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低频耳屏刺激可降低高血压青年人群的血压:一项小规模单盲对照随机临床试验的结果。

Low-Level Tragus Stimulation Attenuates Blood Pressure in Young Individuals With Hypertension: Results From a Small-Scale Single-Blind Controlled Randomized Clinical Trial.

机构信息

Department of Cardiology The First Hospital of China Medical University Shenyang China.

Department of Cardiology Zhongshan Hospital, Fudan University Shanghai China.

出版信息

J Am Heart Assoc. 2024 Oct;13(19):e032269. doi: 10.1161/JAHA.123.032269. Epub 2024 Sep 18.

DOI:10.1161/JAHA.123.032269
PMID:39291497
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11681467/
Abstract

BACKGROUND

Hypertension is a significant risk factor for cardiovascular and chronic kidney diseases. Its management in young people remains limited. Device-based therapies, such as low-level tragus stimulation (LL-TS), a noninvasive method that reduces sympathetic activity, have recently been explored for resistant hypertension.

METHODS AND RESULTS

This trial involved patients with Grade 1 hypertension with no other medical history. LL-TS (20 Hz, 1 mA, 1 h/day) was applied for 3 months on the tragus (Intervention group [IG]) or earlobe (Control group [CG]). Blood pressure and outcomes were assessed at the first, second, and third months. Among 40 patients, 21 were in IG and 19 in CG. Baseline systolic blood pressure was similar between IG (142.62±8.18 mm Hg) and CG (143.00±8.61 mm Hg), =0.89. Post-LL-TS, systolic blood pressure showed significant reductions in IG compared with CG at the first (IG: 134.47±5.95 mm Hg, CG: 141.28±6.78 mm Hg, =0.002), second (IG: 132.50±7.51 mm Hg, CG: 140.62±7.15 mm Hg, =0.001), and third months (IG: 128.81±7.13 mm Hg, CG: 136.51±7.96 mm Hg, =0.003). diastolic blood pressure also differed significantly: first month (IG: 85.34±5.81 mm Hg, CG: 89.74±6.32 mm Hg, =0.03), second month (IG: 82.12±5.22 mm Hg, CG: 88.57±7.11 mm Hg, =0.002), and third month (IG: 80.71±5.96 mm Hg, CG: 87.55±5.26 mm Hg, =0.001). Heart rate was unchanged (>0.05). Only 0.01% of IG subjects reported site irritation, with no serious adverse events.

CONCLUSIONS

LL-TS led to significant blood pressure reductions in young patients with essential hypertension. Further larger trials are needed to confirm the safety and efficacy of LL-TS.

REGISTRATION

URL: https://www.chictr.org.cn/; Unique identifier: ChiCTR2000038448.

摘要

背景

高血压是心血管疾病和慢性肾病的重要危险因素。年轻人的高血压管理仍受到限制。基于设备的治疗方法,如低频耳屏刺激(LL-TS),作为一种降低交感神经活动的非侵入性方法,最近已被探索用于治疗难治性高血压。

方法和结果

本试验纳入了无其他病史的 1 级高血压患者。LL-TS(20Hz,1mA,1h/d)在耳屏(干预组 [IG])或耳垂(对照组 [CG])上应用 3 个月。在第 1、第 2 和第 3 个月评估血压和结局。40 例患者中,21 例在 IG,19 例在 CG。IG 的收缩压基线(142.62±8.18mmHg)与 CG(143.00±8.61mmHg)相似,=0.89。LL-TS 后,IG 的收缩压与 CG 相比在第 1 个月(IG:134.47±5.95mmHg,CG:141.28±6.78mmHg,=0.002)、第 2 个月(IG:132.50±7.51mmHg,CG:140.62±7.15mmHg,=0.001)和第 3 个月(IG:128.81±7.13mmHg,CG:136.51±7.96mmHg,=0.003)显著降低。舒张压也有显著差异:第 1 个月(IG:85.34±5.81mmHg,CG:89.74±6.32mmHg,=0.03)、第 2 个月(IG:82.12±5.22mmHg,CG:88.57±7.11mmHg,=0.002)和第 3 个月(IG:80.71±5.96mmHg,CG:87.55±5.26mmHg,=0.001)。心率无变化(>0.05)。IG 受试者仅有 0.01%报告局部刺激,无严重不良事件。

结论

LL-TS 可显著降低原发性高血压年轻患者的血压。需要进一步的大型试验来确认 LL-TS 的安全性和有效性。

登记

网址:https://www.chictr.org.cn/;唯一标识符:ChiCTR2000038448。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac17/11681467/97c43e1f6bea/JAH3-13-e032269-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac17/11681467/335cbc1b8a07/JAH3-13-e032269-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac17/11681467/c1200afe8be6/JAH3-13-e032269-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac17/11681467/b9bcc6761628/JAH3-13-e032269-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac17/11681467/97c43e1f6bea/JAH3-13-e032269-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac17/11681467/335cbc1b8a07/JAH3-13-e032269-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac17/11681467/c1200afe8be6/JAH3-13-e032269-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac17/11681467/b9bcc6761628/JAH3-13-e032269-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac17/11681467/97c43e1f6bea/JAH3-13-e032269-g003.jpg

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本文引用的文献

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