Henderson Jillian T, Hwang Ann C, Harper Cynthia C, Stewart Felicia H
Center for Reproductive Health Research & Policy, University of California, San Francisco, CA 94143, USA.
Contraception. 2005 Sep;72(3):175-8. doi: 10.1016/j.contraception.2005.03.011.
Extensive data from clinical trials document mifepristone's safety and efficacy for induced abortion, but less information is available about its safety in routine clinical use.
Data on mifepristone abortion use from the Planned Parenthood Federation of America, the largest provider of mifepristone abortion in the United States, from 2001 through the first quarter of 2004 were collected using a centralized reporting system. Over the study period, 95,163 mifepristone abortions were provided. Reportable events are complications requiring inpatient or outpatient hospital treatment.
Overall, 2.2 per 1000 women (95% CI 1.9-2.5) experienced a complication, most commonly, heavy bleeding. Mifepristone abortion mortality is estimated to be 1.1 per 100,000 based on one death (95% CI 0.3-5.9).
The safety of mifepristone is high; few serious medical complications occur in routine clinical use.
临床试验的大量数据证明了米非司酮用于人工流产的安全性和有效性,但关于其在常规临床应用中的安全性信息较少。
使用集中报告系统收集了美国最大的米非司酮流产服务提供商美国计划生育联合会2001年至2004年第一季度米非司酮用于流产的数据。在研究期间,共提供了95,163例米非司酮流产服务。可报告事件为需要住院或门诊治疗的并发症。
总体而言,每1000名妇女中有2.2例(95%可信区间1.9 - 2.5)出现并发症,最常见的是大出血。基于一例死亡病例,米非司酮流产死亡率估计为每100,000例中有1.1例(95%可信区间0.3 - 5.9)。
米非司酮的安全性较高;在常规临床应用中很少发生严重的医学并发症。