Dickinson J E, Godfrey M, Evans S F
Department of Obstetrics and Gynaecology, University of Western Australia, Perth, Australia.
J Matern Fetal Med. 1998 May-Jun;7(3):115-9. doi: 10.1002/(SICI)1520-6661(199805/06)7:3<115::AID-MFM3>3.0.CO;2-N.
A prospective randomized, double-blind, controlled clinical trial to compare the clinical efficacy and side effects of intravaginal misoprostol with the traditional prostaglandin, gemeprost, in second-trimester pregnancy interruption was conducted. A sample size of 100 women was calculated to demonstrate that misoprostol was as effective as gemeprost in achieving delivery within 24 hours (alpha = 0.1, 80% power). Women were recruited with fetal death in utero, severe fetal anomaly, or psychosocial pregnancy termination between 14 and 28 weeks gestation and randomized to receive either 1 mg gemeprost 3 hourly for 5 doses, or 200 mcg misoprostol 6 hourly for 4 doses, intravaginally. The therapeutic regimens were repeated if undelivered by 24 hours. Those undelivered after 48 hours received an extra-amniotic PGF2 alpha infusion. The median gestation at recruitment was identical: gemeprost 19 weeks (IQ 17-22 weeks) vs. misoprostol 19 weeks (IQ 17-21 weeks), P = 0.887. Delivery within 24 hours occurred in 75.1% of women receiving gemeprost and 74.9% receiving misoprostol (P = 1.0). The median time from prostaglandin commencement to delivery was similar: gemeprost 13.7 hours (IQ 9.0-23.5 hours) vs. misoprostol 16.9 hours (IQ 10.3-23.5 hours), P = 0.769. A significant reduction in the incidence of vomiting in women randomized to misoprostol occurred (34% vs. 13.2%, P = 0.017). There was no significant difference in the incidence of maternal fever > 37.5 degrees C, nausea, diarrhea, or placental retention. A 200-fold pharmaceutical cost advantage was observed with the use of misoprostol compared with gemeprost. Intravaginal misoprostol performs as effectively as gemeprost in achieving delivery in the second trimester without increase in adverse effects and displaying a significant cost advantage.
开展了一项前瞻性随机、双盲、对照临床试验，以比较阴道内使用米索前列醇与传统前列腺素吉美前列素在中期妊娠引产中的临床疗效和副作用。计算得出样本量为100名女性，以证明米索前列醇在24小时内实现分娩方面与吉美前列素效果相同（α = 0.1，检验效能80%）。招募妊娠14至28周之间出现宫内死胎、严重胎儿畸形或因社会心理因素要求终止妊娠的女性，并随机分为两组，一组每3小时阴道内给予1 mg吉美前列素，共5剂；另一组每6小时阴道内给予200 mcg米索前列醇，共4剂。若24小时内未分娩，则重复治疗方案。48小时后仍未分娩者接受羊膜外前列腺素F2α输注。入组时的妊娠中位数相同：吉美前列素组为19周（四分位间距17 - 22周），米索前列醇组为19周（四分位间距17 - 21周），P = 0.887。接受吉美前列素的女性中有75.1%在24小时内分娩，接受米索前列醇的女性中有74.9%在24小时内分娩（P = 1.0）。从开始使用前列腺素到分娩的中位数时间相似：吉美前列素组为13.7小时（四分位间距9.0 - 23.5小时），米索前列醇组为16.9小时（四分位间距10.3 - 23.5小时），P = 0.769。随机分组至米索前列醇组的女性呕吐发生率显著降低（34%对13.2%，P = 0.017）。产妇发热>37.5℃、恶心、腹泻或胎盘滞留的发生率无显著差异。与吉美前列素相比，使用米索前列醇在药物成本上有200倍的优势。阴道内使用米索前列醇在中期妊娠引产方面与吉美前列素效果相同，且无不良反应增加，还显示出显著的成本优势。
