脑蛋白水解物治疗急性缺血性脑卒中的疗效及安全性观察  

Therapeutic effect and safety of cerebrolysin in treatment of acute ischemic stroke

作　　者：张露远[1] 王万华[1] 

机构地区：[1]江苏大学附属昆山市第一人民医院神经内科,江苏省215300

出　　处：《中华脑科疾病与康复杂志（电子版）》2013年第4期8-11,共4页Chinese Journal of Brain Diseases and Rehabilitation（Electronic Edition）

摘　　要：目的评价脑蛋白水解物治疗急性缺血性脑卒中的临床疗效及安全性。方法设计并实施了随机、双盲安慰剂对照临床试验,每位受试患者接受为期10 d随机分组治疗和3个月随访,比较脑蛋白水解物和生理盐水安慰剂的疗效差异。对比随访过程中和结束时患者美国国立卫生院卒中量表(National Institutes of Health Stroke Scale,NIHSS)评分和Barthel指数,同时观察两组患者不良反应并进行实验室检查。结果脑蛋白水解物与安慰剂组患者入院时NIH评分分别为9.28±4.24,9.17±3.63,差异无统计学意义(t=0.10,P=0.921),在治疗后的第2、5、10、30及90天,其改善分值和改善率均无统计学差异(P>0.05),而两组患者Barthel指数入院时分别为47.40±22.37,43.96±29.71,差异无统计学意义(t=0.458,P=0.648),同样在治疗后的第2、5、10、30及90天,其改善分值和改善率均无统计学差异(P>0.05)。治疗期间两组均无不良反应发生。结论蛋白水解物有较好的安全性但对于改善急性缺血性脑卒中患者神经功能缺损和日常生活能力效果不明显。[Abstract] Objective To evaluate the efficacy and safety of cerebrolysin in treatment of acute ischemie stroke. Methods A randomized, double-blind, placebo-controlled trial was implemented. Cerebrolysin or saline placebo was intravenously given for 10 days and follow-up for 3 months. The difference of neurological function of acute ischemic stroke patients before and after the therapy. National Institutes of Health Stroke Scale（NIHSS） scores and Barthel index were the criterion of assessment for patients＇prognosis. Meanwhile, adverse event and laboratory examination were observed in the two groups. Results When the patients on admission, the NIHSS of cerebrolysin group was 9. 28 ,＋ 4. 24 and for saline placebo group was 9. 17 _＋ 3.63 （t = 0. 10 ,P = 0. 921 ）. There was no statistical difference of NIHSS point reduction and NIHSS percentage reduction in the 2,5,10,30,90 days of the two different ways of treatment. For the patients on admission,the Barthel index was 47.40 ,＋ 22. 37,43.96 ,＋ 29.71 respectively（ t = 0. 458 ,P = 0. 648 ）. There was also no statistical differences of NIHSS point reduction and NIHSS percentage reduction in the 2,5,10, 30,90 days of the two different ways of treatment. There was no adverse event happened in these two group. Conclusion Cerebrolysiu has good security but little affect in the improvement of neurological function and activities of daily living of patients with acute isehemic stroke.

关 键 词：卒中 缺氧缺血 脑 蛋白水解产物 治疗结果 

分 类 号：R743.3[医药卫生—神经病学与精神病学]