桂枝茯苓胶囊联合米非司酮治疗子宫肌瘤临床疗效和安全性的系统性评价  

A Systematic Review: Efficacy and Safety of Guizhi-Fuling Capsule Combined with Mifepristone in Patients with Uterine Fibroids

作　　者：韩兆忠[1,2,3] 刘茜[2,3] 郑伟然[2,3] 孟晓璞 王振中[2,3] 萧伟[2,3] 

机构地区：[1]天津中医药大学,天津300193 [2]江苏康缘药业股份有限公司,连云港222001 [3]中药制药过程新技术国家重点实验室,连云港222001

出　　处：《世界科学技术-中医药现代化》2016年第3期543-551,共9页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科学技术部"重大新药创制"科技重大专项(2011ZX09101-403):桂枝茯苓胶囊美国临床试验研究;负责人:王振中

摘　　要：目的:考察桂枝茯苓胶囊联合米非司酮治疗子宫肌瘤的有效性和安全性。方法:检索中国学术文献出版总库(CNKI)、维普电子期刊全文数据库(VIP)、万方数据库(Wangfang Data)、中国生物医学文献数据库(CBM)中所有桂枝茯苓胶囊联合米非司酮治疗子宫肌瘤的随机对照试验(RCTs)报道,对符合入排标准的研究采用Cochrane协作网推荐的"偏倚风险评估工具"予以质量评价,利用Revman 5.3对纳入研究的数据进行Meta分析。结果:共检索到247篇相关文献,筛选后共纳入19个试验,共2 069例患者。Meta分析结果显示:1 B超下子宫肌瘤体积:治疗组优于对照组[SMD=-0.69,95%CI(-1.12,-0.58)],差异性有统计学意义(P<0.000 01);2总有效率:治疗组优于对照组[OR=3.46,95%CI(2.05,5.84)],差异有统计学意义(P<0.000 01);3血清激素水平结果:FSH:SMD=-0.78,95%CI(-1.11,-0.46),P<0.000 01;LH:SMD=-0.59,95%CI(-0.91,-0.28),P<0.001;E2:SMD=-0.58,95%CI(-0.87,-0.30),P<0.000 1;P:SMD=-0.84,95%CI(-1.11,-0.56),P<0.000 01。这表明试验组激素水平明显低于对照组;4 3或6个月复发人数,治疗组显著少于对照组OR=0.25,95%CI(0.13,0.50),P<0.000 1。5 6个研究报道了不良事件发生情况,其中治疗组304个病人发生36例(11.84%),对照组298个病人发生60例(20.13%),治疗组显著少于对照组[OR=0.54,95%CI(0.34,0.84),P<0.01]。与药物相关的严重不良反应未见报道。结论:桂枝茯苓胶囊联合米非司酮对治疗子宫肌瘤有协同作用,具有远期疗效好,不良反应少的优点,是一种方便、安全、有效的治疗方法。This study was aimed to review the efficacy and safety of Guizhi-Fuling（GZFL） Capsule plus Mifepristone for the treatment of patients with uterine fibroids. A systemic search was conducted using broad terms to capture the randomized controlled trials（RCTs） involving GZFL Capsule plus Mifepristone（experimental arm） versus Mifepristone alone（control arm） in the treatment of patients with uterine fibroids retrieved from CNKI, VIP, WANFANG DATA and CBM. All eligible studies were evaluated by Cochrane Handbook, and analyzed by the meta-analysis of Revman 5.3 software. The results showed that a total of 247 articles were identified, of which 19 were used in this review, and a total of 2069 patients were enrolled. The results of meta-analysis showed a durable response, that the size of tumor by the ultrasound in experimental arm decreased significantly comparing with the control arm [SMD =-0.69, 95%CI（-1.12,-0.58）] with statistical difference（P〈 0.000 01）. The total effective rate of the experimental arm was better than the control arm [OR = 3.46, 95%CI（2.05, 5.84）] with statistical difference（P〈 0.000 01）. The hormone level in serum was significantly lower in the experimental arm than in the control arm, such as FSH： SMD =-0.78, 95%CI（-1.11,-0.46）, P〈 0.000 01; LH： SMD =-0.59, 95%CI（-0.91,-0.28）, P〈 0.001; E2： SMD =-0.58, 95%CI（-0.87,-0.30）, P〈 0.000 1; P： SMD =-0.84, 95%CI（-1.11,-0.56）, P〈 0.000 01. Recurrence rate by 3 to 6 months following up was lower in the experimental arm than in the control arm [OR = 0.25, 95%CI（0.13, 0.50）], P〈 0.000 1. Among 6 studies, 36 of 304 patients（11.84%） in the experimental arm and 60 of 298 patients（20.13%） in the control arm were reported one or more adverse events. However, the number of adverse events was significantly less in the experimental arm than in the control arm [OR = 0.54, 95%CI（0.34, 0.84）, P〈 0.01]. No treatment-related serious adverse events were reported. It was concluded that GZF

关 键 词：桂枝茯苓胶囊 米非司酮 子宫肌瘤 系统性评价 Meta分析 随机对照试验 

分 类 号：R285.5[医药卫生—中药学]