左归丸加减方联合激素治疗卵巢早衰的Meta分析

Meta-analysis on modified Zuogui Pill combined with hormone in the treatment of premature ovarian failure

目的系统评价左归丸加减方联合激素治疗卵巢早衰(POF)的有效性和安全性。方法计算机检索中英文各数据库,检索时间为各数据库建库至2018年6月,纳入左归丸加减方联合激素治疗POF的随机对照研究(RCT),对纳入文献进行方法学质量评价,采用Rev Man 5. 3软件进行Meta分析。结果共纳入11个RCT,包括1 004例POF患者。Meta分析结果显示:左归丸加减方联合激素治疗POF在总有效率(OR=4. 44,95%CI:3. 10~6. 36,P <0. 000 01),中医证候(头晕、耳鸣、潮热盗汗、五心烦热、腰膝酸软),血清卵泡刺激素(FSH)水平(SMD=0. 54,95%CI:0. 13~0. 95,P=0. 01),黄体生成素(LH)水平(SMD=0. 90,95%CI:0. 45~1. 36,P <0. 000 1),雌二醇(E_2)水平(SMD=1. 26,95%CI:0. 12~2. 40,P=0. 03),子宫内膜厚度(WMD=2. 03,95%CI:0. 07~3. 99,P=0. 04)改善和不良反应发生率(OR=0. 34,95%CI:0. 12~0. 95,P=0. 04)方面均优于单纯激素治疗。结论左归丸加减方联合激素治疗POF的疗效及安全性均优于单纯激素治疗。

Objective To evaluate the effectiveness and safety of modified Zuogui Pill combined with hormone in the treatment of premature ovarian failure ( POF). Methods Randomized controlled trials were carried out by searching Chinese and English databases from the establishing to June, 2018. The methodological quality was assessed in the included randomized controlled trials. The treatment of premature ovarian failure by modified Zuogui Pill combined with hormone was systematically evaluated by RevMan 5. 3 software. Results 11 randomized controlled trials involving 1 004 patients were included. Meta-analysis results showed that total effective rate ( OR = 4. 44, 95% CI: 3. 10 - 6. 36, P <0. 00001 ), Tranditional Chinese Medcine (TCM ) syndromes ( including dizziness, tinnitus, hot flash night sweats, five upset fever, waist and knees), serum follicle stimulating hormone ( FSH ) level [ standardised mean difference (SMD)=0. 54, 95% CI: 0. 13-0.95, P =0. 01 ], luteinizing hormone (LH) level (SMD=0. 90, 95% CI: 0.45 -1.36, P<0.0001), estradiol ( E2) level (SMD = 1.26, 95% CI: 0. 12-2.40, P=0. 03), endometrial thickness [ weighted mean difference ( WMD)= 2. 03, 95% CI: 0. 07 - 3. 99, P = 0. 04 ] improvement and the incidence of adverse reactions ( OR =0. 34, 95% CI: 0. 12 - 0. 95 , P =0. 04) in modified Zuogui Pill combined with hormone therapy were superior to those of pure hormone therapy. Conclusions The modified Zuogui Pill combined with hormone therapy shows better therapeutic effect and safety than hormone therapy on premature ovarian failure.