近日,美国心脏病学家John Mandrola教授评论,直接口服抗凝剂的可靠性在临床实践得以验证,而独立的数据验证性分析将更加显示其优越性。
JACC上近期发表的全球性注册研究(GLORIA-AF研究)对2011年11月到2014年12月心房颤动(AF)患者的数据分析显示,目前AF患者口服抗凝药的选择已经开始更多地由华法林向新型口服抗凝药(NOAC)转变;与华法林相比,NOAC的处方量可高48%~32%。
研究者分析认为,NOAC具有应用如下优势:①应用更加方便(与华法林相比,应用期间无需频繁监测或饮食限制,药物相互作用更少,用药依从性更好);②无需监测抗凝效果,故患者用药体验更好;③与华法林相比,疗效及安全性同样好或更优。
需强调的是,仍有一些人对NOAC的优越性持怀疑态度。英属哥伦比亚大学的药理学家曾发表评论文章认为,临床试验可能存在很多局限性和偏倚。以 ARISTOTLE 研究为例,该研究发现,与华法林相比,阿派沙班可使AF患者的全因死亡发生率降低0.42%。但是,研究中重要统计数据缺失患者的数量达2.1%却高达绝对获益的5倍。此外,制药公司赞助开展的NOAC临床试验可能存在研究不当行为及违规行为(如不良事件报告不准确等),这无疑会影响研究结果的客观与公正。
研究者相信,时间会证明选择应用NOAC的决定是正确的。NOAC确实是AF患者卒中预防不错的选择,有关NOAC临床研究的独立分析减少了我们在决定NOAC优势地位方面犯错误的机会。
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