乳增宁联合他莫昔芬/托瑞米芬治疗乳腺增生的系统评价

Ruzengning and Tamoxifen/Toremifene for Fibrocystic Breast Disease:A Systematic Review

目的系统评价乳增宁联合他莫昔芬(TAM)/托瑞米芬(TOR)治疗乳腺增生的疗效和安全性。方法计算机检索CNKI、CBM、WanFang Data、VIP、PubMed、EMbase、Cochrane Library,检索时间均从建库至2019年3月,纳入有关乳增宁联合TAM/TOR治疗乳腺增生的随机对照试验(Randomized controlled trial,RCT),采用NoteExpress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评价纳入研究质量,使用Revman5.3软件进行Meta分析。结果最终纳入7篇RCT,共计1324例患者。Meta分析结果显示:在总有效率方面,乳增宁+TAM/TOR组优于乳增宁/TAM组[RR=1.16,95%CI(1.11,1.22),P<0.00001];在痊愈率方面,乳增宁+TAM/TOR组优于乳增宁/TAM组[RR=1.39,95%CI(1.08,1.79),P=0.01];在不良反应(ADR)发生率方面,乳增宁+TAM/TOR组低于乳增宁/TAM组[RR=0.27,95%CI(0.14,0.52),P<0.0001];在复发率方面,乳增宁+TAM/TOR组与乳增宁/TAM组无显著差异[RR=0.48,95%CI(0.21,1.12),P=0.09]。结论乳增宁联合他莫昔芬/托瑞米芬治疗乳腺增生疗效更好,不良反应更低。但由于纳入研究质量较低,上述结论尚需更高质量、更大样本的随机双盲对照试验加以证实。

Objective To assess the clinical effectiveness and safety of Ruzengning and Tamoxifen(TAM)/Toremifene(TOR)for Fibrocystic Breast Disease.Method The databases such as the CNKI,CBM,WanFang Data,VIP,PubMed,EMbase,Cochrane Library are searched from the date of their establishment to March 2019.All randomized control trials(RCTs)about the clinical effectiveness and safety of Ruzengning and TAM/TOR for Fibrocystic Breast Disease are included.Manage literature is performed with NoteExpress Software,Data extraction is performed with Excel software,Quality assessment are conducted according to the methods of Cochrane Reviewers’Handbook 5.1 recommend by The Cochrane Collaboration,and meta-analysis is performed with Revman 5.3 software.Results A total of 7 RCTs involving 1324 patients are included.In terms of total efficiency,Ruzengning+TAM/TOR group is better than Ruzengning/TAM group[RR=1.16,95%CI(1.11,1.22),P<0.00001];In terms of Cure rate,Ruzengning+TAM/TOR group is better than Ruzengning/TAM group[RR=1.39,95%CI(1.08,1.79),P=0.01];In terms of ADR rate,Ruzengning+TAM/TOR group is lower than Ruzengning/TAM group[RR=0.27,95%CI(0.14,0.52),P<0.0001].In terms of Recurrence rate,Ruzengning+TAM/TOR group and Ruzengning/TAM group is not statistically significant[RR=0.48,95%CI(0.21,1.12),P=0.09].Conclusion The combination therapy of Ruzengning and TAM/TOR in the treatment of Fibrocystic Breast Disease is more effective and the adverse reaction is lower.Therefore,due to low quality of the included studies,this conclusion has to be further proved with more high-quality,large-scale,and double-blind RCTs.