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ESC 2013:白蛋白对急性卒中患者无益

2013-06-09 晓静 译 医学论坛网

  于第22届欧洲卒中大会(ESC2013)公布的急性卒中白蛋白治疗(ALIAS)3期研究表明,与应用盐水治疗相比,急性卒中患者应用白蛋白治疗无更多获益,且与较多的不良反应(肺水肿)相关。   研究的报告者Myron D. Ginsberg博士表示,虽然白蛋白被认为是一种有前景的治疗方法,但就像其他许多神经保护剂一样,它似乎只在动物中起作用而非在人类中。在前期的临床前研究中,

  于第22届欧洲卒中大会(ESC2013)公布的急性卒中白蛋白治疗(ALIAS)3期研究表明,与应用盐水治疗相比,急性卒中患者应用白蛋白治疗无更多获益,且与较多的不良反应(肺水肿)相关。

  研究的报告者Myron D. Ginsberg博士表示,虽然白蛋白被认为是一种有前景的治疗方法,但就像其他许多神经保护剂一样,它似乎只在动物中起作用而非在人类中。在前期的临床前研究中,白蛋白对卒中显示出了保护作用。

  ALIAS 3期研究的第一部分在纳入434例患者后被迫停止,因为白蛋白组患者早期死亡率似乎增加(13%对5.5%对照组),主要发生在老年及体内液体较多的患者。在排除了年龄在83岁以上的老年、心衰和近期心肌梗死的患者后,研究再次启动。纳入患者平均年龄为64岁,54%男性,20%为非裔美国人,71%有高血压病史。85%的患者接受了组织纤溶酶原激活剂治疗,从症状起始到给予白蛋白或安慰剂治疗的平均时间为206分钟。

  在纳入841例患者后研究因无益而被再次中止,研究显示主要转归无差异。在不良反应方面,肺水肿也是一个问题。

  不良反应表

  终点

  白蛋白组(%)

  对照组(%)

  相对危险

  肺水肿

  13.1

  1.2

  10.8

  气促

  4.3

  1.7

  2.58

  48h内发生房颤

  7.8

  4.6

  1.69

  24 h内发生症状性颅内出血

  4.1

  1.69

  2.4

ALIAS: No Benefit of Albumin in Acute Stroke
LONDON, United Kingdom — Albumin was no more effective than saline control and was associated with more adverse effects in the treatment of patients with acute stroke in a phase 3 study.
The results, from the ALbumin In Acute Stroke (ALIAS) trial, were presented here at the XXII European Stroke Conference (ESC) 2013 by Myron D. Ginsberg, MD, University of Miami Miller School of Medicine, Florida....

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