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针刺治疗颈动脉粥样硬化患者的疗效:一项随机对照临床试验。

Efficacy of acupuncture in patients with carotid atherosclerosis: a randomized controlled clinical trial.

机构信息

Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.

Department of Ultrasound Imaging, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.

出版信息

BMC Complement Med Ther. 2024 Aug 22;24(1):313. doi: 10.1186/s12906-024-04601-3.

Abstract

BACKGROUND

The current clinical management of carotid atherosclerosis is based on the control of risk factors and medicine. However, the risk of adverse events associated with the medicine resulting in concerns and low medication compliance makes it necessary to seek a safer alternative therapy. This study assessed the effectiveness and safety of acupuncture as a treatment for carotid atherosclerosis.

METHODS

In this randomized controlled trial, patients with carotid atherosclerotic plaques were included and randomly assigned (1:1) to receive real acupuncture or sham acupuncture for 12 weeks. The follow-up period was 12 weeks. The primary outcome included carotid intima-media thickness (cIMT), plaque score (PS), plaque volume (PV) and grey-scale median (GSM). Secondary outcome was pulse wave velocity (PWV). Adverse events results were recorded as safety outcomes.

RESULTS

From January 2021 to February 2022, 60 eligible patients were included. 55 patients (91.7%) completed the intervention and the 12-week follow-up and there was no statistical difference in demographics between the groups. At the end of treatment, the real acupuncture group had significantly reduced PS (P = 0.002), PV (P = 0.000), and improved GSM (P = 0.044). There was no significant difference in the reduction in cIMT (Left cIMT: P = 0.338, Right cIMT: P = 0.204) and PWV between the groups (the left BS: P = 0.429; the left ES: P = 0.701; the right BS: P = 0.211; the right ES: P = 0.083). Three mild adverse reactions occurred during the study.

CONCLUSION

This study found that acupuncture had a certain effect on reducing the thickness and volume of carotid plaque and improving the stability of plaque with minor side effects. These findings suggest that acupuncture may be a potential alternative therapy for carotid atherosclerosis.

TRIAL REGISTRATION

This trial has been registered at ClinicalTrials.gov (ChiCTR2100041762). Submitted 30 December 2020, Registered 4 January 2021 Prospectively registered.

摘要

背景

目前,颈动脉粥样硬化的临床治疗主要基于危险因素控制和药物治疗。然而,由于药物治疗相关不良事件的风险导致了人们的担忧和低药物依从性,因此有必要寻求更安全的替代治疗方法。本研究评估了针刺治疗颈动脉粥样硬化的有效性和安全性。

方法

在这项随机对照试验中,纳入了颈动脉粥样硬化斑块患者,并按 1:1 随机分配接受真针刺或假针刺治疗 12 周。随访时间为 12 周。主要结局包括颈动脉内膜中层厚度(cIMT)、斑块评分(PS)、斑块体积(PV)和灰度中位数(GSM)。次要结局为脉搏波速度(PWV)。不良事件结果作为安全性结局记录。

结果

2021 年 1 月至 2022 年 2 月期间,共纳入 60 名符合条件的患者。55 名患者(91.7%)完成了干预和 12 周的随访,两组之间的人口统计学特征无统计学差异。治疗结束时,真针刺组 PS(P=0.002)、PV(P=0.000)显著降低,GSM 改善(P=0.044)。两组间 cIMT 减少无显著差异(左 cIMT:P=0.338,右 cIMT:P=0.204)和 PWV 差异(左 BS:P=0.429;左 ES:P=0.701;右 BS:P=0.211;右 ES:P=0.083)。研究期间发生 3 例轻度不良反应。

结论

本研究发现针刺在降低颈动脉斑块厚度和体积以及改善斑块稳定性方面有一定效果,且副作用较小。这些发现提示针刺可能是颈动脉粥样硬化的一种潜在替代治疗方法。

试验注册

本试验已在 ClinicalTrials.gov 注册(ChiCTR2100041762)。2020 年 12 月 30 日提交,2021 年 1 月 4 日注册,前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24f3/11340065/d732bfbc05ce/12906_2024_4601_Fig1_HTML.jpg

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