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

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2069例患者。Meta分析结果显示：①B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<0.00001）；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<0.00001）；③血清激素水平结果：FSH：SMD=-0.78，95%CI（-1.11，-0.46），P<0.00001；LH：SMD=-0.59，95%CI（-0.91，-0.28），P<0.001；E2：SMD=-0.58，95%CI（-0.87，-0.30），P<0.0001；P：SMD=-0.84，95%CI（-1.11，-0.56），P<0.00001。这表明试验组激素水平明显低于对照组；④3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<0.0001。⑤6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。

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

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 5.3software.The results showed that a total of 247 articles were dentified,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<0.00001).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<0.00001).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<0.00001;LH:SMD=-0.59,95%CI(-0.91,-0.28),P<0.001;E2:SMD=-0.58,95%CI(-0.87,-0.30),P<0.0001;P:SMD=-0.84,95%CI(-1.11,-0.56),P<0.00001.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<0.0001.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 GZFL Capsule plus Mifepristone compared with Mifepristone alone showed well-tolerated,which had a synergisti