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Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019.204 个国家和地区 1990-2019 年 369 种疾病和伤害导致的全球负担:2019 年全球疾病负担研究的系统分析。
Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
2
Pediatric Asthma: A Global Epidemic.儿童哮喘:全球性流行病。
Ann Glob Health. 2019 Jan 22;85(1):6. doi: 10.5334/aogh.2416.
3
Efficacy and safety of fluticasone propionate/formoterol fumarate in pediatric asthma patients: a randomized controlled trial.丙酸氟替卡松/富马酸福莫特罗在儿科哮喘患者中的疗效和安全性:一项随机对照试验。
Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618777924. doi: 10.1177/1753466618777924.
4
Pharmacokinetics of Salmeterol and Fluticasone Propionate Delivered in Combination via Easyhaler and Diskus Dry Powder Inhalers in Healthy Subjects.舒利迭干粉吸入剂(沙美特罗替卡松)在健康受试者中的药代动力学。
J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):290-297. doi: 10.1089/jamp.2017.1437. Epub 2018 Mar 1.
5
Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice.在现实生活实践中,儿童使用孟鲁司特起始治疗后出现的神经精神性药物不良反应。
Eur Respir J. 2017 Nov 22;50(5). doi: 10.1183/13993003.02135-2017. Print 2017 Nov.
6
The national cost of asthma among school-aged children in the United States.美国学龄儿童哮喘的全国成本。
Ann Allergy Asthma Immunol. 2017 Sep;119(3):246-252.e1. doi: 10.1016/j.anai.2017.07.002.
7
Salmeterol and Fluticasone Propionate in Children with Asthma.沙美特罗替卡松丙酸酯用于儿童哮喘治疗
N Engl J Med. 2016 Dec 1;375(22):e46. doi: 10.1056/NEJMc1612973.
8
A 12-week open-label, randomized, controlled trial and 24-week extension to assess the efficacy and safety of fluticasone propionate/formoterol in children with asthma.一项为期12周的开放标签、随机对照试验以及为期24周的延长期试验,以评估丙酸氟替卡松/福莫特罗对哮喘儿童的疗效和安全性。
Ther Adv Respir Dis. 2016 Aug;10(4):324-37. doi: 10.1177/1753465816646320. Epub 2016 May 16.
9
Optimal step-down approach for pediatric asthma controlled by salmeterol/fluticasone: A randomized, controlled trial (OSCAR study).沙丁胺醇/氟替卡松控制的小儿哮喘的最佳降级方法:一项随机对照试验(OSCAR 研究)。
Allergol Int. 2016 Jul;65(3):306-11. doi: 10.1016/j.alit.2016.02.010. Epub 2016 May 4.
10
Systematic review of the toxicity of short-course oral corticosteroids in children.儿童短期口服皮质类固醇毒性的系统评价
Arch Dis Child. 2016 Apr;101(4):365-70. doi: 10.1136/archdischild-2015-309522. Epub 2016 Jan 14.

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.

DOI:10.1136/bmjresp-2023-001706
PMID:37620110
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10450074/
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。