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《Chinese Journal of New Drugs and Clinical Remedies》 2007-02
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Efficacy and safety evaluation of edaravone injection in treatment of acute cerebral infarction:a multicenter,double-blind,and randomized controlled clinical trial

ZHANG Ming,XU Li-jun,DENG Li-ying,LU Jie,REN Hui,YANG Qi-dong,HU Zhi-ping,GUO Chong-lun,MO Jia-peng (Department of Neurology,the Second Affiliated Hospital of Nanchang University,Nanchang JIANGXI 330006,China;Department of Neurology,the Frist Affiliated Hospital of Kunming Medical College,Kunming YUNNAN 650032,China;Department of Neurology,Xiangya Hospital of Central South University,Changsha HU-NAN 410008,China;Department of Neurology,Xiangya Second Hospital of Central South University,Changsha HU-NAN 410008,China)  
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.
【CateGory Index】: R743.3
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