桂枝茯苓胶囊与西药治疗子宫肌瘤疗效比较的系统评价

目的比较桂枝茯苓胶囊与西药治疗子宫肌瘤的有效性和安全性。方法计算机检索CBM（1979～2009）、CNKI（1979～2009）、VIP（1989～2009）和万方数据库（1998～2009）,并辅以手工检索天津中医药大学图书馆过刊资料库,收集桂枝茯苓胶囊和西药比较治疗子宫肌瘤的临床随机对照试验,由两名评价者独立提取资料并按照Cochrane Reviewer＇s Handbook 5.0进行质量评估,统计学分析采用RevMan 5.0.22软件。结果共纳入8个临床随机对照试验,合计798例患者。Meta分析结果显示：①B超下子宫肌瘤体积差：桂枝茯苓胶囊＋米非司酮优于米非司酮[WMD=0.64,95%CI（0.56,0.71）];②血清激素水平：桂枝茯苓胶囊＋米非司酮与米非司酮在FSH[WMD=2.40,95%CI（–3.09,7.89）]、LH[WMD=1.22,95%CI（–1.05,3.49）]、E2[WMD=11.07,95%CI（–7.70,29.84）]和P[WMD=0.52,95%CI（–0.33,1.37）]方面,差异均无统计学意义;③临床症状改善有效率：桂枝茯苓胶囊试验组在月经过多[RR=1.10,95%CI（1.00,1.20）]、痛经[RR=1.56,95%CI（1.22,1.99）]、腹痛腹胀[RR=1.34,95%CI（1.11,1.61）]方面均优于米非司酮;④临床总有效率：桂枝茯苓胶囊＋米非司酮优于米非司酮[RR=1.16,95%CI（1.02,1.32）];⑤远期疗效：4个试验提示试验组远期疗效优于对照组。结论桂枝茯苓胶囊与米非司酮合用与单用米非司酮比较在缩小子宫肌瘤体积、改善临床症状、提高临床总有效率和远期疗效上有一定优势;而单用桂枝茯苓胶囊与单用米非司酮比较尚未见疗效差异。由于纳入研究质量不高,上述结论尚需更多高质量的随机双盲对照试验加以验证。

Guizhifuling Capsule versus Western Medicine for the Treatment of Uterine Myoma:A Systematic Review

Objective To assess the efficacy and safety of Guizhifuling capsule versus western medicine in the treatment of uterine myoma.Methods Randomized controlled trials（RCTs） involving Guizhifuling capsule versus western medicine in the treatment of uterine myoma were identified from CBM（1978 to 2009）,VIP（1989 to 2009）,WANFANG Database（1998 to 2009）,CNKI（1979 to 2009）.We also manually searched relevant journals from Tianjin University of Traditional Chinese Medicine.Data were extracted and evaluated by two reviewers independently with a specially designed extraction form.The Cochrane Collaboration＇s RevMan 5.0.22 software was used for data analyses.Results A total of 8 trials involving 798 patients were included.The results of meta-analyses showed that,a） the mean uterine myoma volume in the experimental group was different when compared with the mifepristone group（WMD= 0.64,95%CI 0.56 to 0.71）;b） no difference was found between the experimental group and the mifepristone group in serums hormone level,such as,follicle-stimulating hormone（WMD= 2.40,95%CI – 3.09 to 7.89）,luteinizing hormone（WMD= 1.22,95%CI – 1.05 to 3.49）,estriol（WMD= 11.07,95%CI – 7.70 to 29.84）,and P（WMD= 0.52,95%CI – 0.33 to 1.37）;c） As for clinical symptoms effective rate,significant difference was noted between the experimental group and the mifepristone group,such as,menorrhagia（RR= 0.49,95%CI 0.25 to 0.94）,dysmenorrheal（RR= 0.12,95%CI 0.04 to 0.38）,and bellyache and abdominal distension（RR= 0.28,95%CI 0.12 to 0.62）;d） In terms of the total effective rate,significant differences were noted between the experimental group and the mifepristone group（RR= 1.16,95%CI 1.02 to 1.32）;and e） Four trials reported the long-term follow-up results in which the experimental group was better than that in the control group.Conclusion The treatment of uterine myoma by Guizhifuling capsule plus mifepristone is superior to that by mifepristone alone in reducing uterine myoma volume,clinical symptom,and long-term follow-up results.Singly using Guizhifuling capsule is not inferior to western medicine.Further large-scale trials are required to define the role of Guizhifuling capsule in the treatment of uterine myoma.