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CARE:一项关于儿童哮喘患者家庭雾化治疗依从性的观察性研究。

CARE: an observational study of adherence to home nebulizer therapy among children with asthma.

机构信息

Children's Hospital of Nanjing Medical University, 72 Guangzhou Road, Nanjing 210008, China.

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.

出版信息

Ther Adv Respir Dis. 2021 Jan-Dec;15:1753466620986391. doi: 10.1177/1753466620986391.

Abstract

BACKGROUND

The prevalence of pediatric asthma in China is approximately 3%, and asthma remains poorly controlled in many of these patients. This study assessed the rate of adherence to home nebulizer treatment in paediatric patients in China.

METHODS

The CARE study was a 12-week, multicentre, prospective, observational study across 12 tertiary hospitals in China. Patients were aged 0-14 years, clinically diagnosed with asthma and prescribed home nebulizer inhaled corticosteroid (ICS) therapy for ⩾3 months. The primary endpoint was electronically monitored treatment adherence. Patients attended onsite visits at 0, 4, 8 and 12 weeks to assess asthma control, severity and treatment adherence (recorded by electronic monitoring devices and caregivers).

RESULTS

The full analysis set included 510 patients. Median treatment adherence reported by electronic monitoring devices was 69.9%, and median caregiver-reported adherence was 77.9%. The proportion of patients with well-controlled asthma increased from 12.0% at baseline to 77.5% at visit 4. Increased time between asthma diagnosis and study enrolment was a significant predictor for better adherence [coefficient: 0.01,  = 0.0138; 95% confidence interval (CI): 0.00, 0.01] and asthma control (odds ratio = 1.001,  = 0.0498; 95% CI: 1.000, 1.002). Negative attitude to treatment by the caregiver was associated with poorer asthma control.

CONCLUSIONS

Adherence to home nebulization, a widely used treatment for asthma, was high among Chinese pediatric patients. Asthma control improved with increasing treatment duration. These results suggest that home nebulization of ICS is an effective and recommendable long-term treatment for paediatric patients with asthma.ClinicalTrials.gov identifier: NCT03156998

摘要

背景

中国儿童哮喘的患病率约为 3%,许多患者的哮喘仍未得到良好控制。本研究评估了中国儿科患者家庭雾化治疗的依从率。

方法

CARE 研究是一项为期 12 周、多中心、前瞻性、观察性研究,在中国 12 家三级医院进行。患者年龄 0-14 岁,临床诊断为哮喘,接受家庭雾化吸入皮质类固醇(ICS)治疗 ⩾3 个月。主要终点是通过电子监测评估治疗依从性。患者在 0、4、8 和 12 周时进行现场就诊,以评估哮喘控制、严重程度和治疗依从性(通过电子监测设备和护理人员记录)。

结果

全分析集纳入 510 例患者。电子监测设备报告的中位治疗依从率为 69.9%,中位护理人员报告的依从率为 77.9%。基线时哮喘控制良好的患者比例为 12.0%,第 4 次就诊时增至 77.5%。哮喘诊断至研究入组时间的延长是治疗依从性更好的显著预测因素[系数:0.01,=0.0138;95%置信区间(CI):0.00,0.01]和哮喘控制(比值比=1.001,=0.0498;95%CI:1.000,1.002)。护理人员对治疗的消极态度与哮喘控制不佳有关。

结论

中国儿科患者家庭雾化治疗依从性较高,ICS 家庭雾化治疗是一种广泛用于哮喘治疗的有效且推荐的长期治疗方法。

临床试验注册号

NCT03156998

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54d2/7874342/46f6414105d6/10.1177_1753466620986391-fig1.jpg

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