含屈螺酮的口服避孕药与静脉血栓栓塞：美国食品药品监督管理局不良事件报告系统数据库分析
Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database.
作者信息
Madigan David, Shin Jennifer
机构信息
Department of Statistics, Columbia University, New York, NY, USA.
出版信息
Open Access J Contracept. 2018 Apr 11;9:29-32. doi: 10.2147/OAJC.S161737. eCollection 2018.
INTRODUCTION
Substantial evidence suggests that drospirenone-containing oral contraceptives may cause a higher risk of venous thrombotic events than earlier-generation oral contraceptives.
METHODS
To gain insight into recent real-world implications, we conducted an analysis using the US Food and Drug Administration's Adverse Event Reporting System.
RESULTS
Venous thrombotic events continue to be reported at a much higher rate with drospirenone-containing oral contraceptives than the general background. The disproportionality has been rising since 2010. The same behavior is not seen with levonorgestrel-containing oral contraceptives.
CONCLUSION
Our results are consistent with decreased physician and patient awareness of risks associated with drospirenone-containing oral contraceptives.
引言
大量证据表明，含屈螺酮的口服避孕药可能比早期一代口服避孕药导致静脉血栓形成事件的风险更高。
方法
为深入了解近期实际影响，我们使用美国食品药品监督管理局的不良事件报告系统进行了一项分析。
结果
含屈螺酮的口服避孕药报告的静脉血栓形成事件发生率仍远高于一般背景水平。自2010年以来，这种不成比例的情况一直在增加。含左炔诺孕酮的口服避孕药未见同样情况。
结论
我们的结果与医生和患者对含屈螺酮口服避孕药相关风险的认识降低一致。
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