含屈螺酮的口服避孕药可能增加妇女非致死性静脉血栓的风险

目的关注含屈螺酮(drospirenone)的口服避孕药可能增加妇女静脉血栓的风险,为中国临床医生提供最新的相关信息和参考。方法检索相关文献,结合国内外权威药品监管机构的建议,对相关研究进行分析和综述。结果 6项已发表的用来评估含屈螺酮的避孕药是否增加静脉血栓风险的主要流行病学研究,其结论不一致:2项FDA和欧洲药品监管机构所要求的上市后研究没有显示含屈螺酮产品与含左炔诺孕酮(levonorgestrel)或其他孕激素产品在增加静脉血栓风险方面有差异。2009年发表的2份报告指出,与含左炔诺孕酮的避孕药相比,服用含屈螺酮的避孕药的妇女静脉血栓的风险高达1.5～2倍。2011年在英国医学杂志(BMJ)上发表的2篇研究更是认为静脉血栓的风险高达2～3倍。结论最近2年的研究结果一致倾向于含屈螺酮的口服避孕药可能增加妇女静脉血栓的风险,这有待于药品监管机构进一步分析研究,而临床上含屈螺酮的口服避孕药应该谨慎用于有血栓风险的患者。

Drospirenone-containing oral contraceptives may increase the risk of non-fatal venous thromboembolism in women

Objective To pay close attention to the risk of venous thromboembolism(VTE)which may be caused by drospirenone-containing oral contraceptives (OCs) and to provide updated information and reference for Chinese clinicians. Method By analyzing and summarizing the published researches as well as the drug administration’s warning and indications at home and abroad. Result and conclusion Six published epidemiologic studies that evaluated the risk of VTE in women using drospirenone-containing oral contraceptives failed to reach an agreement:Two postmarketing surveillance requested by FDA and European showed no difference in the risk of VTE between drospirenone-containing OCs and levonorgestrel- or other progestogen-containing OCs. While two reports published in 2009 stated that there was approximately 1.5-2 fold increase in the risk of VTE for drospirenone-containing OC users. Two reports published on British Medical Journal (BMJ) in 2011 show that comparing with other progestogen-containing OCs, the risk of VTE caused by drospirenone-containing OCs were 2-3 fold. Researches in the recent two years show the same conclusion that drospirenone-containing OCs may increase the risk of VTE. This conclusion needs to be verified and cleared by the drug administration while the clinicians should cautiously prescribe this kind of OCs to those patients who have the risk of venous thromboembolism.