针刺及其对持续性哮喘患者大脑活动影响的效果：一项随机对照临床试验的研究方案。
Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial.
机构信息
Brain Research Center, Acupuncture and Tuina School/Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, Sichuan, China.
出版信息
Trials. 2020 May 14;21(1):406. doi: 10.1186/s13063-020-04319-w.
BACKGROUND
Previous studies suggested that acupuncture was a promising adjunctive treatment for asthma. However, the underlying mechanism of acupuncture for asthma remains unclear. The aim of the present trial is to explore whether and how specific meridian acupuncture works in quality of life and symptomatic improvement by modulating brain function in patients with asthma.
METHODS/DESIGN: This is a randomized controlled functional brain imaging trial currently being conducted in Sichuan, China. In total, 48 patients with mild to moderate persistent asthma will be recruited randomly and allocated to either of two acupuncture groups: acupuncture at the lung meridian or acupuncture at the heart meridian. The treatment period will last 4 weeks. The Asthma Quality of Life Questionnaire is the primary outcome. The Asthma Control Test, peak expiratory flow rate, forced expiratory volume in 1 s, Montreal Cognitive Assessment, Zung Self-rating Anxiety Scale, and Zung Self-rating Depression Scale will also be used to assess the clinical efficacy of different interventions. Functional magnetic resonance imaging (fMRI) will be performed to detect cerebral activity changes in each group. The clinical data and fMRI data will be analyzed between groups, then, the Pearson correlation analysis will be used to assess the association between the changes of cerebral activity features and the improvement of clinical outcomes in each group.
DISCUSSION
The present study has been established on the basis of the "meridian-viscera relationship" theory of traditional Chinese medicine and the modern central mechanism of acupuncture. The results of this trial would be useful to identify the efficiency of the specific meridian acupuncture for asthma. The investigation of its central mechanism would further expand knowledge of acupuncture for asthma.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR1900027478. Registered on 15 November 2019.
背景
既往研究表明针刺是一种有前途的哮喘辅助治疗方法。然而，针刺治疗哮喘的潜在机制仍不清楚。本试验旨在通过调节哮喘患者的大脑功能，探讨特定经络针刺是否以及如何通过改善生活质量和症状来发挥作用。
方法/设计：这是一项正在中国四川进行的随机对照功能脑成像试验。共招募 48 例轻中度持续哮喘患者，随机分为肺经针刺组和心经针刺组。治疗期为 4 周。哮喘生活质量问卷是主要结局。还将使用哮喘控制测试、呼气峰流速、1 秒用力呼气量、蒙特利尔认知评估量表、zung 自评焦虑量表和 zung 自评抑郁量表评估不同干预措施的临床疗效。将进行功能磁共振成像（fMRI）以检测每组的大脑活动变化。将对各组的临床数据和 fMRI 数据进行组间分析，然后使用 Pearson 相关分析评估各组大脑活动特征的变化与临床结局改善之间的关联。
讨论
本研究基于中医的“经络-脏腑关系”理论和现代针刺中枢机制。该试验的结果将有助于确定特定经络针刺治疗哮喘的疗效。对其中枢机制的研究将进一步扩展对针刺治疗哮喘的认识。
试验注册
中国临床试验注册中心，ChiCTR1900027478。注册于 2019 年 11 月 15 日。
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