NEJM:利伐沙班用于住院患者出院后的血栓预防疗效分析

2018-09-20 xing.T MedSci原创

由此可见,对于出院后45天的患者,利伐沙班相比于安慰剂并不能显著降低静脉血栓栓塞引起的症状性静脉血栓栓塞和死亡风险,但大出血的发生率很低。

因疾病住院的患者出院后仍存在发生静脉血栓栓塞的风险,但延长血栓预防治疗在此类患者中的作用是一个存在争议的问题。近日,顶级医学期刊NEJM上针对这一问题发表了一篇研究文章。

在这项随机、双盲试验中,研究人员将根据改良的静脉血栓栓塞国际医疗预防登记处(IMPROVE)评分(分数范围从0到10,更高的分数表明静脉血栓栓塞的风险更高)为4或更高的患者或评分为2或3且血浆d-二聚体水平超过正常范围上限的两倍(根据当地实验室标准确定)的静脉血栓栓塞风险增加的病人在出院时随机分配至每日一次利伐沙班,剂量为10mg(肾功能不全患者进行剂量调整)或安慰剂治疗,治疗时间为45天。该研究的主要疗效结局是症状性静脉血栓栓塞复合事件或由静脉血栓栓塞引起的死亡。该研究的主要的安全性结局为大出血。

在接受随机分组的12024名患者中,12019名患者被纳入意向治疗分析。6007名给予利伐沙班治疗的患者中有50名(0.83%)患者和6012名给予安慰剂治疗的患者中有66名(1.10%)患者发生了主要疗效结局(风险比为0.76; 95%置信区间[CI]为0.52至1.09; P=0.14)。利伐沙班组的0.18%患者和安慰剂组的0.42%患者发生了有症状的非致命性静脉血栓栓塞的预期次要结局(风险比为0.44; 95%CI为0.22至0.89)。利伐沙班组5982名患者中有17名(0.28%)患者和安慰剂组5980名患者中有9名(0.15%)患者出现大出血(风险比为1.88; 95%CI为0.84至4.23)。

由此可见,对于出院后45天的患者,利伐沙班相比于安慰剂并不能显著降低静脉血栓栓塞引起的症状性静脉血栓栓塞和死亡风险,但大出血的发生率很低。
 
原始出处:
 
Alex C. Spyropoulos, et al.Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness. N Engl J Med 2018; https://www.nejm.org/doi/full/10.1056/NEJMoa1805090
 
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    2018-09-20 内科新手

    谢谢梅斯提供这么好的信息,学到很多

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    2018-09-20 183****7028

    学习

    0

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