Tejuja S, Choudhury S D, Manchanda P K
Contraception. 1978 Dec;18(6):641-52. doi: 10.1016/0010-7824(78)90048-3.
The Indian Council of Medical Research initiated a multicentric trial with prostaglandins in 1976 to assess the safety and efficacy of their use in midtrimester abortions. PGF2 alpha and 15-Me-PGF2 alpha were compared using the intra-amniotic (I.A.) route. 15-Me-PGF2 alpha was also evaluated by extra-amniotic (E.A.) route. With intra-amniotic instillation, success rate was 88.1 per cent with PGF2 alpha and 93.0 per cent with 15-Me-PGF2 alpha within 48 hours and by the extra-amniotic route it was 78.1 per cent within 36 hours. The mean induction-abortion interval was 19 hours with I.A. and 14.8 hours with E.A. Abortions were complete in 48.8 per cent of the women following I.A. PGF2 alpha, 56.0 per cent following I.A. 15-Me-PGF2 alpha and only 23.0 per cent following E.A. administration. Vomiting and diarrhoea were the most commonly reported side effects. Cervical injuries were 4.7 per cent with I.A. PGF2 alpha, 1.4 per cent with I.A. 15-Me-PGF2 alpha and only 0.6 per cent with E.A. route.
1976年,印度医学研究理事会发起了一项关于前列腺素的多中心试验,以评估其在中期妊娠流产中使用的安全性和有效性。使用羊膜腔内(I.A.)途径比较了前列腺素F2α和15-甲基前列腺素F2α。15-甲基前列腺素F2α也通过羊膜腔外(E.A.)途径进行了评估。采用羊膜腔内滴注,前列腺素F2α在48小时内的成功率为88.1%,15-甲基前列腺素F2α为93.0%;通过羊膜腔外途径,在36小时内的成功率为78.1%。平均引产-流产间隔时间,羊膜腔内滴注为19小时,羊膜腔外途径为14.8小时。羊膜腔内注射前列腺素F2α后,48.8%的妇女流产完全;羊膜腔内注射15-甲基前列腺素F2α后,这一比例为56.0%;而羊膜腔外给药后仅为23.0%。呕吐和腹泻是最常报告的副作用。羊膜腔内注射前列腺素F2α时宫颈损伤发生率为4.7%,羊膜腔内注射15-甲基前列腺素F2α时为1.4%,羊膜腔外途径仅为0.6%。