急性脑卒中白蛋白治疗试验第 1 部分：探索性疗效分析。
The Albumin in Acute Stroke Part 1 Trial: an exploratory efficacy analysis.
机构信息
Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Foothills Hospital, Room 1242A, 1403 29th St. NW, Calgary, Alberta, T2N 2T9, Canada.
出版信息
Stroke. 2011 Jun;42(6):1621-5. doi: 10.1161/STROKEAHA.110.610980. Epub 2011 May 5.
BACKGROUND AND PURPOSE
The Albumin in Acute Stroke (ALIAS) Part 2 Trial is directly testing whether 2 g/kg of 25% human albumin (ALB) administered intravenously within 5 hours of ischemic stroke onset results in improved clinical outcome. Recruitment into Part 1 of the ALIAS Trial was halted for safety reasons. ALIAS Part 2 is a new, reformulated trial with more-stringent exclusion criteria. Our aim was to explore the efficacy of ALB in the ALIAS Part 1 data and to assess the statistical assumptions underlying the ALIAS Part 2 Trial.
METHODS
ALIAS is a multicenter, blinded, randomized controlled trial. Data on 434 subjects, comprising the ALIAS Part 1 subjects, were analyzed. We examined both the thrombolysis and nonthrombolysis cohorts combined and separately in a "target population" by excluding subjects who would not have been eligible for the ALIAS Part 2 Trial; the latter comprised patients >83 years of age, those with elevated baseline troponin values, and those with in-hospital stroke. We examined the differences in the primary composite outcome, defined as a modified Rankin Scale score of 0 to 1 and/or a National Institutes of Health Stroke Scale score of 0 to 1 at 90 days after randomization.
RESULTS
In the combined thrombolysis plus nonthrombolysis cohorts of the target population, 44.7% of subjects in the ALB group had a favorable outcome compared with 36.0% in the saline group (absolute effect size=8.7%; 95% CI, -2.2% to 19.5%). Among thrombolyzed subjects of the target population, 46.7% had a favorable outcome in the ALB group compared with 36.6% in the saline group (absolute effect size=10.1%; 95% CI, -2.0% to 20.0%).
CONCLUSIONS
Preliminary results from the ALIAS Part 1 suggest a trend toward a favorable primary outcome in subjects treated with ALB and support the validity of the statistical assumptions that underlie the ALIAS Part 2 Trial. The ALIAS Part 2 Trial will confirm or refute these results.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov/ALIAS. Unique identifier: NCT00235495.
背景与目的
Albumin in Acute Stroke（ALIAS）第 2 部分试验直接测试了在缺血性卒中发作后 5 小时内静脉内给予 2 克/公斤 25%人白蛋白（ALB）是否导致临床结局改善。由于安全性原因，ALIAS 第 1 部分的入组被停止。ALIAS 第 2 部分是一项新的、重新设计的试验，具有更严格的排除标准。我们的目的是探讨 ALB 在 ALIAS 第 1 部分数据中的疗效，并评估 ALIAS 第 2 部分试验的统计假设。
方法
ALIAS 是一项多中心、盲法、随机对照试验。对包含 ALIAS 第 1 部分受试者的 434 例受试者的数据进行了分析。我们通过排除不符合 ALIAS 第 2 部分试验条件的受试者，在“目标人群”中同时和分别对溶栓和非溶栓队列进行了研究；后者包括年龄>83 岁的患者、基线肌钙蛋白值升高的患者和住院期间发生卒中的患者。我们检查了主要复合结局的差异，该结局定义为随机分组后 90 天时改良 Rankin 量表评分 0-1 分和/或国立卫生研究院卒中量表评分 0-1 分。
结果
在目标人群的溶栓加非溶栓联合队列中，ALB 组 44.7%的受试者有良好的结局，而生理盐水组为 36.0%（绝对效应大小=8.7%；95%CI，-2.2%至 19.5%）。在目标人群的溶栓患者中，ALB 组 46.7%的受试者有良好的结局，而生理盐水组为 36.6%（绝对效应大小=10.1%；95%CI，-2.0%至 20.0%）。
结论
ALIAS 第 1 部分的初步结果表明，接受 ALB 治疗的受试者有良好结局的趋势，并支持 ALIAS 第 2 部分试验的统计假设的有效性。ALIAS 第 2 部分试验将证实或反驳这些结果。
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