Halpern Vera, Raymond Elizabeth G, Lopez Laureen M
Clinical Sciences, FHI 360, 359 Blackwell St, Suite 200, Durham, North Carolina, USA, 27701.
Cochrane Database Syst Rev. 2014 Sep 26;2014(9):CD007595. doi: 10.1002/14651858.CD007595.pub3.
Repeated use of postcoital hormonal contraception is not currently recommended due to the higher risk of side effects and lower contraceptive effectiveness compared to other modern methods of contraception. However, emerging evidence indicates renewed interest in a regular coitally-dependent method of oral contraception. We evaluated the existing data on safety and effectiveness of pericoital use of levonorgestrel and other hormonal drugs to prevent pregnancy.
To determine the effectiveness and safety of repeated use of pre- and postcoital hormonal contraception for pregnancy prevention.
We searched until 1 September 2014 for trials that tested repeated pre- and postcoital use of hormonal drugs for pregnancy prevention. Databases included CENTRAL, MEDLINE, and POPLINE. We searched for current trials via ClinicalTrials.gov and ICTRP. For the initial review, we also searched EMBASE, CINAHL, and LILACS, and wrote to researchers to identify other trials.
We considered published and unpublished studies of repeated postcoital or immediately precoital use of hormonal drugs for contraception with pregnancy as an outcome.
Two authors independently confirmed eligibility and extracted data from the included studies. We calculated confidence intervals (CI) around individual study Pearl indices using a Poisson distribution. We presented individual study estimates and pooled estimates and their 95% CI, where appropriate.
We found 22 trials that evaluated pericoital use of LNG and other hormonal drugs on a regular basis to prevent pregnancy. The studies included a total of 12,400 participants, and were conducted in Europe, Asia, and the Americas. The drugs and doses evaluated included levonorgestrel (LNG) 0.75 mg (11 studies), LNG in doses other than 0.75 mg (4 trials), and hormones other than LNG (7 trials). Outcomes included pregnancy rates, discontinuation, side effects, and acceptability.Pericoital levonorgestrel was reasonably efficacious and safe. The pooled Pearl Index for the 0.75 mg dose of LNG was 5.4 per 100 woman-years (95% CI 4.1 to 7.0). The pooled Pearl Index for all doses of LNG was 5.0 per 100 woman-years (95% CI 4.4 to 5.6). Other hormonal drugs appeared promising but most of them were not studied extensively. Menstrual irregularities were the most common side effects reported. However, the studies provided no consistent evidence of a relationship between bleeding abnormalities and either frequency of pill intake or total dose of the drug. Non-menstrual side effects were reportedly mild and not tabulated in most studies. Most women liked the pericoital method in spite of frequent menstrual irregularities.
AUTHORS' CONCLUSIONS: The studies of pericoital LNG regimens provided promising results but many had serious methodological issues. Most reports were decades old and provided limited information. However, we considered the evidence to be moderate quality because of the large number of participants from diverse populations, the low pregnancy rates, and the consistent results across studies. Rigorous research is still needed to confirm the efficacy and safety of pericoital use of LNG as a primary means of contraception among women with infrequent intercourse. If the method is shown to be efficacious, safe and acceptable, the results may warrant revision of the current World Health Organization recommendations and marketing strategies.
与其他现代避孕方法相比,由于副作用风险较高且避孕效果较低,目前不建议重复使用性交后激素避孕法。然而,新出现的证据表明,人们对一种常规的性交依赖型口服避孕方法重新产生了兴趣。我们评估了关于使用左炔诺孕酮及其他激素药物进行性交前后避孕的安全性和有效性的现有数据。
确定重复使用性交前和性交后激素避孕法预防妊娠的有效性和安全性。
我们检索至2014年9月1日,查找测试重复使用性交前和性交后激素药物预防妊娠的试验。数据库包括Cochrane系统评价数据库、医学期刊数据库和人口信息数据库。我们通过临床研究数据库和国际临床试验注册平台检索当前的试验。对于初次综述,我们还检索了荷兰医学文摘数据库、护理学与健康领域数据库以及拉丁美洲及加勒比地区健康科学数据库,并致信研究人员以确定其他试验。
我们考虑了已发表和未发表的关于重复性交后或性交前立即使用激素药物避孕并以妊娠为结局的研究。
两位作者独立确认纳入标准并从纳入研究中提取数据。我们使用泊松分布计算各研究个体的Pearl指数的置信区间。在适当情况下,我们呈现了个体研究估计值、合并估计值及其95%置信区间。
我们发现22项试验评估了定期使用左炔诺孕酮及其他激素药物进行性交前后避孕。这些研究共纳入12,400名参与者,在欧洲、亚洲和美洲开展。所评估的药物和剂量包括0.75毫克左炔诺孕酮(11项研究)、非0.75毫克剂量的左炔诺孕酮(4项试验)以及非左炔诺孕酮的激素(7项试验)。结局包括妊娠率、停药情况、副作用和可接受性。性交前后使用左炔诺孕酮相当有效且安全。0.75毫克剂量左炔诺孕酮的合并Pearl指数为每100妇女年5.4(95%置信区间4.1至7.0)。所有剂量左炔诺孕酮的合并Pearl指数为每100妇女年5.0(95%置信区间4.4至5.6)。其他激素药物似乎有前景,但大多数未得到广泛研究。月经不规律是报告的最常见副作用。然而,这些研究未提供一致证据表明出血异常与服药频率或药物总剂量之间存在关联。据报道,非月经副作用较轻,且在大多数研究中未详细列出。尽管月经频繁不规律,但大多数女性喜欢性交前后避孕法。
关于性交前后使用左炔诺孕酮方案的研究提供了有前景的结果,但许多研究存在严重的方法学问题。大多数报告是几十年前的,提供的信息有限。然而,由于来自不同人群的参与者数量众多、妊娠率低且各研究结果一致,我们认为证据质量为中等。仍需要进行严格研究以确认性交前后使用左炔诺孕酮作为性交不频繁女性主要避孕方法的有效性和安全性。如果该方法被证明有效、安全且可接受,结果可能值得修订世界卫生组织当前的建议和营销策略。