Auger Catherine, Hernando Vanessa, Galmiche Hubert
Medical Device Department, French National Authority for Health, Saint-Denis La Plaine, France.
Respir Care. 2017 Feb;62(2):236-245. doi: 10.4187/respcare.04877.
The aim of this systematic review is to examine the benefit/risk ratio of the use of mechanical insufflation-exsufflation (MI-E) devices for airway clearance in patients with neuromuscular diseases. A search was conducted for relevant studies in MEDLINE, the Cochrane Library, and the Health Technology Assessment Database using the main key words: cough, airway clearance, in-exsufflation. The search limits were studies published in English and French between 1970 and 2014 (literature watch until December 2015). The methodological quality of the studies was assessed using (1) the Cochrane Collaboration's risk of bias tool for randomized controlled trials and (2) the Institute of Health Economics' 20-item checklist for comparative and observational studies. Data were extracted into an evidence table according to (1) study design, (2) population characteristics (including age and type of diseases) and intervention (MI-E associated or not with other interventions), (3) outcome measures, and (4) key findings. Twelve studies met the inclusion criteria (4 randomized controlled trials, 3 comparative studies, and 5 observational studies). The quality of the selected studies was poor. None of the studies reported survival outcome. All studies evaluated change of pulmonary function parameters, such as peak expiratory flow. This review underlines the lack of robust data on mechanical medical devices used for airway clearance. The current scientific evidence does not support the use of MI-E for cough augmentation in patients with neuromuscular diseases, but health-care professionals are faced with the reality of medical practice and the absence of alternatives. Most European and American guidelines recommend the use of MI-E despite low-level evidence. However, even if performing comparative trials in a specific population is difficult, the medical device industry should provide reliable data to assist health-care professionals, providers, and payers in the decision-making process. This is the only way to ensure the best treatment for patients.
本系统评价的目的是探讨在神经肌肉疾病患者中使用机械吸气-呼气（MI-E）装置进行气道清理的获益/风险比。使用主要关键词“咳嗽”“气道清理”“吸气-呼气”在医学文献数据库（MEDLINE）、考克兰图书馆和卫生技术评估数据库中检索相关研究。检索限制为1970年至2014年期间以英文和法文发表的研究（文献检索截至2015年12月）。使用（1）考克兰协作网针对随机对照试验的偏倚风险工具，以及（2）卫生经济学会针对比较性和观察性研究的20项清单对研究的方法学质量进行评估。根据（1）研究设计、（2）人群特征（包括年龄和疾病类型）及干预措施（MI-E是否与其他干预措施联合使用）、（3）结局指标，以及（4）主要研究结果，将数据提取到证据表中。12项研究符合纳入标准（4项随机对照试验、3项比较性研究和5项观察性研究）。所选研究的质量较差。没有一项研究报告生存结局。所有研究均评估了肺功能参数的变化，如呼气峰值流速。本评价强调了在用于气道清理的机械医疗设备方面缺乏有力数据。目前的科学证据不支持在神经肌肉疾病患者中使用MI-E来增强咳嗽，但医护人员面临医疗实践的现实情况且缺乏替代方法。尽管证据水平较低，但大多数欧美指南仍推荐使用MI-E。然而，即使在特定人群中进行比较试验很困难，医疗器械行业也应提供可靠数据以协助医护人员、供应商和支付方进行决策。这是确保为患者提供最佳治疗的唯一途径。
