【作者】 黄燕； 裴建； 王新志； 杨友松； 谭吉林； 顾卫； 董梦久； 曹晓岚； 李军； 魏江磊； 刘军； 汪涛； 陈眉； 范薇； 王小同； 安冬青； 邹忆怀； 董少龙； 任丁； 刘毅； 陈园桃； 董强； 梁伟雄； 蔡业峰； 郭建文； 李伟峰； 欧爱华； 熊宁宁； 邹建东；

【Author】 Yan HUANG,Jian PEI,Xinzhi WANG,et al (The Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou,510120,China)

【机构】 广东省中医院；

【摘要】 背景建立体现中医自身治疗特色和疗效优势的评价指标是中医临床研究的方向之一。中风病的研究朝着规范化和标准化方向发展。缺血中风作为中风的主要类型,是待攻克的一种疾病。前期研究将急性中风分为阳类证和阴类证进行辩证论治。目的研究中医综合方案治疗急性缺血中风阴类证的疗效及安全性评价。方法采用前瞻性、多中心、中央随机、平行对照临床试验的设计方法,分别用中医综合方案和西医加中药安慰剂治疗,观察相关指标。结果符合方案并随访完整的共537例。中医综合方案可改善患者21天的神经功能缺损程度(P<0.05);90天随访时,中医综合方案可减少6.3%的患者丧失生活能力(BI<75,20%VS 26.3%),增加8.6%的患者独立生活(mRS 0—1级,59.3%Vs 67.9%);减轻21天、60天、90天的中医症征。随着随访时间的延长,中医综合治疗方案有提高患者生存质量的趋势。不良反应两组无明显差别。结论中医综合治疗方案疗效确切,疗效优势在治疗21天后逐渐显现,降低患者的神经功能缺损,提高90天生活能力,降低残障水平。更多还原

【Abstract】 Background Reflected the context of the establishment of Chinese medicine treatment characteristics and efficacy of their own superiority clinical evaluation is one of the study directions.The direction of study of stroke patients is the development of standardization. Ischemic stroke as the main types of stroke is a disease to be overcome.Preliminary studies of acute stroke will be divided into yin-yang type of certification and certification to the dialectical category of governance.Objective Researching on integrated traditional Chinese medicine in the treatment of acute ischemic stroke of yin type of patients.Evaluation the efficacy and safety.Methods A multi-center,single blinded,random and control clinical trial was adopted with 537 patients with AIS,they were divided into the treatment group treated with herbal protocol, and the control group treated with western medicine plus placebo,and AIS related indexes were assessed after treatment.Results In line with the program,and follow-up of a total of 537 cases of complete.Integrated program of Chinese medicine can improve the neurological deficit score(National Institute of Health Stroke Scale,NIHSS) determined on the 21st day after treatment was ameliorated in the treatment group(P<0.05).Moreover,the 90-day follow up showed that the severe disability rate was lower(BI<75,20%VS 26.3%)(P<0.01),the complete rehabilitation and mild disability rate(mRS 0-1,59.3%Vs 67.9%) were higher(P<0.05) in the Test group and than those in the control group.76 cases of adverse reaction/events happened;which manifested as digestive symptom,skin action,bleeding tendency and aminopherase higher,but had no statistical difference in two groups. Conclusion the program is comprehensive the advantages traditional Chinese medicine and Western medicine,multi-center randomized controlled trials to prove the exact effect of the program, efficacy advantages in the treatment of 21 days after emerging,lower in patients with neurological deficit and improve the capacity of 90 days of life,reduce the level of disability.更多还原