摘要
目的 观察丁苯酞注射液对急性脑梗死患者的有效性和安全性.方法多中心、随机、双盲双模拟、阳性药物平行对照Ⅲ期临床研究.共入组552例起病48 h内,美国国立卫生研究院卒中量表（National Institutes of Health Stroke Scale,NIHSS）评分为 6～25分的急性缺血性卒中患者,其中丁苯酞注射液组和奥扎格雷钠注射液组分别为370例和182例.结果 丁苯酞组治疗前、治疗后第8天和第15天的NIHSS总评分分别为8.64±3.03、6.45±3.88和4.71±3.90,Barthel指数分别为45.42±20.82、55.60±25.64和65.39±26.85,治疗后第15天NIHSS评分及Barthel指数与治疗前评分的差值两组比较差异有统计学意义（Wilcoxon秩和检验方法,z=2.21,经P=0.027; z=2.50,P=0.012）,在调整治疗前的NIHSS评分和既往有症状的卒中发生次数后,该差异仍存在,丁苯酞组优于奥扎格雷钠组.治疗后第15天丁苯酞组有效率显著高于奥扎格雷钠组（OR=1.67,95%CI科1.15~2.42）.丁苯酞组和奥扎格雷钠组不良事件发生率差异无统计学意义,两组最常见不良事件为丙氨酸氨基转移酶升高,两组发生率差异无统计学意义（Fisher 确切概率法,2.74%与4.44%,P=0.34）.结论 丁苯酞注射液用于治疗急性脑梗死是有效和安全的,在第15天静脉给药结束时,其疗效优于奥扎格雷钠注射液.临床试验注册 中国临床试验注册中心（ChiCTR-TRC-09000483）.
Objective To assess the efficacy and safety of dl-3-n-butylphthalide injection in acute ischemic stroke patients. Methods A randomized, double-blind, double-dummy trial enrolled 552 patients in China, if they were within 48 hours of onset of ischemic stroke, and had a score from 6 to 25 on the National Institutes of Health Stroke Scale （NIHSS）. Three hundred and seventy patients were randomly assigned to receive infusion of dl-3-n-butylphthalide and 182 patients received infusion of ozagrel. Results In dl-3-n-butylphthalide group, NIHSS score at baseline, on the 8th and 15th days were 8.64 ±_ 3.03, 6.45 ± 3.88 and 4.71 ± 3.90 respectively, whereas Barthel index score were 45.42 ± 20.82,55.60 ± 25.64 and 65.39 ± 26.85 respectively. The difference of NIHSS score between the 15th day and baseline was significantly higher in dl-3-n-butylphthalide group as compared with ozagrel group （Wileoxon rank sum test, z = 2.21, P = 0. 027）. Similar result was found when Barthel index was evaluated （z = 2.50, P = 0. 012 ） , suggesting a favorable outcome of dl-3-n-butylphthalide treatment. Among the 5~5 subjects included in the efficacy analysis, 14 days of treatment with dl-3-n-butylphthalide was significantly associated with a favorable outcome than that in 14-day treatment with ozagrel as measured by NIHSS（z = 2.21, P = 0. 027）and Barthel index （z = 2.50, P = 0. 012）. The effective rate on the 15th day was significantly higher in dl-3-n- butylphthalide group as compared with that in ozagrel group. The rate of adverse events was similar between two groups （2.74% vs 4.44% ,P = 0.34）. Elevated alanine aminotransferase was the most common adverse event. Conclusion This trial suggested that the 14-day treatment with dl-3-n-butylphthalide could improve outcomes on the 15th day after stroke, and intravenous administration of dl-3-n-butylphthalide was safety. Trial registration Chinese Clinical Trial Registry （ChiCTR-TRC-09000483）.
出处
《中华神经科杂志》
CAS
CSCD
北大核心
2014年第2期113-118,共6页
Chinese Journal of Neurology
关键词
脑梗死
苯呋喃类
随机对照试验
Brain infarction
Benzofurans
Randomized controlled trial
