Purpose:Through the collection of literatures,evidence-based medicine was used to systematically evaluate the efficacy and safety of addition and subtraction of Fangji Huangqi Tang combined with western medicine in the treatment of adult primary nephrotic syndrome.Method:Based on the systematic evaluation method provided by the International Cochrane Collaboration,Tsinghua Tongfang CNKI series database,Wanfang Series Data Resource System,database of Chinese science and technology journals,database of Chinese biomedical literature,Pubmed,COCHRAN library.Randomized controlled trials of all the addition and subtraction of Fangji Huangqi Tang combined with western medicine in the treatment of adult primary nephrotic syndrome.The search period is from the establishment of the reservoir to January 2018,and manually search the relevant domestic professional magazine and conference information.The two reviewers independently selected documents,extracted data,and included research quality evaluations according to the inclusion and exclusion criteria established.After cross-checking and agreeing to reach a unanimous opinion,the collected data were processed using statistical methods of meta-analysis.The software used is Rev Man5.3.First of all,to analyze the heterogeneity of each included study data,the method used is χ2 test,the test standard is α = 0.1,I2 = 50%.If P≥0.10 and I2≤50%,it indicates that there is no obvious statistical heterogeneity among the research data,which can be analyzed by the fixed effect model.If P<0.1 and(or)I2>50%,it indicates that the statistical heterogeneity among the research data is large,and the source of heterogeneity needs to be further analyzed.Subgroup analysis or sensitivity analysis is used for processing.If no obvious source of heterogeneity can be found,a random effects model can be used for analysis.Odd ratio was used as the effect variable for the second-order data.When the analysis data is a continuous variable and the measurement method or unit is exactly the same,the mean difference is used as the effect amount;If different,we use the standardized mean difference as effect.The data of the secondary variables and continuous variables are represented by 95% confidence intervals.Result: Final inclusion of 13 articles that meet the criteria for a total of 913 patients.All included articles are Chinese literature and all studies are randomized controlled trials.The control group were treated with Western conventional regimens including hormone immunosuppression、diuretic、prote inuria、lipid-lowering、anticoagulation and etc.The experimental group were in the control group on the basis of Western conventional treatment program combined with addition and subtraction of Fangji Huangqi Tang.Meta analysis results show:In the total clinical efficiency,addition and subtraction of Fangji Huangqi Tang combined with western medicine group was better than western medicine group[OR=3.27,95% CI(2.08,5.14),P<0.00001];The difference was statistically significant.Observed aspects of the test indicators,whether it is urinary protein quantitation 24 hours after treatment[MD=-0.89,95% CI(-1.06,0.73),P<0.00001]、plasma albumin levels[MD=4.72,95% CI(3.94,5.51),P<0.00001]、total cholesterol[MD=-1.09,95% CI(-1.68,-0.49),P=0.0003]、triglycerides[MD=-24.69,95% CI(-31.07,-18.31),P<0.00001] or interleukin-6(IL-6)[MD=-24.69,95% CI(-31.07,-18.31),P<0.00001] and IL-8[MD=-27.64,95% CI(-39.43,-15.85),P<0.00001],the addition and subtraction of Fangji Huangqi Tang combined with Western medicine group was better than that of western medicine group,and the difference was statistically significant.In the case of publication bias,take the total efficiency as an example,use the funnel graph to analyze the publication bias of 13 included documents.The results suggest possible potential publication bias.In terms of safety,only two of the 11 studies included reported adverse events or adverse events during the trial,and the remaining nine studies did not submit the adverse reactions in the course of treatment with the addition and subtraction of Fangji Huangqi Tang combined with western medicine;Because of incomplete data,it is impossible to carry out statistical analysis.Discuss:The results of this study show that the addition of antifungal Huangqi Decoction combined with western medicine in the treatment of adult primary nephrotic syndrome can significantly improve the total effective rate of clinical treatment,reduce 24 h urinary protein,increase plasma albumin levels,reduce lipid to improve lipid metabolism in vivo and Reduce the body’s expression of inflammatory cytokines,it is worth to promote clinical use.However,adverse effects included in the study were not standardized or data were missing,and their safety was not evaluated effectively.The safety of the study is for further study.Due to the quality of the included literature,the small sample size,and the publication bias,which indicates that there is some publication bias that affects the credibility of the above results,the evidence in this study is of limited strength.The future still requires large,multicenter,high-quality randomized controlled trials to confirm the effectiveness and safety of Fang Ji Huangqi soup combined with Western medicine in the treatment of adult primary nephrotic syndrome. |