Creinin M D, Vittinghoff E
Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco General Hospital.
JAMA. 1994 Oct 19;272(15):1190-5.
To compare the safety and efficacy of early abortion by administration of methotrexate and misoprostol vs administration of misoprostol alone.
Randomized controlled trial.
San Francisco (Calif) General Hospital.
Pregnant women at 56 days' gestation or less seeking elective abortion. Sixty-three women volunteered for the trial; 61 completed the study and are included in the analysis.
Intramuscular administration of 50 mg of methotrexate per square meter of body surface area followed 3 days later by vaginal administration of 800 micrograms of misoprostol (group 1) or the same dose of misoprostol given alone (group 2). The misoprostol dose was repeated 24 hours later if abortion had not occurred.
Successful abortion, duration of vaginal bleeding, side effects, and change in beta-human chorionic gonadotropin (beta-hCG) level. An abortion was considered successful if the pregnancy ended without requiring a surgical procedure.
Complete abortion occurred in 28 (90%) of 31 patients in group 1 and 14 (47%) of 30 patients in group 2 (P < .001). Seventeen (61%) of the 28 women in group 1 who aborted did so the same day as misoprostol administration; vaginal bleeding lasted a mean (+/- SD) of 10 (+/- 4) days, and beta-hCG level was less than or equal to 10 IU/L by a mean of 31 (+/- 6) days after methotrexate administration. The 11 other women in group 1 who aborted did so after a mean delay of 29 (+/- 11) days; vaginal bleeding lasted 7 (+/- 4) days, and beta-hCG level was less than or equal to 10 IU/L by a mean of 24 (+/- 11) days after the abortion. There were three treatment failures in group 1: two ongoing pregnancies (6%) and one incomplete abortion (3%). For the 14 women with successful abortions in group 2, vaginal bleeding lasted a mean of 10 (+/- 6) days and beta-hCG level was less than or equal to 10 IU/L by mean of 39 (+/- 18) days after the misoprostol. There were 16 treatment failures in group 2: eight ongoing pregnancies (27%), and eight incomplete abortions (27%). Methotrexate side effects were minimal. Misoprostol side effects were diarrhea in 18% and nausea and vomiting in 5%.
Methotrexate and vaginal misoprostol are more effective than misoprostol alone. Both drugs are available throughout the United States, and both drugs are inexpensive. This combination may offer an alternative to the use of antiprogestin and prostaglandin for medical abortion.
比较甲氨蝶呤与米索前列醇联合用药早期流产与单用米索前列醇的安全性和有效性。
随机对照试验。
加利福尼亚州旧金山总医院。
妊娠56天及以内寻求选择性流产的孕妇。63名女性自愿参加试验；61名完成研究并纳入分析。
按每平方米体表面积肌肉注射50mg甲氨蝶呤，3天后阴道给予800μg米索前列醇（第1组），或单用相同剂量的米索前列醇（第2组）。若流产未发生，24小时后重复米索前列醇剂量。
流产成功、阴道出血持续时间、副作用及β-人绒毛膜促性腺激素（β-hCG）水平变化。若妊娠无需手术干预而结束，则视为流产成功。
第1组31例患者中有28例（90%）完全流产，第2组30例患者中有14例（47%）完全流产（P<0.001）。第1组28例流产女性中有17例（61%）在使用米索前列醇当天流产；阴道出血平均（±标准差）持续10（±4）天，甲氨蝶呤给药后平均31（±6）天β-hCG水平≤10IU/L。第1组另外11例流产女性平均延迟29（±11）天流产；阴道出血持续7（±4）天，流产后平均24（±11）天β-hCG水平≤10IU/L。第1组有3例治疗失败：2例持续妊娠（6%）和1例不全流产（3%）。第2组14例流产成功的女性中，阴道出血平均持续10（±6）天，米索前列醇给药后平均39（±18）天β-hCG水平≤10IU/L。第2组有16例治疗失败：8例持续妊娠（27%）和8例不全流产（27%）。甲氨蝶呤副作用极小。米索前列醇副作用为腹泻18%，恶心和呕吐5%。
甲氨蝶呤与阴道米索前列醇联合用药比单用米索前列醇更有效。两种药物在美国均可获得且价格低廉。这种联合用药可能为药物流产中使用抗孕激素和前列腺素提供一种替代方案。
