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含屈螺酮口服避孕药的安全性:基于142475女性年观察数据的欧洲口服避孕药主动监测研究的最终结果

The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation.

作者信息

Dinger Jürgen C, Heinemann Lothar A J, Kühl-Habich Dörthe

机构信息

Center for Epidemiology and Health Research (ZEG), 10115 Berlin, Germany.

出版信息

Contraception. 2007 May;75(5):344-54. doi: 10.1016/j.contraception.2006.12.019. Epub 2007 Feb 23.

DOI:10.1016/j.contraception.2006.12.019
PMID:17434015
Abstract

OBJECTIVES

The study was conducted to compare risks of adverse cardiovascular and other events associated with the use of drospirenone (DRSP)-containing oral contraceptives (OCs) and other OCs.

METHODS AND MATERIALS

The European Active Surveillance study (EURAS) was a multinational, prospective, noninterventional cohort study of new users of DRSP, levonorgestrel (LNG) and other progestin-containing OCs. Semiannual follow-up was based on mailed questionnaires, with additional follow-up procedures when needed.

RESULTS

Overall, 58,674 women were followed for 142,475 women-years of observation. Loss to follow-up was 2.4%. Serious adverse and fatal events were rare, and rate ratios were close to unity (1.0). Cox regression analysis of cardiovascular outcomes yielded hazard ratios for DRSP-containing vs. LNG-containing and other OCs of 1.0 and 0.8 (upper 95% confidence limits, 1.8 and 1.3) for venous, and 0.3 and 0.3 (upper 95% confidence limits, 1.2 and 1.5) for arterial thromboembolism, respectively.

CONCLUSIONS

Risks of adverse cardiovascular and other serious events in users of a DRSP-containing OC are similar to those associated with the use of other OCs.

摘要

目的

开展本研究以比较使用含屈螺酮(DRSP)的口服避孕药(OCs)和其他OCs相关的不良心血管及其他事件风险。

方法与材料

欧洲主动监测研究(EURAS)是一项针对DRSP、左炔诺孕酮(LNG)及其他含孕激素OCs新使用者的多国前瞻性非干预队列研究。每半年通过邮寄问卷进行随访,必要时采用额外的随访程序。

结果

总体而言,58,674名女性接受了142,475女性年的观察随访。随访失访率为2.4%。严重不良事件和致命事件罕见,率比接近1.0。心血管结局的Cox回归分析显示,含DRSP的OCs与含LNG的OCs及其他OCs相比,静脉血栓形成的风险比分别为1.0和0.8(95%置信上限分别为1.8和1.3),动脉血栓栓塞的风险比分别为0.3和0.3(95%置信上限分别为1.2和1.5)。

结论

使用含DRSP的OCs的使用者发生不良心血管及其他严重事件的风险与使用其他OCs相关的风险相似。

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