FDA批准非药物疗法NeuroMetrix治疗纤维肌痛,是一种创新神经调节医疗器械

2022-06-17 MedSci原创 MedSci原创

FDA

 

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纤维肌痛是一种以全身疼痛、疲劳、睡眠不佳、记忆和注意力障碍、情绪障碍等致残症状为特征的慢性病。该类患者的健康相关生活质量较低,住院的可能性是没有纤维肌痛患者的两倍。此外,纤维肌痛的病因尚不清楚,但科学研究指出,这可能与中枢神经系统处理正常感觉和疼痛的方式异常有关。目前,针对纤维肌痛的治疗方式多为药物治疗,而NeuroMetrix开发的Quell是一种经皮神经电刺激设备(TENS),以非入侵的方式帮助具有高度疼痛敏感性的成人减轻纤维肌痛症状,该设备可在睡眠期间使用。5月19日,NeuroMetrix宣布Quell获FDA批准上市,Quell的批准得到一项双盲、随机、含假治疗对照的临床试验的支持。临床试验结果显示,在对所有受试者(N=119)的意向治疗(ITT)分析中,多个次要终点指标均为阳性。

本文盘点的几款诊疗设备为疾诊断提供了新的技术手段,为疗法创新提供了新的思路,也为医药行业注入了新的生机与活力,此外,还有更多医疗器械与诊断公司正在积极探索诊疗新方式,提升患者健康相关生活质量。

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    2022-11-15 bugit
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    2022-07-26 一闲
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    2022-06-17 学医无涯

    学习一下

    0

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