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基于耳针降压作用的肾素-血管紧张素系统机制的研究:一项随机对照试验的研究方案。

Renin-angiotensin system mechanism underlying the effect of auricular acupuncture on blood pressure in hypertensive patients with phlegm-dampness constitution: Study protocol for a randomized controlled trial.

机构信息

School of Nursing, Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China.

School of Nursing, Anhui Medical University, He Fei Shi, Anhui Province, China.

出版信息

PLoS One. 2024 Feb 1;19(2):e0294306. doi: 10.1371/journal.pone.0294306. eCollection 2024.

DOI:10.1371/journal.pone.0294306
PMID:38300960
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10833565/
Abstract

BACKGROUND

Phlegm-dampness constitution is a traditional Chinese medicine constitution typically associated with essential hypertension. Previous studies have demonstrated that auricular acupuncture effectively decreases blood pressure and adjusts the constitution. However, the mechanism underlying auricular acupuncture's effect is poorly understood.

METHODS

A non-blinded, randomized controlled trial will be undertaken between September 2022 and May 2023. Eighty essential hypertensive patients with a phlegm-dampness constitution will be randomly allocated to one of two groups. The intervention group will receive eight weeks of auricular acupuncture and regular use of antihypertensive drugs, while the control group will only receive antihypertensive drugs. The primary outcome will be any mean differences in office systolic blood pressure. The secondary outcomes investigations will include proteins of the renin-angiotensin system, office blood pressure of different genotypes, and phlegm-dampness constitution scores.

DISCUSSION

By demonstrating how auricular acupuncture affects the renin-angiotensin system, this research will offer significant new information on the mechanism underlying the action of auricular acupuncture in hypertension. Moreover, the results will provide crucial clinical information on the associations between renin-angiotensin system gene polymorphisms and the antihypertensive effects of auricular acupuncture.

TRIAL REGISTRATION

Registered at the chictr.org.

摘要

背景

痰湿体质是一种与原发性高血压密切相关的中医体质类型。既往研究表明,耳针能有效降低血压并调整体质。然而,耳针作用的机制尚不清楚。

方法

本研究将采用非盲法、随机对照试验,于 2022 年 9 月至 2023 年 5 月期间进行。将 80 例痰湿体质的原发性高血压患者随机分为两组。干预组接受 8 周的耳针治疗和常规使用降压药,对照组仅使用降压药。主要结局指标为诊室收缩压的任何平均差异。次要结局指标将包括肾素-血管紧张素系统蛋白、不同基因型的诊室血压和痰湿体质评分。

讨论

本研究通过证明耳针对肾素-血管紧张素系统的影响,为耳针对高血压作用的机制提供了重要的新信息。此外,结果将为肾素-血管紧张素系统基因多态性与耳针降压作用之间的关联提供重要的临床信息。

试验注册

在中国临床试验注册中心注册,注册号为 ChiCTR2200055506。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56c6/10833565/38869daccb44/pone.0294306.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56c6/10833565/bc9072656587/pone.0294306.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56c6/10833565/38869daccb44/pone.0294306.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56c6/10833565/bc9072656587/pone.0294306.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56c6/10833565/38869daccb44/pone.0294306.g002.jpg

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Front Cell Infect Microbiol. 2022 Jun 1;12:859708. doi: 10.3389/fcimb.2022.859708. eCollection 2022.
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The Association Between Traditional Chinese Medicine Body Constitution Deviation and Essential Hypertension: A Case-Control Study.中医体质偏颇与原发性高血压的相关性:病例对照研究。
J Nurs Res. 2021 Jun 14;29(4):e160. doi: 10.1097/JNR.0000000000000442.
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Enlightenment about using TCM constitutions for individualized medicine and construction of Chinese-style precision medicine: research progress with TCM constitutions.
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Sci China Life Sci. 2021 Dec;64(12):2092-2099. doi: 10.1007/s11427-020-1872-7. Epub 2020 Dec 30.
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Clinical research linking Traditional Chinese Medicine constitution types with diseases: a literature review of 1639 observational studies.临床研究将中医体质类型与疾病联系起来:1639 项观察性研究的文献综述。
J Tradit Chin Med. 2020 Aug;40(4):690-702. doi: 10.19852/j.cnki.jtcm.2020.04.019.
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2020 International Society of Hypertension global hypertension practice guidelines.2020年国际高血压学会全球高血压实践指南
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