Grimes David A, Lopez Laureen M, O'Brien Paul A, Raymond Elizabeth G
Behavioral and Biomedical Research, Family Health International, PO Box 13950, Research Triangle Park, North Carolina, USA, NC 27709.
Cochrane Database Syst Rev. 2010 Jan 20(1):CD007541. doi: 10.1002/14651858.CD007541.pub2.
The introduction of a new progestin-only oral contraceptive in Europe has renewed interest in this class of oral contraceptives. Unlike the more widely used combined oral contraceptives containing an estrogen plus progestin, these pills contain only a progestin (progestogen) and are taken without interruption. How these pills compare to others in their class or to combined oral contraceptives is not clear.
This review examined randomized controlled trials of progestin-only pills for differences in efficacy, acceptability, and continuation rates.
We searched the computerized databases MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, LILACS, and EMBASE for studies of progestin-only pills. We also searched for current trials via ClinicalTrials.gov and ICTRP.
We included all randomized controlled trials in any language that included progestin-only pills for contraception. We incorporated any comparison with a progestin-only pill; this could include different doses, other progestin-only pills, combined oral contraceptives, or other contraceptives.
The first author abstracted the data and entered the information into RevMan 5. Another author performed a second, independent data abstraction to verify the initial data entry. Because of disparate exposures, we were not able to combine studies in meta-analysis.
Six trials met the inclusion criteria. In the trial comparing the desogestrel versus levonorgestrel progestin-only pill, desogestrel was not associated with a significantly lower risk of accidental pregnancy; the rate ratio was 0.27 (95% CI 0.06 to 1.19). However, the desogestrel progestin-only pill caused more bleeding problems, although this difference was not statistically significant. The trial comparing low-dose mifepristone versus a levonorgestrel progestin-only pill found similar pregnancy rates. In the trial comparing ethynodiol diacetate versus a combined oral contraceptive, irregular cycles occurred in all women assigned to the progestin-only pill (odds ratio 135.96; 95% CI 7.61 to 2421.02). In a trial comparing two progestin-only and two combined oral contraceptives, the progestin-only pill containing levonorgestrel 30 mug had higher efficacy than did the pill containing norethisterone 350 mug. An early trial found megestrol acetate inferior to other progestin-only pills in terms of efficacy. A study of the timing of pill initiation after birth found no important differences, but high losses to follow up undermined the trial.
AUTHORS' CONCLUSIONS: Evidence is insufficient to compare progestin-only pills to each other or to combined oral contraceptives.
一种新型纯孕激素口服避孕药在欧洲的推出,重新引发了人们对这类口服避孕药的兴趣。与更广泛使用的含有雌激素加孕激素的复方口服避孕药不同,这些药丸仅含有一种孕激素(孕酮),且需不间断服用。目前尚不清楚这些药丸与同类其他产品或复方口服避孕药相比效果如何。
本综述对纯孕激素避孕药的随机对照试验进行研究,以比较其在疗效、可接受性和持续使用率方面的差异。
我们在计算机化数据库MEDLINE、Cochrane对照试验中心注册库(CENTRAL)、POPLINE、LILACS和EMBASE中检索了关于纯孕激素避孕药的研究。我们还通过ClinicalTrials.gov和ICTRP检索了当前的试验。
我们纳入了所有语言的随机对照试验,这些试验包含用于避孕的纯孕激素避孕药。我们纳入了与任何纯孕激素避孕药的比较;这可能包括不同剂量、其他纯孕激素避孕药、复方口服避孕药或其他避孕药。
第一作者提取数据并将信息录入RevMan 5。另一位作者进行了第二次独立的数据提取,以验证初始数据录入。由于暴露情况不同,我们无法在荟萃分析中合并研究。
六项试验符合纳入标准。在比较去氧孕烯与左炔诺孕酮纯孕激素避孕药的试验中,去氧孕烯与意外怀孕风险显著降低无关;率比为0.27(95%可信区间0.06至1.19)。然而,去氧孕烯纯孕激素避孕药导致更多出血问题,尽管这一差异无统计学意义。比较低剂量米非司酮与左炔诺孕酮纯孕激素避孕药的试验发现怀孕率相似。在比较醋酸炔诺二醇与复方口服避孕药的试验中,所有分配到纯孕激素避孕药组的女性均出现月经周期不规律(优势比135.96;95%可信区间7.61至2421.02)。在一项比较两种纯孕激素避孕药和两种复方口服避孕药的试验中,含30微克左炔诺孕酮的纯孕激素避孕药比含350微克炔诺酮的避孕药疗效更高。一项早期试验发现醋酸甲地孕酮在疗效方面不如其他纯孕激素避孕药。一项关于产后开始服药时间的研究未发现重要差异,但高失访率影响了该试验。
证据不足以比较纯孕激素避孕药之间或与复方口服避孕药的差异。