脑栓通胶囊对缺血性中风患者随访半年生存质量指标评分变化的影响  

Effect of Naoshuantong capsule on change of SSQOL index in patients with ischemic stroke in six mouths follow-up

作　　者：叶晓勤[1,2] 谢雁鸣[1] 邹忆怀[3] 赵性泉[4] 韩舰华[5] 王新志[6] 马云枝[6] 毕齐[7] 解庆凡[8] 赵建军[9] 曹晓岚[10] 陈红霞 王诗忠[12] 闫咏梅[13] 韩祖成 易丹辉[15] 王永炎[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]安徽中医药大学中医临床学院,安徽合肥230038 [3]北京中医药大学东直门医院,北京100007 [4]首都医科大学附属天坛医院,北京100050 [5]天津中医药大学第二附属医院,天津300210 [6]河南中医学院第一附属医院,河南郑州450003 [7]首都医科大学附属安贞医院,北京100029 [8]邢台市人民医院,河北邢台054031 [9]长春中医药大学附属医院,吉林长春130021 [10]山东中医药大学第二附属医院,山东济南250011 [11]广州中医药大学第二附属医院,广东广州510120 [12]福建中医药大学第二附属医院,福建福州350003 [13]陕西中医学院附属医院,陕西咸阳712000 [14]陕西省中医医院,陕西西安710003 [15]中国人民大学统计学院,北京100872

出　　处：《中国中药杂志》2015年第21期4297-4300,共4页China Journal of Chinese Materia Medica

基　　金：国家高新技术研究发展计划(863)项目(2007AA02Z4B2)

摘　　要：针对上市药脑栓通胶囊开展上市后再评价,观察其对缺血性中风患者随访6个月后生存质量的影响并对其不良反应进行监测,为缺血性中风患者恢复期二级预防治疗提供借鉴和参考。696例患者来自全国12家三级甲等医院,通过中央随机系统,随机分为2组,试验组344例、对照组352例。试验组给予脑栓通胶囊+肠溶阿司匹林治疗,对照组给予肠溶阿司匹林治疗。连用6个月后观察患者生存质量,同时观察两组不良事件发生率及治疗前后实验室检查结果。结果提示脑栓通胶囊可用于缺血性中风患者恢复期二级预防治疗,较单独使用阿司匹林在患者生存质量的改善方面具有一定的优势,且未发生与脑栓通胶囊相关的不良事件。脑栓通胶囊在治疗缺血性中风恢复期方面是安全有效的。To evaluate the effect of Naoshuantong capsule on the life quality of patients with ischemic stroke in six months of followup studies,and observe the adverse events. The results would provide reference for the secondary prevention on the recovery stage of ischemic stroke. 696 patients from 12 Class III Grade I hospitals nationwide were divided into 2 groups by central randomization system. The study group,344 cases,were treated with Naoshuantong capsule plus Aspirin,and the control group,352 cases,were treated with Aspirin. The patients were treated for 6 months. At the end of treatment,SS-QOL used for evaluating the quality of life was observed. The safety index was defined by adverse observation event. The incidence of adverse events and laboratory tests results were observed before and after treatment at the same time. The results indicated that compared to the control group,the treatment group had significant statistical difference in the impact of effort,self-care ability and the the work or labor ability of patients（ P 0. 05）. No serious adverse events were observed. Naoshuantong capsule showed some superiority to Asprin on improving the quality of life on patients with ischemic stroke,and it could be used in secondary prevention on the recovery stage of ischemic stroke. Naoshuantong capsule is safe and effective in the treatment of convalescence ischemic stroke.

关 键 词：脑栓通胶囊 缺血性中风 生存质量 随访研究 

分 类 号：R743.3[医药卫生—神经病学与精神病学]