乌利普里斯塔酸盐与勒沃诺格斯特勒用于紧急避孕:一个随机的非劣势性试验和元分析
Anna F Glasier1, Sharon T Cameron, Paul M Fine
1National Health Service Lothian, Edinburgh, UK. Anna.Glasier@nhslothian.scot.nhs.uk
Lancet (London, England)
|February 2, 2010
概括
乌利普里斯塔酸是紧急避孕的有效替代品,在未经保护的性行为后最多5天可可靠地预防意外怀孕. 这种方法的安全性和有效性与levonorgestrel相美,为妇女和医疗保健提供者提供了有价值的选择.
科学领域:
- 生殖健康 生殖健康
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 目前的紧急避孕 (EC) 方法是时间敏感的,需要在没有保护的性交和排卵之前尽快使用.
- 乌利普里斯塔酸盐 (UPA) 与莱沃诺格斯特勒 (LNG) 治疗EC的疗效和安全性需要直接比较.
研究的目的:
- 为了比较ulipristal酸盐与levonorgestrel用于紧急避孕的疗效和安全性.
- 评估ulipristal酸盐与levonorgestrel相比在无保护性交后72小时内不劣.
主要方法:
- 一个随机的,多中心的,非劣等性试验,涉及2221名寻求紧急避孕的妇女.
- 参与者接受了单次口服剂量30毫克乌利普里斯塔酸盐 (n=1104) 或1.5毫克勒格斯特勒 (n=1117).
- 进行了当前试验和先前研究的元分析,以进一步评估疗效.
主要成果:
- 在72小时内,怀孕率为ulipristal酸盐的1.8% (15/844) 和levonorgestrel的2.6% (22/852) (OR 0.68,95%CI 0.35-1.31).
- 在72至120小时的时间窗口中,发生了三次怀孕,所有怀孕都是在Levonorgestrel组.
- 分析 (0-72小时) 显示,乌利普里斯塔酸盐 (1.4%) 与莱沃诺格斯特雷尔 (2.2%;OR 0.58,p=0.046) 的怀孕率明显较低.
- 头痛是最常见的不良事件,在两组中发病率相似.
结论:
- 乌利普里斯塔酸是一种安全有效的紧急避孕替代品.
- 它可以在未受保护的性行为后长达5天有效地使用,提供更广泛的治疗窗口.
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