坤泰胶囊联合激素替代治疗用于卵巢早衰疗效及安全性的系统评价

目的:基于荟萃分析(Meta分析)方法,系统评价坤泰胶囊联合激素替代治疗(hormone replacement therapy,HRT)用于卵巢早衰的疗效及安全性。方法:检索中国期刊全文数据库、维普数据库、万方数据库、中国生物医学文献数据库和PubMed数据库,检索时限为建库至2018年12月31日,收集坤泰胶囊联合HRT用于卵巢早衰的随机对照临床研究文献(研究组患者使用坤泰胶囊联合HRT;对照组患者单纯使用HRT),采用“偏倚风险评估工具”进行质量评价,运用RevMan 5.3软件对患者治疗前后的卵泡刺激素(FSH)、黄体生成素(LH)和雌二醇(E2)水平,症状积分,总有效率和不良反应发生情况进行Meta分析。结果:最终纳入15篇文献,涉及1343例患者。Meta分析结果显示,与单纯使用HRT比较,坤泰胶囊联合HRT能明显降低卵巢早衰患者的FSH水平(MD=-7.13,95%CI=-8.08^-6.19,P<0.00001)、LH水平(MD=-5.43,95%CI=-6.99^-3.88,P<0.00001),明显提高E2水平(SMD=1.14,95%CI=0.73~1.54,P<0.00001),明显降低症状积分(MD=-4.42,95%CI=-5.55^-3.28,P<0.00001),明显提高治疗总有效率(OR=3.53,95%CI=2.53~4.94,P<0.00001)和安全性(OR=0.56,95%CI=0.31~1.01,P=0.05),差异均有统计学意义。结论:坤泰胶囊联合HRT有明显优势,能在一定程度上改善卵巢早衰患者的临床症状,减少不良反应,提高安全性,可以作为较好的辅助搭配治疗。

Systematic Review of Efficacy and Safety of Kuntai Capsules Combined with Hormone Replacement Therapy in the Treatment of Premature Ovarian Failure

OBJECTIVE:To systematically evaluate the efficacy and safety of Kuntai capsules combined with hormone replacement therapy(HRT)in the treatment of premature ovarian failure based on the Meta-analysis method.METHODS:CNKI,VIP database,Wanfang database,CBM and PubMed were retrieved to collect the randomized controlled trials of Kuntai capsules combined with HRT in the treatment of premature ovarian failure(the study group was treated with Kuntai capsules combined with HRT,while the control group received HRT).The retrieval time was from establishment of the database to Dec.31st,2018.The risk of bias assessment tool was used for quality assessment.Meta-analysis was conducted on the levels of follicle-stimulating hormone(FSH),luteinizing hormone(LH)and estradiol(E2),symptom score before and after treatment,total effective rate and incidence of adverse drug reactions by using RevMan 5.3 software.RESULTS:Totally 15 literature were collected,including 1343 patients.Meta analysis results showed that compared with HRT alone,Kuntai capsules combined with HRT can significantly reduce the levels of FSH(MD=-7.13,95%CI=-8.08--6.19,P<0.00001)and LH(MD=-5.43,95%CI=-6.99--3.88,P<0.00001),significantly increase the levels of E2(SMD=1.14,95%CI=0.73-1.54,P<0.00001),and significantly reduce the symptom score(MD=-4.42,95%CI=-5.55--3.28,P<0.00001),significantly improve the total effective rate(OR=3.53,95%CI=2.53-4.94,P<0.00001)and safety(OR=0.56,95%CI=0.31-1.01,P=0.05),the differences were statistically significant.CONCLUSIONS:Kuntai capsules combined with HRT has obvious advantages,which can improve the clinical symptoms of patients with premature ovarian failure,reduce the adverse drug reactions,improve the safety,and can be used as the adjuvant treatment.