消结安胶囊治疗乳腺增生症有效性和安全性的Meta分析  

Meta-analysis of Efficacy and Safety of Xiaojiean Capsule in the Treatment of Hyperplasia of Mammary Glands

作　　者：彭喆睿 邓明港 丘婕帆 张志将[1] PENG Zherui;DENG Minggang;QIU Jiefan;ZHANG Zhijiang(Shool of Public Health,Wuhan University,Wuhan 430071,China)

机构地区：[1]武汉大学公共卫生学院,武汉430071

出　　处：《宁夏医科大学学报》2023年第11期1143-1148,共6页Journal of Ningxia Medical University

摘　　要：目的探讨消结安胶囊治疗乳腺增生症的有效性及安全性。方法在中国临床试验注册中心及6个数据库中,检索关于在乳腺增生症患者中开展的消结安胶囊单用或联合三苯氧胺使用(治疗组)对比三苯氧胺(对照组)的随机对照试验(RCT),检索时间限定为从建库至2022年1月18日。采用R语言分析软件对纳入研究的数据进行Meta分析,借助TSA v0.9软件进行试验序贯分析。结果与三苯氧胺相比,消结安胶囊在提高临床有效率[OR=3.24,95%CI(2.08,5.05),P<0.001]、临床痊愈率[OR=1.62,95%CI(1.25,2.09),P<0.001]、减少不良反应发生率[OR=0.12,95%CI(0.04,0.34),P=0.02]方面效果显著。结论治疗乳腺增生症方面,消结安胶囊无论是单独应用还是联合三苯氧胺应用相比于单独使用三苯氧胺,前者的临床疗效好,安全性更高。Objective To explore the effectiveness and safety of xiaojiean capsules in the treatment of breast hyperplasia.Methods Studies published before January 18,2022,were searched based on standardized rules in several mainstream databases.The inclusion criteria were the RCT of xiaojiean capsule used alone or in combination with tamoxifen(the treatment group)versus tamoxifen use alone(the control group)to treat hyperplasia of mammary glands.R language software package was applied for Meta-analysis of the included kinds of literature,and TSA v0.9 software was performed for trial sequential analysis.Results Compared with tamoxifen,xiaojiean capsule had significant effects in improving clinical efficacy[OR=3.24,95%CI(2.08,5.05),P<0.001],clinical cure rate[OR=1.62,95%CI(1.25,2.09),P<0.001],and the incidence of adverse reactions were reduced[OR=0.12,95%CI(0.04,0.34),P=0.02].Conclusion Current evidence indicates the use of xiaojiean capsule,either alone or in combination with tamoxifen,has advantages over tamoxifen alone in the treatment of breast hyperplasia,especially in terms of clinical efficacy and drug side effects.

关 键 词：消结安胶囊 乳腺增生症 随机对照试验 META分析 

分 类 号：R285[医药卫生—中药学]