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一项开放性、单臂、剂量递增研究,旨在评估极低频磁场治疗急性缺血性脑卒中的安全性和耐受性。

An open-label, one-arm, dose-escalation study to evaluate safety and tolerability of extremely low frequency magnetic fields in acute ischemic stroke.

机构信息

Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, Università Campus Bio-Medico di Roma, Rome, Italy.

Fondazione Alberto Sordi - Research Institute for Ageing, Rome, Italy.

出版信息

Sci Rep. 2017 Sep 22;7(1):12145. doi: 10.1038/s41598-017-12371-x.

Abstract

Extremely low frequency magnetic fields (ELF-MF) could be an alternative neuroprotective approach for ischemic stroke because preclinical studies have demonstrated their effects on the mechanisms underlying ischemic damage. The purpose of this open-label, one arm, dose-escalation, exploratory study is to evaluate the safety and tolerability of ELF-MF in patients with acute ischemic stroke. Within 48 hours from the stroke onset, patients started ELF-MF treatment, daily for 5 consecutive days. Clinical follow-up lasted 12 months. Brain MRI was performed before and 1 month after the treatment. The distribution of ELF-MF in the ischemic lesion was estimated by dosimetry. Six patients were stimulated, three for 45 min/day and three for 120 min/day. None of them reported adverse events. Clinical conditions improved in all the patients. Lesion size was reduced in one patient stimulated for 45 minutes and in all the patients stimulated for 120 minutes. Magnetic field intensity within the ischemic lesion was above 1 mT, the minimum value able to trigger a biological effect in preclinical studies. Our pilot study demonstrates that ELF-MF are safe and tolerable in acute stroke patients. A prospective, randomized, placebo-controlled, double-blind study will clarify whether ELF-MFs could represent a potential therapeutic approach.

摘要

极低频磁场(ELF-MF)可能是缺血性中风的一种替代神经保护方法,因为临床前研究已经证明了它们对缺血性损伤机制的影响。本项开放性标签、单臂、剂量递增、探索性研究的目的是评估急性缺血性中风患者接受 ELF-MF 的安全性和耐受性。在中风发作后 48 小时内,患者开始接受 ELF-MF 治疗,每天连续 5 天。临床随访持续 12 个月。在治疗前和治疗后 1 个月进行脑 MRI。通过剂量测定法估计 ELF-MF 在缺血性病变中的分布。对 6 名患者进行了刺激,3 名患者每天刺激 45 分钟,3 名患者每天刺激 120 分钟。他们均未报告不良事件。所有患者的临床状况均有所改善。1 名接受 45 分钟刺激的患者和所有接受 120 分钟刺激的患者的病灶大小均有所缩小。缺血性病变内的磁场强度超过 1 mT,这是临床前研究中能够引发生物学效应的最小值。我们的初步研究表明,ELF-MF 在急性中风患者中是安全且耐受良好的。一项前瞻性、随机、安慰剂对照、双盲研究将阐明 ELF-MFs 是否可以成为一种潜在的治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d470/5610302/aa43695a5d60/41598_2017_12371_Fig1_HTML.jpg

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