依达拉奉注射液治疗急性脑梗死疗效及安全性随机双盲多中心研究  

Efficacy and safety evaluation of edaravone injection in treatment of acute cerebral infarction:a multicenter,double-blind,and randomized controlled clinical trial

作　　者：张明[1] 徐丽君[1] 邓丽影[1] 卢洁[1] 任慧[2] 杨期东[3] 胡治平[4] 郭崇伦[1] 莫家鹏[1] 

机构地区：[1]南昌大学第二附属医院神经科,江西南昌330006 [2]昆明医学院第一附属医院神经科,云南昆明650032 [3]中南大学湘雅医院神经科,湖南长沙410008 [4]中南大学湘雅二医院神经科,湖南长沙410008

出　　处：《中国新药与临床杂志》2007年第2期105-108,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:观察依达拉奉注射液治疗急性脑梗死的疗效和安全性。方法:采用多中心、随机双盲、安慰剂平行对照试验。急性脑梗死病人202例。治疗组100例,给予依达拉奉30 mg加入氯化钠注射液100 mL, iv,gtt,bid×14 d;对照组102例,给予等量氯化钠注射液10 mL加入氯化钠注射液100 mL,iv,gtt, bid×14 d;2组病人基础治疗相同。治疗前,治疗后d 7,d 14,d 28对2组病人进行神经功能缺损评分和日常生活能力评分,并进行疗效比较。结果:治疗后d 28治疗组和对照组日常生活能力有效率分别为77．0％和27．4％(P<0．000 1),神经功能缺损有效率分别为78．0％和26．5％(P<0．000 1)。治疗组不良事件发生率为4．0％,对照组为6．9％(P>0．05)。结论:依达拉奉注射液能有效改善急性脑梗死病人的神经功能缺损和日常生活能力,未见明显不良反应。AIM： To evaluate the clinical effects and safety of edaravone injection on acute cerebral infarction （ACI）. METHODS： A multicenter, randomized, placebo-controlled, parallel, double-blind trial was carried out on patients with ACI. Two hundred and two patients were randomly allocated to treatment group （n = 100） and control group （n = 102）. Besides the basic treatment, the individual in treatment group received edaravone 30 mg dissolved in sodium chloride injection 100 mL, twice a day, for lg d, while that of the control group received similar quantity of sodium chloride injection to those of edaravone group but without edaravone. Before treatment and at 7 th, lg th and 28 th day after treatment, the neurological deficits and activities of daily living （ADL） were evaluated using European Stroke Scale （ESS） and Bathel index respectively. RESULTS： After 28 d of treatment, the effective rates of ADL in treatment group and control group were 77.0 % and 27.4 % respectively （P 〈 0.000 1 ）, while those of the neurological deficits （ESS） were 78.0 % and 26.5 % respectively （P 〈 0.000 1）. The adverse reactions occurred as 4.0 % and 6.9 % （P 〉 0.05） in the former and later group, showing no significant difference. CONCLUSION： Edaravone injection provides effective improvements for both neurological deficits and ADL in ACI without conspicuous adverse reactions.

关 键 词：依达拉奉 自由基清除剂 脑梗死 药物评价 双盲法 随机对照试验 

分 类 号：R971[医药卫生—药品] R743[医药卫生—药学]