坤泰胶囊联合克龄蒙治疗卵巢早衰疗效的荟萃分析

目的系统评价坤泰胶囊联合克龄蒙治疗卵巢早衰的临床疗效,以期为临床提供循证参考。方法计算机搜索PubMed、Embase、Cochrane library、CNKI、VIP、万方数据库,收集关于坤泰胶囊联合克龄蒙治疗卵巢早衰的随机对照试验(randomized controlled trials,RCTs),2名研究者独立严格进行纳入研究的质量评价和资料提取,采用RevMan 5.2软件进行meta分析。结果最终纳入14个RCTs,共1380例患者。Meta分析结果显示,与对照组比较,坤泰胶囊联合克龄蒙组总有效率[OR=3.76,95%CI=(2.49,5.70),P<0.00001]、缓解临床症状(Kupperman评分)[MD=-3.95,95%CI=(-4.88,-3.03),P<0.00001]、降低血中FSH水平[MD=-8.25,95%CI=(-10.70,-5.79),P<0.00001]、提高血中E2水平[MD=14.62,95%CI=(12.05,17.19),P<0.00001]均存在明显优势,差异均有统计学意义;而在降低血中LH水平、降低不良反应发生率方面,则差异无统计学意义。结论坤泰胶囊联合克龄蒙治疗卵巢早衰具有一定疗效,但现有研究质量偏低,且数量偏少,需要更多高质量、多中心的随机双盲临床试验的进一步验证。

Meta-analysis of the Efficacy of Kuntai Capsule Combined with Climen in the Treatment of Premature Ovarian Failure

OBJECTIVE To provide evidence for clinic by systematic evaluating the efficacy of Kuntai Capsule combined with Climen in the treatment of premature ovarian failure. METHODS The PubMed, Embase, Cochrane library, CNKI, VIP and WanFang databases were searched for randomized controlled trials(RCTs) of Kuntai Capsule combined with Climen in the treatment of premature ovarian failure. Two researchers independently and strictly conducted the quality evaluation and data extraction of the included studies, and meta analysis was conducted with RevMan 5.2 software. RESULTS A total of 14 RCTs were included, involved 1 380 patients. The results of meta-analysis showed that the total efficiency[OR=3.76, 95% CI=(2.49, 5.70), P<0.000 01], the score of Kupperman[MD=-3.95, 95% CI=(-4.88, -3.03), P<0.000 01], decreasing the serum levels of FSH[MD=-8.25, 95% CI=(-10.70, -5.79, P<0.000 01)] and increasing the serum levels of E₂[MD=14.62, 95% CI=(12.05, 17.19), P<0.000 01] in test group were better than control group, with statistical significance. But There was no statistical significance neither in decreasing the serum levels of LH nor reducing the incidence of adverse reactions between Kuntai Capsule combined with Climen group and control group. CONCLUSION Kuntai Capsule combined with Climen have potential advantages in the treatment of premature ovarian failure. However, the quality of existing research is low and the number is too small, which required more high-quality, multi-center randomized double-blind clinical trials for further validation.