Schaff E A, Penmetsa U, Eisinger S H, Franks P
Department of Family Medicine, University of Rochester, NY 14620, USA.
J Reprod Med. 1997 Jan;42(1):56-60.
To determine whether methotrexate as a single agent for induced abortion in pregnancies up to 5 weeks is as effective, has fewer side effects and is as acceptable to subjects as the combination of methotrexate and misoprostol.
Women with no greater than a 5-week gestation were compared with a historical control group of consecutive women presenting for a medical abortion matched for gestational age. Subjects received intramuscular methotrexate on day 1. The study group received no misoprostol until day 21, when it was offered if the abortion had not yet occurred. The control group self-administered one or more doses of misoprostol within the first week after methotrexate. A complete abortion was defined by either negative transvaginal ultrasound or negative urine pregnancy test. All subjects completed a daily symptom log and satisfaction questionnaire. The analysis consisted of a comparison of the study group and control group for completion and timing of the abortion, symptoms and subject satisfaction.
There were 40 study subjects and 53 controls. All subjects had a medical abortion without surgery. Ten (25%) of the 40 study subjects reached study day 21 without bleeding: 4 used misoprostol and 6 chose to wait for the abortion to occur spontaneously. One of the 10 subjects had persistent embryonic cardiac activity at 21 days and aborted after misoprostol. The mean number of days to bleeding was 15.5 days (SD 7.8 days) for the study group as compared with 8.1 days (SD 11.3) (P = .0003) for the control group. There was no significant difference in the number of days of bleeding, gastrointestinal side effects or reported subject satisfaction.
While methotrexate as a single agent was effective in inducing abortion in early pregnancy, 15% of the study subjects finally used misoprostol, the abortion took significantly longer, and side effects were not less common as compared with those in subjects who received the combination of methotrexate and misoprostol.
确定甲氨蝶呤作为孕5周以内人工流产的单一用药,在效果、副作用及受试者接受度方面是否与甲氨蝶呤和米索前列醇联合用药相当。
将妊娠不超过5周的女性与同期前来接受药物流产且孕周匹配的历史对照组女性进行比较。受试者在第1天接受甲氨蝶呤肌内注射。研究组在第21天之前不使用米索前列醇,若至第21天仍未流产则给予米索前列醇。对照组在甲氨蝶呤注射后的第一周内自行服用一剂或多剂米索前列醇。完全流产定义为经阴道超声检查呈阴性或尿妊娠试验呈阴性。所有受试者均填写每日症状日志及满意度调查问卷。分析内容包括比较研究组和对照组在流产完成情况、流产时间、症状及受试者满意度方面的差异。
研究组有40名受试者,对照组有53名受试者。所有受试者均通过药物流产而非手术流产。40名研究组受试者中有10名(25%)至第21天仍未出血:4名使用了米索前列醇,6名选择等待自然流产。这10名受试者中有1名在第21天时胚胎仍有心跳,使用米索前列醇后流产。研究组出血的平均天数为15.5天(标准差7.8天),而对照组为8.1天(标准差11.3天)(P = 0.0003)。在出血天数、胃肠道副作用或受试者报告满意度方面,两组无显著差异。
虽然甲氨蝶呤作为单一用药在早期妊娠引产中有效,但15%的研究组受试者最终使用了米索前列醇,流产时间显著延长,且与接受甲氨蝶呤和米索前列醇联合用药的受试者相比,副作用并不少见。