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神经调节的一些未获美国食品药品监督管理局批准的用途:证据综述

Some Non-FDA Approved Uses for Neuromodulation: A Review of the Evidence.

作者信息

Lee Samuel, Abd-Elsayed Alaa

机构信息

University of Cincinnati College of Medicine, University of Cincinnati, Cincinnati, Ohio, U.S.A.

Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, U.S.A.

出版信息

Pain Pract. 2016 Sep;16(7):935-47. doi: 10.1111/papr.12405. Epub 2015 Nov 25.

DOI:10.1111/papr.12405
PMID:26603822
Abstract

INTRODUCTION

Neuromodulation, including spinal cord stimulation and peripheral nerve field stimulation, has been used with success in treating several painful conditions. The FDA approved the use of neuromodulation for a few indications. We review evidence for neuromodulation in treating some important painful conditions that are not currently FDA approved.

METHODS

This review included an online web search for only clinical trials testing the efficacy of neuromodulation in treating coronary artery disease, peripheral vascular disease (PVD), headache, and peripheral field stimulation.

RESULTS

Our systematic literature search found 10, 6, and 3 controlled studies relating to coronary artery disease, PVD, and headache, respectively. Our review also included 5 noncontrolled studies relating to peripheral field stimulation, as no controlled studies had been completed.

CONCLUSION

This review article shows compelling evidence based on clinical trials that neuromodulation can be of benefit for patients with serious painful conditions that are not currently approved by the FDA.

摘要

引言

神经调节,包括脊髓刺激和周围神经场刺激,已成功用于治疗多种疼痛病症。美国食品药品监督管理局(FDA)已批准神经调节用于一些适应症。我们回顾了神经调节在治疗目前尚未获得FDA批准的一些重要疼痛病症方面的证据。

方法

本综述仅包括在线网络搜索,以查找测试神经调节治疗冠状动脉疾病、外周血管疾病(PVD)、头痛和周围场刺激疗效的临床试验。

结果

我们的系统文献检索分别发现了10项、6项和3项与冠状动脉疾病、外周血管疾病和头痛相关的对照研究。我们的综述还包括5项与周围场刺激相关的非对照研究,因为尚未完成对照研究。

结论

这篇综述文章基于临床试验显示了令人信服的证据,即神经调节对目前尚未获得FDA批准的严重疼痛病症患者可能有益。

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