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米索前列醇舌下含服、口服及阴道给药用于孕早期末和孕中期初流产的比较研究

A comparative study on sublingual versus oral and vaginal administration of misoprostol for late first and early second trimester abortion.

作者信息

Ganguly Rajendra Prasad, Saha Shyama Prasad, Mukhopadhyay Sima, Bhattacharjee Nabendu, Bhattacharyya Subir Kumar, Patra Kajal Kumar

机构信息

Department of Obstetrics and Gynaecology, RG Kar Medical College, Kolkata 700004.

出版信息

J Indian Med Assoc. 2010 May;108(5):283-4, 286.

Abstract

To compare the effectiveness, side-effects and outcome of sublingual with oral and vaginal administrations of misoprostol for induction of abortion in late first and early second trimester of gestation (9 to 16 weeks), a comparative observational study was carried out among 258 women with a period of gestation between 9 and 16 weeks, scheduled to have medical abortion, and randomly allocated into three groups and offered sublingual, oral and vaginal routes of misoprostol administration (400 mcg of misoprostol 6 hourly, maximum up to four dosages) respectively. Primary outcome measure was complete abortion rate and the secondary outcome measures were incidence of cases where surgical evacuation required, failure rate and induction-abortion interval. Development of side-effects and subjective assessment of patient's comfort with the different routes of administration were also recorded. Rate of complete abortion was higher in sublingual group in comparison to oral (p = 0.0338) and vaginal route (p = 0.5627). Surgical evacuation was required in less number of cases in sublingual group. Induction-abortion interval was also least with the sublingual route le, p < or = 0.0001 (versus oral) and 0.0011 (versus vaginal). Failure rate was highest with the oral route and least with the sublingual route. The patients were least comfortable with the vaginal route. Gastro-intestinal side-effects were least with the vaginal route, but significant vaginal bleeding (> 250 ml) was little bit higher with this route. Though misoprostol is effective in inducing medical abortion irrespective of the route of administration, sublingual route gives better results as compared to oral (statistically significant) and vaginal routes (in some respects, not of much statistical significance).

摘要

为比较米索前列醇舌下含服、口服及阴道给药用于妊娠早期(9至16周)引产的有效性、副作用及结局,对258名妊娠9至16周计划进行药物流产的妇女开展了一项比较性观察研究,她们被随机分为三组,分别给予米索前列醇舌下含服、口服及阴道给药(每6小时400微克米索前列醇,最多4剂)。主要结局指标为完全流产率,次要结局指标为需手术清宫的病例发生率、失败率及引产至流产间隔时间。还记录了副作用的发生情况及患者对不同给药途径舒适度的主观评估。舌下含服组的完全流产率高于口服组(p = 0.0338)和阴道给药组(p = 0.5627)。舌下含服组需手术清宫的病例数较少。舌下含服途径的引产至流产间隔时间也最短,即p≤0.0001(与口服相比)和0.0011(与阴道给药相比)。口服途径的失败率最高,舌下含服途径的失败率最低。患者对阴道给药途径的舒适度最低。胃肠道副作用在阴道给药途径中最少,但该途径的严重阴道出血(>250毫升)略多。尽管无论给药途径如何,米索前列醇在引产方面均有效,但与口服(具有统计学意义)和阴道给药途径(在某些方面,统计学意义不大)相比,舌下含服途径效果更佳。

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