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

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。

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

AIM:To evaluate the clinical effects and safety of edaravone injection on acute cerebral in- farction (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 14 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, 14 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.