通心络胶囊治疗早期缺血性脑卒中的临床研究  

Clinical effect of Tong Xin Luo capsule on the treatment of early ischemic stroke

作　　者：欧阳征 唐红宇 王爱民 刘青芳 

机构地区：[1]长沙市第一医院神经内科一病室,湖南410005

出　　处：《现代医药卫生》2017年第11期1604-1607,共4页Journal of Modern Medicine & Health

基　　金：国家"973"基金资助项目(2012CB518606)

摘　　要：目的评价早期应用通心络胶囊治疗缺血性脑卒中对患者生活自理能力的改善程度及安全性。方法选取参与该研究的全国50余家医疗中心2013年11月至2016年1月收治的早期缺血性脑卒中患者1 968例为研究对象,采用中央动态随机分组法将其分为观察组和对照组,各984例。对照组服用安慰剂,观察组服用通心络胶囊治疗。比较两组患者生活自理能力改善情况[改良Rankin量表(m RS)]、日常生活能力量表[巴氏指数(BI)]、美国国立卫生研究院卒中量表(NIHSS)、总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、脑动脉狭窄、颈动脉斑块面积及不安全事件的发生率。结果治疗后,观察组患者m RS≤1级者及NIHSS≤1分或改善4分及以上的患者所占比例,以及BI评分和HDL-C水平明显高于对照组,而TC、TG、LDL-C水平低于对照组,差异均有统计学意义(P<0.05)。观察组患者治疗后脑动脉狭窄和颈动脉斑块面积均低于对照组,差异有统计学意义(P<0.05)。两组患者不安全事件发生率比较,差异无统计学意义(P>0.05)。结论早期缺血性脑卒中患者早期(发病72 h内)服用通心络胶囊能够显著提高生活自理能力、日常生活能力,改善神经功能缺损,降低血脂、脑动脉狭窄和颈动脉斑块面积,安全有效,值得临床推广应用。Objective To investigate the improvement level of life self-care ability and safety of Tong Xin Luo capsule used for patients with ischemic stroke. Methods A total of 1 968 patients with early ischemic stroke received more than 50 Chi- nese medical center from November 2013 to January 2016 were selected as the research object, interactive Web-based randomization system was used to divide the patients into observation group and control group, 984 cases in each group. The control group was given a placebo ,the observation group was treated by Tong Xin Luo capsule. The improvement level of life self-care ability [modified Rankin scale （mRS）] ,activity of daily living scale [Barthel Index （BI）] ,the NIH stroke scale （NIHSS） scores ,total cholesterol （TC）,triglyceride glycerol （TG）,low density lipoprotein cholesterol （LDL-C）, high density lipoprotein cholesterol （HDL-C）, cerebral artery stenosis, carotid plaque area and the incidence of unsafe event in two groups were compared. Results After treatment, the account for patients with mRS ~〈 1 grade and NIHSS ~〈 1 point or improved more than the 4 points of the observation group were more than those of the control group, and BI scores and levels of HDL-C of the observation group were higher than those of the control group ,but,the levels of TC, TG and LDL-C of the observation group were lower than those of control group, the differences were statistically significant （P〈0.05）. After treatment, the cerebral artery stenosis and carotid plaque area in the observation group were lower than those in the control group, the differences were statistically significant （P〈0.05）.There was no significant difference in the incidence of unsafe event between the two groups （P〉0.05）. Conclusion Patients with early ischemic stroke are treated early （within 72 h of the onset） by Tong Xin Luo capsule can significantly improve life self-care ability, ability of daily life, improve neurologic impairment, reduce blood lipid, cerebral arter

关 键 词：卒中 脑缺血 心血管药物(中药) 通心络胶囊 

分 类 号：R743.3[医药卫生—神经病学与精神病学]