米非司酮预处理用于早期妊娠丢失的药物治疗。
Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss.
机构信息
From the Pregnancy Early Access Center (PEACE), Division of Family Planning (C.A.S., S.S.), Department of Obstetrics and Gynecology (C.A.S., S.S., K.T.B.), University of Pennsylvania, Philadelphia; the Department of Public Health Sciences, University of Virginia, Charlottesville (S.J.R.); the Department of Obstetrics and Gynecology, University of California, Davis, Sacramento (M.D.C.); and the Department of Obstetrics and Gynecology, Montefiore Hospital and Albert Einstein College of Medicine, Bronx, NY (J.A.).
出版信息
N Engl J Med. 2018 Jun 7;378(23):2161-2170. doi: 10.1056/NEJMoa1715726.
BACKGROUND
Medical management of early pregnancy loss is an alternative to uterine aspiration, but standard medical treatment with misoprostol commonly results in treatment failure. We compared the efficacy and safety of pretreatment with mifepristone followed by treatment with misoprostol with the efficacy and safety of misoprostol use alone for the management of early pregnancy loss.
METHODS
We randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed to receive pretreatment with 200 mg of mifepristone, administered orally, followed by 800 μg of misoprostol, administered vaginally (mifepristone-pretreatment group), or 800 μg of misoprostol alone, administered vaginally (misoprostol-alone group). Participants returned 1 to 4 days after misoprostol use for evaluation, including ultrasound examination, by an investigator who was unaware of the treatment-group assignments. Women in whom the gestational sac was not expelled were offered expectant management, a second dose of misoprostol, or uterine aspiration. We followed all participants for 30 days after randomization. Our primary outcome was gestational sac expulsion with one dose of misoprostol by the first follow-up visit and no additional intervention within 30 days after treatment.
RESULTS
Complete expulsion after one dose of misoprostol occurred in 124 of 148 women (83.8%; 95% confidence interval [CI], 76.8 to 89.3) in the mifepristone-pretreatment group and in 100 of 149 women (67.1%; 95% CI, 59.0 to 74.6) in the misoprostol-alone group (relative risk, 1.25; 95% CI, 1.09 to 1.43). Uterine aspiration was performed less frequently in the mifepristone-pretreatment group than in the misoprostol-alone group (8.8% vs. 23.5%; relative risk, 0.37; 95% CI, 0.21 to 0.68). Bleeding that resulted in blood transfusion occurred in 2.0% of the women in the mifepristone-pretreatment group and in 0.7% of the women in the misoprostol-alone group (P=0.31); pelvic infection was diagnosed in 1.3% of the women in each group.
CONCLUSIONS
Pretreatment with mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone. (Funded by the National Institute of Child Health and Human Development; PreFaiR ClinicalTrials.gov number, NCT02012491 .).
背景
与子宫吸引术相比，早期妊娠流产的医学管理是一种替代方法，但米索前列醇的标准治疗通常会导致治疗失败。我们比较了米非司酮预处理后再用米索前列醇与单独使用米索前列醇治疗早期妊娠流产的疗效和安全性。
方法
我们随机分配了 300 名患有胚囊或胚胎或胎儿死亡的女性，她们分别接受了 200mg 米非司酮的口服预处理，然后接受了 800μg 的米索前列醇阴道给药（米非司酮预处理组），或单独接受了 800μg 的米索前列醇阴道给药（米索前列醇组）。在使用米索前列醇后 1 至 4 天，由一名不知道治疗分组的研究人员对参与者进行了评估，包括超声检查。对于未排出妊娠囊的女性，我们提供期待治疗、第二次米索前列醇剂量或子宫吸引术。我们在随机分组后 30 天内对所有参与者进行了随访。我们的主要结局是首次随访时一次使用米索前列醇后排出妊娠囊，且在治疗后 30 天内无需进一步干预。
结果
在米非司酮预处理组的 148 名女性中，有 124 名（83.8%；95%置信区间[CI]，76.8 至 89.3）在第一次随访时完全排出了妊娠囊，而在米索前列醇组的 149 名女性中，有 100 名（67.1%；95%CI，59.0 至 74.6）排出了妊娠囊（相对风险，1.25；95%CI，1.09 至 1.43）。子宫吸引术在米非司酮预处理组的发生率低于米索前列醇组（8.8% vs. 23.5%；相对风险，0.37；95%CI，0.21 至 0.68）。米非司酮预处理组有 2.0%的女性发生需要输血的出血，米索前列醇组有 0.7%的女性发生（P=0.31）；两组各有 1.3%的女性诊断为盆腔感染。
结论
与单独使用米索前列醇相比，米非司酮预处理后再用米索前列醇治疗更有可能成功治疗早期妊娠流产。（由国家儿童健康与人类发展研究所资助；PreFaiR ClinicalTrials.gov 编号，NCT02012491）。
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