Creinin M D
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, PA 15213-3180, USA.
Contraception. 1997 Dec;56(6):367-71. doi: 10.1016/s0010-7824(97)00173-x.
Methotrexate (50 mg/m2 intramuscularly and 50 mg orally) followed by vaginal misoprostol have proven to be > 90% effective at causing abortion in women at less than 49 days' gestation. Although the effectiveness of the oral dose (which has a lower serum bioavailability) demonstrates that a methotrexate dose of 50 mg/m2 may be more than necessary, an intramuscular regimen is more advantageous because it is less costly. This trial was designed to investigate the potential effectiveness of a single dose of methotrexate, 75 mg intramuscularly, in a regimen for early abortion. One hundred subjects received 75 mg methotrexate intramuscularly followed 5 to 6 days later by 800 micrograms misoprostol vaginally. The misoprostol dose was repeated if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), duration of vaginal bleeding, and side effects. One subject was lost to follow-up. Complete abortion occurred in 94 of 99 (94.9%, 95% CI 90.6, 99.3%) patients. The complete abortion rate was no different for earlier gestations: 38 of 40 (95.0%, 95% CI 88.2, 100%) at up to 42 days' gestation and 56 of 59 (94.9%, 95% CI 89.3, 100%) at more than 42 days' gestation (p = 0.99). Abortion occurred in the 24 h following the initial or repeat misoprostol dose (immediate success) in 70.7%; the remaining 24.2% of women who aborted did so after a delay of 22 +/- 10 days (mean + standard deviation). Vaginal bleeding lasted 17 +/- 8 days and 11 +/- 7 days in immediate success and delayed success patients, respectively. Overall, 77.8%, 86.9%, and 91.9% of patients had passed the pregnancy by 14, 28, and 35 days, respectively, after receiving methotrexate. This preliminary evaluation demonstrates that a medical abortion regimen using 75 mg methotrexate intramuscularly appears to have similar effectiveness to one with 50 mg/m2 methotrexate.
甲氨蝶呤（50mg/m²肌肉注射及50mg口服）随后给予阴道米索前列醇，已被证明在妊娠少于49天的女性中导致流产的有效率>90%。尽管口服剂量（其血清生物利用度较低）的有效性表明50mg/m²的甲氨蝶呤剂量可能超过必要剂量，但肌肉注射方案更具优势，因为成本更低。本试验旨在研究单剂量75mg甲氨蝶呤肌肉注射在早期流产方案中的潜在有效性。100名受试者接受75mg甲氨蝶呤肌肉注射，5至6天后给予800μg米索前列醇阴道给药。如果流产未发生，则重复米索前列醇剂量。结局指标包括流产成功（无需手术的完全流产）、阴道出血持续时间及副作用。1名受试者失访。99名患者中有94名（94.9%，95%CI 90.6，99.3%）发生完全流产。早期妊娠的完全流产率无差异：妊娠42天及以内的40名患者中有38名（95.0%，95%CI 88.2，100%），妊娠超过42天的59名患者中有56名（94.9%，95%CI 89.3，100%）（p = 0.99）。70.7%的患者在首次或重复米索前列醇给药后的24小时内发生流产（即刻成功）；其余24.2%流产的女性在延迟22±10天（均值±标准差）后发生流产。即刻成功和延迟成功的患者阴道出血分别持续17±8天和11±7天。总体而言，分别有77.8%、86.9%和91.9%的患者在接受甲氨蝶呤后的14天、28天和35天内排出妊娠物。该初步评估表明，使用75mg甲氨蝶呤肌肉注射的药物流产方案似乎与使用50mg/m²甲氨蝶呤的方案具有相似的有效性。
