米非司酮配伍米索前列醇行药物流产的安全性评价

Side effect of mifepristone in combination with misoprostol for medical abortion

目的 评价米非司酮配伍米索前列醇行药物流产的安全性。方法 检索国内外 9个医学数据库及 9种中文期刊。采用循证医学的方法对收集有关药物流产安全性研究的文献 ,进行质量评价和数据提取 ;对数据不能合并进行分析时 ,则行定性系统评价。结果 共收集、纳入文献 10 1篇 ,病例 136 4例。其中为药物严重不良反应 115例 ( 8 4 3% ) ,包括药物过敏性和失血性休克、药物中毒性心律失常、抽搐及胎儿畸形等 ;一般不良反应 10 15例 ( 74 4 1% ) ,包括异常出血和轻、中度过敏反应等。系统评价提示 ,药物流产后出血量过多、腹痛、发热和眩晕的发生率比手术流产高 ,相对危险度(RR)及 95 %可信限 (CI)范围分别为 3 2 7,1 14～ 9 38;1 6 3,1 14～ 2 34;1 5 8,1 0 3～ 2 4 4 ;和1 36 ,1 0 6～ 1 75。药物流产后的出血时间比手术流产长 ,加权均数差 (WMD)为 6 4 9,95 %CI为6 0 8～ 7 80。药物流产有并发症者 177例 ( 12 98% ) ,包括滋养细胞疾病、宫腔粘连和继发不孕。为异位妊娠而误用药物流产者 5 7例 ( 4 18% )。结论 药物流产的严重不良反应发生率较低 ,不影响药物流产的临床应用 ,但需要健全监测药物流产不良反应的制度 ;减少药物流产后出血 。

Objective To assess the safety of mifepristone in combination with misoprotol for medical abortion Method Literatures on the safety of medical abortion were searched in 9 databases worldwide and 9 Chinese medical journals Results A total of 101 articles and 1364 women were collected Severe side effects including allergic or hemorrhagic shock, arrhythmia, convulsion and newborn deformities were observed in 115 cases A total of 1015 cases appeared vaginal bleeding, mild or moderate allergic reaction Systematic review found the relative risks (95% confidence interval, CI ) of bleeding, abdominal pain, fever and dizziness in the medical abortion population were 3 27 (1 14 ～ 9 38), 1 63 (1 14～ 2 34), 1 58 (1 03～ 2 44) and 1 36 (1 06～1 75), respectively These were higher in the medical abortion population than that in the surgical abortion population In addition, the duration of bleeding caused by medical abortion was longer than that caused by surgical abortion Its weighted mean difference was 6 49 and 95% CI was 6 08～7 80 Conclusions The incidence of side effects caused by this medical abortion was low However, attention should be paid in clinical practice to the rare, but severe adverse events caused by this treatment It is necessary to establish a comprehensive nationwide reporting system for these adverse events