A kind of Chinese medicine preparation and preparation method for the treatment of toxic and side effects behind the nasopharyngeal carcinoma radiotherapy
Technical field
The present invention relates to technical field of Chinese medicines, relate in particular to a kind of Chinese medicine preparation and preparation method for the treatment of toxic and side effects behind the nasopharyngeal carcinoma radiotherapy.
Background technology
(nasopharynega carcinoma NPC) is a kind of common malignancy that is primary in rhinitis mucosa covering epithelium to nasopharyngeal carcinoma, and is relevant with viral infection, and has the Inheritance tendency.Nasopharyngeal carcinoma is in south east asia and China south, and especially Guangdong Province's sickness rate is very high, and according to World Health Organization's statistics, about nasopharyngeal carcinoma of about 80% occurs in China in the world, and therefore, the treatment of nasopharyngeal carcinoma is an important research direction of China's treatment of cancer.
At present, the mode for the treatment of nasopharyngeal carcinoma mainly is operation, radiation and chemotherapy.Because nasopharynx is positioned at head central authorities, closely link to each other with basis cranii, vital tissue organ close relation with it, and nasopharyngeal carcinoma on every side has stronger aggressive, very easily invades structures surrounding, lymphatic metastasis rate height, so adopt the mode of excision very difficult.Chemotherapy fails to improve total survival rate, only can be as the auxiliary treatment means of radiotherapy, and chemotherapeutics such as cisplatin (DDP) use simultaneously with radiotherapy, and the energy loss body healthy energy of hurting sb.'s feelings makes toxic and side effects bigger.
Nasopharyngeal carcinoma is the lower squamous cell carcinoma of differentiation more than 90%, responsive to radiotherapy, thus radiotherapy be nasopharyngeal carcinoma main also be the most effective treatment means.The prognosis of nasopharyngeal carcinoma is with closely related by stages, 5 years survival rates of the nasopharyngeal carcinoma of radiation alone, I~IV phase is respectively 90%, 70%, 51% and 22%, present domestic III, the patient of IV phase have accounted for 2/3, and these patients exist high recurrence and high transfer case, advocate Comprehensive Treatment more, and chemotherapy still lacks individual scheme, chemotherapy can increase patient's body and mental burden simultaneously, and associated death increases, and seriously reduces patient's life quality.For early stage nasopharyngeal carcinoma, then advocate radiation alone, unsuitable combined with chemotherapy.Therefore, how to improve diagnosis of nasopharyngeal carcinoma, early treatment, how to improve its survival rate and life quality, then seem particularly important.
Radiotherapy is the first-selected Therapeutic Method of nasopharyngeal carcinoma, but ray is in the damage cancerous cell, normal structure wounds that also can be partially damaged, generation toxicity.Clinical manifestation after the damage can be divided into two kinds of acute reaction and late responses.Oral mucosa and skin injury are common toxicities, it be since ray except coup injury mucosa and skin, and make microvascular tube wall generation swelling in the launched field, spasm, tube chamber narrows down or stops up, make the bad and influence healing of damaged position blood supply, even ulcer, secondary infection etc., pharyngalgia appears then, drinking-water and feed difficulty, poor appetite, weak, dry skin dermatitis and moist reaction, severe patient is forced to suspend radiotherapy, needing strengthens suiting the medicine to the illness reaches treatments such as support, so both reduced patient's life quality, prolong treatment time again, increased patient's psychology and financial burden, even reduced radiocurable effect.
Therefore, during chemicotherapy treatment synchronously, prevent toxicity, the especially generation of oral mucosa reaction after underwent can alleviate patient's misery, guarantees to treat and carries out smoothly.Studies show that normal cell protective agent A Mifuding (Amifostine) has tangible curative effect to alleviating during the head and neck tumor chemoradiotherapy toxicities such as oral mucosa reaction after underwent, and the part patient is benefited.But because this drug price costliness needs repeatedly intravenously administrable, wide clinical application is restricted.
There is the tradition of utilizing the treatment by Chinese herbs nasopharyngeal carcinoma in China, the America and Europe also with its as a supplement alternative medicine study, a large amount of scientific achievements show in recent years: Chinese medicine uses the modern medicine treatment to have superiority with modern medicine combined treatment nasopharyngeal carcinoma than simple, and development prospect is wide.Chinese medicine can alleviate toxicity in the nasopharyngeal carcinoma chemicotherapy, suppress radiotherapy district's collagen fiber anabolic effect, alleviates sequela at a specified future date; Strengthen tumor to the sensitivity of chemicotherapy, the existence of the remaining cancerous cell of inhibition, improve cure rate, the immunity of enhancing body is improved quality of life of patient, improve long term survival rate and late result etc., so the effect of Chinese medicine in the treatment nasopharyngeal carcinoma is more and more noticeable.
Summary of the invention
Technical problem to be solved by this invention is, overcome ray toxicity that produces in the damage cancerous cell after the existing radiation alone, utilize the traditional theory of Chinese medical science of China, provide that a kind of side effect is little, good effect, cost is low, cure rate is high, have no drug resistance, at the clinical efficacy that improves the nasopharyngeal carcinoma patient, quality of life, survival rate, especially the toxic and side effects aspect has the Chinese medicine of greater advantage.
For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of toxic and side effects behind the nasopharyngeal carcinoma radiotherapy, comprise following raw medicinal material: Radix Codonopsis, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Fructus Jujubae, Radix Pseudostellariae, Herba Ecliptae, Fructus Lycii, Fructus Ligustri Lucidi, Radix Platycodonis, Flos Chrysanthemi, the Rhizoma Atractylodis Macrocephalae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Stigma Croci, Radix Glycyrrhizae, the Radix Paeoniae Alba, Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Radix Rehmanniae, Herba Menthae, Periostracum Cicadae and Nidus Vespae.
Wherein: the ratio of weight and number of each raw medicinal material in the described Chinese medicine preparation can be preferably, Radix Codonopsis 20~40 weight portions, Radix Ophiopogonis 15~25 weight portion, Fructus Schisandrae Chinensis 20~30 weight portions, the Radix Astragali 20~40 weight portions, Caulis Spatholobi 10~30 weight portions, Rhizoma Belamcandae 10~25 weight portions, Fructus Jujubae 20~35 weight portions, Radix Pseudostellariae 20~30 weight portions, Herba Ecliptae 16~28 weight portions, Fructus Lycii 20~35 weight portions, Fructus Ligustri Lucidi 10~16 weight portions, Radix Platycodonis 10~20 weight portions, Flos Chrysanthemi 20~40 weight portions, the Rhizoma Atractylodis Macrocephalae 15~30 weight portions, Radix Asparagi 20~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~35 weight portions, Stigma Croci 15~25 weight portions, Radix Glycyrrhizae 10~20 weight portions, the Radix Paeoniae Alba 12~25 weight portions, Radix Scrophulariae 10~30 weight portions, Herba Dendrobii 15~26 weight portions, Rhizoma Polygonati Odorati 15~25 weight portions, the Rhizoma Pinelliae 20~36 weight portions, Radix Rehmanniae 10~25 weight portions, Herba Menthae 10~20 weight portions, Periostracum Cicadae 25~40 weight portions and Nidus Vespae 20~45 weight portions.
Wherein: the ratio of weight and number of each raw medicinal material in the described Chinese medicine preparation can also be preferably, Radix Codonopsis 20~30 weight portions, Radix Ophiopogonis 15~20 weight portion, Fructus Schisandrae Chinensis 20~25 weight portions, the Radix Astragali 20~30 weight portions, Caulis Spatholobi 10~20 weight portions, Rhizoma Belamcandae 15~25 weight portions, Fructus Jujubae 25~35 weight portions, Radix Pseudostellariae 25~30 weight portions, Herba Ecliptae 20~26 weight portions, Fructus Lycii gives 20~30 weight portions, Fructus Ligustri Lucidi 10~14 weight portions, Radix Platycodonis 16~20 weight portions, Flos Chrysanthemi 20~35 weight portions, the Rhizoma Atractylodis Macrocephalae 15~25 weight portions, Radix Asparagi 25~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~30 weight portions, Stigma Croci 15~20 weight portions, Radix Glycyrrhizae 10~16 weight portions, the Radix Paeoniae Alba 12~20 weight portions, Radix Scrophulariae 10~20 weight portions, Herba Dendrobii 15~20 weight portions, Rhizoma Polygonati Odorati 20~25 weight portions, the Rhizoma Pinelliae 20~30 weight portions, Radix Rehmanniae 10~20 weight portions, Herba Menthae 15~20 weight portions, Periostracum Cicadae 25~35 weight portions and Nidus Vespae 30~45 weight portions.
Wherein: the ratio of weight and number of each raw medicinal material in the described Chinese medicine preparation has and can be preferably, Radix Codonopsis 25 weight portions, Radix Ophiopogonis 18 weight portion, Fructus Schisandrae Chinensis 22 weight portions, the Radix Astragali 25 weight portions, Caulis Spatholobi 16 weight portions, Rhizoma Belamcandae 17 weight portions, Fructus Jujubae 30 weight portions, Radix Pseudostellariae 28 weight portions, Herba Ecliptae 22 weight portions, Fructus Lycii 25 weight portions, Fructus Ligustri Lucidi 12 weight portions, Radix Platycodonis 18 weight portions, Flos Chrysanthemi 26 weight portions, the Rhizoma Atractylodis Macrocephalae 23 weight portions, Radix Asparagi 27 weight portions, Radix Adenophorae (Radix Glehniae) 28 weight portions, Stigma Croci 20 weight portions, Radix Glycyrrhizae 13 weight portions, the Radix Paeoniae Alba 14 weight portions, Radix Scrophulariae 16 weight portions, Herba Dendrobii 18 weight portions, Rhizoma Polygonati Odorati 22 weight portions, the Rhizoma Pinelliae 24 weight portions, Radix Rehmanniae 15 weight portions, Herba Menthae 16 weight portions, Periostracum Cicadae 30 weight portions and Nidus Vespae 35 weight portions.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and when the dosage form of described Chinese medicine preparation was oral liquid, its preparation method may further comprise the steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, adding with respect to 3 times~6 times in mixture amount determining alcohol is 75%~85% alcohol reflux 2 times~4 times, each 2 hours~3 hours, filter, filtrate merges, and reclaims ethanol, relative density is 1.30~1.32 mastic when being concentrated into 70 ℃, and is standby;
Second step was mixed in proportion all the other raw medicinal materials, added with respect to 4~8 times of water gagings of mixture, boiled 2~4 hours, filtered, and relative density is 1.27~1.29 mastic when being concentrated into 70 ℃;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 50 ℃~65 ℃ reduced vacuum dryings, and powder gets dry extract;
The 4th step added ethanol in the described dried cream powder that the 3rd step was obtained, and obtained containing pure mastic, described contain pure mastic to contain the alcohol amount be 65%~70%; Contain pure mastic and carry out cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment successively described, obtain the dealcoholysis mastic, wherein, the cold preservation processing time is 36~48 hours;
The 5th step added cane sugar powder and active carbon in the described dealcoholysis mastic with the acquisition of the 4th step, carried out heat treated, filtration treatment, dilution process successively, obtained semi-finished product; The weight ratio of described dealcoholysis mastic and described cane sugar powder is 1: 0.2~0.4; The weight ratio of described dealcoholysis mastic and described active carbon is 1: 0.001~0.002; The described heat treated time is 30~60 minutes, and temperature is 100 ℃~140 ℃;
The 6th step, again semi-finished product are carried out filtration treatment, embedding processing, sterilization treatment successively, namely get the oral liquid finished product of described Chinese medicine preparation.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and when the dosage form of described Chinese medicine preparation was tablet, its preparation method may further comprise the steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, adding with respect to 3 times~6 times in mixture amount determining alcohol is 75%~85% alcohol reflux 2 times~4 times, each 2 hours~3 hours, filter, filtrate merges, and reclaims ethanol, relative density is 1.30~1.32 mastic when being concentrated into 70 ℃, and is standby;
Second step was mixed in proportion all the other raw medicinal materials, added with respect to 4~8 times of water gagings of mixture, boiled 2~4 hours, filtered, and relative density is 1.27~1.29 mastic when being concentrated into 70 ℃;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 50 ℃~65 ℃ reduced vacuum dryings, and powder gets dry extract;
In the 4th step, described dried cream powder and starch that the 3rd step was obtained carry out the mixing processing, obtain the mastic mixture; The weight ratio of described mastic and described starch is 1: 0.01~0.02; Described mastic mixture is carried out pelletization treatment, dried, obtain the mastic compound particles;
The 5th step, described mastic compound particles and Pulvis Talci, magnesium stearate that the 4th step obtained are carried out mixing processing, tabletting processing, Cotton seeds successively, namely get the tablet finished product of described Chinese medicine preparation; The weight ratio of described mastic compound particles, described Pulvis Talci, described magnesium stearate is 100: 1~3: 0.15~0.3.
Beneficial effect of the present invention:
Chinese medicine preparation provided by the invention, principle according to determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, to set upright, with YIN nourishing and the production of body fluid promoting, benefiting QI and nourishing blood, enriching yin and nourishing kidney, heat-clearing and toxic substances removing etc. are the Therapeutic Principle, overcome the toxicity that ray produces after the existing radiation alone in the damage cancerous cell, not only can improve the whole body situation, alleviate put, chemotherapy side effect, and can improve curative effect, have the advantage that side effect is little, cost is low, have no drug resistance, at the clinical efficacy that improves the nasopharyngeal carcinoma patient, quality of life, survival rate, especially the toxic and side effects aspect has greater advantage.
The specific embodiment
In order to alleviate or to eliminate toxic and side effects behind the nasopharyngeal carcinoma radiotherapy, the invention provides a kind of mode of therapy of combining Chinese and Western medicine, in nasopharyngeal carcinoma chemicotherapy process, take traditional Chinese medicine simultaneously, the two combination not only can improve the whole body situation, alleviate put, chemotherapy side effect, and can improve curative effect.Principle according to determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, to set upright, with YIN nourishing and the production of body fluid promoting, benefiting QI and nourishing blood, enriching yin and nourishing kidney, heat-clearing and toxic substances removing etc. are the Therapeutic Principle, the invention provides a kind of Chinese medicine preparation for the treatment of toxic and side effects behind the nasopharyngeal carcinoma radiotherapy, comprise following raw medicinal material: Radix Codonopsis, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Fructus Jujubae, Radix Pseudostellariae, Herba Ecliptae, Fructus Lycii, Fructus Ligustri Lucidi, Radix Platycodonis, Flos Chrysanthemi, the Rhizoma Atractylodis Macrocephalae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Stigma Croci, Radix Glycyrrhizae, the Radix Paeoniae Alba, Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Radix Rehmanniae, Herba Menthae, Periostracum Cicadae and Nidus Vespae.
Wherein, each raw medicinal material pharmacology is as follows:
Radix Codonopsis: sweet in the mouth, property is flat, goes into lung, spleen channel, and the QI invigorating strengthening the spleen is arranged, the effect of nourishing blood to promote the production of body fluid, be mainly used in deficiency of both the splenic and pulmonary QI or QI and blood deficiency fatigue and weakness, breathe hard, symptom such as cough spontaneous perspiration etc., Radix Codonopsis is longer than the spleen reinforcing nourishing the stomach, transfer regulating the function of middle-JIAO, have the effect of nourishing blood concurrently, its property is flat, spleen invigorating fortune and not dry; Flavour is cloudy and not wet, can improve modulation on immune status, improves resistance against diseases, facilitating digestion absorbs, and improves metabolism, promotes intestinal to the absorption of nutrient substance, Radix Codonopsis has certain antitumor assosting effect, can suppress the growth of gross tumor volume and weight, and reduces and shift.
Radix Ophiopogonis: sweet in the mouth, little hardship, cold nature.GUIXIN, lung, stomach warp.YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire.Be used for dryness of the lung dry cough.The chronic consumptive disease cough, Tianjin wound is thirsty, vexed insomnia, interior-heat is quenched one's thirst, the dryness of the intestine constipation; Pharyngeal diphtheria.
Fructus Schisandrae Chinensis: sour in the mouth, sweet, warm in nature.Return lung, the heart, kidney channel.Restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.Be used for the chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, the deficient pulse of losing heart, interior-heat is quenched one's thirst, palpitation and insomnia.
The Radix Astragali: sweet in the mouth, warm in nature.Return lung, spleen channel.Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.It is weak to be used for the deficiency of vital energy, anorexia and loose stool, and sinking of QI of middle-JIAO, the chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, the exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle is difficult bursts, and burst for a long time and do not hold back, the blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.
Caulis Spatholobi: bitter in the mouth, sweet, warm in nature.Return liver, kidney channel.Enrich blood, invigorate blood circulation, collateral dredging.Be used for menoxenia, blood deficiency and yellow complexion, paralysis and numbness, rheumatic arthralgia.
Rhizoma Belamcandae: bitter in the mouth, cold in nature.Return lung meridian.Heat-clearing and toxic substances removing, expectorant, sore-throat relieving.Be used for the pent-up of pyretic toxicity phlegm-fire, laryngopharynx swelling and pain, accumulation and obstruction of sputum, cough and asthma.
Fructus Jujubae: sweet in the mouth, warm in nature.Return spleen, stomach warp.Invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.Be used for insufficiency of the spleen lack of appetite, weak loose stool, woman hysteria.
Radix Pseudostellariae: sweet in the mouth, little hardship, property is flat.Return spleen, lung meridian.Replenishing QI to invigorate the spleen, promoting the production of body fluid for nourishing the lung.It is tired to be used for insufficiency of the spleen body, and inappetence is weak after being ill, deficiency of both vital energy and Yin, and spontaneous perspiration is thirsty, dryness of the lung dry cough.
Herba Ecliptae: sweet in the mouth, acid, cold in nature.Return kidney, Liver Channel.Nourishing the liver and kidney, cooling blood for hemostasis.Be used for odontoseisis, early whitening of beard and hair, vertigo and tinnitus, soreness of the waist and knees, deficiency of YIN heat in blood, haematemesis, epistaxis, hematuria, dysentery, metrostaxis, traumatic hemorrhage.
Fructus Lycii: sweet in the mouth, property are flat, go into liver, kidney channel, liver and kidney tonifying is arranged, nourish blood enrich blood, the effect of replenishing vital essence to improve eyesight, nourishing the lung to arrest cough, be mainly used in soreness of the waist and knees, dizziness and tinnitus, seminal emission tinnitus, the unconsciously sweat and tire of Liver and kidney two void, asthenia of essence and blood; The sexual impotence of insufficiency of kidney-YANG, sterile; Cards such as the dim-sighted and deficiency of YIN chronic cough of the eyes of deficiency of YIN-essence, deficiency of liver-blood, Fructus Lycii can promote liver cell regeneration, the effect of enhancing non-specific immunity function.
Fructus Ligustri Lucidi: sweet in the mouth, hardship, cool in nature.Return liver, kidney channel.Nourishing the liver and kidney, black hair makes eye bright.Be used for vertigo and tinnitus, soreness of the waist and knees, early whitening of beard and hair, poor vision.
Radix Platycodonis: bitter in the mouth, suffering, property is flat.Return lung meridian.Lung qi dispersing, sore-throat relieving eliminates the phlegm, evacuation of pus.Be used for cough with copious phlegm, uncomfortable in chest not smooth, pharyngalgia, hoarseness, lung abscess vomiting pus, skin infection difficulty in discharging of pus.
Flos Chrysanthemi: sweet in the mouth, hardship, cold nature.Return lung, Liver Channel.Diffusing wind heat clearing away, suppressing the hyperactive liver makes eye bright.Be used for anemopyretic cold, it is dizzy to have a headache, conjunctival congestion and swelling pain, and eyes is dim-sighted.
The Rhizoma Atractylodis Macrocephalae: bitter in the mouth, sweet, warm in nature.Return spleen, stomach warp.Invigorating the spleen and benefiting QI, the dampness diuretic, hidroschesis, antiabortive.Be used for insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.The Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.Be used for insufficiency of the spleen lack of appetite, the loose stool of having loose bowels, frequent fetal movement.The Rhizoma Atractylodis Macrocephalae also has effects such as antioxidation, slow down aging, blood sugar lowering, anticoagulation, antitumor, the Rhizoma Atractylodis Macrocephalae can improve body's immunological function, leukocyte increasing quantity, the special active immunity of new-added item cancer cell antigen antibody, by reducing the rate of increase of oncocyte, lower the aggressive of tumor tissue, improve body antitumor respond and to the cytotoxic effect of oncocyte, thereby suppress tumor.
Radix Asparagi: sweet in the mouth, hardship, cold in nature.Return lung, kidney channel.Nourishing YIN to relieve dryness, lung heat clearing is promoted the production of body fluid.Be used for dryness of the lung dry cough, pertussis expectorant is glutinous, dry throat and mouth, dryness of the intestine constipation.
Radix Adenophorae (Radix Glehniae): sweet in the mouth, little hardship, cold nature.Return lung; The stomach warp.Replenishing YIN and removing heat; Moistening the lung and resolving phlegm; Reinforcing stomach reg fluid.Main deficiency of YIN chronic cough; The consumptive disease expectorant blood of coughing; Cough caused by dryness expectorant is few; The deficiency-heat sore throat; Tianjin wound is thirsty
Stigma Croci: sweet in the mouth, property is flat.Go into the heart, Liver Channel.Blood circulation promoting and blood stasis dispelling, dispersing stagnation and relieving accumulation of pathogens.Control troubled thoughts pent-up, the chest and diaphragm painful abdominal mass is vexed, spits blood, and typhoid fever is gone mad, and is frightened fear in a trance, women's amenorrhea, postnatal blood stasis stomachache, tumbling and swelling.
Radix Glycyrrhizae: sweet in the mouth, property is flat.GUIXIN, lung, spleen, stomach warp.Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.Be used for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
The Radix Paeoniae Alba: bitter in the mouth, acid, cold nature.Return liver, spleen channel.The suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.It is dizzy to be used for headache, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.
Radix Scrophulariae: sweet in the mouth, hardship, one-tenth, cold nature is gone into lung, stomach, kidney channel, have clearing away heat and cooling blood, nourishing YIN to lower pathogenic fire, the effect of detoxicating and resolving stagnation of pathogens is used for the warm febrile disease blood of joining the army, consumption of YIN caused by febrile disease, the impairment of body fluid constipation, hectic fever due to YIN-deficiency phthisical cough, conjunctival congestion redness, give as security back pain, cards such as carbuncle sore tumefacting virus have remarkable inhibitory action to staphylococcus aureus, diphtheria corynebacterium, Bacillus typhi etc., also have the effect of antiinflammatory.
Herba Dendrobii: cold nature, sweet in the mouth is gone into stomach, kidney channel, has reinforcing stomach reg fluid, nourishing YIN and clearing away heat, the effect of lung moistening kidney tonifying is used for consumption of body fluid by heat, low grade fever excessive thirst, the few tongue of red tongue; Deficiency of stomach-Yin, thirsty and dry pharynx, vomiting is eaten less, vague epigastralgia, the few tongue of tongue light; Deficiency of kidney yin, cards such as blurring of vision.
Rhizoma Polygonati Odorati: sweet in the mouth, cold nature.Attach to the lung and stomach meridians.Nourishing YIN to relieve dryness, promoting the production of body fluid to quench thirst.Be used for the lung stomach-Yin and hinder, cough caused by dryness-heat, dry throat and mouth, interior-heat is quenched one's thirst.
The Rhizoma Pinelliae: acrid in the mouth, warm in nature; Poisonous.Return spleen, stomach, lung meridian.Drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.Be used for the abundant expectoration cough with asthma, the phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, the syncope due to accumulation of phlegm headache, vomiting regurgitation, breast gastral cavity painful abdominal mass is vexed, globus hystericus; Give birth to external treatment carbuncle sucutaneous nodule.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) is used for stopping nausea and vomiting by lowering the adverse flow of QI more.
Radix Rehmanniae: sweet in the mouth, cold in nature.GUIXIN, liver, kidney channel.Clearing away heat and cooling blood, yin nourishing is promoted the production of body fluid.Be used for calentura crimson tongue excessive thirst, interior-heat caused by deficiency of YIN, the hectic fever due to YIN-deficiency consumptive fever, interior-heat is quenched one's thirst, and spits blood, and epistaxis is sent out the speckle dermexanthesis.
Herba Menthae: acrid in the mouth, cool in nature.Return lung, Liver Channel.Dispelling wind-heat.The refresh oneself, rash.Be used for anemopyretic cold, pathogenic wind-warm from the beginning of, headache, conjunctival congestion, sore throat, aphtha, rubella, measles, breast side of body feeling of distension and oppression.
Periostracum Cicadae: sweet in the mouth, cold in nature.Return lung, Liver Channel.Diffusing wind heat extraction, sore-throat relieving, rash, nebula removing, spasmolytic.Be used for anemopyretic cold, pharyngalgia, hoarseness, measles without adequate eruption, rubella pruritus, conjunctival congestion cataracta, convulsion with spasms, tetanus.
Nidus Vespae: sweet in the mouth, property is flat.Return the stomach warp.Dispel the wind merit poison, parasite killing, pain relieving.Be used for toothache due to dental caries, sore swollen toxin, acute mastitis, scrofula, skin stubborn dermatitis, fungal infection of hand and foot.
Wherein: the ratio of weight and number of each raw medicinal material in the described Chinese medicine preparation can be preferably, Radix Codonopsis 20~40 weight portions, Radix Ophiopogonis 15~25 weight portion, Fructus Schisandrae Chinensis 20~30 weight portions, the Radix Astragali 20~40 weight portions, Caulis Spatholobi 10~30 weight portions, Rhizoma Belamcandae 10~25 weight portions, Fructus Jujubae 20~35 weight portions, Radix Pseudostellariae 20~30 weight portions, Herba Ecliptae 16~28 weight portions, Fructus Lycii 20~35 weight portions, Fructus Ligustri Lucidi 10~16 weight portions, Radix Platycodonis 10~20 weight portions, Flos Chrysanthemi 20~40 weight portions, the Rhizoma Atractylodis Macrocephalae 15~30 weight portions, Radix Asparagi 20~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~35 weight portions, Stigma Croci 15~25 weight portions, Radix Glycyrrhizae 10~20 weight portions, the Radix Paeoniae Alba 12~25 weight portions, Radix Scrophulariae 10~30 weight portions, Herba Dendrobii 15~26 weight portions, Rhizoma Polygonati Odorati 15~25 weight portions, the Rhizoma Pinelliae 20~36 weight portions, Radix Rehmanniae 10~25 weight portions, Herba Menthae 10~20 weight portions, Periostracum Cicadae 25~40 weight portions and Nidus Vespae 20~45 weight portions.
Wherein: the ratio of weight and number of each raw medicinal material in the described Chinese medicine preparation can also be preferably, Radix Codonopsis 20~30 weight portions, Radix Ophiopogonis 15~20 weight portion, Fructus Schisandrae Chinensis 20~25 weight portions, the Radix Astragali 20~30 weight portions, Caulis Spatholobi 10~20 weight portions, Rhizoma Belamcandae 15~25 weight portions, Fructus Jujubae 25~35 weight portions, Radix Pseudostellariae 25~30 weight portions, Herba Ecliptae 20~26 weight portions, Fructus Lycii 20~30 weight portions, Fructus Ligustri Lucidi 10~14 weight portions, Radix Platycodonis 16~20 weight portions, Flos Chrysanthemi 20~35 weight portions, the Rhizoma Atractylodis Macrocephalae 15~25 weight portions, Radix Asparagi 25~30 weight portions, Radix Adenophorae (Radix Glehniae) 25~30 weight portions, Stigma Croci 15~20 weight portions, Radix Glycyrrhizae 10~16 weight portions, the Radix Paeoniae Alba 12~20 weight portions, Radix Scrophulariae 10~20 weight portions, Herba Dendrobii 15~20 weight portions, Rhizoma Polygonati Odorati 20~25 weight portions, the Rhizoma Pinelliae 20~30 weight portions, Radix Rehmanniae 10~20 weight portions, Herba Menthae 15~20 weight portions, Periostracum Cicadae 25~35 weight portions and Nidus Vespae 30~45 weight portions.
Wherein: the ratio of weight and number of each raw medicinal material in the described Chinese medicine preparation has and can be preferably, Radix Codonopsis 25 weight portions, Radix Ophiopogonis 18 weight portion, Fructus Schisandrae Chinensis 22 weight portions, the Radix Astragali 25 weight portions, Caulis Spatholobi 16 weight portions, Rhizoma Belamcandae 17 weight portions, Fructus Jujubae 30 weight portions, Radix Pseudostellariae 28 weight portions, Herba Ecliptae 22 weight portions, Fructus Lycii 25 weight portions, Fructus Ligustri Lucidi 12 weight portions, Radix Platycodonis 18 weight portions, Flos Chrysanthemi 26 weight portions, the Rhizoma Atractylodis Macrocephalae 23 weight portions, Radix Asparagi 27 weight portions, Radix Adenophorae (Radix Glehniae) 28 weight portions, Stigma Croci 20 weight portions, Radix Glycyrrhizae 13 weight portions, the Radix Paeoniae Alba 14 weight portions, Radix Scrophulariae 16 weight portions, Herba Dendrobii 18 weight portions, Rhizoma Polygonati Odorati 22 weight portions, the Rhizoma Pinelliae 24 weight portions, Radix Rehmanniae 15 weight portions, Herba Menthae 16 weight portions, Periostracum Cicadae 30 weight portions and Nidus Vespae 35 weight portions.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and when the dosage form of described Chinese medicine preparation was oral liquid, its preparation method may further comprise the steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, adding with respect to 3 times~6 times in mixture amount determining alcohol is 75%~85% alcohol reflux 2 times~4 times, each 2 hours~3 hours, filter, filtrate merges, and reclaims ethanol, relative density is 1.30~1.32 mastic when being concentrated into 70 ℃, and is standby;
Second step was mixed in proportion all the other raw medicinal materials, added with respect to 4~8 times of water gagings of mixture, boiled 2~4 hours, filtered, and relative density is 1.27~1.29 mastic when being concentrated into 70 ℃;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 50 ℃~65 ℃ reduced vacuum dryings, and powder gets dry extract;
The 4th step added ethanol in the described dried cream powder that the 3rd step was obtained, and obtained containing pure mastic, described contain pure mastic to contain the alcohol amount be 65%~70%; Contain pure mastic and carry out cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment successively described, obtain the dealcoholysis mastic, wherein, the cold preservation processing time is 36~48 hours;
The 5th step added cane sugar powder and active carbon in the described dealcoholysis mastic with the acquisition of the 4th step, carried out heat treated, filtration treatment, dilution process successively, obtained semi-finished product; The weight ratio of described dealcoholysis mastic and described cane sugar powder is 1: 0.2~0.4; The weight ratio of described dealcoholysis mastic and described active carbon is 1: 0.001~0.002; The described heat treated time is 30~60 minutes, and temperature is 100 ℃~140 ℃;
The 6th step, again semi-finished product are carried out filtration treatment, embedding processing, sterilization treatment successively, namely get the oral liquid finished product of described Chinese medicine preparation.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and when the dosage form of described Chinese medicine preparation was tablet, its preparation method may further comprise the steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, adding with respect to 3 times~6 times in mixture amount determining alcohol is 75%~85% alcohol reflux 2 times~4 times, each 2 hours~3 hours, filter, filtrate merges, and reclaims ethanol, relative density is 1.30~1.32 mastic when being concentrated into 70 ℃, and is standby;
Second step was mixed in proportion all the other raw medicinal materials, added with respect to 4~8 times of water gagings of mixture, boiled 2~4 hours, filtered, and relative density is 1.27~1.29 mastic when being concentrated into 70 ℃;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 50 ℃~65 ℃ reduced vacuum dryings, and powder gets dry extract;
In the 4th step, described dried cream powder and starch that the 3rd step was obtained carry out the mixing processing, obtain the mastic mixture; The weight ratio of described mastic and described starch is 1: 0.01~0.02; Described mastic mixture is carried out pelletization treatment, dried, obtain the mastic compound particles;
The 5th step, described mastic compound particles and Pulvis Talci, magnesium stearate that the 4th step obtained are carried out mixing processing, tabletting processing, Cotton seeds successively, namely get the tablet finished product of described Chinese medicine preparation; The weight ratio of described mastic compound particles, described Pulvis Talci, described magnesium stearate is 100: 1~3: 0.15~0.3.
Below adopt embodiment to describe embodiments of the present invention in detail, how the application technology means solve technical problem to the present invention whereby, and the implementation procedure of reaching technique effect can fully understand and implements according to this.
Embodiment 1: the oral solutions of the present invention's preparation
Radix Codonopsis 250g, Radix Ophiopogonis 180g, Fructus Schisandrae Chinensis 220g, Radix Astragali 250g, Caulis Spatholobi 160g, Rhizoma Belamcandae 170g, Fructus Jujubae 300g, Radix Pseudostellariae 280g, Herba Ecliptae 220g, Fructus Lycii 250g, Fructus Ligustri Lucidi 120g, Radix Platycodonis 180g, Flos Chrysanthemi 260g, Rhizoma Atractylodis Macrocephalae 230g, Radix Asparagi 270g, Radix Adenophorae (Radix Glehniae) 280g, Stigma Croci 200g, Radix Glycyrrhizae 130g, Radix Paeoniae Alba 140g, Radix Scrophulariae 160g, Herba Dendrobii 180g, Rhizoma Polygonati Odorati 220g, Rhizoma Pinelliae 240g, Radix Rehmanniae 150g, Herba Menthae 160g, Periostracum Cicadae 300g and Nidus Vespae 350g.
Its preparation method may further comprise the steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, adding with respect to 5 times in mixture amount determining alcohol is 80% alcohol reflux 4 times, each 2 hours, filter, filtrate merges, and reclaims ethanol, relative density is 1.30 mastic when being concentrated into 70 ℃, and is standby;
Second step was mixed in proportion all the other raw medicinal materials, added with respect to 6 times of water gagings of mixture, boiled 3 hours, filtered, and relative density is 1.29 mastic when being concentrated into 70 ℃;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 60 ℃ of reduced vacuum dryings, and powder gets dry extract;
The 4th step added ethanol in the dried cream powder that the 3rd step was obtained, and obtained containing pure mastic, contain pure mastic to contain the alcohol amount be 65%; To contain pure mastic and carry out cold preservation processing, precipitation process, filtration treatment, recovery Ethanol Treatment successively, and obtain the dealcoholysis mastic, wherein, the cold preservation processing time is 48 hours;
The 5th step added cane sugar powder and active carbon in the dealcoholysis mastic with the acquisition of the 4th step, carried out heat treated, filtration treatment, dilution process successively, obtained semi-finished product; The weight ratio of dealcoholysis mastic and cane sugar powder is 1: 0.3; The weight ratio of dealcoholysis mastic and active carbon is 1: 0.001; The heat treated time is 60 minutes, and temperature is 120 ℃;
The 6th step, again semi-finished product are carried out filtration treatment, embedding processing, sterilization treatment successively, namely get the oral liquid finished product of Chinese medicine preparation.
Embodiment 2: the tablet of the present invention's preparation
Radix Codonopsis 280g, Radix Ophiopogonis 160g, Fructus Schisandrae Chinensis 240g, Radix Astragali 220g, Caulis Spatholobi 120g, Rhizoma Belamcandae 220g, Fructus Jujubae 260g, Radix Pseudostellariae 260g, Herba Ecliptae 200g, Fructus Lycii 220g, Fructus Ligustri Lucidi 130g, Radix Platycodonis 160g, Flos Chrysanthemi 280g, Rhizoma Atractylodis Macrocephalae 180g, Radix Asparagi 250g, Radix Adenophorae (Radix Glehniae) 260g, Stigma Croci 160g, Radix Glycyrrhizae 110g, Radix Paeoniae Alba 160g, Radix Scrophulariae 110g, Herba Dendrobii 150g, Rhizoma Polygonati Odorati 240g, Rhizoma Pinelliae 250g, Radix Rehmanniae 120g, Herba Menthae 170g, Periostracum Cicadae 320g and Nidus Vespae 380g.
Its preparation method may further comprise the steps,
The first step, Radix Codonopsis, the Radix Astragali, Caulis Spatholobi, Rhizoma Belamcandae, Radix Pseudostellariae, Radix Asparagi, Radix Adenophorae (Radix Glehniae), Radix Scrophulariae, Herba Dendrobii, Rhizoma Polygonati Odorati, the Rhizoma Pinelliae, Periostracum Cicadae and Nidus Vespae are mixed, adding with respect to 6 times in mixture amount determining alcohol is 85% alcohol reflux 3 times, each 3 hours, filter, filtrate merges, and reclaims ethanol, relative density is 1.31 mastic when being concentrated into 70 ℃, and is standby;
Second step was mixed in proportion all the other raw medicinal materials, added with respect to 8 times of water gagings of mixture, boiled 4 hours, filtered, and relative density is 1.28 mastic when being concentrated into 70 ℃;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 65 ℃ of reduced vacuum dryings, and powder gets dry extract;
In the 4th step, dried cream powder and starch that the 3rd step was obtained carry out the mixing processing, obtain the mastic mixture; The weight ratio of mastic and starch is 1: 0.02; The mastic mixture is carried out pelletization treatment, dried, obtain the mastic compound particles;
The 5th step, mastic compound particles and Pulvis Talci, magnesium stearate that the 4th step obtained are carried out mixing processing, tabletting processing, Cotton seeds successively, namely get the tablet finished product of Chinese medicine preparation; The weight ratio of mastic compound particles, Pulvis Talci, magnesium stearate is 100: 3: 0.25.
Toxicity test:
Acute toxicity test
With the oral solutions of the embodiment of the invention 1 preparation and the tablet of embodiment 2 preparations, tablet dissolved offers medicine for respectively 2 groups of white mice feedings with 160 times and 220 times of clinical consumption per day in distilled water, observes 7; All white mice are strong as a result deposits, and its activity, diet, hair, Excreta are no abnormal, do not see toxic reaction.Irritation test is carried out in white mouse oral cavity and damaged skin, and not seeing has irritative response and other untoward reaction.
Long term toxicity test
The oral solutions of the embodiment of the invention 1 preparation is pressed 8.15g crude drug/kg and 18.34g crude drug/kg to two groups of mices, the tablet of the embodiment of the invention 2 preparations is pressed 19.25g crude drug/kg and 40.34g crude drug/kg to two groups of mices, to 4 groups of mices difference 12 weeks of continuous use, every day 2 times, and after 4 weeks of drug withdrawal, the result shows: Chinese medicine of the present invention is to the hair of 4 groups of test mices, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, indexs such as blood fat all do not have obvious influence, the internal organs naked eyes do not find that difference changes and the histological examination result shows, after 12 weeks of medication and 4 weeks of drug withdrawal, each internal organs of mice all do not have obvious change.Illustrate that toxicity is little after Chinese medicine of the present invention is to the mice long-term prescription, also do not have the difference reaction after the drug withdrawal, application safety.
Clinical experiment:
1.1 case grouping
Nasopharyngeal carcinoma case 242 examples are included in this research altogether in, all derive from February, 2009~2012, the court inpatient in year October.Male 140 examples in all cases, women 102 examples, the age, the mean age was 48.2 years old from 21 years old~70 years old, Karnofky marks all greater than 70 minutes; All confirm through pathology before all patient's radiotherapies, and all have CT/MRI to check for clinical 92 by stages, all do checking and confirm no chemicotherapy contraindication that all patients all are no transition nasopharyngeal carcinoma (M0) before the chemotherapy before the chemotherapy by clinical criteria.Case is divided into two groups at random, 122 examples are organized in treatment, male 72 examples, and women 50 examples, matched group 120 examples, male 68 examples, women 52 examples, two groups of clinical datas have comparability, see Table 1.
Table 1 liang group patient clinical data relatively
Annotate:
*Pathology WHO classification: The World Health Organization (WHO) is divided into the pathomorphology of nasopharyngeal carcinoma: (1) WHO I type, the keratinizing squamous cell carcinoma of breaking up good and medium differentiation; (2) WHO II type, the cancer of differentiation difference; (3) WHOIII type, undifferentiated carcinoma or lymphepithelioma.
△Clinical stages: I phase-T1N0M0; II phase-T2N0M0, T0~T2N1M0; III phase-T3N0~N2M0, T0~T3N2M0; IVa phase-T4N0~N3M0, T0~T4N3M0; IVb phase-any T, any N, any M1.
1.2 Therapeutic Method
Two groups of cases all adopt the thermoplastic facial film to fix, and locate under CT or X line analog machine, the 6MV-X roentgenization, and the neck tangential field all adopts the 60Co-r roentgenization.(1) the plumbous technology of two dimension retaining: patient's normal bit of lying on the back, dehisce to contain plug, at digital X line simulated positioner (the logical company of nuclear) picked-up spacer, and delineate the face neck and unite open country and the preceding little open country of face ear, manufacture retaining lead stamp tool after finishing, determine to establish wild border respectively according to CT, following neck tangential field is determined the upper bound according to spacer and calculating penumbra.The oversubscription segmentation method is adopted in the gradation of radiotherapy dosage, and 120cGy/ time, BID/ days, the nasopharynx accumulated dose was 72~76.8Gy/60~64 time, and the face neck is united the open country of contracting on the spacer after wild nasopharynx part dosage reaches 43.2Gy/36 time/24 days.Full neck tangent line preventive dose reached for 50Gy/25 time/5 weeks, and the cervical region positive region adopts the electronics line according to lymph node size benefit amount 16~26Gy, conventional gradation, 200cGy/ time.(2) strength regulated shape-adapted radiotherapy technology (IMRT): the patient adopts head and neck pendulum position fixture, and supine body position obtains the treatment plan designed image under CT, and partly the patient adopts MRI image co-registration, GTV:72~78Gy, 2.2~2.4Gy/ time; CTV1:66~68Gy, 2.1~2.2Gy/ time; CTV2:56~62Gy, 2Gy/ time; GTVN:66~78Gy, 2.2~2.4Gy/ time; CTVN:52~55Gy, 1.6~1.8Gy/ time; All patients all calculate with PTV, and 95% for describing dosage.Part patient adopts dosage dynamic I MRT (2~3 CT/MRI).
Two groups of equal synchronous chemotherapy, chemotherapy adopts the DF scheme: cis-diaminedichloroplatinum (CDDP) is 80mg/m
2, d1,5-fluorouracil (5-FU) is 500mg/m
2, d1-3.Per 3 weeks repeat chemotherapy 1 time, amount to 2 cycles.
The extract oral liquor that cooperates the embodiment of the invention 1 on the basis of the radiotherapy for the treatment of group cancer, chemotherapy, each 2 doses, every day three times, every mouthful of decoction being taken warmly is again and again repeatedly slowly swallowed, and finishes up to the chemicotherapy general plan.
1.3 observation index and method
(1) checks the whole blood routine weekly 1 time in the treatment.Per 2 weekly checks 1 liver, renal function and electrocardiogram.The toxicity grade scale that observation caliber: RTOG (radiation oncology treatment cooperative groups), WHO formulate.Mucosa reaction: 0 grade, normal; The I level, erythema has mild pain, does not need analgesic; The II level, mottled mucositis, companion's serosity is oozed out medium degree pain; The III level, slabbing cellulose mucositis, sharp ache needs analgesic; The IV level, hemorrhage, ulcer, necrosis.
(2) short term effect: according to WHO treatment malignant tumor evaluation criteria evaluation curative effect, divide and alleviate (CR) fully: all visible at least 4 weeks of pathological changes complete obiteration; Part is alleviated (PR): the tumor size estimation is dwindled 〉=50% 4 week at least; No change (NC): no at least 4 weeks of significant change, comprise that pathological changes is stable, the tumor size estimation enlarges less than 25%, dwindles less than 50%; Pathological changes expansion (PD); New focus occurs or original pathological changes estimates to enlarge>25%4 ranking nasopharynx part primary tumors and Cervical Lymph Node Metastasis kitchen range gross tumor volume changes.
1.4 statistical method
Meet rank test, paired t-test and independent sample t check with statistical package SPSS1010 Wileoxon.
1.5 result
1.5.1 two groups of acute reactions relatively, the results are shown in Table 2, the treatment group obviously is better than matched group to alleviating of oral mucosa and gastrointestinal reaction, has significant difference (P<0.05) on the statistics.
Table 2 liang group acute reaction
Annotate: two indexs compare p<0.05 between two groups.
1.5.2 two groups of peripheral blood indexs relatively
Leukocyte (WBC), erythrocyte (RBC), hemoglobin (Hb) descend and obviously alleviate tool significant difference on the statistics (P<0.05) than matched group in the reaction of experimental group blood system.See Table 3.
Table 3 liang group blood system toxicity
Annotate:
*P<0.05,
△P>0.05.
1.5.3 the comparison of two groups for the treatment of front and back hepatic and renal functions
As seen from Table 4: alanine aminotransferase behind the experimental group chemicotherapy (ALT), blood urea nitrogen (UN), blood creatinine (CR), gamma glutamyltransferase (GGT) value significantly reduce tool statistical significance (P<0.05); And control group A LT, UN, CR value do not have significant change (P>0.05) before than chemicotherapy.
Compare before and after the treatment of table 4 hepatic and renal function
1.5.4 two groups of short term effects relatively, sees Table 5.
Group |
CR |
PR |
NC |
PD |
Effective percentage (%) |
The treatment group |
68 |
39 |
15 |
0 |
87.7 |
Matched group |
35 |
40 |
44 |
1 |
62.5 |
This intellectual property of primary enforcement that all are above-mentioned is not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above only is preferred embodiment of the present invention, is not to be the restriction of the present invention being made other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away to any simple modification, equivalent variations and remodeling that above embodiment does, still belongs to the protection domain of technical solution of the present invention according to technical spirit of the present invention.