针刺治疗中风后偏瘫的临床转化研究方案  

Acupuncture treatment programs for post-stroke motor rehabilitation in community hospitals:study protocol of a multicenter,randomized,controlled trial

作　　者：傅勤慧[1] 裴建[1] 佳奇[1] 宋毅[1] 顾悦华[1] 尤晓欣[1] 

机构地区：[1]上海中医药大学龙华医院针灸科,上海200032

出　　处：《中西医结合学报》2012年第5期516-524,共9页Journal of Chinese Integrative Medicine

基　　金：上海市卫生局重点项目;国家中医药管理局重点学科项目

摘　　要：背景:中国每年新发中风约200万人。中风病约50%的高致残率给病人和家庭带来了沉重的负担。中风后遗症患者的症状以运动功能障碍为主,直接影响了患者的生活质量。针刺在中国社区治疗中风后偏瘫的临床实践中有极广泛的应用。本课题的研究目标为将已有的科研成果转化为社区中风后偏瘫针刺治疗方案,并优化临床治疗方案和评价方法。方法与设计:采用多中心分层区组随机化分组方法,计算将要入组的样本量为124例。先按美国国立卫生研究院神经功能缺损量表评分,将124名偏瘫患者分为轻中重3层后,再随机分成针刺治疗组和对照组。根据改良的Ashworth评分将患者的偏瘫类型分为软瘫(弛缓性瘫痪)和硬瘫(痉挛性瘫痪),采用不同的治疗方案。治疗组:常规综合康复方案加针刺治疗驰缓性瘫痪或痉挛性瘫痪的方案。对照组予常规综合康复方案。主要结局指标有简化Fugl-Meyer运动功能量表评分、改良Barthel指数、中风负担量表评分;次要结局指标为修正的Rankin量表评分、中风中医症征积分表评分和Ashworth评分。于治疗4、8周后观察疗效,并于6个月时进行随访。讨论:本试验的预期结果为,针刺治疗能改善社区内中风后偏瘫患者的运动功能,减轻患者的负担。该结果将为针刺治疗中风的研究方案转化到社区提供依据。临床试验注册号:ChiCTR-TRC-11001347。Stroke is responsible for increasingly high rates of mortality and disability worldwide. Approximately two million people suffer from stroke for the first time in China each year. The high incidence （50%） of post-stroke disability brings a heavy burden to patients and their caregivers. Acupuncture has been widely used in the communities for post-stroke rehabilitation in China. The objective of this trial is to apply our acupuncture research achievement to treatment and evaluation of post-stroke hemiplegic patients in community. METHODS AND DESIGN. A multicenter, randomized, controlled trial will be performed in Longhua Hospital and a number of community health service centers in Shanghai. A total of 124 patients （estimated sample size） with post-stroke hemiplegia will be randomly divided into an acupuncture group and a control group. The patients undergoing randomization should be stratified according to National Institutes of Health Stroke Scale score at baseline. Within the acupuncture group, different acupuncture protocols are administered to patients with flaccid paralysis or spastic paralysis based on the Ashworth Scale. Patients in the acupuncture group will also be treated with comprehensive rehabilitation therapy. The control group will be treated with comprehensive rehabilitation therapy only. The primary outcome measures are the Simplified FugI-Meyer Motor Scale, the Modified Barthel Index, and the Burden of Stroke Scale. Secondary outcome measures are the modified Rankin Scale, the modified Ashworth Scale and the Stroke Scale of Traditional Chinese Medicine. Outcome measures will be performed after 4 and 8 weeks of treatment. The patients will be followed up after 6 months. DISCUSSION. The results of this study are expected to demonstrate that our standardized acupuncture protocol for treating and evaluating post-stroke hemiplegic patients will improve motor function and lessen the burden of post-stroke patients within the communities. This will provide the evidence to support successful transl

关 键 词：中风 偏瘫 中风后遗症 社区医学 针灸疗法 临床试验 临床方案 

分 类 号：R246[医药卫生—针灸推拿学]