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Tiotropium as an add-on treatment to inhaled corticosteroids in children with severe and mild symptomatic asthma: Multi-center observational study for efficacy and safety analysis.噻托溴铵作为中重度症状性哮喘儿童吸入性糖皮质激素的附加治疗:疗效和安全性分析的多中心观察性研究
Exp Ther Med. 2022 Jul 19;24(3):577. doi: 10.3892/etm.2022.11514. eCollection 2022 Sep.
2
The Effect of Tiotropium in Symptomatic Asthma Despite Low- to Medium-Dose Inhaled Corticosteroids: A Randomized Controlled Trial.噻托溴铵对接受低至中剂量吸入性糖皮质激素治疗的症状性哮喘的影响:一项随机对照试验
J Allergy Clin Immunol Pract. 2016 Jan-Feb;4(1):104-13.e2. doi: 10.1016/j.jaip.2015.08.017. Epub 2015 Nov 7.
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Tiotropium in asthmatic adolescents symptomatic despite inhaled corticosteroids: a randomised dose-ranging study.噻托溴铵用于尽管使用吸入性糖皮质激素仍有症状的哮喘青少年:一项随机剂量范围研究。
Respir Med. 2014 Sep;108(9):1268-76. doi: 10.1016/j.rmed.2014.06.011. Epub 2014 Jul 17.
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Once-daily tiotropium Respimat(®) 5 μg is an efficacious 24-h bronchodilator in adults with symptomatic asthma.每日一次的噻托溴铵Respimat(®)5微克对有症状的成年哮喘患者是一种有效的24小时支气管扩张剂。
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Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis.噻托溴铵Respimat®每日一次作为症状性哮喘成年患者至少吸入糖皮质激素的附加治疗的安全性和耐受性:一项汇总安全性分析。
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Burden of Asthma and Role of 2.5 µg Tiotropium Respimat as an Add-On Therapy: A Systematic Review of Phase 2/3 Trials.哮喘负担和 2.5μg 噻托溴铵 Respimat 作为附加治疗的作用:2/3 期试验的系统评价。
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本文引用的文献

1
Forced Expiratory Flow (FEF) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis.在接受噻托溴铵治疗的有症状哮喘儿童和青少年中,将用力呼气流量(FEF)作为临床终点:一项事后分析。
Pulm Ther. 2020 Dec;6(2):151-158. doi: 10.1007/s41030-020-00117-6. Epub 2020 May 12.
2
Efficacy of Chinese Children's Asthma Action Plan in the management of children with asthma.中国儿童哮喘行动计划在儿童哮喘管理中的疗效。
Allergy Asthma Proc. 2020 Jan 1;41(1):e3-e10. doi: 10.2500/aap.2020.41.190010.
3
Tiotropium add-on therapy is safe and reduces seasonal worsening in paediatric asthma patients.噻托溴铵附加疗法安全,并可减少儿科哮喘患者的季节性恶化。
Eur Respir J. 2019 Jun 13;53(6). doi: 10.1183/13993003.01824-2018. Print 2019 Jun.
4
Preventing Severe Asthma Exacerbations in Children. A Randomized Trial of Mite-Impermeable Bedcovers.预防儿童重度哮喘恶化。防螨床罩的随机试验。
Am J Respir Crit Care Med. 2017 Jul 15;196(2):150-158. doi: 10.1164/rccm.201609-1966OC.
5
A phase III randomized controlled trial of tiotropium add-on therapy in children with severe symptomatic asthma.一项噻托溴铵附加疗法治疗重度有症状哮喘儿童的 III 期随机对照试验。
J Allergy Clin Immunol. 2017 Nov;140(5):1277-1287. doi: 10.1016/j.jaci.2017.01.014. Epub 2017 Feb 9.
6
A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma.噻托溴铵用于重度症状性哮喘青少年的随机对照试验。
Eur Respir J. 2017 Jan 11;49(1). doi: 10.1183/13993003.01100-2016. Print 2017 Jan.
7
Uncontrolled asthma and its risk factors in Chinese children: A cross-sectional observational study.中国儿童未控制哮喘及其危险因素:一项横断面观察性研究。
J Asthma. 2016 Sep;53(7):699-706. doi: 10.3109/02770903.2016.1144199. Epub 2016 May 17.
8
Tiotropium add-on therapy in adolescents with moderate asthma: A 1-year randomized controlled trial.噻托溴铵附加疗法治疗青少年中度哮喘:一项为期 1 年的随机对照试验。
J Allergy Clin Immunol. 2016 Aug;138(2):441-450.e8. doi: 10.1016/j.jaci.2016.01.011. Epub 2016 Mar 5.
9
New and future strategies to improve asthma control in children.改善儿童哮喘控制的新策略和未来策略。
J Allergy Clin Immunol. 2015 Oct;136(4):848-59. doi: 10.1016/j.jaci.2015.07.007. Epub 2015 Aug 28.
10
Lung-Function Trajectories Leading to Chronic Obstructive Pulmonary Disease.导致慢性阻塞性肺疾病的肺功能轨迹。
N Engl J Med. 2015 Jul 9;373(2):111-22. doi: 10.1056/NEJMoa1411532.

噻托溴铵作为中重度症状性哮喘儿童吸入性糖皮质激素的附加治疗:疗效和安全性分析的多中心观察性研究

Tiotropium as an add-on treatment to inhaled corticosteroids in children with severe and mild symptomatic asthma: Multi-center observational study for efficacy and safety analysis.

作者信息

Aierken Aibibai, Yu Su Fu Bu Wei Mai Erye Mu, Xu Peiru

机构信息

Department of Pediatrics, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region 830054, P.R. China.

Department of Pediatrics, The First People's Hospital of Kashi, Kashi, Xinjiang Uygur Autonomous Region 844000, P.R. China.

出版信息

Exp Ther Med. 2022 Jul 19;24(3):577. doi: 10.3892/etm.2022.11514. eCollection 2022 Sep.

DOI:10.3892/etm.2022.11514
PMID:35949336
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9353548/
Abstract

Children aged 6-11 years with uncontrolled asthma are treated with low-dose inhaled corticosteroid (ICS) with stepwise increase in ICS dosage and/or add-on maintenance treatment, as necessary. The objective of the present study was to evaluate the efficacy and safety of tiotropium add-on treatment in children with severe and mild symptomatic asthma. The present prospective cohort study included 144 children with severe and mild asthma (age, 6-11 years) who received ICS (budesonide) with ≥1 controller treatment combination therapies for ≥1 month and score ≥1.5 based on Asthma Control Questionnaire-Interviewer-Administered. In addition to ICS with ≥1 controller treatment, children received 5 µg once-daily tiotropium (treatment group; n=72) or did not receive tiotropium (control group; n=72). The peak forced expiratory volume in 1-sec change from the baseline 3 h post-administration of tiotropium was significantly improved in the treatment group compared with the control group (384±31 vs. 248±28 ml; P<0.0001). The trough forced expiratory volume in 1-sec (224±28 vs. 140±31 ml; P<0.0001) and forced expiratory flow at 25-75% of forced vital capacity (389±36 vs. 116±27 ml/sec; P<0.0001) showed significant improvement following treatment with tiotropium. Significant differences were noted for trough forced vital capacity (153±29 vs. 139±30 ml/sec; P<0.0001), mean weekly rescue treatment usage (0.29±0.08 vs. 0.36±0.09; P<0.0001), mean weekly peak expiratory flow measurement (4.12±3.56 vs. 7.46±3.29 l/min; P<0.0001) and mean weekly symptom-free time (0.19±0.04 vs. 0.16±0.04 days; P<0.0001) between both cohorts. Children of both groups tolerated any adverse effects. Tiotropium 5 µg administered once/day as an add-on treatment to ICS with ≥1 controller treatments in children (6-11 years of age) with severe and mild symptomatic asthma was found to be efficacious and safe (level of evidence 2; technical efficacy stage 4).

摘要

6至11岁未得到有效控制的哮喘儿童,必要时采用低剂量吸入性糖皮质激素(ICS)治疗,并逐步增加ICS剂量和/或添加维持治疗。本研究的目的是评估噻托溴铵添加治疗对重度和轻度症状性哮喘儿童的疗效和安全性。本前瞻性队列研究纳入了144例重度和轻度哮喘儿童(年龄6至11岁),这些儿童接受ICS(布地奈德)联合≥1种控制治疗组合疗法≥1个月,且根据哮喘控制问卷-访谈者管理版评分≥1.5。除了ICS联合≥1种控制治疗外,儿童接受每日一次5μg噻托溴铵治疗(治疗组;n = 72)或不接受噻托溴铵治疗(对照组;n = 72)。与对照组相比,治疗组在给予噻托溴铵后3小时,1秒用力呼气容积峰值较基线的变化显著改善(384±31 vs. 248±28 ml;P<0.0001)。1秒用力呼气容积谷值(224±28 vs. 140±31 ml;P<0.0001)和用力肺活量25%-75%时的用力呼气流量(389±36 vs. 116±27 ml/秒;P<0.0001)在接受噻托溴铵治疗后显示出显著改善。两组在用力肺活量谷值(153±29 vs. 139±30 ml/秒;P<0.0001)、平均每周急救治疗使用次数(0.29±0.08 vs. 0.36±0.09;P<0.0001)、平均每周呼气峰值流速测量值(4.12±3.56 vs. 7.46±3.29 l/分钟;P<0.0001)和平均每周无症状时间(0.19±0.04 vs. 0.16±0.04天;P<0.0001)方面存在显著差异。两组儿童对任何不良反应均耐受。对于6至11岁患有重度和轻度症状性哮喘的儿童,每日一次给予5μg噻托溴铵作为ICS联合≥1种控制治疗的添加治疗,被发现是有效且安全的(证据级别2;技术疗效阶段4)。