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孕12 - 20周时,米索前列醇舌下含服与口服联合米非司酮用于药物流产的前瞻性随机对照研究。

A prospective randomized comparison of sublingual and oral misoprostol when combined with mifepristone for medical abortion at 12-20 weeks gestation.

作者信息

Tang Oi Shan, Chan Carina C W, Kan Anita S Y, Ho Pak Chung

机构信息

Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China.

出版信息

Hum Reprod. 2005 Nov;20(11):3062-6. doi: 10.1093/humrep/dei196. Epub 2005 Jul 21.

DOI:10.1093/humrep/dei196
PMID:16037110
Abstract

BACKGROUND

Sublingual misoprostol has been shown to be effective in medical abortion. A prospective double-blinded placebo-controlled trial was done to compare the efficacy and side-effects of sublingual to oral misoprostol when used with mifepristone for medical abortion from 12 to 20 weeks gestation.

METHODS

A total of 120 women at 12-20 weeks of gestation were randomized to receive 200 mg oral mifepristone followed by either sublingual or oral misoprostol 400 mg every 3 h for a maximum of five doses 36-48 h later. The course of misoprostol was repeated if the woman did not abort within 24 h.

RESULTS

There was no significant difference (P = 0.43) in the success rate at 24 h [relative risk = 1.075; 95% confidence interval (CI): 0.94-1.19]. Abortion occurred in 91.4% in the sublingual group (95% CI: 81.0-96.7%) as compared to 85.0% (95% CI: 73.7-92.1%) in the oral group. The median induction-to-abortion interval was significantly shorter (P = 0.009) in the sublingual group (5.5 h) as compared to the oral group (7.5 h). The incidence of fever was higher in the sublingual group (P < 0.0001). The incidences of other side-effects were similar.

CONCLUSION

Sublingual misoprostol, when combined with mifepristone, is effective for medical abortion in the second trimester. The induction-to-abortion interval is shorter when sublingual misoprostol is used when compared to oral misoprostol.

摘要

背景

已证明米索前列醇舌下含服在药物流产中有效。进行了一项前瞻性双盲安慰剂对照试验,以比较米索前列醇舌下含服与口服在与米非司酮联合用于妊娠12至20周药物流产时的疗效和副作用。

方法

总共120名妊娠12至20周的妇女被随机分组,先口服200毫克米非司酮,随后每3小时舌下含服或口服400毫克米索前列醇,最多服用五剂,36至48小时后进行。如果妇女在24小时内未流产,则重复米索前列醇疗程。

结果

24小时成功率无显著差异(P = 0.43)[相对危险度 = 1.075;95%置信区间(CI):0.94 - 1.19]。舌下含服组流产率为91.4%(95%CI:81.0 - 96.7%),口服组为85.0%(95%CI:73.7 - 92.1%)。与口服组(7.5小时)相比,舌下含服组诱导至流产的中位间隔时间显著更短(P = 0.009)(5.5小时)。舌下含服组发热发生率更高(P < 0.0001)。其他副作用发生率相似。

结论

米索前列醇舌下含服与米非司酮联合用于中期妊娠药物流产有效。与口服米索前列醇相比,舌下含服米索前列醇时诱导至流产的间隔时间更短。

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