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布地奈德吸入剂与莫米松吸入剂治疗中国轻度持续性哮喘儿童的单中心回顾性研究

Inhaled Budesonide vis-à-vis Inhaled Mometasone in Chinese Children with Mild Persistent Asthma: A Single-Center, Retrospective Study.

作者信息

Gao Pei, Ding Ying, Yin Bingru, Gu Haoxiang

机构信息

Department of Respiratory Medicine, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.

出版信息

Pharmacology. 2021;106(11-12):616-622. doi: 10.1159/000518733. Epub 2021 Sep 9.

Abstract

INTRODUCTION

A very limited option of inhaled corticosteroids (ICSs) is approved for pediatric use in China because in children the use of ICSs for long periods is associated with dose-dependent growth reduction. Due to the lack of consensus on which is the best ICS-based treatment option to manage mild persistent asthma in children, the present study was performed to evaluate the efficacy and safety of budesonide (BUD)-based therapy vis-à-vis mometasone-based therapy in children with mild persistent asthma.

METHODS

A single-center, retrospective study was conducted in asthmatic children aged between 6 and 11 years. BUD and mometasone furoate (MF) were administered as per the approved dosing regimen using pressurized metered-dose inhalers via oral inhalation route for a period of 12 weeks. The study outcome was assessed in terms of the forced expiratory volume in 1 s (FEV1), symptom scores, and nonoccurrence of side effects.

RESULTS

Among the 77 asthmatic children, 71 completed the study treatment and were used in carrying out the analysis. The improvement of spirometric parameters like FEV1, Tiffeneau-Pinelli index (FEV1/forced vital capacity [FVC]), and peak expiratory flow (PEF) values observed in the MF cohort was significantly greater than those of the BUD cohort (p < 0.05 for all). An increase of approximately 12%/child was observed for FEV1/FVC ratios for the BUD cohort and MF cohorts. After the 12-week study, the PEFm and PEFe values increased to about 50 L/min/child for the BUD cohort and about 98 L/min/child for the MF cohort. During the study, no asthma exacerbation event was observed in the MF cohort, whereas 1 child in the BUD cohort had asthma exacerbation in week 4. The use of rescue medication during the study was required for 16.2 and 6% of children, respectively, for BUD and MF cohorts. Owing to low dosing frequency, MF could provide a better treatment approach than BUD due to improved patient compliance.

CONCLUSIONS

Although both drugs showed improvement in the quality of life of asthmatic children with manageable treatment-emergent adverse effects, the improvement was augmented in MF-treated children.

LEVEL OF EVIDENCE

The level of evidence was III. Technical Efficacy Stage: The technical efficacy stage was 4.

摘要

引言

在中国,仅有非常有限的几种吸入性糖皮质激素(ICS)被批准用于儿科,因为儿童长期使用ICS与剂量依赖性生长发育迟缓有关。由于对于哪种基于ICS的治疗方案是管理儿童轻度持续性哮喘的最佳方案缺乏共识,本研究旨在评估布地奈德(BUD)治疗方案与糠酸莫米松治疗方案相比,在轻度持续性哮喘儿童中的疗效和安全性。

方法

对6至11岁的哮喘儿童进行了一项单中心回顾性研究。按照批准的给药方案,使用压力定量吸入器经口服吸入途径给予BUD和糠酸莫米松(MF),为期12周。根据1秒用力呼气量(FEV1)、症状评分和无副作用情况评估研究结果。

结果

在77名哮喘儿童中,71名完成了研究治疗并用于分析。在MF组中观察到的肺功能参数改善,如FEV1、蒂芬诺-皮内利指数(FEV1/用力肺活量[FVC])和呼气峰值流速(PEF)值,显著大于BUD组(所有p值均<0.05)。BUD组和MF组的FEV1/FVC比值每儿童增加约12%。12周研究后,BUD组的PEFm和PEFe值每儿童增加至约50 L/min,MF组每儿童增加至约98 L/min。研究期间,MF组未观察到哮喘加重事件,而BUD组有1名儿童在第4周出现哮喘加重。在研究期间,BUD组和MF组分别有16.2%和6%的儿童需要使用急救药物。由于给药频率低,MF因改善了患者依从性,可提供比BUD更好的治疗方法。

结论

尽管两种药物在哮喘儿童的生活质量改善方面均有表现,且治疗引起的不良反应可控,但MF治疗的儿童改善更为明显。

证据水平

证据水平为III。技术疗效阶段:技术疗效阶段为4。

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