Biogen Idec/Massachusetts College of Pharmacy and Health Sciences, School of Pharmacy, Worcester, Manchester, MA, USA.
Ann Pharmacother. 2011 Jun;45(6):780-6. doi: 10.1345/aph.1P704. Epub 2011 Jun 10.
To review the pharmacology, pharmacokinetics, efficacy, and safety of data of ulipristal acetate, a new emergency contraceptive approved for use up to 120 hours after unprotected intercourse.
Articles pertaining to the topic were identified and reviewed through searches of PubMed (1994-March 2011) and clinicaltrials.gov, using the key terms ulipristal and CDB-2914. Ella approval documents were obtained and reviewed from Drugs@FDA on the Food and Drug Administration (FDA) Web site.
All published data and FDA approval documents examining pharmacologic, pharmacokinetic, and clinical studies related to ulipristal acetate as an emergency contraceptive were evaluated. Selected studies included 3 randomized trials and 1 meta-analysis.
Ulipristal acetate is a progesterone agonist/antagonist emergency contraceptive approved for the prevention of pregnancy to be taken as soon as possible, within 120 hours after unprotected intercourse or a known or suspected contraceptive failure. Based upon results of the Phase 3 clinical trials used to obtain approval, ulipristal acetate administration was at least as effective as levonorgestrel in the reduction of pregnancy rate when studied alone after unprotected intercourse and when taken up to 120 hours after unprotected intercourse. Commonly reported adverse effects associated with ulipristal acetate in trials included headache, breast tenderness, nausea, and abdominal pain.
Ulipristal acetate is effective as an emergency contraceptive for up to 120 hours after unprotected intercourse. Because ulipristal is available only via prescription, it may be covered by insurance. However, the additional factors of travel expenses and time to make and attend a physician appointment must be taken into account when considering use of ulipristal as an emergency contraceptive. Due to the similarity of its structure to mifepristone, controversy regarding ulipristal's mechanism of action has arisen.
综述屈螺酮醋酸酯作为一种新的紧急避孕药的药理学、药代动力学、疗效和安全性数据，该药获准在无保护性交后 120 小时内使用。
通过在 PubMed（1994 年至 2011 年 3 月）和 clinicaltrials.gov 上搜索关键词 ulipristal 和 CDB-2914，查找与该主题相关的文章，并进行综述。在 FDA 网站的 Drugs@FDA 上获取并查阅 Ella 的批准文件。
评估了所有关于屈螺酮醋酸酯作为紧急避孕药的药理学、药代动力学和临床研究的已发表数据和 FDA 批准文件。选择的研究包括 3 项随机试验和 1 项荟萃分析。
屈螺酮醋酸酯是一种孕激素激动剂/拮抗剂紧急避孕药，获准用于预防怀孕，在无保护性交后 120 小时内尽快服用，或已知或疑似避孕失败。基于获得批准的 3 期临床试验结果，在单独研究无保护性交后和无保护性交后 120 小时内使用，屈螺酮醋酸酯的使用在降低妊娠率方面至少与左炔诺孕酮一样有效。在试验中，与屈螺酮醋酸酯相关的常见不良反应包括头痛、乳房触痛、恶心和腹痛。
屈螺酮醋酸酯在无保护性交后 120 小时内作为紧急避孕药有效。由于屈螺酮只能凭处方获得，因此可能由保险覆盖。然而，在考虑将屈螺酮用作紧急避孕药时，必须考虑到旅行费用和预约医生的时间等额外因素。由于其结构与米非司酮相似，因此关于屈螺酮作用机制的争议已经出现。
