吸入型糖皮质激素治疗儿童哮喘有效性与安全性的临床研究

Efficacy and safety of corticosteroid inhalation in the treatment of childhood asthma

摘要:

目的 吸入型糖皮质激素作为儿童哮喘预防性抗炎治疗的第一线药物,其效应性、安全性已成为 医患双方共同关注的焦点。但目前长期吸入治疗对肾上腺皮质功能和生长发育影响的国内研究为数不多,因此我 们进行一项对照研究以观察二丙酸倍氯米松(BDP)治疗儿童哮喘的疗效及副作用。方法 50例哮喘儿童根据病 情严重程度,在快速缓解后给予不同剂量二丙酸倍氯米松吸入,为期6月～2.5年。治疗期间定期随访,观察临床 疗效,监测最高呼气流速(PEFR)值,测量体重、身高及修改吸入剂量,并进行24小时尿游离皮质醇含量测定。结 果 临床总有效率90%(45/50),与对照组[70%(21/30)]相比差异有显著性意义(P<0.05),吸入BDP后6个 月时PEFR值和初诊时相比较差异有显著性意义(P<0.05),患儿身高、体重与同龄正常值比较无异常(P> 0.05);24h尿游离皮质醇在正常范围。结论 吸入二丙酸倍氯米松治疗不同严重程度的儿童哮喘,疗效好,而且 安全。

Abstract:

Objective The efficacy of long-term corticosteroid inhalation and its influences on adrenal gland function and growth & development in the treatment of childhood asthma are the concerns of many doctors and parents. This study examined the efficacy and safety of long-term beclomethaone dipropionate (BDP) inhalation in the treatment of this disorder by a control study. Methods Eighty children with asthma were randomly assigned into two groups: a Study group (n=50) and a Control group (n=30). Children from the Study group were regularly given BDP inhalation treatment during the remission stage. The initial dosage was different in patients with different severity (mild:250 μg/d, medium:500 μg/d, and severe:750 μg/d). Afterwards, the dosages were adjusted according to patients′ responses to this therapy. BPD inhalation duration was from 6 months to 2.5 years. During the treatment, regular follow-ups were performed to observe therapeutic effects and to measure patients′ peak expiratory flow rate (PEFR), 24-hr-urine free cortisol concentrations, body weight and height. The asthmatic children who did not receive or received irregular BPD inhalation during the remission stage served as the Control group.Results After 6 months of BPD inhalation, the effective rate in the Study group was significantly higher than that in the Control group [90%(45/50) vs 70%(21/30), P<0.05].The PEFR of the Study group significantly increased with treatment. The children′s body weight and height were not different from the normal children. The concentrations of 24-hr-urine free cortisol were also kept normal.Conclusions Long-term BPD inhalation appears to be effective and safe in the treatment of childhood asthma.