Velazco A, Varela L, Tanda R, Sánchez C, Barambio S, Chami S, Valero F, Aragón S, Marí J, Carbonell J L
Hospital Gineco-Obstétrico Eusebio Hernández (Maternidad Obrera), Ciudad Habana, Cuba.
Eur J Contracept Reprod Health Care. 2000 Dec;5(4):227-33. doi: 10.1080/13625180008500410.
The objectives of the present clinical study were to evaluate the safety and efficacy of misoprostol (Cytotec) self-administered into the vagina for medical abortion in adolescents under the age of 18 years. After obtaining written consent from the patients and parents or guardians, a group of 150 adolescents with gestations between 35 and 63 days received 800 microg of vaginal misoprostol every 24 h, up to a maximum of three main doses, for abortion. Outcomes assessed included successful abortion (complete abortion without surgery), side-effects, decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time for the return of menses. Complete abortion occurred in 133/150 (88.7%, 95% confidence interval 82-93) patients. The frequencies of nausea, vomiting and diarrhea were statistically significantly higher when compared to those obtained for adult females. Vaginal bleeding lasted for 12.7 +/- 5.7 days (median 12 days, range 1-23 days). The mean expulsion time was 6.8 +/- 2.4 h (median 6 h, range 3-14 h) for those who aborted after the first misoprostol dose. The mean time for the return of menses, for those who aborted with misoprostol, was 34.7 +/- 3.4 days. The mean decrease in hemoglobin was statistically significant (p = 0.001), but had no clinical relevance. Taking into account the high abortion rate obtained, we could conclude that misoprostol alone is a valid method for terminating unwanted pregnancies in adolescents under the age of 18 years.
本临床研究的目的是评估米索前列醇(喜克溃)经阴道自行给药用于18岁以下青少年药物流产的安全性和有效性。在获得患者及其父母或监护人的书面同意后,一组150例妊娠35至63天的青少年每24小时接受800微克阴道米索前列醇,最多使用三个主要剂量进行流产。评估的结果包括流产成功(无需手术的完全流产)、副作用、血红蛋白降低情况、阴道出血平均时间、平均排出时间和月经恢复平均时间。133/150(88.7%,95%置信区间82 - 93)例患者发生了完全流产。与成年女性相比,恶心、呕吐和腹泻的发生率在统计学上显著更高。阴道出血持续12.7±5.7天(中位数12天,范围1 - 23天)。首次服用米索前列醇后流产者的平均排出时间为6.8±2.4小时(中位数6小时,范围3 - 14小时)。使用米索前列醇流产者的月经恢复平均时间为34.7±3.4天。血红蛋白的平均降低在统计学上具有显著性(p = 0.001),但无临床意义。考虑到获得的高流产率,我们可以得出结论,单独使用米索前列醇是终止18岁以下青少年意外妊娠的一种有效方法。