Division of Pulmonary and Critical Care Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Division for New Technology Assessment, National Evidence-Based Healthcare Collaborating Agency, Seoul, Korea.
Yonsei Med J. 2020 Dec;61(12):1024-1033. doi: 10.3349/ymj.2020.61.12.1024.
Patients with respiratory failure associated with neurological dysfunction often require mechanical ventilator support, which poses increased economic burden and ventilator-associated complications. A diaphragm pacing system (DPS) is an implanted device that provides respiratory support for such patients. In this systematic review, we reviewed the literature to assess the safety and efficacy of DPS for patients with respiratory failure resulting from amyotrophic lateral sclerosis (ALS) or cervical spinal cord injuries.
The following databases were searched from July 10 to July 30, 2018: MEDLINE, EMBASE, Cochran library, KoreaMed, Research Information Sharing Service, Korean studies Information Service System, Korea Institute of Science and Technology Information, and Korean Medical database. The abstracts and full texts of the searched articles were reviewed by two reviewers.
The search keywords generated 197 articles: two randomized controlled trials, two case-control studies, and one case report involving patients with ALS; one cohort study, one case-control study, and two case reports involving patients with cervical spine injury; and one case report involving patients with both conditions were included. The primary outcome was safety profile (complications and adverse event) and efficacy (overall survival and sleep improvement). Complications and adverse events were more common in patients with ALS and spinal cord injury receiving DPS than in controls. Efficacy outcomes were inconsistent across ALS studies.
Based on safety and efficacy results, we do not support using DPS to manage respiratory failure in patients with ALS or cervical spine injury.
患有与神经功能障碍相关的呼吸衰竭的患者通常需要机械通气支持,这会增加经济负担和与通气相关的并发症。膈肌起搏系统(DPS)是一种植入式设备,可为此类患者提供呼吸支持。在本系统评价中,我们对评估 DPS 治疗因肌萎缩侧索硬化症(ALS)或颈脊髓损伤导致呼吸衰竭患者的安全性和疗效的文献进行了回顾。
我们于 2018 年 7 月 10 日至 7 月 30 日检索了以下数据库:MEDLINE、EMBASE、Cochrane 图书馆、韩国医学数据库、研究信息共享服务、韩国研究信息服务系统、韩国科学技术信息研究所和韩国医学数据库。由两名评审员对检索到的文章的摘要和全文进行了审查。
搜索关键词生成了 197 篇文章:两项随机对照试验、两项病例对照研究和一项涉及 ALS 患者的病例报告;一项队列研究、一项病例对照研究和两项涉及颈脊髓损伤患者的病例报告;以及一项涉及两种情况的病例报告。主要结局是安全性概况(并发症和不良事件)和疗效(总体生存率和睡眠改善)。接受 DPS 的 ALS 和脊髓损伤患者的并发症和不良事件比对照组更常见。ALS 研究的疗效结果不一致。
基于安全性和疗效结果,我们不支持使用 DPS 来治疗 ALS 或颈脊髓损伤患者的呼吸衰竭。