伦敦玛丽女王大学研究人员开展的SCRATCH-HTN临床试验表明,通过耳部神经刺激的非侵入性设备对治疗高血压是安全的,并且易于患者在家中使用1。该试验共纳入63名高血压患者,所有患者均已服用至少一种降压药物但血压仍未达标1。患者每天使用设备30分钟,持续2周,之后每周使用一次,总疗程为10周1。
在全体受试者的分析中,接受主动神经刺激组与接受假装置组的血压变化未显示统计学显著差异1。然而,针对重度高血压患者的预先指定亚组分析显示,接受主动刺激的患者血压下降幅度显著大于假装置组1。这一结果表明该疗法在更严重的高血压患者群体中可能具有更显著的治疗效果,需要进一步的大规模研究来验证1。
该设备由Afferent Medical Solutions公司开发,使用两个小夹子固定在耳屏上1。这项研究由英国国家卫生研究所(NIHR)资助,研究结果发表在《高血压》杂志上,该杂志为美国心脏协会期刊1。
Researchers at Queen Mary University of London have completed the SCRATCH-HTN clinical trial, demonstrating that a non-invasive device for auricular nerve stimulation is safe and suitable for home use in managing high blood pressure.1 The trial enrolled 63 hypertensive patients who were already taking at least one blood pressure medication but had not achieved adequate control.1
Participants used the device, developed by Afferent Medical Solutions and secured to the ear with two small clips, for 30 minutes daily over two weeks, followed by weekly sessions for a total of 10 weeks.1 While the overall patient population showed no statistically significant difference in blood pressure reduction between the active stimulation group and the sham device group, a pre-specified analysis of patients with severe hypertension revealed substantially greater blood pressure decreases in those receiving active stimulation compared to controls.1 The findings were published in Hypertension, a journal of the American Heart Association, with funding from the National Institute for Health Research in the United Kingdom.1
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