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管理中重度小儿哮喘:丙酸氟替卡松/沙美特罗疗效和安全性的范围评价。

Managing moderate-to-severe paediatric asthma: a scoping review of the efficacy and safety of fluticasone propionate/salmeterol.

机构信息

Pediatric Pulmonology Division, Hospital Santa Casa de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

Department of Pediatrics, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand.

出版信息

BMJ Open Respir Res. 2023 Aug;10(1). doi: 10.1136/bmjresp-2023-001706.

Abstract

BACKGROUND

Fluticasone propionate/salmeterol xinafoate (FP/SAL) is an inhaled corticosteroid (ICS) and long-acting β-agonist (LABA) combination, indicated for the regular treatment of children (aged >4 years) with asthma that is inadequately controlled with ICS monotherapy plus as-needed short-acting β-agonists, or already adequately controlled with ICS/LABA.

OBJECTIVE

Compared with the adult population, fewer clinical studies have investigated the efficacy of FP/SAL in paediatric patients with moderate and moderate-to-severe asthma. In this review, we synthesise the available evidence for the efficacy and safety of FP/SAL in the paediatric population, compared with other available therapies indicated for asthma in children.

ELIGIBILITY CRITERIA

A literature review identified randomised controlled trials and observational studies of FP/SAL in the paediatric population with moderate-to-severe asthma.

SOURCES OF EVIDENCE

The Medline database was searched using PubMed (https://pubmed.ncbi.nlm.nih.gov/), with no publication date restrictions. Search strategies were developed and refined by authors.

CHARTING METHODS

Selected articles were screened for clinical outcome data (exacerbation reduction, nocturnal awakenings, lung function, symptom control, rescue medication use and safety) and a table of key parameters developed.

RESULTS

Improvements in asthma outcomes with FP/SAL include reduced risk of asthma-related emergency department visits and hospitalisations, protection against exercise-induced asthma and improvements in measures of lung function. Compared with FP monotherapy, greater improvements in measures of lung function and asthma control are reported. In addition, reduced incidence of exacerbations, hospitalisations and rescue medication use is observed with FP/SAL compared with ICS and leukotriene receptor antagonist therapy. Furthermore, FP/SAL therapy can reduce exposure to both inhaled and oral corticosteroids.

CONCLUSIONS

FP/SAL is a reliable treatment option in patients not achieving control with ICS monotherapy or a different ICS/LABA combination. Evidence shows that FP/SAL is well tolerated and has a similar safety profile to FP monotherapy. Thus, FP/SAL provides an effective option for the management of moderate-to-severe asthma in the paediatric population.

摘要

背景

丙酸氟替卡松/沙美特罗(FP/SAL)是一种吸入性皮质类固醇(ICS)和长效β-激动剂(LABA)的组合药物,适用于那些通过ICS 单药治疗联合按需使用短效β-激动剂仍未能充分控制病情的,或已经通过 ICS/LABA 充分控制病情的儿童(年龄>4 岁)哮喘患者的常规治疗。

目的

与成年人群相比,较少的临床研究调查了 FP/SAL 在中度和中重度哮喘儿童患者中的疗效。在本次综述中,我们综合了 FP/SAL 在儿科人群中的疗效和安全性的现有证据,与其他适用于儿童哮喘的可用疗法进行了比较。

纳入标准

对 FP/SAL 在中度至重度哮喘儿童人群中的随机对照试验和观察性研究进行了文献回顾。

证据来源

使用 PubMed (https://pubmed.ncbi.nlm.nih.gov/)对 Medline 数据库进行了搜索,未对出版日期进行限制。作者制定并完善了搜索策略。

图表方法

筛选出了有临床结局数据(减少哮喘加重、夜间觉醒、肺功能、症状控制、急救药物使用和安全性)的入选文章,并制定了关键参数表。

结果

FP/SAL 可改善哮喘结局,包括降低哮喘相关急诊就诊和住院风险、预防运动诱导性哮喘以及改善肺功能测量值。与 FP 单药治疗相比,报告的肺功能和哮喘控制改善更大。此外,与 ICS 和白三烯受体拮抗剂治疗相比,FP/SAL 可减少哮喘加重、住院和急救药物使用的发生率。此外,FP/SAL 治疗可以减少吸入和口服皮质激素的暴露。

结论

FP/SAL 是那些不能通过 ICS 单药治疗或其他 ICS/LABA 联合治疗实现控制的患者的可靠治疗选择。证据表明,FP/SAL 具有良好的耐受性,且与 FP 单药治疗的安全性相似。因此,FP/SAL 为儿科人群中中重度哮喘的管理提供了一种有效的选择。

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