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Objective:To compare the efficacy and safety between WangShiBaoChiWan and mosapride in the treatment of functional dyspepsia (FD).Methods:From September 2019 to September 2020, patients with postprandial fullness and early satiation who met the Rome Ⅳ criteria for FD diagnosis were enrolled from 15 hospitals, including the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical College. The subjects were randomly divided into WangShiBaoChiWan (experimental) group and mosapride (control) group in the ratio of 1∶1. The treatment regimens were WangShiBaoChiWan+ mosapride simulator, WangShiBaoChiWan simulator+ mosapride, respectively with a treatment period of 2 weeks. The primary efficacy outcome was the improvement rates of main symptoms before and after treatment, the secondary efficacy primary efficacy outcome was the total clinical effective rate and the change of the single symptom score. And the safety indicator included adverse events. Independent sample t-test, paired t-test and chi-square test were used for statistical analysis. Results:A total of 251 FD patients were enrolled in the full analysis set, including 124 in the experimental group and 127 in the control group; 241 FD patients were in the per-protocol analysis set, including 117 in the experimental group and 124 in the control group. The analysis of per-protocol analysis set showed that the improvement rates of the main symptoms of the experimental group and the control group were (66±29)% and (60±30)%, respectively, and the difference was not statistically significant ( P>0.05). The improvement rate of the main symptoms of the experimental group reached 117% of that of the control group, which exceeded the expected non-inferiority standard of 80%. The total clinical effective rates of the experimental group and the control group were 76.07% (89/117) and 75.81% (94/124), respectively, and the difference was not statistically significant ( P>0.05). The results of full analysis set showed that the incidence of adverse events of the experimental group and the control group was 1.62% (2/124) and 1.57% (2/127), respectively, and the difference was not statistically significant ( P>0.05). There were no serious adverse events in the two groups. Conclusion:The improvement rate of the main symptoms of WangShiBaoChiWan is not inferior to that of mosapride in the treatment of FD, and it has good safety.
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Objective To explore the spatial-temporal characteristics of influenza epidemic in Hubei from 2009 to 2020, and make short-term prediction to provide reference for influenza prevention and control strategies. Methods Time series seasonal decomposition model and geographic spatial analysis method were used to analyze spatial-temporal evolution characteristics of influenza prevalence in Hubei during 2009-2020. LSTM neural network model was used to predict the monthly influenza incidence from 2020 to 2023. Results Influenza was mainly prevalent in the end of winter and the beginning of spring (December to March) were periods of high influenza incidence. In recent years, the influenza pandemic has shown an increasing trend. Influenza epidemic was characterized by significant spatial differentiation, with “A-shaped point-axis structure” surrounding counties were more severe . The epidemic center of gravity experienced a spatial evolution process from west to east and from north to south. LSTM neural network model predicted that although the influenza incidence rate from January 2020 to December 2023 is lower than that in 2019, it is still at a high level, and shows a peak epidemic in winter and spring. Conclusion Influenza epidemic in Hubei is characterized by a high epidemic period in late winter and early spring, and the southeast of Hubei is the key epidemic area. It is suggested that publicity and prevention and control should be strengthened according to people, time and place, and key populations and areas should be encouraged to receive influenza vaccines in advance.
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Objective:To explore the efficacy and safety of Ganhai Weikang capsule (GWC) in the treatment of functional dyspepsia (FD).Methods:A randomized, double-blind, placebo-controlled parallel, multi-center, superiority clinical trial was conducted. From March 2018 to April 2020, totally 324 patients with dyspepsia symptoms, who were diagnosed as chronic non-atrophic gastritis by endoscopy and pathology and met the Rome Ⅳ diagnostic criteria for FD from 7 top hospitals were enrolled, including the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), Heilongjiang Hospital of Traditional Chinese Medicine, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Qilu Hospital of Shandong University, the First Affiliated Hospital of Zhejiang University, Beijing Hospital of Traditional Chinese Medicine of Capital Medical University and the Third Xiangya Hospital of Central South University. The patients were randomly divided into the GWC group and the placebo group according to the ratio of 1∶1. The patients of GWC group were given GWC and the patients of placebo group were given GWC capsule simulant. The patients of both groups orally took capsules before meals, 2.4 g each time and 3 times per day, and the course of treatment was 4 weeks. The main efficacy index was the total clinical effective rate after 4 weeks, and the secondary efficacy index was the changes of clinical symptom scores of upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety. The safety index included laboratory tests and adverse events. Chi-square test and Wilcoxon rank sum test were used for statistical analysis.Results:A total of 320 FD patients were enrolled in the full analysis set (FAS), which included 161 cases in GWC group and 159 cases in placebo group. A total of 298 cases were in the per-protocol set (PPS), 149 cases each in GWC group and placebo group. The results of FAS and PPS both showed that the total clinical effective rates of the GWC group were higher than those of the placebo group (84.5%, 136/161 vs. 44.0%, 70/159 and 83.9%, 125/149 vs. 46.3%, 69/149), and the differences were statistically significant ( χ2=57.07 and 46.32, both P<0.001). In addition, the differences of the total score of main symptoms and each symptom (upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety) before and after treatment of GWC group were all higher than those of the placebo group (FAS: 10 (7, 14) vs. 5 (3, 11); 3 (2, 4) vs. 2 (0, 3); 2 (0, 4) vs. 1 (0, 3); 3 (1, 4) vs. 2 (1, 3); 2 (0, 4) vs. 1 (0, 3). PPS: 10 (7, 13) vs. 5 (3, 11); 3 (2, 4) vs. 2 (0, 3); 2 (0, 4) vs. 1 (0, 2); 3 (1, 4) vs. 2 (1, 3); 2 (0, 4) vs.1 (0, 3)), and the differences were statistically significant (FAS: Z=5.80, 5.91, 3.19, 3.72 and 3.30; PPS: Z=5.14, 5.11, 2.86, 3.21 and 2.84; all P<0.01). The results of FAS and PPS indicated that the improvement rates of main symptoms and each symptom (upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety) of GWC group were all higher than those of the placebo group (FAS: 77.8% (54.6%, 91.3%) vs. 42.9% (28.6%, 61.5%); 100.0% (60.0%, 100.0%) vs. 50.0% (25.0%, 60.0%); 100.0% (50.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 71.4% (33.3%, 100.0%) vs. 41.4% (25.0%, 66.7%); 100.0% (50.0%, 100.0%) vs. 50.0% (20.0%, 100.0%). PPS: 77.8% (54.2%, 89.5%) vs. 44.0% (28.6%, 65.0%); 100.0% (60.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 100.0% (50.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 71.4% (33.3%, 100.0%) vs. 46.4% (25.0%, 66.7%); 100.0% (50.0%, 100.0%) vs. 50.0% (20.0%, 100.0%)), and the differences were statistically significant (FAS: Z=8.60, 7.72, 4.98, 4.24 and 5.61; PPS: Z=7.90, 7.03, 4.49, 3.88 and 4.83; all P<0.001). After 2 weeks of treatment, the differences of the total score of main symptoms and score of each symptom (upper abdominal pain, upper abdominal burning and early satiety) before and after treatment of GWC group were all higher than those of the placebo group (5.0 (3.0, 8.0) vs. 4.0 (2.0, 6.0); 2.0 (1.0, 2.0) vs. 2.0 (0.0, 2.0); 1.5 (0.0, 2.0) vs. 1.0 (0.0, 2.0); 1.5 (0.0, 2.0) vs. 1.0 (0.0, 2.0)), and the differences were statistically significant ( Z=2.95, 3.44, 2.43 and 2.79, all P<0.05). There was no significant difference in the incidence of adverse events between the GWC group and the placebo group (0.6%, 1/163 vs. 0, 0/159). Conclusion:The clinical total effective rate of GWC in the treatment of FD is superior to that of placebo and it has good safety.
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Objective:To investigate the clinical efficacy of Jinghua Weikang capsule combined with Bifidobacterium for curing patients featured by spleen-stomach damp-heat syndrome and Helicobacter pylori (Hp) infection with low DOB values.Methods:To enroll 130 cases who were admitted to the Digestion Center of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University from March 2019 to March 2020. According to the treaatment protocols, the quadruple therapy group and dual therapy group, each had 65 patients. The quadruple therapy group had two different treatment protocols, 34 cases with Rabeprazole sodium enteric-coated tablet, Bismuth potassium citrate capsule, Amoxicillin capsule, and Clarithromycin, the other one had 31 cases with Rabeprazole sodium enteric-coated tablet, Bismuth potassium citrate capsule, Amoxicillin capsule, and Levofloxacin tablets. The Dual therapy group was treated with Jinghua Weikang capsule combined with Bifidobacterium. As for quadruple therapy group, 14 days was a course of treatment, while28 days was a course of treatment for dual therapy group. The two groups were treated for one course, respectively. The TCM syndromes were scored before and after treatment. After 4-weeks long drug withdrawal, all cases were reexamined via 13C-UBT. The Hp eradication rate, efficacy evaluation and adverse reactions were compared between both groups.Results:The eradication rate was 90.8% (59/65) in quadruple therapy group and 78.5% (51/65) in dual therapy group. There was no statistical difference between two groups ( χ2=3.78, P=0.052). As for quadruple therapy group, the eradication rate was 91.2% (31/34) in Protocol One and 90.3% (28/31) in Protocol Two. There was no statistical difference between two protocols ( χ2=0.01, P=0.906). After treatment, the TCM syndrome score of quadruple therapy group [(7.02±0.89) vs. (6.51±0.85), Z=-3.01], was significantly higher than that of dual therapy group ( P<0.01). The total effective rate was 93.9% (61/65) in dual therapy group and 78.5% (51/65) in quadruple therapy group. There was statistically significantly difference between two groups ( χ2=6.45, P=0.011). The adverse reactions was 24.6% (16/65) in quadruple therapy group and 6.2% (4/65) in dual therapy group. There was statistically significantly difference in two groups ( χ2=8.51, P=0.004). Conclusions:The Jinghua Weikang capsule combined with Bifidobacterium had curative effects on Hp infected patients with low DOB values. It could improve TCM Syndromes with little adverse reactions.
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Objective:To observe the curative effect of He Style fire acupuncture on functional dyspepsia of deficiency cold of spleen and stomach syndrome.Methods:Sixty patients who met the inclusion criteria from March 2017 to March 2019 in Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University were divided into 2 groups according to the random number table method, with 30 in each group. The control group was given mosapride tablets, one tablet (5 mg) each time half an hour before meals. On the basis of the control group, the treatment group was given fire acupuncture on Zusanli(ST36), Zhongwan(CV12), Pishu(BL20), Weishu(BL21), Guanyuan(CV4) and Qihai (CV6) twice a week. The course of treatment for both groups of patients was 4 weeks. A follow-up was visited at 1 month after the treatment. The total Symptom Scores and Health-Related Quality of Life Scale (SF-36) scores were performed before and after treatment, and the total scores of syndromes of patients with Deficiency cold of spleen and stomach before and after treatment were used for clinical efficacy evaluation, and adverse events during treatment were recorded.Results:The total efficiency of the treatment group was 93.3% (28/30), and 76.7% (23/30) in the control group, and the 2 groups were statistically significant ( χ2=4.78, P<0.05). After treatment, the upper abdominal pain, upper abdominal burning, postprandial fullness and discomfort, early satiety, and total scores in the treatment group were significantly lower than those in the control group ( t values were 4.27, 5.16, 3.93, 4.69, 4.28, respectively, all Ps<0.05); during follow-up, the upper abdominal pain, upper abdominal burning, postprandial fullness and discomfort and the total scores in the treatment group were significantly lower than those in the control group ( t values were 3.63, 3.22, 4.03, 3.04, respectively, all Ps<0.05). In terms of SF-36, after treatment, the treatment group showed significantly higher scores in the control group of physical function, physiology, mental health, and health changes compared with the control group ( t values were 2.97, 4.05, 4.22, 3.05, respectively, all Ps<0.05). During follow-up, the treatment group with physiological function, physical function, physical pain, overall health, life vitality, mental health, health changes scores were significantly higher than those in the control group ( t values were 3.27, 4.23 3.85, 3.15, 3.25, 6.15, 3.85, respectively, all Ps<0.05). Conclusion:He Style fire acupuncture combined with western medicine treatment can improve the symptoms of upper abdominal pain and upper abdominal burning, and the quality of lifein the patients with functional dyspepsia.
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Objective:To explore the effect of Tongxie-Yaofang on visceral sensitivity in IBS-D and the possible mechanism. Methods:Divided 30 male SD rats (one-day old) into normal group (10 rats) and IBS-D model group (20 rats) randomly. IBS-D was induced by the method of neonatal maternal separation and restraint stress. After successful modeling, the IBS-D model group was randomly divided into model group and Tongxie-Yaofang group, with 10 rats in each group. Tongxie-Yaofang group was given Tongxie-Yaofang formula, 4.92 g/ml by gavage, while the normal and model groups were given the same amount of normal saline, rats were gavaged with 2 ml/100 g body weight once a day for 14 days. The electromyography of the exorectus muscle was used to meature colorectal distension and by using electronic constant pressure apparatus to evaluate visceral sensitivity. The morphology of colon by HE staining and Enzyme-linked immunosorbent assay (ELISA) were used to determine the level of colonic 5-hydroxytryptamine (5-HT), qPCR was used to detect the colonic mRNA expression of serotonin transporter (SERT) and Western blot was used to detect SERT expression in colon and hypothalamus. Results:Compared with the model group, at the expansion pressure of 60 mmHg and 80 mmHg, the electromyographic response [(179.51 ± 18.26)% vs. (226.42 ± 25.78)%; (242.13 ± 15.42)% vs. (306.02 ± 51.51)%] in Tongxie-Yaofang group was significantly decreased ( P<0.05 or P<0.01). The colonic content of 5-HT was significantly lower than that in the model group [(8.85 ± 0.53) ng/mg vs.(12.25 ± 1.95) ng/mg] ( P<0.01), the expression of SERT mRNA (0.85 ± 0.12 vs. 0.38 ± 0.02) and SERT protein (0.53 ± 0.11 vs. 0.36 ± 0.17) in the colon was significantly increased ( P<0.05 or P<0.01), the expression of SERT protein (0.88 ± 0.12 vs. 0.36 ± 0.13) in the hypothalamus was significantly increased ( P<0.05). Conclusion:Tongxie-Yaofang could relieve the visceral hypersensitivity, which may be achieved by regulating the 5-HT and SERT expression.
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OBJECTIVE:To establish QAMS method for simultaneou s determination of 7 effective components in Yao medicine Yueli yaomi spray ,such as α-cyperone,α-pinene,β-pinene,limonene,β-elemene,caryophyllene oxide and ligustilide , so as to provide method reference for the quality control of the preparation. METHODS :GC method was adopted. The determination was performed on DB- 1701P capillary column ,using nitrogen as carrier gas. The temperature of the hydrogen flame ion detector was 240 ℃. The temperature was programmed ,the inlet temperature was 240 ℃,the injection volume was 1 μL and the split ratio was 20 ∶ 1. Using limonene as internal reference ,the relative correction factors of other 6 components were calculated,the contents of them were calculated with relative correction factors ,and then compared with the results of internal standard method (using naphthalene as internal standard ). RESULTS :The mass concentration linear range of α-cyperone, α-pinene,β-pinene,limonene,β-elemene,caryophyllene oxide and ligustilide were 0.008 9-1.110 0,0.028 3-3.540 0,0.020 5- 2.560 0,0.023 0-2.880 0,0.016 3-2.035 0,0.013 1-1.640 0,0.008 3-1.040 0 mg/mL(all r>0.999 0);the limits of quantification were 0.005 6,0.013 1,0.011 4,0.018 6,0.010 8,0.008 9,0.004 5 mg/mL;the detection limits were 0.001 9,0.004 1,0.003 7, 0.006 2,0.003 5,0.002 9,0.001 5 mg/mL;RSDs for precision ,stability(24 h),and repeatability tests were all less than 2% (n=5 or n=6); the average recoveries were 98.48% , 014) 101.37%,97.96%,99.80%,102.79%,97.77%,102.14%, and RSDs were all lower than 2%(n=9),respectively. The average relative correction factors of α-cyperone,α-pinene, β-pinene,β-elemene,caryophyllene oxide and ligustilide were 1.045 8,0.621 0,0.488 5,0.382 9,0.708 9,0.956 9 respectively,and the RSDs were all lower than 2%(n=6). There wa s no statistical significance in contents of 7 components between QAMS method and internal standard method (P>0.05). CONCLUSIONS :The established QAMS method is simple , accurate,stable and reproducible ,and can be used for simultaneous determination for 7 components in Yueli yaomi spray.
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BACKGROUND/AIMS: This study was designed to investigate the effect of Fengliao-Changweikang (FLCWK) in diarrhea-predominant irritable bowel syndrome (IBS-D) rats and explore its underlying mechanisms. METHODS: IBS-D model rats were induced by neonatal maternal separation (NMS) combined with restraint stress (RS). In in vivo experiments, the model rats were randomly divided into 5 groups: NMS + RS, FLCWK (low dose, middle dose, and high dose), and pinaverium bromide. The normal control (no handling) rats were classified as the NH group. The therapeutic effect of FLCWK was evaluated by fecal characteristics, electromyographic response and abdominal withdrawal reflex scores. In in vitro experiments, the model rats were randomly divided into 2 groups: NMS + RS, FLCWK (middle dose), and no handling rats were used as the NH group. The differences in basic tension and ACh-induced tension of isolated colonic longitudinal smooth muscle strips (CLSMs) among the 3 groups were observed. In addition, different inhibitors (nifedipine, TMB-8, L-NAME, methylene blue, and 4-AP) were pretreated to explore the underlying mechanisms. RESULTS: In in vivo experiments, fecal characteristics, electromyographic response, and abdominal withdrawal reflex scores significantly improved in the FLCWK group, compared with the NMS + RS group. In in vitro experiments, the basic tension and ACh-induced tension of CLSMs in IBS-D rats were significantly inhibited by FLCWK. After pre-treatment with different inhibitors, the ACh-induced tension of CLSMs in each group showed no significant difference. CONCLUSIONS: FLCWK manifested curative effect in IBS-D rats by inhibiting colonic contraction. The underlying mechanisms may be related to regulatory pathway of nitric oxide/cGMP/Ca2+ and specific potassium channels.
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Animals , Rats , Colon , Gastrointestinal Motility , Herbal Medicine , In Vitro Techniques , Irritable Bowel Syndrome , Methylene Blue , Muscle, Smooth , NG-Nitroarginine Methyl Ester , Nitric Oxide , Potassium Channels , ReflexABSTRACT
Objective To investigate the expression of CD40,CD40L and MMP9 in carotid atherosclerotic plaques and evaluate their roles in carotid atherosclerotic plaque stability.Methods Carotid atherosclerotic plaques were isolated in carotid eversion endarterectomy (GEE) in 37 patients with high-grade stenosis (>70%) including 20 stroke (A group) and 17 non-stroke patients (B group).The control group included samples of normal carotid artery from 11 normal individuals,The RNA expression levels of CD40,CD40 L and MMP9 in all A,B and control groups were quantitatively detected by real-time quantification polymerase chain reaction (PCR) and the protein expression levels were detected by Western blotting analysis.The expression and distribution of CD40,CD40L and MMP9 in carotid atherosclerotic plaques were detected by immunohistochemistry staining.Then correlations between CD40-CD40L and MMP9 were statistically analyzed.Results The relative CD40 mRNA level in high-grade stenosis of A group,B group and normal control were 2.41±0.43,1.03±0.38 and 0.31±0.12,respectively,and MMP9 mRNA 6.88±1.57,1.90±0.44 and 0.39±0.12,respectively.The levels of CD40 and MMP9 mRNA in A group were significantly higher than those in B group (P=0.000),the levels of CD40 and MMP9 in B group were significantly higher than those in controls (P=0.000).There was a linear correlation between CD40 and MMP9 mRNA (r=0.929,P=0.000).However,there were no significantly difference in mRNA levels of CD40L between carotid atherosclerosis and controls.The protein expression levels of CD40,CD40L and MMP9 in A group were significantly higher than those in B group (FCD40=104.100,P=0.000;FCD40L=129.932,P=0.000;FMMP9=13.565,P=0.021) and B group higher than normal controls (FCD40=115.848,P = 0.000;FCD40L= 30.482,P=0.005;FMMP9=35.557,P=0.004).The areas of positive staining of CD40,CD40L and MMP9 in immunochemistry study in A group were significantly higher than those in B group and B group was significantly higher than controls.There were linear correlations between positive staining areas Of CD40 and CD40L,CD40 and MMP9,CD40L and MMP9 (r=0.963,0.959,0.929,P=0.000).Expressions of CD40,CD40L and MMP9 were significantly higher in the shoulder areas of the atherosclerotic plaques than in other areas.Conclusions The CD40-CD40L has an important role in the formation of carotid atherosclerosis and plaque instability,probably by up-regulating MMP9.The expression of CD40L may be regulated by post-transcriptional modification to exert biological effects.
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Objective: To explore the distribution characteristic of syndromes and the rule of the differentiation of symptoms and signs of functional dyspepsia(FD).Methods: We investigated and analyzed the 565 cases of FD by the epidemiological ascertainment methods,and had the second differentiation of symptoms and signs by "cold,heat,deficiency,exc ess" on the basis of the traditional method,then established the database and had a statistical analysis by SPSS.Results: Based on the differentiation of symptoms and signs of "cold,heat,deficiency,excess",FD could be mainly classified as asthenia cold syndrome-insufficiency(or deficiency-cold) of the spleen and stomach,excess-heat syndrome dampness-heat of spleen and stomach,deficiency-excess complicated syndrome spleen-deficiency and qi stagnation,and cold-heat complicated syndrome.Conclusion: It is a brief,clear and also feasible method for the differentiation of symptoms and signs of FD with the class of "cold,heat,deficiency,excess".
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Objective To study the epidemiological characteristics of diarrhea-predominant irritable bowel syndrome (IBS-D) as well as the relationship between the main syndromes and different factors. Method The relevant information of patients were collected by clinical epidemiological method and the relationship between the main characteristics of the IBS-D syndromes and different factors was explored with the major syndromes as the key link. Result Most of the cases aged 30~49 years old. Special hobbies of patients followed by drinking, smoking, addicting spicy, addicting coffee and so on. Poor emotion, mental stress and diet were the main inducements. Liver stagnation and spleen deficiency has the highest percentage (44.7%). The distribution of syndromes in different ages, different genders, different occupations and different education had no significant difference. Conclusion The number of IBS-D hospital visiting-patients is lower than the actual number of illness people. Mental factors are important internal factors, and dietary factors may be an important external factor. Different factors have no effect on the distribution of syndromes.
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Objective: To assess the e cacy and safety of treating D-IBS with Chinese herbal medicine. Methods: To collect comprehensively the RCTs of treating D-IBS with Chinese herbal medicine by computer search. Results: Up to Nov. 2007, one hundred and sixty-three trials were included. There have 14150 patients, the maximum sample number is 234, the minimum is 40, and the average sample is 87. Because of the complex and various interventions, we just do descriptive analysis. It indicated that the Chinese herbal medicine intervention has obvious e cacy, its cure rate was(50.80?24.70)%,total e ective rate was(90.68?7.30)%and recurrence rate was(18.99?10.61)% all better than the western medicine. Conclusion: Compared with the western medicine and placebo, the Chinese herbal medicine had obvious e cacy in improving the global symptom’s cure rate, total e ective rate, symptom score and recurrence rate, and didn’t discovery seriously adverse reaction.