文献类型：期刊文献

中文题名：米非司酮治疗围绝经期功能失调性子宫出血疗效与安全性的系统评价

英文题名：Efficacy and Safety Mifepristone for Perimenopause Dysfunctional Uterine Bleeding: A Systematic Review

作者：顾静[1,2];杨克虎[1];张莉[3];汪小刚[3]

第一作者：顾静

机构：[1]兰州大学循证医学中心;[2]甘肃中医学院;[3]兰州大学基础医学院

第一机构：兰州大学循证医学中心

年份：2012

卷号：12

期号：4

起止页码：451

中文期刊名：中国循证医学杂志

外文期刊名：Chinese Journal of Evidence-Based Medicine

收录：CSTPCD;;Scopus;CSCD:【CSCD_E2011_2012】；

语种：中文

中文关键词：米非司酮;围绝经期;功能失调性子宫出血;系统评价

外文关键词：Mifepristone; Perimenopause; Dysfunctional uterine bleeding; Systematic review

摘要：目的系统评价米非司酮治疗围绝经期功能失调性子宫出血的疗效与安全性。方法计算机检索VIP、CNKI、WanFang Data、CBM,收集以米非司酮为主要干预措施治疗功能失调性子宫出血的随机对照试验(RCT),按Cochrane系统评价方法,评价纳入研究的方法学质量并提取有效数据进行Meta分析。结果共纳入了40个RCT,包括3 850例围绝经期功能性子宫出血患者。按照对照组干预药物特点分为两个亚组,即:诊刮+米非司酮vs.诊刮+雌孕激素,诊刮+米非司酮vs.诊刮+抗雌激素作用的药物。Meta分析结果显示:与诊刮联合雌孕激素相比,诊刮联合米非司酮可明显提高围绝经期功能性子宫出血症状和体征改善的总有效率[RR=1.11,95%CI(1.06,1.16),P<0.000 01],减少复发[RR=0.44,95%CI(0.36,0.52),P<0.000 01],但在子宫内膜的变化、血红蛋白的改善和FSH、LH、E2、P激素水平等方面差异无统计学意义。试验组和对照组出现不同程度皮疹、潮热、恶心、厌食、呕吐、乳胀等不良反应,但均无肝肾损害。因随访时间短,未能评价其长期安全性。结论本系统评价显示诊刮联合米非司酮治疗围绝经期功能性子宫出血的总有效率,减少复发率方面,具有一定的治疗优势,而在调节性激素水平、抑制子宫内膜增殖和改善贫血方面与诊刮联合其他雌孕激素组比较差异无统计学意义。由于纳入文献质量不高,存在较大偏倚风险,且不能评价米非司酮的长期安全性,导致该结果对围绝经期功能性子宫出血临床治疗的指导意义受限。
Objective To evaluate the efficacy and safety of mifepristone for perimenopause dysfunctional uterine bleeding（PDUB）.Methods Such databases as VIP,CNKI,Wanfang and CBM were retrieved for collecting randomized controlled trials（RCTs） on mifepristone for PDUB.The quality of included studies was evaluated and Meta-analysis was performed according to the Cochrane methods.Results Forty RCTs involving 3 850 PDUB patients were included.The control group was divided into two sub-groups according to the features of intervention drugs： the sub-group of diagnostic curettage plus progestational hormone,and the sub-group of diagnostic curettage plus antiestrogenic drugs.The Meta-analysis indicated that compared with the sub-group of diagnostic curettage plus progestational hormone,the diagnostic curettage plus mifepristone group was more effective to increase the total effective rate,such as improving symptoms and signs of PDUB（RR=1.11,95%CI 1.06 to 1.16,P0.000 01）,and to reduce recurrence（RR=0.44,95%CI 0.36 to 0.52,P0.000 01）.But no differences were found between the two groups in the change of endometrial thickness,contents of hemoglobin,and serum level of FSH,LH,E2 and P hormone.Both the intervention and control groups appeared mild adverse reactions,such as rashes,tidal fever,nausea,anorexia,vomiting and breast distending,but with no liver and kidney damages.The long-term safety failed to be evaluated due to short follow-up time.Conclusion Based on this review,diagnostic curettage plus mifepristone shows certain advantage in the treatment of PDUB including the total effective rate and reducing recurrence.But there is no difference in regulating sex hormone level,inhibiting endometrial proliferation and improving anemia compared with the group of diagnostic curettage plus progestational hormone.However,this evidence is not strong enough due to the low quality of included trials,possible bias risk,and failure of evaluating its long-term safety.