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目的评价进口奥拉西坦注射液与国产奥拉西坦注射液治疗急性缺血性脑卒中的有效性和安全性。方法由四川大学华西医院为负责单位,广西壮族自治区人民医院、桂林医学院附属医院、吉林省人民医院神经内科、昆明医科大学第二附属医院、兰州大学第一医院、四川省人民医院、苏州大学附属第一医院、天津中医药大学第一附属医院、重庆三峡中心医院、苏州大学附属第二医院为参加单位,于2013年3月—2014年7月对进口奥拉西坦注射液(韩国高丽制药株式会社生产)与国产奥拉西坦注射液(商品名:欧兰同,哈尔滨三联药业有限公司生产)治疗急性缺血性脑卒中有效性和安全性进行随机盲法、阳性药对照、多中心临床试验。将240例急性缺血性脑卒中患者随机分为试验组(基础治疗+进口奥拉西坦注射液组)和对照组(基础治疗+国产奥拉西坦注射液组),每组各120例。分别于治疗1、2周后和治疗结束后12周随访。最终纳入符合方案集分析的共200例,其中试验组101例,对照组99例。分别使用美国国立卫生研究院卒中量表(National Institute of Health Stroke Scale,NHISS)、改良Rankin量表(Modified Rankin Scale,m RS)和巴氏指数(Barthe Index,BI)来评估受试者的神经功能缺损程度、病残程度、生活质量和治疗有效率。安全性评估指标包括不良事件和生命体征。结果试验组和对照组的NHISS评分在治疗前分别为(7.46±1.99)、(7.20±2.47)分,治疗1周后分别为(5.81±2.30)、(5.54±2.58)分,治疗2周后分别为(3.93±2.40)、(3.79±2.39)分,治疗结束后12周分别为(1.85±1.63)、(2.08±2.01)分,两组比较差异均无统计学意义(P>0.05);两组在治疗1、2周后和治疗结束后12周的m RS分级、BI比较差异均无统计学意义(P>0.05);治疗后各时点的NHISS评分、m RS分级、BI与该组治疗前比较差异均有统计学意义(P<0.05)。两组各时点的治疗有效率比较差异均无统计学意义(P>0.05)。试验组共50例(41.66%)发生111例次(92.50%)不良事件,对照组共61例(50.83%)发生145例次(120.83%)不良事件,两组比较差异无统计学意义,且绝大多数不良反应为轻度。两组患者治疗2周后的生命指征比较差异均无统计学意义(P>0.05)。结论进口奥拉西坦注射液与国产奥拉西坦注射液治疗急性缺血性脑卒中的疗效无明显差异,且安全性均良好。
Objective To evaluate the effectiveness and safety of imported oxiracetam injection and domestic oxiracetam injection in the treatment of acute ischemic stroke. Methods Huaxi Hospital of Sichuan University as the responsible unit, the Guangxi Zhuang Autonomous Region People’s Hospital, Guilin Medical College Hospital, Jilin Province People’s Hospital Department of Neurology, Kunming Medical University Second Affiliated Hospital, Lanzhou University First Hospital, Sichuan Provincial People’s Hospital, Suzhou University The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Chongqing Three Gorges Central Hospital, the Second Affiliated Hospital of Suzhou University as a participant, from March 2013 to July 2014 imported oxiracetam injection (Korea Korea Pharmaceutical Co., Ltd.) and domestic oxiracetam injection (trade name: Ou Lan Tong, Harbin triple Pharmaceutical Co., Ltd.) for the treatment of acute ischemic stroke effectiveness and safety of randomized blind, positive drug control, Multi-center clinical trial. 240 patients with acute ischemic stroke were randomly divided into experimental group (basic treatment + imported oxiracetam injection group) and control group (basic treatment + domestic oxiracetam injection group), 120 cases in each group . They were followed up for 1,2 weeks after treatment and 12 weeks after the end of treatment, respectively. Finally, a total of 200 patients were enrolled in accordance with the program set analysis, including 101 cases in the experimental group and 99 cases in the control group. The subjects’ nerves were assessed using the National Institutes of Health Stroke Scale (NHISS), Modified Rankin Scale (m RS) and Barthe Index (BI) Degree of functional impairment, degree of disability, quality of life and treatment effectiveness. Safety assessment indicators include adverse events and vital signs. Results The scores of NHISS in test group and control group were (7.46 ± 1.99) and (7.20 ± 2.47) before treatment and (5.81 ± 2.30) and (5.54 ± 2.58) after treatment for one week respectively. After 2 weeks of treatment, (3.93 ± 2.40) and (3.79 ± 2.39) points respectively. After treatment for 12 weeks, they were (1.85 ± 1.63) and (2.08 ± 2.01) points respectively. There was no significant difference between the two groups (P> 0.05). There were no significant differences in mRS classification and BI between the two groups after treatment for 1, 2 weeks and 12 weeks after treatment (P> 0.05); NHISS score, m RS classification, BI and Group before treatment were statistically significant differences (P <0.05). There was no significant difference in the treatment efficiency between the two groups at each time point (P> 0.05). A total of 111 adverse events (92.50%) occurred in 50 patients (41.66%) in the experimental group, and 145 events (120.83%) occurred in 61 patients (50.83%) in the control group. There was no significant difference between the two groups The vast majority of adverse reactions were mild. There was no significant difference in life indications between the two groups after 2 weeks of treatment (P> 0.05). Conclusion The efficacy of oxiracetam injection and domestic oxiracetam injection in the treatment of acute ischemic stroke has no significant difference, and the safety is good.