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紧急避孕的干预措施。

Interventions for emergency contraception.

作者信息

Cheng L, Gülmezoglu A M, Oel C J, Piaggio G, Ezcurra E, Look P F A

机构信息

International Peace Maternity and Child Health Hospital (IPMCH), China Welfare Institute, 145 Guangyuan Road, 910 Hengshan Road, Shanghai, China, 200030.

出版信息

Cochrane Database Syst Rev. 2004(3):CD001324. doi: 10.1002/14651858.CD001324.pub2.

Abstract

BACKGROUND

In emergency contraception a drug or IUD is used to prevent pregnancy shortly after unprotected intercourse. Except for some Western-European countries and China, emergency contraception is largely under-utilised worldwide. In many developing countries lack of access to emergency contraception may subject women to unsafe abortions, which contribute significantly to maternal mortality and morbidity. Currently, several interventions (IUD, the Yuzpe regimen, levonorgestrel, mifepristone, danazol and some combination regimens) are available for emergency contraception. Information on the comparative efficacy, safety and convenience of these methods is crucial for reproductive health care providers and the women they serve.

OBJECTIVES

To determine which emergency contraceptive method following unprotected intercourse is the most effective, safe and convenient to prevent pregnancy.

SEARCH STRATEGY

The search included the Cochrane Controlled Trials Register, Popline, MEDLINE, Chinese biomedical databases and UNDP/UNFPA/WHO/World Bank Special Programme on Human Reproduction (HRP) emergency contraception database (July 2003). Content experts and pharmaceutical companies were contacted.

SELECTION CRITERIA

Randomised controlled trials and controlled clinical trials including women attending services for emergency contraception following a single act of unprotected intercourse were eligible.

DATA COLLECTION AND ANALYSIS

Data on outcomes and trial characteristics were extracted in duplicate and independently by two reviewers. Quality assessment was also done by two reviewers independently. Meta-analysis results are expressed as relative risk (RR) using a fixed-effects model with 95% confidence interval (CI). In the presence of significant heterogeneity a random-effect model was applied.

MAIN RESULTS

Forty-eight trials with 33110 women were included. Most trials were conducted in China (37/48). Levonorgestrel is more effective than the Yuzpe regimen in preventing pregnancy (2 trials, RR: 0.51; 95% CI: 0.31 to 0.83). Single dose (1.5 mg) administration seems to have similar effectiveness as the standard 12 hours apart split-dose (0.75 mg twice) of levonorgestrel (2 trials, RR: 0.77, 95% CI: 0.45 to 1.30). Levonorgestrel has similar effectiveness to mid-dose (8 trials, RR: 1.64; 95% CI: 0.82 to 3.25) or low-dose (7 trials, RR: 1.38; 95% CI: 0.93 to 2.05) mifepristone. Low-dose (=< 10 mg) mifepristone is similarly effective as mid doses (25-50 mg) when only high quality trials are considered. Delay in the onset of subsequent menses is the main unwanted effect of mifepristone and seems to be dose-related. The Yuzpe regimen can be used when levonorgestrel and mifepristone are not available. Half-dose Yuzpe with single administration is associated with fewer side-effects but it is not clear whether it is as effective as the standard Yuzpe regimen (RR: 1.41; 95% CI: 0.76 to 2.61).

REVIEWERS' CONCLUSIONS: Levonorgestrel 1.5 mg (two split doses or a single dose) and low and mid-doses (25-50 mg) of mifepristone offer high efficacy with an acceptable side-effect profile. Single dose simplifies the use of levonorgestrel for emergency contraception without an increase in side-effects. However, mifepristone might delay the following menstruation, which could increase anxiety, particularly in higher doses. The Yuzpe regimen could be used if levonorgestrel or mifepristone are not available. The intrauterine device (IUD) is another effective emergency contraceptive, and can be kept for ongoing contraception.

摘要

背景

在紧急避孕中,药物或宫内节育器用于在无保护性交后不久预防怀孕。除了一些西欧国家和中国,紧急避孕在全球范围内的利用率普遍较低。在许多发展中国家,无法获得紧急避孕措施可能会使妇女面临不安全堕胎的风险,这对孕产妇死亡率和发病率有重大影响。目前,有几种干预措施(宫内节育器、Yuzpe方案、左炔诺孕酮、米非司酮、达那唑和一些联合方案)可用于紧急避孕。这些方法的相对疗效、安全性和便利性信息对于生殖健康护理提供者及其服务的妇女至关重要。

目的

确定无保护性交后哪种紧急避孕方法在预防怀孕方面最有效、最安全且最方便。

检索策略

检索包括Cochrane对照试验注册库、Popline、MEDLINE、中国生物医学数据库以及联合国开发计划署/联合国人口基金/世界卫生组织/世界银行人类生殖特别规划署(HRP)紧急避孕数据库(2003年7月)。还联系了内容专家和制药公司。

入选标准

随机对照试验和对照临床试验,包括在单次无保护性交后寻求紧急避孕服务的妇女。

数据收集与分析

由两名评审员独立重复提取关于结局和试验特征的数据。质量评估也由两名评审员独立进行。荟萃分析结果以相对风险(RR)表示,采用固定效应模型,95%置信区间(CI)。若存在显著异质性,则应用随机效应模型。

主要结果

纳入了48项试验,共33110名妇女。大多数试验在中国进行(48项中的37项)。左炔诺孕酮在预防怀孕方面比Yuzpe方案更有效(2项试验,RR:0.51;95%CI:0.31至0.83)。单剂量(1.5毫克)给药似乎与左炔诺孕酮标准的间隔12小时分两次给药(每次0.75毫克)效果相似(2项试验,RR:0.77,95%CI:0.45至1.30)。左炔诺孕酮与中剂量(8项试验,RR:1.64;95%CI:0.82至3.25)或低剂量(7项试验,RR:1.38;95%CI:0.93至2.05)米非司酮效果相似。仅考虑高质量试验时,低剂量(≤10毫克)米非司酮与中剂量(25 - 50毫克)效果相似。米非司酮的主要不良影响是随后月经周期延迟,且似乎与剂量相关。当无法获得左炔诺孕酮和米非司酮时,可使用Yuzpe方案。单次给予半剂量Yuzpe副作用较少,但尚不清楚其是否与标准Yuzpe方案效果相同(RR:1.41;95%CI:0.76至2.61)。

评审员结论

1.5毫克左炔诺孕酮(分两次或单次给药)以及低剂量和中剂量(25 - 50毫克)米非司酮疗效高且副作用可接受。单剂量简化了左炔诺孕酮用于紧急避孕的使用方式且不增加副作用。然而,米非司酮可能会延迟下次月经,这可能会增加焦虑,尤其是高剂量时。如果无法获得左炔诺孕酮或米非司酮,可使用Yuzpe方案。宫内节育器是另一种有效的紧急避孕方法,且可保留用于持续避孕。

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