Skyla宫内节育器通过FDA核准

Skyla宫内节育器已被美国食品药品管理局(FDA)批准上市。该设备的生产商拜耳医疗保健公司美国医学事务部主管兼副总裁Pamela A. Cyrus博士在新闻发布会上表示，这是近12年来首个进入美国市场的新型宫内节育器(IUD)。

根据生产商的说法，从2月11日开始患者就可以凭医生处方购买Skyla(宫内左炔诺孕酮释放系统)13.5 mg了。

加利福尼亚州托伦斯市Harbor–UCLA医学中心的妇产科教授Anita L. Nelson博士指出：“Skyla预防妊娠的有效率达到99%以上。并且，Skyla可用于经产或从未生育的妇女，对于在未来3年内不希望妊娠的妇女而言是一种重要的避孕新选择。”

Skyla的获准得到一项Ⅲ期试验数据的支持，在该研究中有1,432例年龄18~35岁的妇女使用这种设备避孕。这是在欧洲、拉丁美洲、美国和加拿大的11个国家进行的一项随机开放标记研究。研究排除了产后6周以内、有异位妊娠病史、有临床显著卵巢囊肿以及HIV或性传播感染高危的妇女。

主要疗效终点为基于28天等值暴露周期使用Pearl指数计算得出的妊娠率，用于评估避孕的可靠性。在第1年内，接受Skyla治疗的妇女提供了15,763个可评估的28天周期的数据，在3年治疗期间，共提供了39,368个可评估周期的数据。

基于开始治疗后和Skyla取出或排出后7天内发生的5次妊娠，第1年使用的PI估计值为0.41，95%置信区间上限为0.96。

在接受Skyla治疗的妇女中，22%因不良事件而停止该治疗。发生率超过5%的不良反应包括外阴阴道炎(20%)、腹部/盆腔疼痛(19%)、痤疮/脂溢性皮炎(15%)、卵巢囊肿(13%)、头痛(12%)、痛经(9%)、乳房疼痛/不适 (9%)、出血增加(8%)和恶心(6%)。

Skyla T型支架的测量值为28 mm×30 mm，置入管的外径为3.8 mm。在取出Skyla之后，妇女可立即妊娠。根据研究数据，有77%希望受孕的妇女在取出Skyla后第1年内成功妊娠。

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By: MARY JO DALES, Internal Medicine News Digital Network

The Food and Drug Administration has approved the Skyla intrauterine device.

The device is the first new IUD to be brought to the U.S. market in 12 years, Dr. Pamela A. Cyrus, vice president and head of U.S. medical affairs for Bayer HealthCare Pharmaceuticals, the device’s manufacturer, said in a press release.

Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of Feb. 11, according to the manufacturer.

Skyla "is more than 99% effective at preventing pregnancy," Dr. Anita L. Nelson, professor of obstetrics and gynecology at Harbor–UCLA Medical Center, Torrance, Calif., said in the Bayer statement. "Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don’t want to become pregnant for up to three years."

The approval of Skyla is supported by data from a phase III trial of 1,432 women aged 18-35 years who received the device. Nearly 40% (556 women) were nulliparous. The trial was a multicenter, multinational, randomized open-label study conducted in 11 countries in Europe, Latin America, the United States, and Canada. The trial excluded women less than 6 weeks post partum, those with a history of ectopic pregnancy, those with clinically significant ovarian cysts, and those with HIV or otherwise at high risk for sexually transmitted infections.

The pregnancy rate using the Pearl Index calculated based on 28-day equivalent exposure cycles was the primary efficacy endpoint used to assess contraceptive reliability. Skyla-treated women provided 15,763 evaluable 28-day cycle equivalents in the first year and 39,368 evaluable cycles over the 3-year treatment period.

The PI estimate for the first year of use based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.

Of Skyla-treated women, 22% discontinued the study treatment because of an adverse event. Adverse reactions occurring in at least 5% of users were vulvovaginitis (20%), abdominal/pelvic pain (19%), acne/seborrhea (15%), ovarian cyst (13%), headache (12%), dysmenorrhea (9%), breast pain/discomfort (9%), increased bleeding (8%), and nausea (6%).

The Skyla T-body measures 28 mm x 30 mm, and the outer diameter of the placement tube is 3.8 mm. Women can become pregnant as soon as Skyla is removed. Based on study data, 77% of women who wanted to conceive became pregnant sometime in the first year after Skyla was removed.