CN116966249A - Traditional Chinese medicine composition for treating ulcerative colitis - Google Patents
Traditional Chinese medicine composition for treating ulcerative colitis Download PDFInfo
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Abstract
The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating ulcerative colon, which is prepared from the following traditional Chinese medicine raw materials: radix Codonopsis, rhizoma Dioscoreae, coicis semen, radix Sangusorbae preparata, rhizoma Bletillae, herba Patriniae, fructus evodiae, pericarpium Granati, notoginseng radix, and Glycyrrhrizae radix. The invention has the advantages that: the traditional Chinese medicine composition has the advantages of definite curative effect, no toxic or side effect, low cost and convenient popularization and application, and has better clinical curative effect on ulcerative colitis through years of clinical application, observation and analysis.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating ulcerative colitis.
Background
Ulcerative colitis (ulcerative colitis, UC) is a modern refractory disease, the pathogenesis of which is currently unknown, and is manifested by abnormal intestinal mucosal immune response and impaired epithelial barrier function, which is a chronic inflammatory disease of the intestinal tract. Intestinal lesions typically progress proximally from the distal mucosa, and may extend continuously to the terminal ileum. Clinical symptoms are most typical of repeated diarrhea, mucopurulent bloody stool, abdominal pain, fecal urgency and the like, and may be accompanied by systemic reactions and parenteral manifestations.
Western medicine treatment aims at inducing remission, maintaining remission, reducing recurrence, preventing and treating complications and the like. The clinically common therapeutic drugs include 5-aminosalicylic acid preparation, glucocorticoid, immunosuppressant, various biological preparations and the like, and if the medical treatment is ineffective and serious complications are accompanied, the surgical treatment needs to be considered. Generally speaking, western medicines and treatment means are commonly used in the clinic of UC, partial toxic and side effects exist, a few patients have drug resistance, a step-up treatment scheme which is gradually upgraded is needed, most treatment means are not very expensive, economic pressure and psychological burden of the patients are easily increased after long-term use, and the whole health of the patients can be directly or indirectly influenced. The traditional Chinese medicine has obvious advantages in improving the quality of life and health condition by comprehensively treating the UC patient based on syndrome differentiation.
According to the clinical characteristics of UC, it can be classified into the categories of "dysentery", "resting dysentery", "diarrhea", "intestinal wind", "intestine ", "adverse side effect", etc. in traditional Chinese medicine. The Chinese medicine has quite a long history in treating UC as seen in the ancient books of the Chinese medicine such as Huangdi's interior passage, the name of "intestine " was first put forward, shang Han Lian Bing Lun (treatise on Cold-induced diseases) and the like which recorded the manifestation and treatment of symptoms related to the disease. In recent years, a plurality of researches show that the UC can be integrally regulated through a plurality of targets such as anti-inflammatory, immunity regulating, intestinal flora regulating and the like, the curative effect is stable, the side effect is small, and the long-term recurrence rate is low.
Disclosure of Invention
The invention aims at overcoming the defects in the prior art, and provides a traditional Chinese medicine composition for treating ulcerative colitis, which has small side effect and can be taken for a long time, and an application of the traditional Chinese medicine composition in preparation of medicines for treating ulcerative colitis.
The onset of UC is marked by spleen deficiency and damp-heat. Spleen deficiency causes weakness in transportation and transformation, water dampness is generated internally, heat is generated for a long time, damp-heat is downwards infused into large intestine, damp-heat and qi and blood are paced, large intestine conduction is lost, descending is performed for a long time, and intestinal collaterals are damaged, so that the disease is difficult to heal due to the deficiency of the spleen and the stomach, and the disease is difficult to heal due to repeated deficiency of the spleen and the stomach. Therefore, the invention provides an important treatment method for strengthening spleen, tonifying qi, clearing heat and resolving dampness, and can be used for UC whole-course management.
The invention provides a traditional Chinese medicine composition for treating ulcerative colitis, which comprises the following raw materials in parts by weight: 3-60 parts of codonopsis pilosula, 3-60 parts of Chinese yam, 3-60 parts of coix seed, 3-30 parts of garden burnet root charcoal, 2-15 parts of rhizoma bletillae, 6-30 parts of herba patriniae, 2-18 parts of fructus evodiae, 3-30 parts of pericarpium granati, 1-12 parts of pseudo-ginseng and 2-12 parts of liquorice.
Further, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6-30 parts of codonopsis pilosula, 6-30 parts of Chinese yam, 6-30 parts of coix seed, 6-15 parts of garden burnet root charcoal, 3-12 parts of common bletilla tuber, 9-30 parts of herba patriniae, 3-12 parts of evodia rutaecarpa, 6-15 parts of pericarpium granati, 2-6 parts of pseudo-ginseng and 3-9 parts of liquorice.
Further, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of codonopsis pilosula, 10 parts of Chinese yam, 10 parts of coix seed, 15 parts of garden burnet root charcoal, 6 parts of rhizoma bletillae, 10 parts of herba patriniae, 6 parts of fructus evodiae, 15 parts of pericarpium granati, 3 parts of pseudo-ginseng and 6 parts of liquorice.
In the composition, the radix codonopsis pilosulae, the coix seed and the pseudo-ginseng are combined into monarch drugs, the Chinese yam, the charred radix sanguisorbae and the rhizoma bletillae are combined into ministerial drugs, the evodia rutaecarpa, the herba patriniae and the pericarpium granati are combined into adjuvant drugs, and the liquorice is used as conductant drugs.
In a second aspect, the invention provides an application of the traditional Chinese medicine composition in preparing medicines for treating ulcerative colitis.
In a third aspect of the present invention, there is provided a pharmaceutical preparation comprising the above-described Chinese medicinal composition for treating ulcerative colitis as an active ingredient, wherein the pharmaceutical preparation is prepared into a pharmaceutically usual dosage form by a conventional preparation method in the art.
Further, the pharmaceutical preparation is decoction, tablets, capsules, granules, pills, mixture, oral liquid or syrup.
Furthermore, the pharmaceutical preparation also comprises pharmaceutically acceptable auxiliary materials.
Further, the pharmaceutical preparation can be prepared by the following method: (A) Weighing the medicinal material components, and mixing to obtain a mixture; (B) Adding a pharmaceutically acceptable carrier into the mixture, and preparing the mixture by adopting a conventional preparation method in the field.
In a fourth aspect of the invention there is provided the use of a pharmaceutical formulation as described above in the manufacture of a medicament for the treatment of ulcerative colitis.
The compound Chinese medicine preparation is prepared based on years of clinical practice by taking the theory of traditional Chinese medicine as guidance and carefully selecting medicine compositions, has obvious difference with the earlier-disclosed spleen-strengthening dampness-resolving soup (Liu Yuting, hao Weiwei, and the like) combined with the spleen-strengthening dampness-resolving soup to clear the influence of the intestinal thrombus on the life quality of patients with spleen deficiency and damp-heat type ulcerative colitis, has obvious effects on compatibility of medicines of Nanjing university of Chinese medicine [ J ],2015,31 (6): 517-520 ], reduces the quantity of medicine flavor and can obviously increase clinical curative effect by adjusting monarch, minister, assistant and guide medicines of related medicines. The spleen strengthening and dampness resolving Shang Yaowei disclosed in the earlier stage achieves more than twenty flavors, and the traditional Chinese medicine compound provided by the invention simplifies the quantity of the medicines into ten flavors. Meanwhile, the traditional Chinese medicine compound regulating pseudo-ginseng is used as a monarch drug, the efficacy of removing blood stasis, stopping bleeding, removing necrotic tissue and promoting tissue regeneration is improved, and the invention has the clinical application of the Fugu. In addition, the traditional Chinese medicine compound of the invention adjusts the garden burnet root charcoal and the bletilla tuber to be ministerial drugs. The garden burnet charcoal has the effects of cooling blood and stopping bleeding, detoxifying and healing sores, and in the processing process of the garden burnet, the content of tannins in the garden burnet is obviously increased after the garden burnet charcoal is fried, and the hemostatic effect is achieved, and in addition, the content of calcium ions closely related to blood coagulation is also obviously increased, so that the hemostatic effect of the garden burnet is enhanced. The bletilla striata has the effects of promoting tissue regeneration, treating sore, astringing and stopping bleeding, and modern pharmacological research shows that the bletilla striata has the effects of resisting bacteria, stopping bleeding and promoting wound healing. Is currently used for treating digestive tract ulcers and ulcerative colitis clinically. The total effective rate of the spleen-strengthening dampness-resolving decoction disclosed in the earlier stage is 83.33%, while the total effective rate of the traditional Chinese medicine compound is 90%, so that the clinical curative effect is obviously improved. Meanwhile, the traditional Chinese medicine compound can effectively improve the life quality of patients, and further improve the response rate of the endoscope and the healing rate of mucous membranes of the patients.
In the formula, codonopsis pilosula, coix seed and pseudo-ginseng are taken as monarch drugs to play roles of replenishing qi to invigorate the spleen, activating blood and stopping bleeding. The codonopsis pilosula is sweet and flat, and is an essential drug for tonifying middle-jiao and Qi, tonifying Qi, promoting the production of body fluid and nourishing blood; coix seed, semen Coicis, with the effects of promoting diuresis, removing dampness, invigorating spleen, relieving diarrhea, and radix Codonopsis together with Sijunzi decoction. "life-saving collection and diarrhea theory" is: "promoting blood circulation to treat purulent stool with self-healing", the patient purges red, white and purulent blood or pure and fresh blood, which is caused by stagnation of damp-heat toxin, unsmooth intestinal qi movement, blood stasis, damage of lipid collaterals and putrefaction into purulent stool. Notoginseng radix is known as "Notoginseng radix" in "true Chinese herbal medicine," so that the world only knows the functions of stopping bleeding and stopping pain, but the pain is caused by blood stasis, and the blood is stopped by spreading. Notoginseng radix has bitter and warm smell and can differentiate blood into its blood stasis. According to the record of 'above', the effects of removing blood stasis, stopping bleeding, dredging collaterals, relieving pain, promoting the circulation of qi and removing necrotic tissue and promoting tissue regeneration are achieved.
In the basic experiments related to the pseudo-ginseng in the earlier stage of the subject group, the pseudo-ginseng is found to be capable of effectively improving DAI score, colon length and tissue injury score of a DSS induced UC rat model, regulating tight junction proteins such as ZO-1 and Occludin, claudin and improving intestinal permeability. Therefore, in the application of clinical prescription, the notoginseng is used as a monarch drug for the first time, the dosage of the notoginseng is increased, the clinical curative effect is ensured, and the prescription has great difference with the original prescription of the spleen-strengthening dampness-resolving soup, and has a certain innovation.
In the recipe, chinese yam, garden burnet root, and rhizoma bletillae are taken as ministerial drugs together, and have the effects of strengthening spleen, tonifying qi, cooling blood, stopping bleeding, detoxifying and healing sore. The Chinese yam has sweet taste and flat property, enters spleen, lung and kidney meridians, has the effects of tonifying lung and spleen, and excreting dampness to stop diarrhea, and plays a role in treating both principal and secondary aspect of disease in the treatment process of UC with principal deficiency as excessive and deficiency-heat as the principal and secondary aspect of disease. Rhizoma bletillae is sweet, bitter and astringent in taste, cold in nature, enters stomach meridian, lung meridian and liver meridian, and has the effects of healing sore, tonifying lung, detumescence, hemostasis, promoting granulation and the like. Sanguisorba officinalis charcoal is recorded in Shen nong Ben Cao Jing at the earliest time, has slightly cold nature, sour, bitter and astringent taste, enters large intestine and liver meridian, and has the effects of cooling blood, stopping bleeding, detoxifying and healing sore.
In the formula, the evodia rutaecarpa, the patrinia herb and the pericarpium granati are taken as adjuvant drugs and have the effects of clearing heat and expelling pus, warming kidney and dispelling cold, and astringing intestines and relieving diarrhea. The damp-heat accumulated in the intestines causes stagnation of qi and blood in the intestines, stasis of the intestinal collaterals, blood failure and meat rot, and the internal ulcer becomes an ulcer. The theory of Su Mi-Zhen Dai Lun (large theory of Su-Wen and Zhen) states that "sudden and forceful discharge is caused by heat", and the patients are urgent and later on, and then they are urgent like arrow, and the anus is hot like cauterized, which is the sign of damp-heat. Herba Patriniae has effects of clearing heat, expelling pus, removing toxic substance, resolving carbuncle, removing blood stasis and relieving pain; punica Granati peel is used to treat diarrhea with astringents. Jingyue, the term "spleen and kidney deficiency" refers to the condition of the spleen and kidney deficiency, but affecting coldness and causing dysentery. Therefore, it is important to warm and tonify kidney yang, as well as spleen. Fructus evodiae in Sishen pill is taken for warming kidney, dispelling cold, astringing intestine and relieving diarrhea.
Glycyrrhrizae radix is used as guiding drug and harmonizes the drugs. All Fang Hanwen is used together and treats both principal and secondary aspect of disease, and is a good prescription for strengthening spleen, tonifying qi, clearing damp-heat, promoting blood circulation and astringing ulcer, and is suitable for the core pathogenesis of ulcerative colitis.
The invention has the advantages that:
the invention provides a traditional Chinese medicine compound preparation with the effects of strengthening spleen, tonifying qi, clearing damp-heat, promoting blood circulation and healing ulcer by combining with the knowledge of the core pathogenesis of ulcerative colitis, and can be used for improving clinical symptoms of patients, improving the healing rate of mucosa under intestinal endoscopes of the patients, improving the survival quality of the patients, and has definite and obvious curative effect through clinical application and pharmacological research confirmation. The traditional Chinese medicine composition has the advantages of low cost of raw materials, simple and convenient preparation, convenient use, small side effect, long-term administration, and good clinical curative effect on ulcerative colitis through years of clinical application, observation and analysis.
Detailed Description
The following provides a detailed description of embodiments of the present invention with reference to examples.
Example 1: the traditional Chinese medicine composition of the invention
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6 parts of codonopsis pilosula, 6 parts of Chinese yam, 6 parts of coix seed, 6 parts of garden burnet root charcoal, 3 parts of rhizoma bletillae, 6 parts of herba patriniae, 3 parts of fructus evodiae, 6 parts of pericarpium granati, 2 parts of pseudo-ginseng and 2 parts of liquorice.
Example 2: the traditional Chinese medicine composition of the invention
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of codonopsis pilosula, 10 parts of Chinese yam, 10 parts of coix seed, 15 parts of garden burnet root charcoal, 6 parts of rhizoma bletillae, 10 parts of herba patriniae, 6 parts of fructus evodiae, 15 parts of pericarpium granati, 3 parts of pseudo-ginseng and 6 parts of liquorice.
Example 3: the traditional Chinese medicine composition of the invention
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of codonopsis pilosula, 15 parts of Chinese yam, 15 parts of coix seed, 15 parts of garden burnet root charcoal, 6 parts of rhizoma bletillae, 18 parts of herba patriniae, 6 parts of fructus evodiae, 18 parts of pericarpium Granati, 3 parts of pseudo-ginseng and 6 parts of liquorice.
Example 4: the traditional Chinese medicine composition of the invention
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 21 parts of codonopsis pilosula, 27 parts of Chinese yam, 27 parts of coix seed, 18 parts of garden burnet root charcoal, 9 parts of rhizoma bletillae, 21 parts of herba patriniae, 6 parts of fructus evodiae, 21 parts of pericarpium granati, 6 parts of pseudo-ginseng and 9 parts of liquorice.
Example 5: the traditional Chinese medicine composition of the invention
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of codonopsis pilosula, 30 parts of Chinese yam, 30 parts of coix seed, 18 parts of garden burnet root charcoal, 12 parts of rhizoma bletillae, 30 parts of herba patriniae, 6 parts of fructus evodiae, 18 parts of pericarpium Granati, 9 parts of pseudo-ginseng and 9 parts of liquorice.
Example 6: the traditional Chinese medicine composition of the invention
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 3 parts of codonopsis pilosula, 3 parts of Chinese yam, 3 parts of coix seed, 3 parts of garden burnet root charcoal, 2 parts of rhizoma bletillae, 6 parts of herba patriniae, 2 parts of fructus evodiae, 3 parts of pericarpium Granati, 1 part of pseudo-ginseng and 2 parts of liquorice.
Example 7: the traditional Chinese medicine composition of the invention
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 60 parts of codonopsis pilosula, 60 parts of Chinese yam, 60 parts of coix seed, 30 parts of garden burnet root charcoal, 15 parts of rhizoma bletillae, 30 parts of herba patriniae, 18 parts of fructus evodiae, 30 parts of pericarpium granati, 12 parts of pseudo-ginseng and 12 parts of liquorice.
Example 8: the traditional Chinese medicine composition of the invention
The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of codonopsis pilosula, 10 parts of Chinese yam, 10 parts of coix seed, 15 parts of garden burnet root charcoal, 6 parts of rhizoma bletillae, 9 parts of herba patriniae, 12 parts of fructus evodiae, 15 parts of pericarpium Granati, 3 parts of pseudo-ginseng and 3 parts of liquorice.
Example 9: preparation of decoction
The traditional Chinese medicine decoction is prepared by a conventional preparation method, namely weighing the traditional Chinese medicine composition in any one of the embodiments 1-8, and adding water to decoct the traditional Chinese medicine composition into the decoction.
Example 10: preparation of tablets/capsules
Weighing the Chinese medicinal composition according to any one of embodiments 1-8, grinding, decocting, concentrating under reduced pressure to obtain extract, drying and pulverizing the extract, granulating, adding pharmaceutical adjuvants, and making into tablet or capsule.
Example 11: preparation of granule
Weighing the traditional Chinese medicine composition in any one of embodiments 1-8, grinding, decocting, concentrating under reduced pressure to obtain extract, drying and pulverizing the extract, and making into granule.
Example 12: preparation of pill/mixture/oral liquid/syrup
Weighing the traditional Chinese medicine composition in any one of embodiments 1-8, grinding, decocting, taking supernatant, and concentrating into thick extract; adding proper pharmaceutical adjuvants (white sugar, mel, benzoic acid or ethyl hydroxy benzoate, etc.), and making into pill, mixture, oral liquid or syrup.
Example 13: pharmacodynamic experiments of the Chinese medicinal composition
Case sources: a total of 60 UC patients were observed in this study, cases are from the department of gastroenterology, outpatient service and ward of the department of dawn and Shanghai traditional Chinese medicine university, which are affiliated to Yueyang traditional Chinese medicine and Western medicine combination hospitals and Shanghai traditional Chinese medicine university, which are affiliated to dawn and dawn hospitals, in 5 months of 2020 to 2 months of 2022.
(II) inclusion criteria:
(1) enteroscopy is performed in 6 months, and enteroscopy and pathological results meet the UC active period diagnosis standard;
(2) improving the Mayo score for 3-10 points, wherein the illness state is the mild-moderate;
(3) the differentiation of the traditional Chinese medicine is that of spleen deficiency and damp-heat;
(4) the sex is unlimited for people between 18 years and 75 years;
(5) voluntarily attending the clinical study and signing informed consent.
(III) exclusion criteria:
(1) the score of the modified Mayo is less than 3 or more than 10, and the UC disease belongs to the severe patients in the remission stage or the activity stage;
(2) allergic to known ingredients of mesalazine or the granule formulation of the traditional Chinese medicine composition of the invention;
(3) patients with severe primary diseases combined with other systems;
(4) UC with severe complications;
(5) during gestation, lactation, or recently fertility planners;
(6) other drug clinical researchers have participated in for 3 months;
(7) in addition to mesalazine treatment, other UC treatment regimens such as immune formulations, biological formulations, etc. are also being performed;
(8) there was a history of hormonal drugs, antibiotics, probiotic preparations or food use in approximately 2 weeks.
(IV) study method:
1. baseline data: the 60 patients were randomized into treatment and control groups according to a random number table method, 30 each, with age (40.73±12.55) of the treatment composition group; average course (41.68± 54.01) months; control group age (47.47 ±14.03); average course of disease (33.20.+ -. 38.80). The difference of the sex, age, course of disease and other data of the two groups of patients has no statistical significance (P > 0.05), and has comparability.
2. The medicine taking method comprises the following steps:
treatment group: administration of the particles of the present invention; the granule comprises the following components: 10g of codonopsis pilosula, 10g of Chinese yam, 10g of coix seed, 15g of garden burnet root charcoal, 6g of rhizoma bletillae, 10g of herba patriniae, 6g of fructus evodiae, 15g of pericarpium granati, 3g of pseudo-ginseng and 6g of liquorice. The granule is taken for half an hour to 1 hour after breakfast and supper, 2 bags are taken once every day, the granule is fully dissolved by boiled water before taking, and the granule is taken in a palatable temperature for 8 weeks of treatment course.
Control group: a traditional Chinese medicine granule simulation agent and mesalazine enteric coated tablet (manufacturer: dr. Falk Pharma GmbH;0.5 g/tablet; approval document: registration number H20100110) are administered. Taking the Chinese medicinal granule simulator from half an hour to 1 hour after breakfast and supper, twice a day, and 2 bags at a time, fully dissolving the granule with boiled water before taking, and taking the granule until the temperature is palatable; mesalazine enteric-coated tablet (0.5 g/tablet) is taken half an hour to 1 hour after breakfast, middle and supper three times a day, 2 tablets at a time, and 8 weeks in course of treatment.
And (V) observing indexes:
clinical efficacy and clinical remission rate were assessed according to the modified Mayo scoring criteria, and endoscopic response rate and mucosal healing rate were assessed according to the Baron endoscope score. The effective rate of the Chinese medicine symptoms is evaluated according to the quantitative classification table of the main symptoms of the ulcerative colitis.
(six) curative effect judgment criteria:
clinical efficacy and remission rate were calculated from the modified Mayo score. The clinically effective representative score is reduced by more than or equal to 30% or reduced by more than or equal to 3% relative to the baseline value, and the score of the blood score is reduced by more than or equal to 1 score or the score of the score is 0 or 1 score. Clinical effectiveness = number of active persons/total number of persons in the group x 100%. Clinical remission represents score less than or equal to 2 and no single score > 1 score; clinical remission rate = number of remissions/total number of groups x 100%.
Endoscopic response rate and mucosal healing rate were calculated from Baron endoscope scores. Endoscopic responses represent at least a 1 point decrease in endoscopic scores from baseline, endoscopic response rate = endoscopic response number/total number of groups x 100%. Mucosal healing represents an absolute score of 0 or 1 score for the endoscope, rate of mucosal healing = number of mucosal healers/total number of groups x 100%.
The Chinese medicine symptom related scores are calculated according to the quantitative grading table of the main symptoms of the ulcerative colitis. The traditional Chinese medicine symptom calculation formula adopts nimodipine method: [ (pre-treatment symptom score-post-treatment symptom score)/(pre-treatment symptom score ] ×100%). Clinical recovery: the symptom is disappeared or the symptom integral is reduced by more than or equal to 95 percent after treatment; the effect is shown: the integral of symptoms after treatment is reduced by less than 95% compared with the integral of symptoms before treatment; the method is effective: the integral of symptoms after treatment is reduced by less than 70% compared with the integral of symptoms before treatment; invalidation: the integral of symptoms after treatment is reduced by < 30% compared with the integral of symptoms before treatment; weighting: post-treatment symptomatic integral > pre-treatment. The effective rate of Chinese medicine symptoms is = (cure + significant + effective) case number/total case number x 100%. The following principles are followed for the determination of the single curative effect of the Chinese medicine symptoms: the disappearance of symptoms of traditional Chinese medicine after treatment is clinical control; symptoms are still on but score decrease of level 2 is significant; the integration is effectively reduced by 1 stage; none of the above are invalid.
And (seventh) data analysis:
the study was statistically analyzed using SPSS 25.0. The metering data based on normal distribution and variance homogeneity adopts t test, paired sample t test is adopted in the group, two independent sample t test is adopted between groups, and the result passes the mean number + -standardDifference of accuracyIs described in the form of (a). For the metering materials or grade data which do not accord with normal distribution or variance uniformity, wilcoxon symbol rank test is adopted in the group, non-parametric (Mann-Whitney U) rank sum test is adopted between the groups, and the statistics are described in the forms of average rank order and the like. Chi-square test x 2 The (test) or Fisher exact probability method is used for counting data analysis, and the statistical result is expressed by the total rate or the composition ratio. Finally calculate statistics (t, Z, x) 2 ) And the corresponding p value, the p is less than 0.05, which is considered to have statistical significance.
(eighth) results:
1. improved Mayo score comparison
Prior to treatment, two groups of modified Mayo scores were compared using t-test, t= 1.157, p=0.252, and the differences were statistically significant (p > 0.05). After treatment, the treatment group improvement Mayo score adopts a rank sum test, and the difference is statistically significant (p < 0.05) with z= -4.636 and p=0.000; the control group uses rank sum test, z= -4.171, p=0.000, the difference is statistically significant (p < 0.05). After treatment, the two groups of modified Mayo scores were tested using t-test, t= 3.179, p=0.002, and the differences were statistically significant (p < 0.05). It was demonstrated that both groups reduced the improved Mayo score for the patients and that the treatment group was superior to the control group. See table 1.
Table 1 two groups of patients Mayo score comparison
Note that: p < 0.01 compared to pre-treatment and #p < 0.05 compared to control.
2. Comparison of clinical effective rates
According to the improved Mayo score calculation, the clinical effective number of the treatment group is 27, the clinical effective rate is 90.0% in the treatment group, and the treatment group has 3 patients without treatment; the number of clinically effective people in the control group is 19, and the number of clinically effective people in the control group is 11The clinical effective rate is 63.3 percent. Through chi-square test 2 =5.963, p=0.015, and the differences in the two groups were statistically significant (p < 0.05). See table 2.
Table 2 comparison of clinical efficacy of two groups of patients [ example (%)
3. Comparison of clinical remission rates
According to the calculation of the modified Mayo score, the clinical remission number of the treatment group is 13, 17 patients are not remitted, and the clinical remission rate is 43.3%; the number of clinical remissions in the control group is 8, 22 cases are not remitted, and the clinical remission rate is 26.7%. Through chi-square test, x 2 The two groups of differences were statistically not significant (p > 0.05) =1.832, p=0.176. See table 3.
Table 3 comparison of clinical remission rates for two groups of patients [ example (%)
Baron endoscopic score comparison
Before treatment, the two groups of Baron endoscopy scores adopt a rank sum test, wherein Z= -1.739, and P=0.082, and the difference has no statistical significance (P > 0.05), so that the two groups of Baron endoscopy scores are comparable. After treatment, treatment group Baron scores were tested using rank sum, z= -4.132, p=0.000, differences were statistically significant (p < 0.05); the control group uses rank sum test, z= -3.049, p=0.002, the difference is statistically significant (p < 0.05). After treatment, the two Baron endoscope scores were compared using a rank sum test, z= -1.316, p=0.188, and the differences were not statistically significant (p > 0.05) as shown in table 4.
Table 4 comparison of Baron endoscope scores for two groups of patients
Note that: p < 0.01 compared to pre-treatment.
5. Endoscopic response rate comparison
According to Baron endoscope score calculation, the number of endoscope response persons in a treatment group is 21, the number of non-response persons is 9, and the endoscope response rate is 70.0%; the number of the endoscope response persons in the control group is 16, the number of the non-response persons is 14, and the endoscope response rate is 53.3%. Through chi-square test, x 2 The two groups of differences were statistically significant (p > 0.05) =1.763, p=0.184. See table 5.
Table 5 comparative endoscopic response rates for two groups of patients [ example (%)
6. Comparison of mucosal healing Rate
According to Baron endoscope score calculation, the number of the mucous membrane healed patients in the treatment group is 20, the number of the mucous membrane healed patients in the treatment group is 10, the mucous membrane healed rate is 66.7%, the number of the mucous membrane healed patients in the control group is 16, the number of the mucous membrane healed patients in the control group is 14, and the mucous membrane healed rate is 53.3%. Through chi-square test, x 2 The two groups of differences were statistically not significant (p > 0.05) =1.111, p=0.292. See table 6.
Table 6 comparative mucosal healing Rate of two groups of patients [ example (%)
7. Integral comparison of Chinese medicine symptoms
Before treatment, the two groups of Chinese medicine symptoms are integrated by adopting a rank sum test, Z= -0.906, and P=0.365, and the difference has no statistical significance (P > 0.05) and is comparable. After treatment, the Chinese medicine symptoms in the treatment group are integrated by adopting a rank sum test, wherein Z= -4.709, and the difference is statistically significant (P < 0.05); the control group uses rank sum test, z= -3.699, p=0.000, the difference is statistically significant (p < 0.05). After treatment, the two groups of Chinese medicine symptoms are tested by rank sum, Z= -2.006, and P=0.045, and the difference is statistically significant (P < 0.05). It is explained that both the treatment group and the control group can improve the Chinese medicine symptoms of the patients, and the treatment group is superior to the control group. See table 7.
Table 7 comparison of the integral of symptoms in two groups of patients
Note that: p < 0.01 compared to pre-treatment and #p < 0.05 compared to control.
8. Comparison of therapeutic effects of Chinese medicine symptoms
According to the quantitative classification table of the main symptoms of ulcerative colitis, the total effective number of Chinese medicine symptoms in a treatment group is 28 cases, the number of invalid cases is 2 cases, and the effective rate is 93.3%; the total effective number of Chinese medicine symptoms in the control group is 18, the number of invalid people is 12, and the effective rate is 60.0%. Through chi-square test 2 The difference between the two groups was statistically significant (p < 0.05) = 9.317, p=0.002. See table 8.
Table 8 comparative curative effects of Chinese medicine symptoms of two groups of patients (examples)
Ibdq quality of life scale
Before treatment, the total components of the two groups of IBDQ are subjected to rank sum test, Z= -0.858, P=0.391, and the difference has no statistical significance (P > 0.05) and is comparable.
After treatment, the total fraction of IBDQ in the treatment group was rank-sum tested, z= -4.351, p=0.000, the difference being statistically significant (P < 0.05); the control group was rank-sum tested, z= -3.839, p=0.000, the difference being statistically significant (P < 0.05). After treatment, total fraction comparison of the two groups of IBDQ was performed using t-test, t=1.192, p=0.238, the difference was not statistically significant (P > 0.05). See table 9.
Table 9 IBDQ comparison of two groups of patients
Note that: p < 0.01 compared to pre-treatment.
Clinical curative effect observation shows that the traditional Chinese medicine composition can effectively improve clinical symptoms and Chinese medicine symptoms of spleen deficiency damp-heat type mild-moderate UC patients, has better curative effect than mesalazine, and is worthy of intensive study, popularization and application.
The foregoing is merely a preferred embodiment of the present invention, and it should be noted that modifications and additions may be made to those skilled in the art without departing from the method of the present invention, which modifications and additions are also to be considered as within the scope of the present invention.
Claims (8)
1. The traditional Chinese medicine composition for treating ulcerative colitis is characterized by comprising the following raw materials in parts by weight: 3-60 parts of codonopsis pilosula, 3-60 parts of Chinese yam, 3-60 parts of coix seed, 3-30 parts of garden burnet root charcoal, 2-15 parts of rhizoma bletillae, 6-30 parts of herba patriniae, 2-18 parts of fructus evodiae, 3-30 parts of pericarpium granati, 1-12 parts of pseudo-ginseng and 2-12 parts of liquorice.
2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6-30 parts of codonopsis pilosula, 6-30 parts of Chinese yam, 6-30 parts of coix seed, 6-15 parts of garden burnet root charcoal, 3-12 parts of common bletilla tuber, 9-30 parts of herba patriniae, 3-12 parts of evodia rutaecarpa, 6-15 parts of pericarpium granati, 2-6 parts of pseudo-ginseng and 3-9 parts of liquorice.
3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of codonopsis pilosula, 10 parts of Chinese yam, 10 parts of coix seed, 15 parts of garden burnet root charcoal, 6 parts of rhizoma bletillae, 10 parts of herba patriniae, 6 parts of fructus evodiae, 15 parts of pericarpium granati, 3 parts of pseudo-ginseng and 6 parts of liquorice.
4. Use of a traditional Chinese medicine composition according to any one of claims 1-3 for the preparation of a medicament for the treatment of ulcerative colitis.
5. A pharmaceutical preparation comprising the pharmaceutical composition for treating ulcerative colitis according to any one of claims 1-3 as an active ingredient, wherein the pharmaceutical preparation is prepared into a pharmaceutically usual dosage form by a conventional preparation method in the art.
6. The pharmaceutical formulation of claim 5, wherein the pharmaceutical formulation is a decoction, a tablet, a capsule, a granule, a pill, a mixture, an oral liquid, or a syrup.
7. The pharmaceutical formulation of claim 5, further comprising pharmaceutically acceptable excipients.
8. Use of a pharmaceutical formulation according to any one of claims 5-7 for the preparation of a medicament for the treatment of ulcerative colitis.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210736187.6A CN116966249A (en) | 2022-06-27 | 2022-06-27 | Traditional Chinese medicine composition for treating ulcerative colitis |
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| CN202210736187.6A CN116966249A (en) | 2022-06-27 | 2022-06-27 | Traditional Chinese medicine composition for treating ulcerative colitis |
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