坤泰胶囊联合GnRH-a治疗子宫内膜异位症的Meta分析

Meta-analysis of Kuntai Capsules combined with GnRH-a in treatment of endometriosis

系统评价坤泰胶囊联合GnRH-a治疗子宫内膜异位症的有效性和安全性。计算机检索中国知网、万方、维普、PubMed、EMbase、Cochrane Library数据库,检索时间均从建库至2019年5月,收集坤泰胶囊联合GnRH-a治疗子宫内膜异位症的随机对照试验。由2位研究者根据纳入、排除标准进行文献的检索、筛选及资料提取,运用RevMan 5.3软件进行数据分析。共检索出58篇文献,最终纳入13个研究,总样本量1 041例,其中试验组523例,对照组518例。Meta分析结果显示:坤泰胶囊联合GnRH-a组较单纯GnRH-a组可降低子宫内膜异位症患者的促卵泡生成素、促黄体生成素及雌二醇水平,治疗期间围绝经期症状发生的不良事件发生率低(RR=0.46,95%CI[0.35,0.60],P<0.000 01),可以降低患者痛经的VAS评分(MD=-1.85,95%CI[-1.92,-1.78],P<0.000 01),且复发率方面联合用药组更低(RR=0.27,95%CI[0.09,0.77],P=0.01)。该研究发现,坤泰胶囊联合GnRH-a较单纯GnRH-a可降低子宫内膜异位症患者的促卵泡生成素、促黄体生成素及雌二醇水平,降低患者痛经VAS评分方面疗效更好,复发率及不良事件发生率更低,但仍需大规模、多中心、随机、双盲高质量临床试验的支持。

To systemically evaluate the efficacy and safety of Kuntai Capsules combined with GnRH-a in the treatment of endome-triosis. The databases of CNKI, WanFang, VIP, PubMed, EMbase and Cochrane Library were searched from their establishment to May 2019 to collect the randomized controlled trials of Kuntai Capsules combined with GnRH-a in the treatment of endometriosis. The data were searched, screened and extracted by two researchers according to the inclusion and exclusion criteria, and the data were analyzed by using RevMan 5.3 software. A total of 58 articles were collected and 13 studies were included. The total sample size was 1 041 cases, including 523 cases in the experimental group and 518 cases in the control group. The results of Meta-analysis showed that Kuntai Capsules combined with GnRH-a can reduce the level of follicle stimulating hormone(FSH), luteinizing hormone(LH) and estradiol(E2) in patients with endometriosis as compared with GnRH-a alone. With a low incidence of adverse events of peri-meno-pausal symptoms during treatment(RR=0.46, 95%CI[0.35, 0.60], P<0.000 01), it can reduce the VAS score of dysmenorrhea(MD=-1.85,95%CI[-1.92,-1.78],P<0.000 01). The recurrence rate in the combined treatment group was lower than that in the control group(RR=0.27, 95%CI[0.09,0.77], P=0.01). This study showed that Kuntai Capsules combined with GnRH-a can reduce the level of FSH, LH and E2 in patients with endometriosis, reduce the VAS score of dysmenorrhea, with lower incidence of adverse events and recurrence rate, but it still needs large-scale, multicenter, randomized, double-blind and high-quality clinical trials for support and evidence.