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醋酸乌利司他预防排卵的有效性优于左炔诺孕酮:三种紧急避孕方案随机试验汇总数据的分析。

Ulipristal acetate prevents ovulation more effectively than levonorgestrel: analysis of pooled data from three randomized trials of emergency contraception regimens.

机构信息

PROFAMILIA, Santo Domingo, Dominican Republic.

出版信息

Contraception. 2013 Nov;88(5):611-8. doi: 10.1016/j.contraception.2013.05.010. Epub 2013 May 22.

Abstract

BACKGROUND

The days just prior to ovulation are the most crucial for emergency contraception (EC) efficacy. Ulipristal acetate (UPA) and levonorgestrel's (LNG) capacity to inhibit follicular rupture have never been compared directly at this time of the cycle.

STUDY DESIGN

Raw data from three pharmacodynamics studies with similar methodology were pooled to allow direct comparison of UPA, LNG and LNG + meloxicam's ability to prevent ovulation when administered orally in the advanced follicular phase, with a leading follicle of ≥ 18 mm.

RESULTS

Forty eight LNG-treated (1.5 mg) cycles, 31 LNG (1.5 mg) + meloxicam (15 mg), 34 UPA (30 mg) cycles and 50 placebo cycles were compared. Follicle rupture was delayed for at least 5 days in 14.6%, 38.7%, 58.8% and 4% of the LNG-, LNG + meloxicam-, UPA- and placebo-treated cycles, respectively. UPA was more effective than LNG and placebo in inhibiting follicular rupture (p = .0001), while LNG, when administered at this time of the cycle, was not different than placebo. The addition of meloxicam improved the efficacy of LNG in preventing follicular rupture (p = .0292 vs. LNG; p = .0001 vs. placebo; non-significant vs. UPA). UPA was effective in preventing rupture in the 5 days following treatment, even when administered at the time of the luteinizing hormone (LH) surge (UPA 79%, LNG 14% and placebo 10%). None of the treatments were effective when administered on the day of the LH peak. The median time from treatment to rupture was 6 days during the ulipristal cycles and 2 days in the placebo and LNG/LNG + meloxicam cycles (p = .0015).

CONCLUSION

Although no EC treatment is 100% effective in inhibiting follicular rupture when administered in the late follicular phase, UPA is the most effective treatment, delaying ovulation for at least 5 days in 59% of the cycles. LNG is not different from placebo in inhibiting follicular rupture at this advanced phase of the cycle. No treatment was effective in postponing rupture when administered on the day of LH peak.

摘要

背景

排卵前的日子对紧急避孕(EC)的效果至关重要。醋酸乌利司他(UPA)和左炔诺孕酮(LNG)抑制卵泡破裂的能力从未在周期的这个时候进行过直接比较。

研究设计

采用类似方法的三项药效学研究的原始数据进行了汇总,以允许直接比较 UPA、LNG 和 LNG+美洛昔康在口服给药时在卵泡晚期预防排卵的能力,此时的主导卵泡≥18mm。

结果

比较了 48 个 LNG 治疗(1.5mg)周期、31 个 LNG(1.5mg)+美洛昔康(15mg)、34 个 UPA(30mg)周期和 50 个安慰剂周期。在至少 14.6%、38.7%、58.8%和 4%的 LNG-、LNG+美洛昔康-、UPA-和安慰剂治疗周期中,卵泡破裂至少延迟了 5 天。UPA 比 LNG 和安慰剂更能抑制卵泡破裂(p=0.0001),而此时给予 LNG 与安慰剂无差异。添加美洛昔康可提高 LNG 预防卵泡破裂的效果(p=0.0292 比 LNG;p=0.0001 比安慰剂;与 UPA 无差异)。UPA 在治疗后 5 天内有效防止破裂,即使在黄体生成素(LH)激增时给药(UPA79%,LNG14%,安慰剂 10%)。在 LH 峰值当天给药时,没有一种治疗方法有效。从治疗到破裂的中位时间在 UPA 周期为 6 天,在安慰剂和 LNG/LNG+美洛昔康周期为 2 天(p=0.0015)。

结论

尽管在晚期卵泡期给予任何 EC 治疗都不能 100%有效抑制卵泡破裂,但 UPA 是最有效的治疗方法,在至少 59%的周期中至少延迟排卵 5 天。在这个周期的晚期阶段,LNG 在抑制卵泡破裂方面与安慰剂无差异。在 LH 峰值当天给药时,没有一种治疗方法能有效推迟破裂。

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