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美国FDA近日批准了抗凝血药物利伐沙班(rivaroxaban,Xarelto)用于降低非瓣膜性心房颤动患者发生中风的风险。批准基于入选14 000名患者的临床试验,与抗凝血药物华法林进行比较,评估了该药的安全性和有效性。结果表明,该药预防中风的疗效与华法林相当。患者应在晚餐时服用该药,以便药物完全吸收。与其他抗凝血药物比较,该药可引起出血但极少导致死亡。临床试验中,该药引起出血风险与华法林相当,但较少出现大脑出血,而胃肠道出血较多。该药包括1项黑框警告,警告患者未经医生同意不可擅自停止用药,否则会增加中风危险。
US FDA recently approved rivaroxaban (Xarelto), an anticoagulant drug, to reduce the risk of stroke in patients with nonvalvular atrial fibrillation. Approved clinical trials based on 14,000 patients enrolled in the study compared with anticoagulant warfarin to assess the safety and efficacy of the drug. The results show that the drug to prevent stroke and warfarin effect. The patient should take the medicine at dinner so that the medication is completely absorbed. It causes bleeding but rarely causes death compared with other anticoagulants. In clinical trials, the drug causes bleeding at a comparable risk to warfarin, but less bleeding from the brain and more bleeding from the gastrointestinal tract. The drug includes a black box warning, warned patients not to stop using the drug without the consent of the doctor, otherwise it will increase the risk of stroke.