米非司酮超药品说明书用药循证评价

Evidence-Based Evaluation of Off-Label Drug Use of Mifepristone

目的为米非司酮超药品说明书用药提供循证依据。方法检索PubMed、Embase、The Cochrane Library、中国知网、维普和万方数据库,检索时限为各数据库自建库起至2023年3月。筛选米非司酮治疗异位妊娠、稽留流产及围绝经期功能失调性子宫出血的系统评价/Meta分析,采用AMSTAR 2量表对纳入文献进行方法学质量评估,并依据GRADE分级对结局指标进行证据质量等级评价。结果共纳入7篇系统评价/Meta分析,其中英文文献1篇,中文文献6篇。方法学质量,低质量1篇,极低质量6篇;结局指标证据质量,中级3个,低级10个,极低级7个。7篇文献中,2篇报道了有利于异位妊娠患者治疗成功率升高,其中1篇还报道了有利于患者持续性异位妊娠发生率降低;1篇报道了有利于稽留流产患者完全流产率升高,二次清宫率降低;4篇报道了有利于围绝经期功能失调性子宫出血患者围绝经期功能性子宫出血症状和体征改善,其中1篇还报道了米非司酮高剂量(12.5 mg/d)的总有效率优于低剂量(6.5 mg/d)。结论米非司酮治疗异位妊娠、稽留流产及围绝经期功能失调性子宫出血的循证依据尚不充分,可能存在潜在的用药安全风险,仍需补充更多的高质量研究进一步考察。

Objective To provide evidence-based basis for the off-label drug use of mifepristone.Methods Systematic reviews/Meta-analyses of mifepristone in the treatment of ectopic pregnancy,missed abortion and perimenopausal dysfunctional uterine bleeding in PubMed,Embase,The Cochrane Library,CNKI,VIP and WanFang databases from the inception of each database to March 2023 were searched.The AMSTAR 2 scale was used to evaluate the methodological quality of the included studies,and the GRADE grading was used to evaluate the quality of evidence for outcome indicators.Results A total of seven systematic reviews/Meta-analyses were included,including one English study and six Chinese studies.One study was of low quality and six were of very-low quality in methodological quality.Three outcome indicators were of medium quality,ten were of low quality and seven were of very-low quality in evidence quality.Among the seven studies,two showed that mifepristone could increase the success rate of ectopic pregnancy treatment in patients,one of which also showed that this drug could decrease the incidence of persistent ectopic pregnancy;one study showed that mifepristone could increase the complete abortion rate of patients with missed abortion,and decrease the secondary uterine-evacuation rate;four studies showed that mifepristone could improve the symptoms and signs of patients with perimenopausal dysfunctional uterine bleeding,one of which also showed that the total effective rate of high-dose mifepristone(12.5 mg/d)was better than that of low dose(6.5 mg/d).Conclusion The evidence-based basis of mifepristone in the treatment of ectopic pregnancy,missed abortion and perimenopausal dysfunctional uterine bleeding is insufficient,and there may be potential medication safety risks.More high-quality researches are still needed for further investigation.