吸入四倍剂量性糖皮质激素预防哮喘恶化：一项随机、双盲、安慰剂对照、平行分组临床试验
2009/09/17
背景：哮喘恶化常不可预测、且后果严重，因此预防就显得尤为重要。本研究目的旨在评价在哮喘控制情况开始恶化时，吸入四倍剂量糖皮质激素能否减少哮喘恶化时口服糖皮质激素的使用。
方法：对403例哮喘患者实施自我管理计划，当患者连续2天呼气流量峰值下降15%或1天下降30%时，随机接受糖皮质激素和安慰剂吸入治疗，患者的其它常规哮喘治疗药物不变。本研究所用的吸入器可提供4倍剂量或常规剂量糖皮质激素。
结果：糖皮质激素治疗组和安慰剂组，分别有9%（18/197）和14%（29/203）的患者出现恶化需要口服糖皮质激素治疗，风险比为0.64（95%CI 0.37~1.11, p = 0.11）。94例受试者中，糖皮质激素治疗过程中哮喘恶化需要口服糖皮质激素治疗的患者远少于安慰剂治疗组：糖皮质激素治疗组为21%（12/56），安慰剂组为50%（19/38），风险比为0.43（95%CI 0.24~0.78, p = 0.004）。
结论：虽然主要结果未显示统计学差异，但当哮喘出现恶化时，四倍糖皮质激素吸入治疗似可减少哮喘急性发作，目前还需进一步研究来证实。
（陈欣 审校）
Oborne J, Mortimer K, Hubbard RB, et al.
Am J Respir Crit Care Med. 2009 Jul 9. [Epub ahead of print]
Quadrupling the Dose of Inhaled Corticosteroid to Prevent Asthma Exacerbations: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Clinical Trial
Oborne J, Mortimer K, Hubbard RB, Tattersfield AE, Harrison TW.
Respiratory Biomedical Research Unit, Division Respiratory Medicine, University of Nottingam, Nottingham, United Kingdom.
BACKGROUND: Asthma exacerbations are unpredictable, disruptive and frightening and are therefore important to prevent. We investigated whether a policy of quadrupling the dose of inhaled corticosteroid when asthma control starts to deteriorate reduces asthma exacerbations requiring treatment with oral corticosteroids.
METHODS: 403 people with asthma were given a self-management plan and randomized to take an active or placebo corticosteroid inhaler in addition to their usual asthma treatment when their peak expiratory flow fell by 15% on two consecutive days or by 30% on one day. The study inhalers provided a quadrupling or no change in corticosteroid dose.
RESULTS: Eighteen of 197 (9%) and 29 of 203 (14%) participants had an exacerbation of asthma requiring treatment with oral corticosteroids in the active and placebo groups respectively, giving a risk ratio of 0.64 (95% CI 0.37 to 1.11, p = 0.11). Of the 94 participants who started the study inhaler far fewer required treatment with oral corticosteroids in the active compared with the placebo group; 12 of 56 (21%) in active group and 19 of 38 (50%) in the placebo groups, giving a risk ratio of 0.43 (95% CI 0.24 to 0.78, p = 0.004).
CONCLUSIONS: Although our primary outcome did not reach statistical significance, quadrupling the dose of inhaled corticosteroid when asthma control starts to deteriorate appears to reduce acute exacerbations of asthma and deserves further investigation Clinical Trials Registry Information:
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医疗救助人群中的流程质量检测与哮喘恶化的关系
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学龄期哮喘儿童的过敏性鼻炎：诊断和治疗欠佳？一项在儿童医院进行的回顾性研究
