• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Prescrire international >Don't rely too heavily on this dabigatran antidote
【24h】

Don't rely too heavily on this dabigatran antidote

机译：不要过分依赖这个Dabigatran解毒剂

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Dabigatran, an oral anticoagulant that acts by inhibiting thrombin, was first marketed in the European Union in 2008. No antidote has been available, complicating the management of patients who have severe bleeding or require emergency surgery. In late 2015, idarucizumab, a monoclonal antibody directed against dabigatran, was authorised in the European Union as a specific antidote for dabigatran. It is administered intravenously. # In early 2016, most data on the efficacy of idarucizumab come from an interim analysis of a non-comparative trial in 123 dabigatran-treated patients who had serious bleeding or required emergency surgery or invasive procedures. All 123 patients received idarucizumab. Twenty-six patients died, 8 from bleeding. Among the 66 patients with bleeding, the duration of the event could not be determined in 18 cases because the site of bleeding was not visible. Among the other 48 patients, the bleeding stopped in 44 cases after a median of about 10 hours. Fifty-two of the 57 patients who received idarucizumab prior to invasive procedures underwent surgery. The surgeons considered their clotting status to be normal in 48 cases and mildly or moderately abnormal in the other 4 cases. The role of idarucizumab in these outcomes is difficult to assess for several reasons, including: the lack of a comparator; the partly subjective end-points as the use of idarucizumab was known; and failure to take into account the natural rate of dabigatran elimination. Although idarucizumab normalised markers of dabigatran activity in most patients, the clinical impact was not reported in terms of the frequency of bleeding or thrombosis. The EU summary of product characteristics states that a second dose of idarucizumab can be administered in case of marked dabigatran exposure (massive ingestion, severe renal impairment), but this was the case for only two patients included in the clinical trial. ? Few data on the adverse effects of idarucizumab are available. Idarucizumab carries a risk of hypersensitiv-ity reactions and of developing anti-idarucizumab antibodies, with unknown consequences. In practice, in 2016, close monitoring of patients on dabigatran and standard management of bleeding and its consequences remain the priority. The clinical effects of idarucizumab are poorly documented. Authorisation of this antidote should not lead to trivialising the use of dabigatran. In 2016, warfarin, a vitamin K antagonist, is the standard oral anticoagulant for most patients, despite its inconvenience.
机译：达比加群是一种通过抑制凝血酶发挥作用的口服抗凝剂，2008年首次在欧盟上市。目前还没有可用的解药，这使严重出血或需要紧急手术的患者的管理变得复杂。2015年末，针对达比加群的单克隆抗体伊达鲁珠单抗在欧盟被授权作为达比加群的特效解毒剂。它是静脉注射的2016年初，关于伊达鲁珠单抗疗效的大部分数据来自对123名达比加群治疗的严重出血或需要紧急手术或侵入性手术的患者进行的非对比试验的中期分析。所有123名患者均接受伊达鲁珠单抗治疗。26名患者死亡，8名死于出血。在66例出血患者中，有18例因出血部位不可见而无法确定事件的持续时间。在其他48名患者中，44名患者的出血在中位数约10小时后停止。在侵入性手术前接受伊达鲁单抗治疗的57名患者中，有52名接受了手术。外科医生认为48例凝血状态正常，其余4例轻度或中度异常。伊达鲁珠单抗在这些结果中的作用很难评估，原因包括：缺乏对照；已知伊达鲁珠单抗使用的部分主观终点；以及没有考虑达比加群的自然消除率。虽然伊达鲁珠单抗使大多数患者的达比加群活性标志物正常化，但在出血或血栓形成的频率方面，没有报道其临床影响。欧盟产品特征总结指出，如果达比加群明显暴露（大量摄入，严重肾损害），可以服用第二剂伊达鲁珠单抗，但临床试验中仅包括两名患者？关于伊达鲁珠单抗不良反应的数据很少。伊达鲁珠单抗具有过敏反应和产生抗伊达鲁珠单抗抗体的风险，其后果未知。在实践中，2016年，密切监测达比加群的患者，并对出血及其后果进行标准管理仍然是当务之急。伊达鲁珠单抗的临床效果缺乏文献记载。这种解毒剂的授权不应导致达比加群的使用变得微不足道。2016年，维生素K拮抗剂华法林成为大多数患者的标准口服抗凝剂，尽管它带来了不便。

著录项

  • 来源
    《Prescrire international》 |2016年第176期|共3页
  • 作者

  • 作者单位
  • 收录信息
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药学;
  • 关键词

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号