苦碟子注射液治疗缺血性中风急性期上市后再评价  

Post-marketing re-evaluation of Kudiezi injection study on early treatment in patients with ischemic stroke

作　　者：叶晓勤[1] 魏戌[2] 谢雁鸣[2] 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[2] 

机构地区：[1]中国中医科学院博士后流动站,北京100700 [2]中国中医科学院中医临床基础医学研究所,北京100700 [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300150 [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250001 [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》2011年第20期2793-2795,共3页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030);国家高技术研究发展计划(863计划)项目(2007AA02Z4B2);中国中医科学院自主选题研究项目(Z0133)

摘　　要：目的:评价苦碟子注射液对缺血性中风急性期患者影响的有效性和安全性。方法:采用实用性随机对照试验,通过中央随机系统,将700例缺血性中风患者随机分为试验组346例、对照组354例。试验组给予苦碟子注射液的基础上加用西医内科基础治疗和中医康复技术,对照组给予西医内科基础治疗加用现代康复技术,疗程为10～21 d,在第7,14,21天3个时间点上观察患者的神经功能缺损(NIHSS评分)和肢体运动功能(FMI评分)。同时观察2组不良事件发生率及治疗前后实验室检查指标。结果:应用广义估计方程模型,发现随着治疗时间的延长,2组NIHSS评分及FMI评分均呈改善趋势,且治疗第14天和第21天NIHSS和FMI评分试验组较对照组相比,具有显著统计学差异(P<0.05)。试验组未发生与苦碟子注射液相关的不良事件。结论:苦碟子注射液对缺血性中风患者的神经功能缺损及肢体运动功能有一定的改善作用。苦碟子注射液在治疗缺血性中风早期康复方面是安全有效的。Objective： To study the effect and safety of Kudiezi injection on patients with acute ischemic stroke. Method： Seven hundreds patients were divided into two groups by central randomization system. The study group, 346 eases, was treated with kudiezi injection plus traditional Chinese medicine（TCM） synthesis rehabilitation project, and the control group, 354 cases, was treated with synthetic rehabilitation project. The patients were treated for 10 to 21 days. Before treatment and at the 7th, 14th and 21th day of treatment, the indexes include NIHSS used for evaluating the neurological deficit degree and the motor function score （Fugl-Meyer） for evaluating motor function were observed. The safety index is defined by adverse observation event and laboratory test. The incidence of adverse events and laboratory tests results were observed before and after treatment at the same time. Result ： Application of generalized estimating equation model, we found that as the treatment time, NIHSS score and FMI score of the two groups showed a trend of improvement. And at the 14th days and 21th days of treatment, compared to the control group the treatment group showed significant statistical difference on the impact of NIHSS and FMI （P 〈 0.05 ）. No serious adverse events were observed. Conelusiort： Kudiezi injection plus TCM rehabilitation project of ischemic stroke showed some superiority to western medicine rehabilitation program on improving the neurological deficit and motor function. Kudiezi injection is safe and effective in the treatment of acute ischemic stroke.

关 键 词：苦碟子注射液 急性缺血性中风 上市后再评价 

分 类 号：R255.2[医药卫生—中医内科学]