TREATMENT OF ACUTE CEREBRAL-HEMORRHAGE WITH INTRAVENOUS GLYCEROL - A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL
TREATMENT OF ACUTE CEREBRAL-HEMORRHAGE WITH INTRAVENOUS GLYCEROL - A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL
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DOI：
10.1161/01.str.23.7.967
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发表时间：
1992-07-01
期刊：
影响因子：
8.3
通讯作者：
FONG, KY
中科院分区：
文献类型：
--
作者：
YU, YL;KUMANA, CR;FONG, KY
背景和目的：然而，静脉注射甘油治疗急性脑出血尚未在严格的临床研究与足够的patientnumber.Methods：我们进行了一项双盲，分层和随机，安慰剂对照的临床试验。仅招募症状发作后24小时内入院的首次卒中患者，前提是计算机断层扫描证实出血并获得知情同意书。使用格拉斯哥昏迷量表将患者分为警戒、半昏迷和昏迷亚组后，107例患者接受了积极治疗（连续6天静脉输注500 ml 10%甘油盐水，持续4小时），109例患者接受了相应的盐水治疗。使用各种客观的评分系统，患者随访长达6 months.Results：在后续，治疗组和对照组的结果的所有措施是非常相似的。6个月时，死亡率分别为37/107和33/109。斯堪的纳维亚卒中研究组评分的相应平均+/-SD改善分别为8.35+/-16.9与11.55+/-15.6（长期）和0.64+/-7.3与2.40+/-6.9（预后），Barthel指数评分的改善分别为10.72+/-24.7与13.95+/-23.3。治疗组和对照组存活者的格拉斯哥昏迷量表评分改善分别为0.81+/-1.5和1.16+/-1.7。溶血（一般亚临床）是唯一的不良反应甘油noted.Conclusions：在治疗组和对照组之间的结果没有任何临床或统计学显着差异，这项试验提供了没有理由甘油治疗急性脑出血。
Background and Purpose: Hitherto, treatment of acute cerebral hemorrhage with intravenous glycerol has not been evaluated in rigorous clinical studies with sufficient patient numbers.Methods: We undertook a double-blind, stratified and randomized, placebo-controlled clinical trial. Only patients with a first stroke admitted to the hospital within 24 hours after onset of symptoms were recruited, provided computed tomography confirmed hemorrhage and informed consent was obtained. After stratification into alert, semicoma, and coma subgroups using the Glasgow Coma Scale, 107 patients received active treatment (500 ml of 10% glycerol in saline by intravenous infusion over 4 hours on 6 consecutive days) and 109 were given corresponding saline treatment. Using a variety of objective scoring systems, patients were followed up for up to 6 months.Results: At follow-up, all measures of outcome in the treated and control groups were very similar. At 6 months, respective mortality rates were 37 of 107 and 33 of 109. Corresponding mean+/-SD improvements in Scandinavian Stroke Study Group scores were 8.35+/-16.9 versus 11.55+/-15.6 (long-term) and 0.64+/-7.3 versus 2.40+/-6.9 (prognostic), and improvements in the Barthel Index ratings were 10.72+/-24.7 versus 13.95+/-23.3, respectively. Glasgow Coma Scale score improvements in the survivors were 0.81+/-1.5 and 1.16+/-1.7 in the treated and control groups, respectively. Hemolysis (generally subclinical) was the only adverse effect of glycerol noted.Conclusions: In the absence of any clinically or statistically significant difference in outcome between the treated and control groups, this trial provides no justification for glycerol therapy following acute cerebral hemorrhage.