Clinical Study Of Chaiqin Tonglin Tablet In The Treatment Of Recurrent Urinary Tract Infection With Liver Stagnation And Qi Stagnation And Lower Coke Dampness-Heat Type

This study consists of two parts.The first part is a Meta analysis of the treatment of recurrent urinary tract infection with traditional Chinese medicine or combined with western medicine.The second part is a clinical study of Chaiqin Tonglin Tablet in the treatment of recurrent urinary tract infection with liver stagnation and qi stagnation and lower Jiao dampness-heat.Study 1: Meta-analysis of traditional Chinese medicine or combined western medicine in the treatment of recurrent urinary tract infectionsObjective: To scientifically evaluate the clinical efficacy of traditional Chinese medicine or combined western medicine in the treatment of recurrent urinary tract infection by using evidence-based medicine tools,and to provide evidence for clinical research.Methods: A literature search was conducted on CNKI,Wanfang,VIP,Pub Med,Cochrane Library,and Web of Science,including 6 Chinese and English databases.Randomized controlled trials(RCTs)of traditional Chinese medicine or combined western medicine in the treatment of recurrent urinary tract infections were searched,and the retrieval time was from the establishment of each database to January 2021.In this study,Rev Man 5.3 software was used for statistical analysis of the included data.Mean difference(MD)was used as the effect scale index for measurement data,and relative risk(RR)was used as the effect index for enumeration data.The confidence intervals(CI)of both groups were 95%,and P ≤ 0.05 indicated that the difference between the two groups was statistically significant.Results: After literature screening,a total of 17 literatures were included,with a total of 1121 cases,of which 16 studies reported recurrence rate.Meta-analysis showed that TCM or combined western medicine could significantly reduce recurrence rate compared with the control group(RR=0.41,95%CI[0.32,0.52]).The difference was statistically significant(P <<0.05).Fourteen literatures reported effective rates,and the results indicated that compared with the control group,the total effective rate(RR=1.15,95%CI[1.06,1.25])could be improved by traditional Chinese medicine or combined western medicine(P < 0.05).Seven literatures reported TCM syndrome scores,and the results showed that TCM or combined western medicine could improve TCM syndrome scores compared with the control group (MD =-6.18,95%CI[-6.81,-5.56]),with statistically significant differences(P < 0.05).Urine Ig A was reported in two literatures,and the results indicated that Chinese medicine or combined with western medicine could increase the level of Urine Ig A compared with the control group(MD =0.31,95%CI[0.07,0.05]),with statistical significance(P < 0.05).Three literatures reported serum estradiol,and the results suggested that Chinese medicine or combined western medicine could increase serum estradiol level compared with the control group(MD =1.10,95%CI[0.31,1.09]),with statistically significant difference(P < 0.05).Conclusion: Chinese medicine or combined with western medicine in the treatment of recurrent urinary tract infection can significantly reduce the recurrence rate of patients,improve the clinical efficiency,improve the TCM syndrome score,and increase the levels of urinary Ig A and serum estradiol.Study 2: Clinical study of Chaiqin Tonglin Tablet in the treatment of recurrent urinary tract infection with liver stagnation and qi stagnation and lower coke dampness-heat typeObjective: To investigate the clinical efficacy and safety of Chaiqin Tonglin Tablets in the treatment of recurrent urinary tract infections caused by liver stagnation and qi stagnation and lower coke dampness-heat.Methods: A randomized,double-blind,placebo-parallel controlled,multicenter clinical trial design was used to conduct this study in 3 centers,and block randomization was used to analyze the data from the included patients in 3 centers.The experimental group was given Chaiqin Tonglin Tablets(4 tablets a time,3 times a day,warm water delivery),and the control group was given Chaiqin Tonglin Tablets placebo(4 tablets a time,3 times a day,warm water delivery).The observation course was 12 weeks,and the patients with no recurrence were followed up for at least 12 weeks after the end of treatment.Patients with no recurrence were followed up until the recurrence of urinary tract infection.The changes of TCM syndrome scores and disease efficacy were observed before and after treatment.Chi-square test or exact probability test or Wilcoxon rank sum test were used for classification data,and CMH test was used when central effect was considered.T-test was used for measurement data.Covariance analysis was used when central and covariate variables were considered.Logistic regression analysis was used when confounding factors were considered.Cox proportional risk model was used to analyze the related factors affecting recurrence.Endpoint events were defined as recurrence,and the survival time from the beginning of medication to recurrence was defined as the time.Kaplan-Meier survival analysis was used to describe the survival analysis.Log-rank and Breslow tests were used to compare the survival rate between the two groups(equivalent to the non-recurrence rate).P≤0.05 indicated a statistically significant difference.SPSS25.0 was used to establish the database and the relevant data were statistically analyzed.Results:1.Curative effect of single symptom of TCM: Experimental group and control group comparison frequency,urgency,urine pain,the lower abdomen detained the acute pain,irritability,bitter,make color of urine and urethral mouth heat,low back pain,constipation,chest tightness or chest pain and depression symptoms when no statistically significant differences between the two groups(P > 0.05),treatment good heave a deep sigh symptoms are similar between the two groups have statistical significance(P ≤0.05)or less.2.Cox regression analysis showed that age,course of disease,TCM syndrome score and antibiotic use intensity(DDD)were risk factors affecting patients’ recurrence(P < 0.05).3.Cox analysis for different subgroups: According to the different profession is divided into physical and Arnold group,according to the results,Arnold beta < 0,HR value < 1,and that taking Chai Qin tube piece of test group compared with control group,the risk of recurrence in patients with decreased,medication for protective factors,can delay the onset of a recurrence relatively,can reduce the risk of recurrent events by 54.2%;According to the Cox analysis of different age groups,β values of age groups ≤45,45 < age ≤55,55 < age ≤60,and 60 < age ≤65 were all < 0 and HR values were all < 1,indicating that compared with the control group,the treatment of Chaiqintonglin Tablets was a protective factor,which could appropriately reduce the risk of recurrence.The delay of recurrence was most significant in patients aged 60 years < age ≤65 years(β < 0,HR < 0.0001).3.Univariate Kaplan-Meier analysis was performed for different subgroups: disease duration≤ 5 years,and the difference between the experimental group and the control group was statistically significant(P < 0.05);When TCM syndrome score ≤20 points,the difference between the experimental group and the control group was statistically significant(P < 0.05).4.A total of 8 adverse events occurred during the trial,including 5 adverse events in the control group(25%)and 3 adverse events in the test group(16.67%),which were unrelated to the drug but related to the underlying diseases of the patients.In this study,all patients were examined for relevant safety indicators before and after treatment,and no obvious abnormalities were found.Conclusions: Chai Qin tong Lin piece for liver and qi stagnation and lower syndrome recurrent urinary tract infection has certain curative effect,the TCM symptom is lighter,relatively short duration patients can bring long-term benefit,and to a certain extent,reduce the child-bearing age,menopause and menopause transition patients with the disease risk of recurrence,the drug efficacy,and in the process of application,No obvious toxic and side effects have been found,which is worthy of clinical application.