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

Curative effect and security of troxerutin and cerebroprotein hydrolysate injection in acute cerebral infarction,a multicenter,randomized,single blind and placebo control study

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14 d，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90 d 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7 d、14 d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14 d、发病后90 d Barthel 指数评价≥75分者所占百分比。结果治疗组发病90 d 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％，P ＜0．01）；用药14 d 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％，P ＜0．01）；治疗组发病90 d 后 Barthel 指数≥75者所占百分比高于对照组（85．38％νs．76．32％，P ＜0．05）。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（P ＞0．05）。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。

Objective To explore the curative effect and security of the troxerutin and cerebroprotein hydrolysate injection （TCHI）in patients with acute cerebral infarction （ACI）. Methods Four hundred and fifty-six ACI patients were recruited and randomly divided into the placebo group of 114 cases （sterilized water for injection）and TCHI group （TCHI for 14 days）of 342 cases,all subjects were administrated with the same basic treatment. The effects were evaluated mainly by Modified Rankin Scale （mRS）.The ratio of patients without significant disability （0-2 level）at 90 day after onset was analyzed. The secondary efficacy indexes were the percentage of NIHSS score reducing 7 or more than baseline after 7 days and 14 days treatment and the percentage of barthel index no less than 75 points after 14 days treatment or on day 90 after onset. Results The percentage of cases without significant disability （0-2 level）at 90 day after onset in the TCHI group was significantly higher than that of the placebo group （83.92%νs. 69.3%,P 〈0.01）. The percentage of NIHSS score reducing 7 or more points in the TCHI group was significantly higher than that of the placebo group after 14 days treatment （31.37%νs. 4.08%,P 〈0.01）. The percentage of Barthel index no less than 75 points in the TCHI group was higher than that of the placebo group at 90 day after onset （85.38%νs. 76.32%,P 〈0.05）. 26 （7.28%） and 11 （9.17%）side effects happened in the TCHI group and the placebo group. There was no statistical＆amp;nbsp;difference between the two groups （P 〉 0.05 ）. Conclusions TCHI can improve the nerve function defect degree in patients with ACI,promote the functional recovery,and lead to less side effect,good safety,it is worthy of clinical application.