文章来源：CFDA 发布时间：2016-01-21 09:51:23 浏览次数：
美国食品药品监督管理局（FDA）曾于2014年11月16日发布药物安全性通讯，提示初步试验数据显示长期抗血小板治疗的患者有临床获益，但非心血管死亡风险升高。因此FDA针对长期抗血小板治疗开展了评估工作。评估结果未发现氯吡格雷对冠状动脉疾病患者或具有冠状动脉疾病风险患者的总体死亡率存在良好或不良影响的证据，也未发现对癌症影响的证据。长期使用血液稀释药物波立维（氯吡格雷）未升高或降低心脏病患者或具有心脏病风险患者的总体死亡风险。此外，双重抗血小板治疗（DAPT）1试验和多项其他临床试验的评价结果也未表明氯吡格雷增加了癌症或癌症所致死亡的风险。
FDA同时提示由于可能导致心脏病发作和血栓风险升高，故患者不应停用氯吡格雷或其他抗血小板药物。如果对氯吡格雷有任何疑问或顾虑，请咨询医疗保健专业人士。医疗保健专业人士在开始治疗前应考虑现有抗血小板药物的获益和风险。
在双重抗血小板治疗（DAPT）的大型临床试验中，为了研究报告的氯吡格雷治疗后死亡和癌症相关死亡风险的升高，FDA审查了DAPT试验及可获得有关死亡率、癌症所致死亡或将癌症报告为不良事件等数据的其他大型长期氯吡格雷临床试验的结果2-13。DAPT试验在行药物洗脱冠脉支架放置术患者中，将接受双重抗血小板12个月治疗（氯吡格雷[波立维]或普拉格雷[Effient]联合阿司匹林）与30个月治疗进行对比。与接受氯吡格雷12个月治疗的患者相比，接受30个月治疗的患者心脏病发作和支架血栓形成的发生率降低，但主要由癌症或外伤所致的死亡率升高。
FDA进行了荟萃分析，对其他多项长期临床试验的结果进行了研究，以评估氯吡格雷对全因死亡率的影响。结果表明，长期（≥12个月）使用氯吡格雷联合阿司匹林进行双重抗血小板治疗与短期（≤6个月）使用氯吡格雷联合阿司匹林或阿司匹林单药治疗相比，未显示改变总体死亡风险。而且，长期治疗时癌症相关死亡风险或癌症相关不良事件也未明显增加。
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