中药口服汤剂联合米非司酮治疗子宫肌瘤的meta分析

A Meta-analysis of TCM Oral Decoction Combined with Mifepristone in the Treatment of Uterine Fibroids

目的:采用meta分析评价中药口服汤剂联合米非司酮治疗子宫肌瘤的疗效性及安全性。方法:检索CNKI、维普、万方、PubMed、The Cochrane数据库自建库至2017年10月关于中药口服汤剂联合米非司酮治疗子宫肌瘤的临床研究文献,选择符合要求的随机对照试验,提取数据并进行质量评价后使用Review Manager5.3软件进行meta分析。结果:最终纳入13个研究,共1300个患者。Meta分析结果显示,①B超下子宫肌瘤体积:治疗组疗效优于对照组[MD=-7.75,95%CI(-10.39,-5.11)],差异具有统计学意义;②B超下子宫体积:治疗组疗效优于对照组[MD=-17.35,95%CI(-23.24,-11.46)],差异具有统计学意义;③临床总有效率:治疗组的临床总有效率高于对照组[RR=1.22,95%CI(1.13,1.31)],差异具有统计学意义;④血清激素水平:4项血清激素指标[卵泡刺激素(FSH)、促黄体生成素(LH)、雌二醇(E2)、孕酮(P)]:中药汤剂联合米非司酮能更好的降低E2、LH、P,但是在降低FSH方面,治疗组和对照组的差异尚不能证明有统计学意义。结论:中药汤剂联合米非司酮治疗子宫肌瘤的临床效果比单纯使用米非司酮治疗的临床效果更好,前者在缩小子宫及肌瘤体积方面有较明显的优势,且无严重不良反应发生,但由于纳入试验的质量不高,尚需要纳入更多高质量的随机对照试验来进行验证。

Objective: To evaluate the clinical efficacy and safety of TCM oral decoction combined with Mifepristone in the treatment of uterine fibroids by Meta-analysis. Methods: CNKI, VIP, Wangfang, PubMed and Cochrane Databases were searched from their establishment to October, 2017 for randomized controlled trials(RCTs) on TCM oral decoction combined with Mifepristone in the treatment of uterine fibroids. According to the inclusion and exclusion criteria to select related RCTs. After all the studies were extracted data and assessed, Meta-analysis was conducted by using Review Manager 5.3 software.Results: A total of 13 RCTs involving 1300 patients were included. Meta-analysis results showed that, in the aspect of uterine fibroids volume change under the B-mode ultrasound, the curative effect in the treatment group was greater than that in the control group [MD =-7.75, 95% CI(-10.39,-5.11)] with statistically significant difference. In the aspect of uterine volume change under the B-mode ultrasound, the curative effect in the treatment group was greater than that in the control group [MD =-17.35, 95% CI(-23.24,-11.46)] with statistically significant difference. The total clinical effective rate in the treatment group was higher than that in the control group [RR = 1.22,95% CI(1.13, 1.31)] with statistically significant difference. In the level of 4 serum hormone indicators [folliclestimulating hormone(FSH), luteinizing hormone(LH), estradiol(E2), progesterone(P)], the decrease of E2, LH and P in the treatment group was greater than that in the control group after using CHM formula combined with Mifepristone. But there was no statistically significant difference in the decrease of FSH between the treatment group and the control group.Conclusion: CHM formula combined with Mifepristone is more effective than Mifepristone alone in the treatment of uterine fibroids. And there is an obvious advantage in the former on reducing the volume of uterus and fibroids without serious adverse reactions. However, due to the low quality of the included RCTs, more high-quality and standardized RCTs are needed to confirm the reliability of the conclusions.