乳宁颗粒治疗乳腺增生症临床疗效及安全性的系统评价

Systematic evaluation of Runing granule in the treatment of hyperplasia of mammary glands

目的:系统评价乳宁颗粒治疗乳腺增生症的临床疗效及安全性。方法:计算机检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库、Cochrane Library、Embase、PubMed、Web of Science,纳入比较乳宁颗粒单用(单用组)或联合其他疗法(联合组)与其他疗法(对照组)治疗乳腺增生症的随机对照试验,检索时间均从建库截至2020年6月。主要观察指标为有效率及不良反应发生率。采用Endnote软件进行文献管理,采用Excel软件进行数据提取,根据Cochrane系统评价手册5.1评价纳入研究的质量,使用Revman 5.3软件进行Meta分析。结果:最终共纳入12项随机对照试验,总计2 447例患者。Meta分析结果显示,在有效率方面,单用组优于对照组( RR=1.17,95% CI:1.00~1.36, P=0.04),联用组优于对照组( RR=1.35,95% CI:1.10~1.67, P=0.005),差异均具有统计学意义;在不良反应发生率方面,单用组低于对照组( RR=0.18,95% CI:0.09~0.34, P<0.01),联用组低于对照组( RR=0.33,95% CI:0.20~0.56, P<0.01),差异均具有统计学意义。 结论:乳宁颗粒单用或者联合其他疗法治疗乳腺增生症效果更好,不良反应发生率更低。

Objective:To assess the clinical effectiveness and safety of Runing granule for hyperplasia of mammary gland.Methods:The databases such as the CNKI,Wanfang Data,VIP,CBM,Cochrane Library,Embase,PubMed and Web of Science are searched from the date of their establishment to June 2020.The main outcome measures were effective rate and incidence of adverse events.All randomized control trial(RCT)about the clinical effectiveness and safety of Runing granule single(single group)or combined with other treatment(combined group)/other treatment(control group)for hyperplasia of mammary gland were included.Endnote software was used to manage literature,Excel software was used to extract data,quality assessment was conducted according to the methods of Cochrane Reviewers′Handbook 5.1 recommend by the Cochrane Collaboration and Revman 5.3 software was used to perform Meta-analysis.Results:Twelve RCT were included with total 2447 patients.In terms of efficiency,Meta-analysis showed single group was better than control group(RR=1.17,95%CI:1.00-1.36,P=0.04),combined group was better than control group(RR=1.35,95%CI:1.10-1.67,P=0.005).In terms of adverse event rate,single group was lower than control group(RR=0.18,95%CI:0.09-0.34,P<0.01),combined group was better than control group(RR=0.33,95%CI:0.20-0.56,P<0.01).Conclusion:The usage of Runing granule single or combined with other treatment in the treatment of hyperplasia of mammary gland is more effective and the adverse reaction is lower.