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一项关于在妊娠中期手术流产前经羊膜腔内或胎儿内给予两种剂量地高辛作为胎儿致死剂的有效性和副作用特征的随机试点研究。

A randomized pilot study on the effectiveness and side-effect profiles of two doses of digoxin as fetocide when administered intraamniotically or intrafetally prior to second-trimester surgical abortion.

机构信息

Planned Parenthood, Los Angeles, CA 90033, USA.

出版信息

Contraception. 2010 Jan;81(1):67-74. doi: 10.1016/j.contraception.2009.08.014.

Abstract

BACKGROUND

Digoxin is commonly used to facilitate second-trimester surgical abortion despite limited data regarding its safety and effectiveness for this indication. We conducted a pilot study to determine the incidence of side effects after digoxin administration and whether effectiveness can be improved with variations in dose and technique.

STUDY DESIGN

Fifty-two women presenting for elective termination of pregnancy between 18 and 24 weeks' gestation were randomized to one of four digoxin treatment groups: 1.0 mg intraamniotic (1.0 IA), 1.0 mg intrafetal (1.0 IF), 1.5 mg intraamniotic (1.5 IA) or 1.5 mg intrafetal (1.5 IF). Ultrasound was used to assess for the presence of fetal cardiac activity prior to the abortion procedure. Data on the presence and severity of pain, nausea and other potential side effects were collected before digoxin injection, immediately following digoxin injection and on the day after digoxin injection.

RESULTS

Digoxin effectively induced fetal death in 87% of women. The failure rate did not vary by route of administration (IA or IF) and was not lowered by increasing the dose from 1.0 to 1.5 mg. IF injections induced fetal death more rapidly than IA injections. Digoxin administration did not result in increased pain or nausea.

CONCLUSIONS

IA or IF injection of digoxin is safe and effective for inducing fetal death prior to second-trimester surgical abortion. Doses greater than 1.0 mg may not be necessary.

摘要

背景

尽管关于地高辛在该适应证中的安全性和有效性的数据有限,但其仍常用于促进妊娠中期的手术流产。我们进行了一项试点研究,以确定地高辛给药后的副作用发生率,以及通过剂量和技术的变化是否可以提高疗效。

研究设计

52 名 18 至 24 孕周行择期终止妊娠的女性随机分为四组地高辛治疗组之一:1.0 mg 羊膜内(1.0 IA)、1.0 mg 胎儿内(1.0 IF)、1.5 mg 羊膜内(1.5 IA)或 1.5 mg 胎儿内(1.5 IF)。在流产程序之前,超声用于评估胎儿心脏活动的存在。在给予地高辛注射之前、注射后即刻以及注射后一天收集关于疼痛、恶心和其他潜在副作用的存在和严重程度的数据。

结果

地高辛有效诱导 87%的女性胎儿死亡。失败率不因给药途径(IA 或 IF)而异,且增加剂量从 1.0 至 1.5 mg 也不会降低失败率。IF 注射比 IA 注射更快地诱导胎儿死亡。地高辛给药不会导致疼痛或恶心增加。

结论

IA 或 IF 注射地高辛用于在妊娠中期手术流产前诱导胎儿死亡是安全有效的。剂量大于 1.0 mg 可能不是必需的。

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