散结镇痛胶囊治疗子宫内膜异位症的Meta分析

Meta-Analysis of Sanjie Analgesic Capsule in Treatment of Endometriosis

目的系统评价散结镇痛胶囊(Sanjie analgesic capsule,SAC)治疗子宫内膜异位症(Endometriosis,EMT)的临床有效性、安全性,以期指导临床用药。方法全面检索SAC治疗EMT的随机对照试验相关文献并进行系统评价,按Jadad量表评价文献的质量,采用Revman4.2软件进行统计分析。结果 13篇文献符合纳入标准,Meta分析结果显示单纯性药物治疗EMT时SAC组临床有效率、妊娠率均高于激素组(P值分别为0.002和0.01),其不良反应率尤其肝功能损害率明显低于激素组(P值分别为<0.00001和0.0003);腹腔镜保守性手术治疗EMT后辅以药物治疗SAC组临床有效率、妊娠率与激素组无明显差别(P分别为0.52和0.12),其肝功能损害亦明显低于激素组(P<0.00001)。倒漏斗图基本对称,发表偏倚较小。结论 SAC治疗EMT是一种有效安全的方法。但还需要严格设计的、大样本的随机双盲对照试验进一步验证。

Objective To make a systematic analysis of the clinical effects and safety of Sanjie analgesic capsule（SAC） in treatment of endometriosis（EMT） in order to guide clinical medication.Methods The documents and literatures of randomized controlled trials about EMT treated by SAC were searched and systematically evaluated.The qualities of all literatures were assessed according to Jadad scale,and all data were analyzed by Revman 4.2 software.Results Thirteen trials were collected according to the inclusion criteria.Meta analysis showed that the clinical efficiency rate and pregnancy rate of single SAC group were higher than those of single gonadal hormone（GH） group（P=0.002 and P=0.01）,the adverse effect rate especially the rate of liver dysfunction of single SAC group were significantly lower than those of single GH group（P0.00001 and P=0.0003）.As assisted treatment by SAC after laparoscopic conservative operation,there was no statistical difference between SAC group and GH group on clinical efficiency rate and pregnancy rate（P=0.52 and P=0.12）,the rate of liver dysfunction of SAC group was also lower than that of GH group（P0.00001）.The symmetry presented in the funnel plot suggested minor publication bias.Conclusion The SAC therapy for EMT is effective and safe.However,this conclusion needed further verification by randomized double-blind controlled trials with larger size sample and more rigorous trial design.