From Planned Parenthood of Houston & Southeast Texas, Houston, Texas; HRA Pharma, Paris, France; Planned Parenthood of the Rocky Mountains, Denver, Colorado; and Planned Parenthood Federation of America, New York, New York.
Obstet Gynecol. 2010 Feb;115(2 Pt 1):257-263. doi: 10.1097/AOG.0b013e3181c8e2aa.
To evaluate the efficacy and safety of ulipristal acetate as emergency contraception in women presenting 48-120 hours after receiving ulipristal acetate for unprotected intercourse.
Women aged 18 years or older with regular cycles who presented for emergency contraception 48 to 120 hours after unprotected intercourse were enrolled in 45 Planned Parenthood clinics and treated with a single dose of 30 mg ulipristal acetate. Pregnancy status was determined by high-sensitivity urinary human chorionic gonadotropin testing and return of menses.
A total of 1,241 women were evaluated for efficacy. Twenty-six were pregnant at follow-up, for a pregnancy rate of 2.1% (95% confidence interval 1.4-3.1%). These results satisfy the protocol-defined statistical criteria for success because the pregnancy rate was lower than both the estimated expected pregnancy rate and a predefined clinical irrelevance threshold. In addition, efficacy did not decrease over time: pregnancy rates were 2.3% (1.4-3.8%), 2.1% (1.0-4.1%), and 1.3% (0.1-4.8%) for intervals of 48 to 72 hours, more than 72 to 96 hours, and more than 96 to 120 hours, respectively. Adverse events were mainly mild or moderate, the most frequent being headache, nausea, and abdominal pain. Cycle length increased a mean of 2.8 days, whereas the duration of menstrual bleeding did not change.
Ulipristal acetate is effective and well-tolerated for emergency contraception 48-120 hours after unprotected intercourse.
II.
评估醋酸乌利司他用于无保护性交后 48-120 小时内紧急避孕的疗效和安全性。
在 45 家计划生育诊所中，招募了年龄在 18 岁及以上、月经周期规律且无保护性交后 48-120 小时内接受紧急避孕的女性，给予单剂量 30mg 醋酸乌利司他。通过高敏尿人绒毛膜促性腺激素检测和月经恢复来确定妊娠情况。
共有 1241 名女性接受了疗效评估。26 名女性在随访时怀孕，妊娠率为 2.1%（95%置信区间 1.4-3.1%）。这些结果满足方案规定的统计学成功标准，因为妊娠率低于估计的预期妊娠率和预先设定的临床无关阈值。此外，疗效并未随时间降低：48-72 小时、72-96 小时和 96-120 小时间隔的妊娠率分别为 2.3%（1.4-3.8%）、2.1%（1.0-4.1%）和 1.3%（0.1-4.8%）。不良事件主要为轻度或中度，最常见的是头痛、恶心和腹痛。月经周期平均延长 2.8 天，而月经出血持续时间没有变化。
醋酸乌利司他在无保护性交后 48-120 小时内用于紧急避孕是有效且耐受良好的。
II。
