依达拉奉注射液治疗急性脑梗死的临床疗效评价

Efficacy evaluation of edaravone injection in treatment of acute cerebral infarction

目的:观察依达拉奉注射液治疗急性脑梗 死的疗效和不良反应。方法:采用随机双盲、安慰剂 平行对照、多中心试验。共入组急性脑梗死病人 224例,实际完成213例,其中依达拉奉组109例 (男性61例,女性48例),安慰剂组104例(男性52 例,女性52例),依达拉奉组使用依达拉奉注射液 30mg加氯化钠注射液250mL,iv,gtt,bid,14d为 一个疗程。安慰剂组为等量安慰剂加氯化钠注射液 250mL,iv,gtt,bid,14d为一个疗程。2组病人基础 治疗相同。记录神经功能缺损评分和日常生活活动 能力评分,以增分率来判断疗效。结果:d21依达 拉奉组神经功能改善的有效率为64.3%,安慰剂组 为33.6%。依达拉奉组日常生活活动能力改善的 有效率为57.8%,安慰剂组为39.2%。依达拉奉 组不良事件发生率为3.5%,安慰剂组为2.7%,无 统计学差异。结论:依达拉奉注射液30mg静脉滴 注,每日2次治疗,能有效改善急性脑梗死的神经功 能缺失和日常生活能力,亦能改善脑梗死病人的远 期日常生活能力,未见明显不良反应。

AIM:To evaluate the clinical effects and adverse reactions of edaravone injection on acute cerebral infarction. METHODS:The experiment was based on random, blind, multi-center and placebo, parallel comparison. Each of the five centers —— containing 48 random numbers randomized preliminarily by SAS —— conducted the clinical research under the principle of random and blindness. Per protocol analysis was carried out on the 213 valid patients out of 224 patients in total dividing into two groups: the treatment group and the placebo control group. One hundred and nine patients in treatment group(M 61, F 48), were given edaravone injection 30 mg dissolved in sodium chloride injection 250 mL for each one, twice a day for 14 d. One hundred and four patients in placebo control group (M 52,F 52) were treated with equal amount of placebo dissolved in 250 mL sodium chloride injection for each one, twice a day for 14 d. The two groups were also given for each patient troxerutin 200 mg dissolved in sodium chloride injection or 5 % glucose once a day for 21 d, and aspirin 50-75 mg·d -1. Assessment scores of nerve function impairment and of daily life activity were recorded; and effects were evaluated according to the increase rates of assessment scores. RESULTS:Through double unblinding, the efficiency of edaravone injection on improving nerve function was 64.3 %,and that of placebo control group was 33.6 %. The efficiency rate of edaravone injection on improving daily activity was 57.8 %, and that of placebo control group was 39.2 %. Main adverse reactions of the treatment group were ALT increase, hemorrhage after infarction, faint, headache, tetter, and so on. The occurrence of adverse reactions in treatment group was 3.5 % and that of placebo control group was 2.7 %. There was no significant difference between the two groups. CONCLUSION: 30 mg dose of edaravone injection used intravenously twice a day can improve the nerve function impairment and daily activity of acute encephalon infarction patients, without obvions adverse reactions.