我国短效口服避孕药有效性、常见副反应和续用率的系统评估

目的:评估0、1、2号片、复方左炔诺孕酮单相片和复方左炔诺孕酮三相片的有效性、常见副反应和续用率。方法:见“我国常用口服避孕药和宫内节育器系统评估的方法概述”(中国计划生育学杂志2005年1期17页)。结果:共检索到10篇相关文献,4篇入选。在比较1号片、复方左炔诺孕酮单相片和复方左炔诺孕酮三相片的随机对照临床试验中,3组6个月累计妊娠率均小于1.1每百妇女,6个月累计续用率均大于80每百妇女,且3组相似。复方左炔诺孕酮三相片点滴出血、月经延长和缩短发生率均低于1号片,其它常见副反应发生率三者相似。在一项0号片的现况调查中,妊娠的发生率为0,突破性出血达16%以上。未检索到有关2号片有效性和续用率的文献。结论:1号片、复方左炔诺孕酮单相片和复方左炔诺孕酮三相片的有效性及续用率相近;1号片的常见副反应发生率高于复方左炔诺孕酮三相片。现有的资料不足以对0、2号片的有效性和续用率进行系统评估。

Systematic Review of the Efficacy, Common Side Effects and Continuation Rates of Daily Pills in China

Objective: To assess efficacy, common side effects and continuation rates of five types of daily pills. Method: See Methodology of Systematic Review of Commonly - used Oral Contraceptives and IUDs in China ( Chinese Journal of Family Planning, 2005,1,17). Results: A total of 10 relevant papers were identified. Of them 4 were included in this review. Based on one randomized clinical trial for Pill No. 1, mono - , and tri - phasic levonorgestrel pills, the cumulative 6 - month failure rates were less than 1. 1 per 100 women, 6 - month continuation rates were over 80 per 100 women, and the rates were similar among three pills. The incidences of spotting, prolonged menstrual period and shortened menstrual period among women who had used tri - phase levonorgestrel pill were less common than that among users of Pill No. 1. The other common side effects were similar among three daily pills. A 1970' s cross - section study investigated the efficacy of Pill No. 0. No failure was reported during up to 18 months of use. However, more than 16% of users reported problem of breakthrough bleeding. No data on clinical performance of pill No. 2 were available. Conclusion: Based on the limited data, the efficacy and continuation rates of Pill No. 1, mono - and tri - phasic levonorgestrel were comparable, although the Pill No. 1 had higher incidence of side effects and inferior cycle control. Data were insufficient to evaluate efficacy and continuation rates for Pill No. 0 and No. 2.