注射用奥拉西坦治疗颅脑损伤的随机、双盲、对照、多中心临床研究  

Double-blind, placebo-controlled, randomized, multicenter studies of oxiracetam in the treatment of brain injury

作　　者：罗成义[1] 柯以铨[1] 徐如祥[1,8] 章翔[2] 顾建文[3] 于如同[4] 王穗暖[5] 王志刚[6] 卢凯旋 万顺 

机构地区：[1]南方医科大学珠江医院神经外科,广东省神经外科研究所,广东省脑功能修复与再生重点实验室,广州510282 [2]第四军医大学西京医院神经外科,西安710032 [3]成都军区总医院神经外科,成都610083 [4]徐州医学院附属医院神经外科,徐州221000 [5]常州市第一人民医院神经外科,213003 [6]山东大学第二医院神经外科,济南250033 [7]湖南省健朗药业有限责任公司,岳阳414000 [8]北京军区总医院神经外科,北京100700

出　　处：《中华神经医学杂志》2011年第2期192-196,共5页Chinese Journal of Neuromedicine

摘　　要：目的 通过对注射用奥拉西坦与注射用吡拉西坦比较的临床研究,评价注射用奥拉西坦治疗颅脑损伤引起的神经功能缺失的临床疗效及安全性. 方法 本研究为随机、双盲、阳性药平行对照、多中心临床试验,收集自2006年9月至2009年1月珠江医院等5家医院收治的239例颅脑损伤和颅脑手术后患者,按照随机数字表法分为试验组（采用注射用奥拉西坦治疗,120例）和对照组（采用注射用吡拉西坦治疗,119例）.比较2组治疗前后美国国立卫生研究院卒中量表（NIHSS）评分、GCS评分、肢体肌力分级、简易智能状态检查量表（MMSE）评分,观察2组的不良反应并进行心电图和实验室检查以了解其安全性. 结果 试验组和对照组NIHSS、GCS评分和肢体肌力分级治疗后较治疗前均有明显改善,差异有统计学意义（P＜0.05）,但改善的程度二者差异无统计学意义（P＞0.05）,且2组均无药物严重不良事件发生. 结论 注射用奥拉西坦与注射用吡拉西坦一样,在治疗颅脑损伤引起的神经功能缺失中疗效显著,安全性好.Objective To evaluate the efficacy and safety of oxiracetam in the treatment of neurological deficits resulting from brain injury through the comparison of oxiracetam for injection and piracetam for injection in clinical trials. Methods A multiple-center, randomized, double-blind,parallel study was performed on 239 patients; these patients were divided into experimental group （oxiracetam for injection, n=120） and control group （piracetam, n=119）. National institutes of health stroke scale （NIHSS）, Glasgow coma scale （GCS）, myodynamia grading, mini-metal state examination （MMSE） were employed to evaluate the therapeutic effects; electrocardiogram and laboratory examination were performed, and the side effects were also observed. Results The scores of NIHSS,GCS and myodynamia grading after treatment in the 2 groups were all significantly higher than those before treatment （P〈0.05）; however, no significant differences on these scores were noted between the experimental group and control group （P〉0.05）. No serious adverse events were noted in both groups.Conclusion Oxiracetam, the same as piracetam, is safe and effective in the treatment of neurological deficits secondary to brain injury.

关 键 词：颅脑损伤 神经功能缺失 奥拉西坦 随机对照试验 双盲法 多中心研究 

分 类 号：R651.15[医药卫生—外科学]