Prolonged use of the etonogestrel implant and levonorgestrel intrauterine device: 2 years beyond Food and Drug Administration-approved duration.
Prolonged use of the etonogestrel implant and levonorgestrel intrauterine device: 2 years beyond Food and Drug Administration-approved duration.
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DOI：
10.1016/j.ajog.2017.01.036
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发表时间：
2017-06
影响因子：
9.8
通讯作者：
Peipert JF
中科院分区：
文献类型：
--
作者：
McNicholas C;Swor E;Wan L;Peipert JF
皮下避孕药和52毫克左旋诺孕酮宫内节育器(IUD)目前分别获得FDA批准三年和五年的使用。有限的现有数据表明，这两种方法在这段时间后都是有效的。长期有效的证明将提高该设备的成本效益，并有可能提高患者的延续性和满意度。为了评估避孕植入物和52毫克激素性宫内节育器(IUD)在使用该方法超过当前FDA批准的持续时间两年的妇女中的有效性。我们于2012年1月启动了这项正在进行的前瞻性队列研究。我们正在招募使用避孕药植入物或52毫克左旋诺孕酮宫内节育器的妇女，分别至少3年和5年(2007年或更晚开始使用宫内节育器，或2009年或更晚开始植入)。收集了人口和生殖健康史，以及客观体重指数(BMI)。植入者定期接受静脉穿刺术，以分析血清中的雌孕激素水平。主要结果，意外妊娠率，是按每100个妇女年计算的。我们使用卡方检验和Fisher精确检验分析基线人口学特征，并使用Kruskal-Wallis检验比较按体重指数分层的血清ENG水平。植入物使用者(n=291)贡献了444.0名妇女--为期数年的随访。在过期后的两年随访中，植入物使用者中没有记录到怀孕。计算出种植体在第四年和第五年的失败率分别为每100妇女年0(单边97.5可信区间0-1.48)和每100妇女年0(单边97.5可信区间0-2.65)。在496名左旋诺孕酮宫内节育器使用者中，已完成696.9妇女年的随访。据报道，已有两人怀孕。左旋诺孕酮宫内节育器放置第六年的失败率为每百妇女年0.25(%95可信区间0.04~1.42)，第七年的失败率为每百妇女年0.43(%95可信区间0.08~2.39)。在有血清依托格雷结果的植入者中，方法到期时的中位数为207.7 pg/m L(63.8-802.6 pg/m l)，第四年末为166.1 pg/m l(67.925.0-470.5 p g/m l)，第五年末为153.0 p g/m l(72.1-538.8 p g/m l)。用体重指数比较每个时间点的中位数ENG水平，发现在使用4年结束时，超重女性的血清ENG水平最高(195.9 pg/ml：25.0-450.5)，与正常(178.9 pg/ml：87.0-463.7)和肥胖(137.9 pg/ml：66.0-470.5)女性相比(p=0.04)。这项研究表明，避孕植入物和52毫克激素性宫内节育器在至少两年的额外使用中仍然非常有效。血清依托诺孕酮水平评估显示，所有BMI级别的女性的中位数水平仍高于90pg/ml的排卵阈值。
The subdermal contraceptive implant, and the 52mg levonorgestrel intrauterine device (IUD) are currently FDA-approved for three and five years of use respectively. Limited available data has suggested both of these methods are effective beyond that time. Demonstration of prolonged effectiveness will improve the cost-effectiveness of the device, and potentially patient continuation and satisfaction. To evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device (IUD) in women using the method for two years beyond the current FDA-approved duration. We initiated this ongoing prospective cohort study in January 2012. We are enrolling women using the contraceptive implant or 52-mg levonorgestrel IUD for a minimum of 3 and 5 years, respectively (started IUD in 2007 or later or implant in 2009 or later). Demographic and reproductive health histories, as well as objective body mass index (BMI) were collected. Implant users were offered periodic venipuncture for analysis of serum etonogestrel levels. The primary outcome, unintended pregnancy rates, was calculated per 100 woman-years. We analyzed baseline demographic characteristics using chi-square test and Fisher Exact test, and compared serum ENG levels stratified by body mass index using the Kruskal-Wallis test. Implant users (n=291) have contributed 444.0 women-years of follow-up. There have been no documented pregnancies in implant users during the two years of post-expiration follow-up. Calculated failure rates in the fourth and fifth years for the implant are calculated as 0 (one-sided %97.5 confidence interval (CI) 0–1.48) per 100 woman years at four years and 0 (one-sided %97.5 CI 0–2.65) per 100 women years at five years. Among 496 levonorgestrel IUD users, 696.9 women-years of follow-up have been completed. Two pregnancies have been reported. The failure rate in the sixth year of use of the levonorgestrel IUD is calculated as 0.25(%95 CI 0.04–1.42) per 100 women year; failure rate during the seventh year is 0.43 (%95 CI 0.08–2.39) per 100 women years. Among implant users with serum etonogestrel results, the median etonogestrel level at the time of method expiration was 207.7 pg/mL (range 63.8–802.6 pg/mL), 166.1 pg/mL (range 67.9 25.0 – 470.5 pg/mL) at the end of the fourth year, and 153.0 pg/mL (range 72.1–538.8 pg/mL) at the end of the fifth year. Median ENG levels were compared by BMI at each time point and a statistical difference was noted at the end of four years of use with overweight women having the highest serum ENG (195.9 pg/ml: range 25.0–450.5) when compared to normal (178.9 pg/ml: range 87.0–463.7) and obese (137.9 pg/ml: range 66.0–470.5) women (p=0.04). This study indicates that the contraceptive implant and 52-mg hormonal IUD continue to be highly effective for at least two additional years of use. Serum etonogestrel evaluation demonstrates median levels remain above the ovulation threshold of 90pg/ml for women of in all BMI classes.