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米非司酮联合三剂舌下含服米索前列醇用于孕早期流产:一项试点研究。

First trimester abortion with mifepristone and three doses of sublingual misoprostol: a pilot study.

作者信息

Singh Kishor C, Ummat Seema, Rajaram Shalini, Goel Neerja

机构信息

Department of Obstetrics and Gynaecology, Fiji School of Medicine, Fiji.

出版信息

Aust N Z J Obstet Gynaecol. 2005 Dec;45(6):495-8. doi: 10.1111/j.1479-828X.2005.00484.x.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of a medical abortion regimen with multiple doses of sublingual misoprostol 24 h after mifepristone.

METHODS

The regimen was designed on the basis of pharmacokinetics of various routes of administration of misoprostol. Forty women < or = 8 weeks' gestation were given mifepristone 200 mg orally, followed 24 h later by three doses of misoprostol 200 microgm sublingually 6 h apart. They were followed up on day 3 and day 14 with transvaginal ultrasound. Pain and bleeding were assessed using a visual analogue scale and acceptability, by a questionnaire.

RESULTS

Abortion outcome was assessed in terms of onset of pain and vaginal bleeding, time of expulsion of products and duration of vaginal bleeding. Seventy-five per cent of women experienced pain within 2 h after first dose of misoprostol. Bleeding began at a mean of 1.41 h after pain and expulsion at a mean of 6.1 h after first dose of misoprostol. Complete expulsion was confirmed in all women (100%) by ultrasound on day 14. The longest duration of bleeding was 12 days (mean 7.2 days) with 87.5% bleeding for < 10 days. Acceptability was 100% but 70% perceived pain to be moderate and 67.5% bleeding to be light or slightly more than menses.

CONCLUSIONS

Medical abortion using three doses of sublingual misoprostol administered 24 h after mifepristone appears to be the most appropriate in terms of pharmacokinetics of the drugs. This pilot study associates the regimen with a short abortion process, which appears to be safe, highly efficacious and acceptable.

摘要

目的

评估米非司酮服用24小时后多次舌下含服米索前列醇药物流产方案的有效性和安全性。

方法

该方案是根据米索前列醇不同给药途径的药代动力学设计的。40名妊娠≤8周的妇女口服200mg米非司酮,24小时后每隔6小时舌下含服3次200μg米索前列醇。在第3天和第14天经阴道超声随访。使用视觉模拟量表评估疼痛和出血情况,并通过问卷调查评估可接受性。

结果

根据疼痛发作、阴道出血、妊娠产物排出时间和阴道出血持续时间评估流产结局。75%的妇女在首次服用米索前列醇后2小时内出现疼痛。出血平均在疼痛后1.41小时开始,排出平均在首次服用米索前列醇后6.1小时。第14天超声检查证实所有妇女(100%)完全排出。最长出血持续时间为12天(平均7.2天),87.5%的妇女出血<10天。可接受性为100%,但70%的人认为疼痛为中度,67.5%的人认为出血为轻度或略多于月经量。

结论

从药物药代动力学角度来看,米非司酮服用24小时后舌下含服3次米索前列醇进行药物流产似乎是最合适的。这项初步研究表明该方案流产过程短,似乎安全、高效且可接受。

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