米屈肼注射液治疗急性脑梗死有效性和安全性的多中心Ⅱ期临床研究  

Efficacy and safety of mildronate injection in treatment of acute ischemic stroke: a multicenter phase Ⅱ trial

作　　者：朱益[1] 赵钢[1] 张光运[1] 李德帅[1] 

机构地区：[1]中国人民解放军第四军医大学第一附属医院神经内科,陕西省西安市710032

出　　处：《国际神经病学神经外科学杂志》2013年第3期208-211,共4页Journal of International Neurology and Neurosurgery

摘　　要：目的观察米屈肼注射液治疗急性脑梗死的有效性和安全性。方法 227例急性脑梗死患者采用米屈肼注射液进行随机、双盲、双模拟、平行对照的多中心临床研究。试验组113例、对照组114例,试验组给予屈肼注射液,对照组给予马来酸桂哌齐特注射液。基础用药给予拜阿司匹林。评价2周后神经功能缺损评分(NIHSS评分)和Barthel指数的变化、实验室检查和安全性评级等。结果试验组和对照组的主要疗效评价指标NIHSS评分、Barthel指数差别均无统计学意义(P>0.05)。两组不良反应发生率相当(P>0.05)。结论米屈肼注射液治疗急性脑梗死临床疗效肯定,而且安全性好。Objective To observe the efficacy and safety of mildronate injection in treating acute cerebral infarction.Methods A randomized,double-blind,double-dummy,parallel-group,and multicenter clinical trial of mildronate injection was performed in 227 patients with acute cerebral infarction.These patients were divided into test group（n=113） and control group（n=114）.The test group was given mildronate injection,while the control group was given cinepazide maleate injection.In addition,both groups were given Bayaspirin as basic treatment.After two weeks of treatment,the efficacy was evaluated using the National Institutes of Health Stroke Scale（NIHSS） and Barthel Index,and the safety was evaluated based on laboratory testing and adverse events.Results There were no significant differences in NIHSS score and Barthel Index score between the test group and control group（P＆gt;0.05）.The two groups had similar incidence rate of adverse events（P＆gt;0.05）.Conclusions Mildronate injection has comparable efficacy and safety to those of cinepazide maleate injection in treating acute cerebral infarction.

关 键 词：米屈肼注射液 急性脑梗死 临床试验 

分 类 号：R743.33[医药卫生—神经病学与精神病学]