Liu Yu-Nan, Zhang Shuang, Xu Dan, Liu Bei, Shan Jin-Jun, Xu Jian-Ya, Zhou Hui-Fang
Affiliated Hospital of Nanjing University of Chinese Medicine Nanjing 210029, China.
Institute of Pediatrics, Nanjing University of Chinese Medicine Nanjing 210023, China.
Zhongguo Zhong Yao Za Zhi. 2020 Apr;45(8):1933-1941. doi: 10.19540/j.cnki.cjcmm.20191127.502.
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(E_2) 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 E_2 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.
系统评价坤泰胶囊联合GnRH-a治疗子宫内膜异位症的疗效及安全性。检索中国知网、万方、维普、PubMed、EMbase和Cochrane图书馆数据库，检索时间从建库至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。由两名研究人员根据纳入和排除标准进行数据检索、筛选和提取，并使用RevMan 5.3软件进行数据分析。共收集到58篇文献，纳入13项研究。总样本量为1 041例，其中试验组523例，对照组518例。Meta分析结果显示，与单用GnRH-a相比，坤泰胶囊联合GnRH-a可降低子宫内膜异位症患者的促卵泡生成素（FSH）、促黄体生成素（LH）和雌二醇（E₂）水平。治疗期间围绝经期症状不良事件发生率较低（RR=0.46，95%CI[0.35，0.60]，P<0.000 01），可降低痛经的视觉模拟评分（VAS）（MD=-1.85，95%CI[-1.92，-1.78]，P<0.000 01）。联合治疗组的复发率低于对照组（RR=0.27，95%CI[0.09，0.77]，P=0.01）。本研究表明，坤泰胶囊联合GnRH-a可降低子宫内膜异位症患者的FSH、LH和E₂水平，降低痛经VAS评分，不良事件发生率和复发率较低，但仍需要大规模、多中心、随机、双盲、高质量的临床试验予以支持和验证。
