曲克芦丁脑蛋白水解物注射液治疗急性脑梗死的随机、单盲和安慰剂对照研究

发布时间：2018-06-15 14:55

  本文选题：曲克芦丁脑蛋白水解物 + 急性脑梗死　； 参考：《中国神经免疫学和神经病学杂志》2016年04期

【摘要】：目的探讨曲克芦丁脑蛋白水解物注射液治疗急性脑梗死的疗效及安全性。方法选取符合入组条件的急性脑梗死患者456例,按1∶3比例随机分为对照组和治疗组,其中治疗组共342例给予曲克芦丁脑蛋白水解物注射液治疗14d,对照组共114例给予灭菌注射用水,两组基础治疗一致。主要疗效观察指标为两组患者发病90d时的改良Rankin量表评价分析无明显残障(0~2级)患者的比例,次要疗效指标为治疗7d、14d后美国国立卫生院神经功能缺损评分(NIHSS)评分较基线降低≥7分者所占百分比和治疗14d、发病后90d Barthel指数评价≥75分者所占百分比。结果治疗组发病90d后无明显残障病例(改良Rankin量表评分0~2级)百分比明显高于对照组(83.92%νs.69.3%,P0.01);用药14d时治疗组NIHSS评分降低≥7分者所占百分比明显高于对照组(31.37%νs.4.08%,P0.01);治疗组发病90d后Barthel指数≥75者所占百分比高于对照组(85.38%νs.76.32%,P0.05)。治疗组和对照组分别发生26例(7.28%)、11例(9.17%)不良反应(一般不良事件),组间比较差异无统计学意义(P0.05)。结论曲克芦丁脑蛋白水解物注射液可改善急性脑梗死患者的神经功能缺损程度,促进功能恢复,且不良反应少,安全性较好,值得临床推广。
[Abstract]:Objective to investigate the efficacy and safety of troxerutin brain protein hydrolysate injection in the treatment of acute cerebral infarction. Methods 456 patients with acute cerebral infarction were randomly divided into control group and treatment group according to 1:3 ratio. 342 cases in the treatment group were treated with troxorutin brain protein hydrolysate injection for 14 days, and 114 cases in the control group were treated with sterilizing water. The main outcome index was the proportion of patients in the two groups who were evaluated by modified Rankin scale at 90 days after onset of the disease. The secondary outcome measures were the percentage of patients with neurological impairment score (NIHSS) of the National Institutes of Health (NIH) reduced 鈮，

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