预防性抗生素在中风研究 (PASS):一个务实的随机的开放标签掩盖的终点临床试验
Willeke F Westendorp1, Jan-Dirk Vermeij1, Elles Zock2
1Department of Neurology, Centre of Infection and Immunity Amsterdam, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
Lancet (London, England)
|January 24, 2015
概括
预防性抗生素治疗的 ceftriaxone 并没有改善急性中风患者的功能结果. 这项研究发现,使用塞夫特里亚克松预防感染或改善中风后的康复没有益处.
科学领域:
- 神经学 神经学
- 传染性疾病 传染性疾病
- 临床试验 临床试验
背景情况:
- 感染在急性中风患者中很常见,对功能结果产生负面影响.
- 预防性抗生素在中风研究 (PASS) 调查了预防性抗生素在急性中风中的疗效.
研究的目的:
- 为了确定是否预防性抗菌素治疗 ceftriaxone 改善了急性中风患者的功能结果.
- 评估 ceftriaxone 对中风幸存者的感染率和死亡率的影响.
主要方法:
- 一个多中心,随机,开放的标签试验,涉及2550名急性中风的成年患者.
- 患者接受了4天内静脉注射塞夫或标准中风病房护理.
- 主要终点是3个月后的功能性结果,使用修改的兰金度量表进行评估.
主要成果:
- 在3个月后,预防性 ceftriaxone 并没有显著改变功能结果 (OR 0.95,p=0.46).
- 没有观察到 ceftriaxone 治疗不良事件的增加.
- 塞夫特里困难菌感染发生在塞夫特里群中的两名患者 (<1%),在对照组中没有患者.
结论:
- 预防性 ceftriaxone 治疗不会改善急性中风的成年人的功能结果.
- 这些发现不支持在急性中风管理中常规使用预防性抗生素.
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