Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland:A meta-analysis and trial sequential analysis  

作　　者：Bao-Yong Lai Ai-Jing Chu Li-Yan Jia Shi-Bing Liang Xiao-Hua Pei 

机构地区：[1]The Third Affiliated Hospital of Beijing University of Chinese Medicine,Beijing 10029,China [2]The School of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing 10029,China [3]Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China [4]The Xiamen hospital of Beijing University of Chinese Medicine,Xiamen 361001,China

出　　处：《Journal of Hainan Medical University》2021年第20期37-43,共7页海南医学院学报（英文版）

基　　金：Standardization Project of Clinical Application Guide for Chinese Patent Medicine in the Treatment of Dominant Diseases(No.SATCM-2015-BZ402)。

摘　　要：Objective:To evaluate the efficacy and safety of Rupi Sanjie(RPSJ)capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland.Methods:A meta-analysis was conducted on randomized controlled trials(RCT)related to RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary gland.The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions.RevMan5.3 and Stata14.0 were used for data analyses.Trial sequential analysis was performed to estimate the sample size of systematic review base on TSA software v0.9.Results:Twenty-two RCTs were totally included in this study,involving 2135 patients.The result showed the clinical recurrence rate of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment alone group(RR:0.25,95%CI[0.17,0.37],P<0.01).The clinical cure rate and total effective rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical treatment group(RR:1.63,95%CI[1.46,1.82],P<0.01);(RR:1.29,95%CI[1.22,1.37],P<0.01).Application of RPSJ capsule decreased the occurrence of adverse events including nausea,vomiting,irregular menstruation,constipation,dizziness,and headache etc.(RR:0.90,95%CI[0.54,1.49],P=0.68).The results of trial sequential analysis demonstrated that the current available data did not reach the expected value.Conclusion:RPSJ capsule plus the conventional surgical treatment was more effective in reducing the clinical recurrence rate,and improving the total clinical effective rate and clinical cure rate,with a decrease in the occurrence of adverse events.

关 键 词：Rupi Sanjie capsule Hyperplasia nodule of mammary GLAND RCTS META-ANALYSIS Trial sequential analysis 

分 类 号：R73[医药卫生—肿瘤]