| Background: the prevalence of Mn in China is on the rise.At present,hormone combined with immunosuppressant is often used in clinical treatment,but it also brings more side effects and adverse reactions.In recent years,traditional Chinese medicine has shown better efficacy and safety in IMN treatment.Objective:to evaluate the clinical efficacy and safety of Yiqi Huoxue Method in the treatment of idiopathic membranous nephropathy(IMN)diagnosed by renal histopathology.Methods:two researchers searched the database comprehensively and systematically from January 2010 to December 2019 according to the Na exclusion standard.The cross databases included CNKI,CBM disc,VIP,Wanfang medical database,web of science,Pub Med,etc.After collecting the data and extracting the data,the Cochrane system evaluation manual and Jadad scoring scale were used for quality evaluation.Finally,Revman 5.3 software was used for meta analysis of the total effective rate,24-hour urine protein quantification,serum albumin,serum creatinine,urea nitrogen,total cholesterol,triglyceride and other outcome indicators and related adverse reactions.All outcome indicators were sensitized according to one by one elimination method Sensibility analysis,and according to the literature quality level,the control group treatment measures for different sub group analysis.Results:1.A total of 438 articles were retrieved from meta analysis of the treatment of IMN by Yiqi Huoxue Method.After repeated comparison and screening with Napai standard,they were finally included in 14 clinical randomized controlled trials.The control group was treated with western medicine alone or combined with immunosuppressive therapy;the experimental group was treated with Yiqi Huoxue Chinese medicine on the basis of the control group.2.In terms of clinical efficacy,the results of heterogeneity of total effective rate [chi~2 = 13.9,df= 12(P = 0.31),I~2 = 14%],using fixed effect model,combined with the analysis results [RR= 1.18,95% CI(1.10,1.26),z = 4.69,P < 0.00001],suggesting that the total effective rate of the experimental group is better than that of the control group;the results of heterogeneity of 24-hour urine protein [chi~2 = 118.10,df= 13(P < 0.00001),I~2 = 89%],using random method The results of combined analysis showed that [MD =-1.11,95% CI(-1.45,-0.77),z = 6.36,P < 0.00001],suggesting that the effect of reducing urinary protein in the experimental group was better than that in the control group;the results of heterogeneity of serum albumin [Chi2 = 71.98,df= 13(P < 0.00001),I~2 = 82%],using the random effect model,combined results [MD =2.85,95% CI(1.98,3.72),z = 6.44,P < 0.00001 The results showed that there was no significant difference between the experimental group and the control group in reducing serum creatinine;The results of urea nitrogen heterogeneity(chi~2 = 242.00,df= 9(P <0.00001),I~2 = 96%).Using the random effect model,the combined results(MD =-0.36,95% CI(-1.35,0.63),z = 0.7,P = 0.48)indicate that there is no significant difference between the experimental group and the control group in reducing urinary nitrogen.The results of total cholesterol heterogeneity(chi~2 =11.89,df= 6(P = 0.06),I~2 = 50%)Results [MD =-0.75,95% CI(-1.03,-0.48),z = 5.36,P < 0.00001],suggesting that the effect of the experimental group is better than that of the control group in reducing total cholesterol;the heterogeneity of triglyceride results [Ch I~2 = 35.79,df= 5(P < 0.00001),I~2 = 86%],using the random effect model,combined results [MD =-0.42,95% CI(-0.71,-0.12),z = 2.7 8,P = 0.005),indicating that the effect of the test group in reducing triglyceride is better than that of the control group.3.Due to the small number of studies,only 24-hour urinary protein subgroup analysis was carried out.(1)The control group was divided into two groups according to different treatment measures:group A was treated with traditional Chinese medicine + western medicine basic therapy vs Western medicine basic therapy;group B was treated with traditional Chinese medicine + basic therapy combined with hormone and / or immunosuppressant vs basic therapy combined with hormone and / or immunosuppressant.Results: the combined effect amount of group A was [MD =-1.07,95% CI(-1.49,-0.65),P < 0.00001],the combined effect amount of group B was[MD =-1.22,95% CI(-1.93,-0.51),P = 0.0007),indicating that the results of the two groups have significance,and the two groups still show a high degree of heterogeneity,indicating that different treatment measures in the control group are not the source of 24-hour urine protein heterogeneity;(2)according to the length of follow-up,the first group(? 90 days)I~2 = 89%,the combined results show MD =-1.25,95% CI(-1.77,-0.72),P < 0.00001;the second group(The results showed that MD =-0.92,95% CI(-1.43,-0.42),P < 0.00001,the two groups still showed high heterogeneity,indicating that the length of follow-up was not the heterogeneity source of 24-hour urine protein quantification.4.Safety heterogeneity [chi~2 = 1.85,df= 6(P = 0.93),I~2 =0%],using fixed effect model,combined results [RR = 0.53,95% CI(0.31,0.89),z = 2.40,P = 0.02],suggesting that the incidence of adverse reactions in the experimental group is lower than that in the control group.5.The results of sensitivity analysis showed that the results of meta analysis of total effective rate,24-hour urinary protein,serum albumin,serum creatinine,urea nitrogen and safety were stable.Among them,two papers of medium and low quality had great influence on the results of heterogeneity of total cholesterol and triglyceride,suggesting that they were the source of heterogeneity.Conclusion:the treatment of IMN mainly by the method of Supplementing Qi and activating blood circulation can improve the total effective rate,reduce 24-hour urine protein quantity,increase serum albumin,reduce total cholesterol and triglyceride... |
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