布地奈德干粉吸入剂治疗中国新诊断的轻度持续性支气管哮喘患者的随机、双盲、多中心临床疗效研究

目的：评估早期使用布地奈德干粉吸入剂对治疗中国新诊断的轻度持续性支气管哮喘(简称哮喘)患者的临床疗效。方法采用随机、对照、双盲、多中心的研究方法,选取年龄5~66岁,被早期诊断为轻度持续性哮喘,诊断时间距第1次访视不超过2年,尚未采用糖皮质激素治疗的患者869例。随机分为布地奈德组435例,给予布地奈德400μg/次,1次/d (如患者年龄<11岁：200μg/次,1次/d)加常规哮喘治疗]和安慰剂组434例,给予安慰剂(用法同布地奈德组)加常规哮喘治疗],随访时间为期3年。结果相对于安慰剂组,布地奈德降低63%的严重哮喘相关事件(severe asthma-related events,SAREs)的发生风险,并显著延迟首次发生 SAREs 的时间风险比(hazard ratio,HR)：0.37；95%置信区间(95% CI )：0.20~0.68；χ2=10.11,P =0.0015]。在访视的第1和第3年,两组患者吸入支气管舒张剂后 FEV1%pred 相对于基线均有降低。其中布地奈德组在访视的第1年,该指标的改善显著优于安慰剂组(95% CI ：1.24~3.76；t =3.89,P =0.0001),在访视的第3年,两组间差异无统计学意义(95% CI ：-0.25~2.62；t =1.62,P =0.1057)。两组相比,布地奈德组患者对药物耐受性良好,布地奈德能改善患者的哮喘控制,并减少额外糖皮质激素的使用,吸入支气管舒张剂前 FEV1%pred 在访视第1年(95% CI ：1.64~5.24；t =3.75,P =0.0002)和第3年 (95% CI ：0.05~3.68；t =2.02,P =0.0435)均有明显改善。结论长期使用布地奈德(1次/d)治疗中国新诊断的轻度持续性哮喘患者,该治疗方案能改善患者的哮喘控制,并明显延缓首次发生 SAREs 的时间。

Effectiveness of long-term inhaled budesonide in Chinese patients with recently-diagnosed,mild persistent ;asthma

Objective To investigat the effectiveness of early intervention with budesonide in Chinese patients with recently-diagnosed,mild persistent asthma treated in the randomised,double-blind START study (ClinicalTrials.gov:NCT00641 914).Methods Patients aged 5-66 years with mild persistent asthma for< 2 years,and no regular corticosteroid treatment (n = 869),were randomised to once-daily budesonide 400 μg (200 μg if<1 1 years) or placebo for 3 years,plus usual asthma treatment. Results Budesonide significantly prolonged the time to first severe asthma-related event (SARE) compared with placebo,resulting in a SARE risk reduction of 63%(HR :0.37,95% CI :0.20-0.68;χ2=10.1 1,P =0.001 5).Postbronchodilator forced expiratory volume in 1 second(FEV1) % predicted was reduced in both groups at years 1 and 3 versus baseline;this reduction was significantly smaller with budesonide than placebo at year 1 (95% CI :1.24-3.76;t =3.89,P =0.000 1)but not year 3 (95% CI:-0.25-2.62;t =1.62,P =0.105 7).Budesonide significantly improved prebronchodilator FEV1 %pred at years 1 (95% CI :1.64-5.24;t = 3.75,P = 0.000 2) and 3 (95% CI :0.05-3.68;t = 2.02,P =0.043 5),and improved asthma control and decreased the need for additional glucocorticosteroids,versus placebo.Budesonide was generally well tolerated.Conclusions Long-term once-daily budesonide significantly prolonged the time to first SARE and improved asthma control versus placebo plus usual asthma treatment in Chinese patients with recently-diagnosed,mild persistent asthma.