Early intervention of recent onset mild persistent asthma in children aged under 11 yrs: the Steroid Treatment As Regular Therapy in early asthma (START) trial
Early intervention of recent onset mild persistent asthma in children aged under 11 yrs: the Steroid Treatment As Regular Therapy in early asthma (START) trial
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DOI：
10.1111/j.1600-5562.2006.00379.x
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发表时间：
2006-05-01
影响因子：
4.4
通讯作者：
O'Byrne, PM
中科院分区：
文献类型：
--
作者：
Chen, YZ;Busse, WW;O'Byrne, PM
已知吸入性皮质类固醇对持续性哮喘有效，但其对近期发作的轻度持续性疾病的长期作用（尤其与儿童相关）需要澄清。本研究的目的是确定定期吸入低剂量布地奈德对11岁以下轻度持续性哮喘儿童的长期疗效，这些儿童在入组后2年内发病。5-10岁的儿童是吸入性类固醇治疗作为早期哮喘常规治疗（START）研究的一部分，他们以双盲方式随机接受每日一次的布地奈德200 μ g或安慰剂（通过Turbuhaler TM）治疗，此外还有常规的临床护理和其他哮喘药物。双盲治疗阶段持续3年。在1974名儿童中，1000名布地奈德组和974名安慰剂组进行了疗效分析。在常规治疗的基础上加用布地奈德每日一次与首次发生严重哮喘相关事件（萨雷）的时间显著增加相关，并显著降低了3年以上发生萨雷的风险。相对于常规治疗（安慰剂）的风险比为0.60（95%置信区间：0.40-0.90; p = 0.012），相对风险降低40%。接受布地奈德治疗的儿童也需要显著减少其他吸入性皮质类固醇的干预（3年内12.3% vs. 22.5%; p < 0.01），口服/全身性皮质类固醇和吸入性短效β 2受体激动剂的使用有减少的趋势。与安慰剂相比，布地奈德治疗对肺功能也有显著的有益作用。总之，与单纯常规治疗相比，在近期发作的轻度持续性哮喘儿童的常规治疗基础上增加布地奈德每日一次的早期干预可降低SARE的长期风险和频率，并改善肺功能。
Inhaled corticosteroids are known to be effective in persistent asthma, but their long-term effect in mild persistent disease of recent onset, which is particularly relevant in children, requires clarification. The objective of this study was to determine the long-term efficacy of regular inhaled low-dose budesonide in children aged < 11 yrs with mild persistent asthma with onset within 2 yrs of enrollment. Children aged 5-10 yrs formed part of the population of the inhaled Steroid Treatment As Regular Therapy in early asthma (START) study, and they were randomized in a double-blind manner to treatment with once daily budesonide 200 mu g or placebo via Turbuhaler (TM) in addition to usual clinical care and other asthma medication. The double-blind treatment phase continued for 3 yrs. Of the 1974 children, 1000 in the budesonide group and 974 in the placebo group, were analyzed for efficacy. Addition of once-daily budesonide to usual care was associated with a significant increase in the time to first severe asthma-related event (SARE) and significantly reduced risk of SARE over 3 yrs. The hazard ratio relative to usual care (placebo) was 0.60 (95% confidence interval: 0.40-0.90; p = 0.012), with a relative risk reduction of 40%. Children receiving budesonide also needed significantly less intervention with other inhaled corticosteroids (12.3% vs. 22.5% over 3 yrs; p < 0.01), with trends towards decreased usage of oral/systemic corticosteroids and inhaled short-acting beta(2)-agonists. Budesonide treatment also had a significant beneficial effect on lung function relative to placebo. In conclusion, early intervention adding once-daily budesonide to usual care in children with mild, persistent asthma of recent onset reduces the long-term risk and frequency of SAREs and improves lung function compared with usual care alone.