亚急性卒中康复的整合医学：一项多中心随机对照试验的研究方案

Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial.

作者信息

Fang Jianqiao, Chen Lifang, Chen Luni, Wang Chao, Keeler Crystal Lynn, Ma Ruijie, Xu Shouyu, Shen Laihua, Bao Yehua, Ji Conghua

机构信息

Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Traditional Chinese Medical University, Hangzhou, Zhejiang, China The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.

Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Traditional Chinese Medical University, Hangzhou, Zhejiang, China.

出版信息

BMJ Open. 2014 Dec 4;4(12):e007080. doi: 10.1136/bmjopen-2014-007080.

DOI:10.1136/bmjopen-2014-007080

PMID:25475247

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4256536/

Abstract

INTRODUCTION

Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation.

METHODS AND ANALYSIS

360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks' follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events.

ETHICS AND DISSEMINATION

Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status.

TRIAL REGISTRATION NUMBER

Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561.

摘要

引言

在中国，许多中风患者接受中西医结合治疗，包括西医基础治疗和常规康复治疗，同时结合针灸和中药。中西医结合疗法对中风康复是否有效仍存在争议，目前针对这种情况的综合治疗方法的研究很少。因此，我们将开展一项多中心、随机、对照、评估者盲法的临床试验，以评估中西医结合疗法对中风康复的有效性。

方法与分析

从浙江省三家大型中医院招募的360名参与者将按1:1的比例随机分为中西医结合康复（IMR）组和传统康复（CR）组。IMR组的参与者除接受西医基础治疗和康复治疗外，还将接受针灸和中药治疗。CR组将不接受针灸和中药治疗。评估数据将在基线、随机分组后4周和8周收集，然后在12周随访时收集。主要结局指标采用改良Barthel指数进行测量。次要结局指标包括美国国立卫生研究院卒中量表（NIHSS）、Fugl-Meyer评估、简易精神状态检查和蒙特利尔认知评估、汉密尔顿抑郁量表和自评抑郁量表，以及不良事件的发生率。