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用于囊性纤维化药物递送的雾化器系统。

Nebuliser systems for drug delivery in cystic fibrosis.

作者信息

Daniels Tracey, Mills Nicola, Whitaker Paul

机构信息

York Teaching Hospital Foundation NHS Trust, York, UK.

出版信息

Cochrane Database Syst Rev. 2013 Apr 30(4):CD007639. doi: 10.1002/14651858.CD007639.pub2.

DOI:10.1002/14651858.CD007639.pub2
PMID:23633344
Abstract

BACKGROUND

Nebuliser systems are used to deliver medications to control the symptoms and the progression of lung disease in people with cystic fibrosis. Many types of nebuliser systems are available for use with various medications; however, there has been no previous systematic review which has evaluated these systems.

OBJECTIVES

To evaluate effectiveness, safety, burden of treatment and adherence to nebulised therapy using different nebuliser systems for people with cystic fibrosis.

SEARCH METHODS

We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearching of relevant journals and abstract books of conference proceedings. We searched the reference lists of each study for additional publications and approached the manufacturers of both nebuliser systems and nebulised medications for published and unpublished data. Date of the most recent search: 15 Oct 2012.

SELECTION CRITERIA

Randomised controlled trials or quasi-randomised controlled trials comparing nebuliser systems including conventional nebulisers, vibrating mesh technology systems, adaptive aerosol delivery systems and ultrasonic nebuliser systems.

DATA COLLECTION AND ANALYSIS

Two authors independently assessed studies for inclusion. They also independently extracted data and assessed the risk of bias. A third author assessed studies where agreement could not be reached.

MAIN RESULTS

The search identified 40 studies with 20 of these (1936 participants) included in the review. These studies compared the delivery of tobramycin, colistin, dornase alfa, hypertonic sodium chloride and other solutions through the different nebuliser systems. This review demonstrates variability in the delivery of medication depending on the nebuliser system used. Conventional nebuliser systems providing higher flows, higher respirable fractions and smaller particles decrease treatment time, increase deposition and may be preferred by people with CF, as compared to conventional nebuliser systems providing lower flows, lower respirable fractions and larger particles. Nebulisers using adaptive aerosol delivery or vibrating mesh technology reduce treatment time to a far greater extent. Deposition (as a percentage of priming dose) is greater than conventional with adaptive aerosol delivery. Vibrating mesh technology systems may give greater deposition than conventional when measuring sputum levels, but lower deposition when measuring serum levels or using gamma scintigraphy. The available data indicate that these newer systems are safe when used with an appropriate priming dose, which may be different to the priming dose used for conventional systems. There is an indication that adherence is maintained or improved with systems which use these newer technologies, but also that some nebuliser systems using vibrating mesh technology may be subject to increased failures.

AUTHORS' CONCLUSIONS: Clinicians should be aware of the variability in the performance of different nebuliser systems. Technologies such as adaptive aerosol delivery and vibrating mesh technology have advantages over conventional systems in terms of treatment time, deposition as a percentage of priming dose, patient preference and adherence. There is a need for long-term randomised controlled trials of these technologies to determine patient-focused outcomes (such as quality of life and burden of care), safe and effective dosing levels of medications and clinical outcomes (such as hospitalisations and need for antibiotics) and an economic evaluation of their use.

摘要

背景

雾化器系统用于为囊性纤维化患者输送药物,以控制肺部疾病的症状和进展。有多种类型的雾化器系统可与各种药物配合使用;然而,此前尚无对这些系统进行评估的系统评价。

目的

评估使用不同雾化器系统对囊性纤维化患者进行雾化治疗的有效性、安全性、治疗负担及依从性。

检索方法

我们检索了Cochrane囊性纤维化和遗传疾病小组试验注册库,其中包括通过全面电子数据库检索、手工检索相关期刊以及会议论文摘要集确定的参考文献。我们检索了每项研究的参考文献列表以获取其他出版物,并联系了雾化器系统和雾化药物的制造商以获取已发表和未发表的数据。最近一次检索日期:2012年10月15日。

选择标准

比较雾化器系统(包括传统雾化器、振动网技术系统、自适应气雾剂输送系统和超声雾化器系统)的随机对照试验或半随机对照试验。

数据收集与分析

两位作者独立评估纳入研究。他们还独立提取数据并评估偏倚风险。第三位作者对无法达成一致的研究进行评估。

主要结果

检索到40项研究,其中20项(1936名参与者)纳入本评价。这些研究比较了通过不同雾化器系统输送妥布霉素、多粘菌素、重组人脱氧核糖核酸酶、高渗氯化钠和其他溶液的情况。本评价表明,根据所使用的雾化器系统不同,药物输送存在差异。与提供较低流速、较低可吸入部分和较大颗粒的传统雾化器系统相比,提供较高流速、较高可吸入部分和较小颗粒的传统雾化器系统可缩短治疗时间、增加沉积量,可能更受囊性纤维化患者青睐。使用自适应气雾剂输送或振动网技术的雾化器可更大程度地缩短治疗时间。自适应气雾剂输送的沉积量(作为起始剂量的百分比)高于传统方式。测量痰液水平时,振动网技术系统的沉积量可能高于传统系统,但测量血清水平或使用γ闪烁显像时沉积量较低。现有数据表明,这些较新的系统在使用适当的起始剂量时是安全的,该起始剂量可能与传统系统使用的不同。有迹象表明,使用这些较新技术的系统可维持或提高依从性,但也有一些使用振动网技术的雾化器系统可能出现更多故障。

作者结论

临床医生应了解不同雾化器系统性能的差异。自适应气雾剂输送和振动网技术等技术在治疗时间、作为起始剂量百分比的沉积量、患者偏好和依从性方面优于传统系统。需要对这些技术进行长期随机对照试验,以确定以患者为中心的结局(如生活质量和护理负担)、药物的安全有效剂量水平和临床结局(如住院次数和抗生素使用需求),并对其使用进行经济学评价。

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