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针刺作为稳定期 COPD 患者辅助治疗的疗效:一项多中心、随机、假对照试验方案。

Efficacy of acupuncture as an adjunctive treatment to patients with stable COPD: a multicenter, randomized, sham-controlled trial protocol.

机构信息

Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No. 37, Shi'er Qiao Road, Jinniu District, Chengdu, 610075, Sichuan, China.

School of Health and Wellness, Panzhihua University, No. 10, North Section of Sanxian Avenue, East District, Panzhihua, 617000, Sichuan, China.

出版信息

BMC Complement Med Ther. 2024 Mar 7;24(1):114. doi: 10.1186/s12906-024-04412-6.


DOI:10.1186/s12906-024-04412-6
PMID:38454410
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10918953/
Abstract

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common respiratory disease and the third leading cause of death worldwide. Previous evidence has shown that acupuncture may be an effective complementary alternative therapy for stable COPD. However, large-sample, rigorously designed long-term follow-up studies still need to be completed. Notably, the relationship between the frequency of acupuncture and clinical efficacy in studies on acupuncture for stable COPD still needs further validation. This study aims to evaluate the efficacy and safety of acupuncture for stable COPD and further investigate the dose-effect relationship of acupuncture. METHODS/DESIGN: This is a multicenter, randomized, controlled trial that uses central randomization to randomly allocate 550 participants in a 1:1:1:1:1 ratio to once a week acupuncture group, twice a week acupuncture group, three times a week acupuncture group, sham acupuncture group and waiting-list control group. The sham acupuncture group will receive placebo acupuncture treatments three times per week, and the waiting-list control group will not receive any form of acupuncture intervention. The study consists of a 2-week baseline, 12-week of treatment, and 52-week of follow-up. Patients with COPD between 40 to 80 years old who have received stable Western medication within the previous 3 months and have had at least 1 moderate or severe acute exacerbation within the past 1 year will be included in the study. Basic treatment will remain the same for all participants. The primary outcome is the proportion of responders at week 12. Secondary outcomes include the proportion of responders at week 64, change in the St. George's Respiratory Questionnaire (SGRQ) Scale, change in the Modified-Medical Research Council (mMRC) Scale, change in the COPD Assessment Test (CAT) Scale, change in the Lung Function Screening Indicators (LFSI), change in the 6-min walk distance (6-MWD), change in Short-Form 36 Health Survey (SF-36) Scale, the number of moderate and severe acute exacerbations and adverse event rate during the follow-up period. DISCUSSION: This study will provide robust evidence on whether acupuncture is safe and effective for treating stable COPD. Meanwhile, comparing the differences in efficacy between different acupuncture frequencies will further promote the optimization of acupuncture for stable COPD. TRIAL REGISTRATION: This study was registered in the Chinese Clinical Trial Registry (ChiCTR2200058757), on April 16, 2022.

摘要

背景:慢性阻塞性肺疾病(COPD)是一种常见的呼吸系统疾病,也是全球范围内的第三大致死原因。既往证据表明,针刺可能是稳定期 COPD 的一种有效补充替代疗法。然而,仍需要完成大样本、设计严谨的长期随访研究。值得注意的是,针刺治疗稳定期 COPD 的研究中,针刺频率与临床疗效之间的关系仍需进一步验证。本研究旨在评估针刺治疗稳定期 COPD 的疗效和安全性,并进一步探讨针刺的量效关系。

方法/设计:这是一项多中心、随机、对照试验,采用中央随机化将 550 名参与者以 1:1:1:1:1 的比例随机分配至每周 1 次针刺组、每周 2 次针刺组、每周 3 次针刺组、假针刺组和等待名单对照组。假针刺组将接受每周 3 次的安慰剂针刺治疗,而等待名单对照组将不接受任何形式的针刺干预。研究包括 2 周的基线期、12 周的治疗期和 52 周的随访期。纳入年龄在 40 至 80 岁之间、在过去 3 个月内接受过稳定的西药治疗且在过去 1 年内至少有 1 次中度或重度急性加重的 COPD 患者。所有参与者的基础治疗保持不变。主要结局为治疗 12 周时的应答者比例。次要结局包括治疗 64 周时的应答者比例、圣乔治呼吸问卷(SGRQ)量表评分变化、改良医学研究委员会(mMRC)量表评分变化、COPD 评估测试(CAT)量表评分变化、肺功能筛查指标(LFSI)变化、6 分钟步行距离(6-MWD)变化、短格式 36 健康调查(SF-36)量表评分变化、随访期间中度和重度急性加重的次数和不良事件发生率。

讨论:本研究将为针刺治疗稳定期 COPD 的安全性和有效性提供有力证据。同时,比较不同针刺频率之间的疗效差异将进一步促进优化稳定期 COPD 的针刺治疗。

试验注册:本研究于 2022 年 4 月 16 日在中国临床试验注册中心(ChiCTR2200058757)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bb4/10918953/4df38e706500/12906_2024_4412_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bb4/10918953/112776cfdd3d/12906_2024_4412_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bb4/10918953/95acfd078984/12906_2024_4412_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bb4/10918953/4df38e706500/12906_2024_4412_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bb4/10918953/112776cfdd3d/12906_2024_4412_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bb4/10918953/95acfd078984/12906_2024_4412_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bb4/10918953/4df38e706500/12906_2024_4412_Fig3_HTML.jpg

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