel and 12-18 parts of codonopsis pilosula.
Within the range of the mixture ratio, the traditional Chinese medicine composition can achieve the purpose of treating diabetic gastroparesis. For convenient preparation, the inventor further prefers the following raw material medicine proportioning modes, and the curative effects of the raw material medicines are determined:
(1) 15g of immature bitter orange, 15g of fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine-processed rhubarb, 9g of pinellia tuber, 10g of ginger, 6g of peach kernel and 15g of codonopsis pilosula;
(2) 12g of immature bitter orange, 20g of fried bighead atractylodes rhizome, 3g of betel nut, 3g of wine-treated rhubarb, 6g of pinellia tuber, 10g of ginger, 6g of peach kernel and 20g of codonopsis pilosula;
(3) 10g of immature bitter orange, 15g of fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine-processed rhubarb, 9g of pinellia tuber, 6g of ginger, 6g of peach kernel and 18g of codonopsis pilosula.
The mechanism of the traditional Chinese medicine is as follows:
immature bitter orange: bitter, pungent and cold in property and flavor, the essential herbs which are responsible for spleen, stomach and liver meridians and can induce food stagnation, they are used to purge stomach excess and resolve hard lumps, so they are mainly indicated for middle energizer to treat blood system, treat fullness and distention between umbilicus and abdomen, eliminate phlegm nodule, expel retained fluid, dispel indigestion, break and consolidate chest, relieve constipation, but not for this reason. For itching skin, it can not nourish the skin surface due to blood stagnation in the middle, and for improper diet, it can not transport and transform due to spleen stagnation, so it is also pungent and bitter to purge. It is the most important term for qi in blood system.
White atractylodes rhizome: invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, arresting sweating, preventing miscarriage, eliminating dampness, invigorating dryness, regulating the middle warmer, invigorating qi, warming the middle warmer, eliminating dampness in spleen and stomach, removing stomach heat, strengthening spleen and stomach, promoting appetite, quenching thirst, and preventing miscarriage. The effective components have strong exciting effect on the gastric fundus muscle, can promote gastrointestinal propulsion, and has obvious functions of promoting gastric emptying and small intestine propulsion.
Betel nut: killing parasites, removing food retention, descending qi, activating stagnancy, promoting diuresis and eliminating dampness.
Wine-processed rhubarb: clear heat-toxicity in the upper energizer blood system, and is indicated for blood-shot eyes, swollen throat and swelling of gum.
Pinellia ternata: dry dampness and resolve phlegm, check adverse rise of qi and arrest vomiting, relieve stuffiness and dissipate nodulation. It is used for treating cough and asthma with excessive phlegm, phlegm and fluid retention, dizziness and palpitation, wind-phlegm vertigo, phlegm syncope, headache, vomiting and regurgitation, chest and epigastric stuffiness, globus hystericus, and carbuncle, swelling and phlegm nodule.
Ginger: induce sweating to relieve exterior syndrome, warm middle energizer to arrest vomiting, warm lung to relieve cough, relieve toxicity of fish and crab, and relieve toxicity of herbs. Is suitable for treating wind-cold, headache, phlegm and fluid retention, cough, stomach cold and emesis; when the patient suffers from ice, snow, water dampness and cold, the ginger decoction is taken urgently to promote blood circulation and dispel cold pathogen.
Peach kernel: has effects of promoting blood circulation, removing blood stasis, loosening bowel to relieve constipation, relieving cough and asthma, and can be used for treating amenorrhea, dysmenorrhea, lump in the abdomen, lung carbuncle, acute injury, intestinal dryness, constipation, cough and asthma.
Codonopsis pilosula: sweet and neutral, tonifying middle-jiao and Qi, harmonizing stomach, promoting the production of body fluid, expelling phlegm and arresting cough. Can be used for treating spleen deficiency, anorexia, loose stool, myasthenia of limbs, palpitation, short breath, dry mouth, spontaneous perspiration, rectocele, and stiff yin. The effective components can improve the content of mucus bound to gastric wall, and has effect in resisting gastric mucosa injury.
The formula has the effects of strengthening spleen, promoting qi circulation, promoting blood circulation and clearing hollow viscera, the bitter orange in the formula has the effects of purging and subsiding diarrhea, the white atractylodes rhizome is sweet and bitter, warm and aromatic in property, the two medicines have the effects of ascending and descending one time, tonifying and purging one time, and tonifying without retention, and the effects of strengthening spleen and relieving fullness are achieved together. Arecae semen and radix et rhizoma Rhei, together with rhizoma Pinelliae Preparatum and rhizoma Zingiberis recens, can be used for lowering adverse qi, relieving vomit, relieving distension and fullness, resolving hard mass, promoting blood circulation, removing blood stasis, and loosening bowel to relieve constipation. The codonopsis pilosula is used for supplementing qi, strengthening spleen and promoting fluid production, so that the pathogenic factors are eliminated without damaging the body resistance, and the medicines are used together to strengthen the spleen and promote qi circulation, activate blood and purge fu-organs and restore gastrointestinal movement.
In use, the traditional Chinese medicine composition can be decocted with water according to the traditional usage of the prescription to obtain decoction for taking, or can be prepared into various solid preparations such as tablets, granules, capsules and the like according to the conventional preparation process after the active ingredients of the preparation are refined by water or other appropriate solvents.
In order to achieve the second purpose, the invention provides application of the traditional Chinese medicine composition in preparing a medicine for treating diabetic gastroparesis.
The invention has the following beneficial effects:
the invention relates to a clinical research for treating severe diabetic gastroparesis by using a pure traditional Chinese medicine decoction, which has the advantages that the traditional Chinese medicine composition has a strict formula, can effectively treat diabetic gastroparesis, improves core symptoms such as nausea, vomiting, postprandial satiety, early satiety, abdominal distension and the like, has a certain regulating effect on blood sugar, does not have adverse reaction during administration and has good administration safety by selecting the components of the formula and controlling the adding amount of the components of the formula.
Detailed Description
In order to more clearly illustrate the invention, the invention is further described below in connection with preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and is not to be taken as limiting the scope of the invention.
Example 1
Basic prescription: 15g of immature bitter orange, 15g of fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine-treated rhubarb, 9g of pinellia tuber, 10g of ginger, 6g of peach kernel and 15g of codonopsis pilosula.
Taking the raw materials according to the above formula, decocting in water for 2 times, each time for 1 hr, filtering, and mixing decoctions to obtain the final product.
Example 2
Basic prescription: 12g of immature bitter orange, 20g of fried bighead atractylodes rhizome, 3g of betel nut, 3g of wine-processed rhubarb, 6g of pinellia tuber, 10g of ginger, 6g of peach kernel and 20g of codonopsis pilosula.
Taking the raw materials according to the above formula, decocting in water for 2 times, each time for 1 hr, filtering, and mixing decoctions to obtain the final product.
Example 3
Basic prescription: 10g of immature bitter orange, 15g of fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine-treated rhubarb, 9g of pinellia tuber, 6g of ginger, 6g of peach kernel and 18g of codonopsis pilosula.
The preparation method comprises taking the above raw materials, decocting in water for 2 times, each for 1 hr, filtering, and mixing decoctions.
Clinical drug effect experiment
1 study object
1.1 general data
Based on a clinical electronic medical record database of Guangan hospital of Chinese academy of traditional Chinese medicine, 45 patients are screened from 1/2006 to 10/1/2012 according to inclusion criteria.
1.2 diagnostic criteria
Western diagnostic criteria: referring to the clinical management guideline for gastroparesis published by the american academy of gastrointestinal diseases (ACG) in 2013, in combination with the history of diabetes, the following criteria were established: (1) has a history of diabetes; (2) with gastroparesis symptoms; (3) eliminating outlet obstruction caused by organ pathological changes of the pylorus; (4) delayed gastric emptying was diagnosed.
The traditional Chinese medicine syndrome differentiation standard is as follows: refer to the reference Standard for diabetes mellitus staging and syndrome differentiation of diabetes mellitus of the institute of Chinese medicine and pharmacy 1992 and the guidelines for clinical research on New Chinese medicine (trial) 2002, which are published in 1992, and are indicated for patients with liver-stomach disharmony and phlegm-dampness stagnation (patients with liver-stomach disharmony and phlegm-dampness stagnation syndrome differentiation standards).
Disharmony between the liver and stomach: (1) distending pain in the stomach or pain in the hypochondrium; (2) frequent belching; (3) pantothenic acid, which is noisy; (4) the tongue is pale red, and the coating is thin, white or thick; (5) the pulse is wiry. Two items are available for diagnosis.
Phlegm-dampness obstructing the middle energizer: (1) epigastric fullness and distention; (2) eating too little and anorexia; (3) dry mouth and bitter taste; (4) nausea and vomiting; (5) scanty and yellow urine; (6) the pulse is slippery. Two items are available for diagnosis.
1.3 inclusion criteria
(1) The definite diagnosis of Diabetic Gastroparesis (DGP) is more than 1 year; (2) conventional medications such as antiemetics and prokinetic drugs are difficult to treat; (3) the Gastroparesis Chief Symptom Index (GCSI) nausea/vomiting score scale score is more than or equal to 3.5.
1.4 exclusion criteria
Patients who have not been re-diagnosed after the initial diagnosis; patients who cannot be called back; patients treated with other interventions (e.g. gastric electrical stimulation, new drugs); patients with primary eating or swallowing disorders, including ruminating syndrome, cardiogenic vomiting and periodic vomiting syndrome, or active malignancies.
2 treatment regimen
2.1 treatment modalities
The original basic treatment was maintained, and patients were selected to take the decoction prepared in example 1, 1 dose per day, 400ml of which were decocted in water, and taken orally 2 times in the morning and evening.
2.2 treatment cycles
The treatment course is 3 months, and the follow-up is set for 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
3 Observation index
The general data of the patients are reviewed and collated from clinical electronic medical records, and the patients are scored. The Gastroparesis Chief Symptom Index (GCSI) is classified into 0 to 56 grades for evaluating gastroparesis symptoms. Wherein, the three sub-tables (nausea/vomiting, postprandial satiety/early satiety, abdominal distension) are grouped, the GCSI total score is counted, and the severity of gastroparesis symptoms is used as a main index for evaluating the curative effect of the traditional Chinese medicine.
4 results of the study
4.1 improvement of nausea/vomiting symptoms
Table 1 shows the change in the nausea/vomiting symptom score scale.
TABLE 1 nausea/vomiting symptom score Scale Change
Figure BDA0003204660010000061
As can be seen from Table 1, the scores of the Chinese medicine symptoms are compared before and after treatment, the nausea/vomiting has very obvious statistical difference (P < 0.01), and the symptoms of nausea/vomiting and the like are obviously improved compared with the symptoms before treatment.
4.2 improvement of postprandial satiety/early satiety symptoms
TABLE 2 change for postprandial satiety/early satiety symptom score Scale
TABLE 2 postprandial satiety/early satiety symptom score Scale Change
Figure BDA0003204660010000062
As can be seen from Table 2, the Chinese medicine symptom scores are compared before and after treatment, the very significant statistical difference (P < 0.01) exists between the postprandial satiety/early satiety, and the symptoms of the postprandial satiety/early satiety and the like are obviously improved compared with the symptoms before treatment.
4.3 amelioration of Abdominal distention feeling symptoms
Table 3 shows the change in the abdominal distension symptom score scale
TABLE 3 Abdominal distention feeling symptom score Scale Change
Figure BDA0003204660010000063
As can be seen from table 3, the scores of the symptoms of the traditional Chinese medicine are compared before and after treatment, the symptoms of the abdominal distension feeling have a very significant statistical difference (P < 0.01) after 4 weeks of treatment, and the symptoms of the abdominal distension feeling are obviously improved compared with the symptoms before treatment.
4.4 improvement of Gastroparesis (GCSI) symptoms
Table 4 shows the total score change of Gastroparesis (GCSI)
TABLE 4 gastroparesis GCSI Total score Change
Figure BDA0003204660010000071
As can be seen from Table 4, the scores of the Chinese medicine symptoms are compared before and after treatment, the Gastroparesis (GCSI) symptoms have very significant statistical difference (P < 0.01), and the Gastroparesis (GCSI) symptoms are obviously improved compared with those before treatment.
4.5 improvement of fasting blood glucose level
Table 5 shows the change in fasting blood glucose level
TABLE 5 changes in fasting blood glucose levels
Figure BDA0003204660010000072
As can be seen from Table 5, the TCM symptom scores were compared before and after treatment, and the fasting blood glucose levels were not statistically different (P > 0.05) after treatment.
4.5 safety assay
All patients have no adverse reaction in the treatment process, and safety indexes such as blood routine before and after treatment, urine routine, stool routine, electrocardiogram, liver function, renal function and the like have no obvious change.
The comprehensive research results show that the traditional Chinese medicine composition provided by the invention has obvious improvement effect on the conditions of patients with diabetic gastroparesis, core symptoms such as nausea, vomiting, postprandial satiety, early satiety, abdominal distension and the like are obviously improved, a certain regulating effect on blood sugar is achieved, the average time for obviously improving the symptoms is 19.6 days, and the patients have no adverse reaction during medication, so that the traditional Chinese medicine composition has good medication safety.
It should be understood that the above-mentioned embodiments of the present invention are only examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention, and it will be obvious to those skilled in the art that other variations or modifications may be made on the basis of the above description, and all embodiments may not be exhaustive, and all obvious variations or modifications may be included within the scope of the present invention.

Claims (8)

1. A traditional Chinese medicine composition for treating diabetic gastroparesis is characterized by being prepared from the following raw material medicines in parts by weight: immature bitter orange, fried bighead atractylodes rhizome, betel nut, wine-processed rhubarb, pinellia tuber, ginger, peach kernel and dangshen.
2. The traditional Chinese medicine composition according to claim 1, wherein the formula of each raw material is as follows: 10-15 parts of immature bitter orange, 10-20 parts of fried bighead atractylodes rhizome, 3-6 parts of betel nut, 3-6 parts of wine-processed rhubarb, 6-9 parts of pinellia ternate, 6-12 parts of ginger, 3-6 parts of peach kernel and 10-20 parts of codonopsis pilosula.
3. The traditional Chinese medicine composition according to claim 1, wherein the formula of each raw material is as follows: 12-15 parts of immature bitter orange, 12-18 parts of fried bighead atractylodes rhizome, 3-6 parts of betel nut, 3-6 parts of wine-processed rhubarb, 6-9 parts of pinellia tuber, 9-12 parts of ginger, 3-6 parts of peach kernel and 12-18 parts of codonopsis pilosula.
4. The traditional Chinese medicine composition according to claim 1, wherein the formula of each raw material is as follows: 15g of immature bitter orange, 15g of fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine-processed rhubarb, 9g of pinellia tuber, 10g of ginger, 6g of peach kernel and 15g of codonopsis pilosula.
5. The traditional Chinese medicine composition according to claim 1, wherein the formula of each raw material is as follows: 12g of immature bitter orange, 20g of fried bighead atractylodes rhizome, 3g of betel nut, 3g of wine-processed rhubarb, 6g of pinellia tuber, 10g of ginger, 6g of peach kernel and 20g of codonopsis pilosula.
6. The traditional Chinese medicine composition according to claim 1, wherein the formula of each raw material is as follows: 10g of immature bitter orange, 15g of fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine-treated rhubarb, 9g of pinellia tuber, 6g of ginger, 6g of peach kernel and 18g of codonopsis pilosula.
7. The Chinese medicinal composition according to claim 1, which is prepared into decoction, granules, capsules, tablets, powder, pills or oral liquid.
8. The use of the Chinese medicinal composition of any one of claims 1-7 in the preparation of a medicament for the treatment of diabetic gastroparesis.
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