哮喘联盟

   摘要
   背景：布地奈德已经获批包括雾化溶液和干粉吸入两种剂行给药，但是其通过压力定量吸入器(pMDI)给药用于哮喘儿科患者的使用尚不明确。
   目的：对6岁到12岁以下的哮喘患儿通过压力定量吸入器给予布地奈德160μg每日两次与安慰剂相比疗效和安全性情况以及证实哮喘患儿吸入性糖皮质激素的必要性。
   方法：一项为期6周的全球、多中心、双盲、平行2期研究，随机入组了304例儿科患者（平均年龄9岁；21.7%<8岁），经过7到21天的导入期后以1：1的比例分为两组，一组通过压力定量吸入器给予160μg布地奈德 (80 μg × 2吸入)每日两次，另一组为安慰剂组。主要研究终点为清晨呼气流量峰值(PEF) 较基线变化；安全性终点包括不良事件，生命体征以及中止用药情况。
   结果：与安慰剂相比，布地奈德治疗能显著改善清晨PEF ，平均治疗结果（布地奈德vs安慰剂）为13.6 升/分 (P < .0001)。与安慰剂相比，布地奈德能显著改善以下情况，包括第一秒用力呼气量、夜间PEF、用力呼出肺活量25%-75%的流量、缓解药物的使用、夜间觉醒、使用急救药物的觉醒以及与基线相比清晨PEF至少增加15-30L/分的患者比例。与安慰剂组相比，布地奈德组出现不良事件或者停药患者数量更少。并无严重的不良事件报道。
   结论：通过压力定量吸入器给予布地奈德160μg每日两次，总体上耐受性良好，并且与安慰剂组相比可以显著改善6岁到12岁哮喘患儿的肺功能、症状，急救药物使用以及夜间觉醒情况，并且该研究证实了使用吸入性糖皮质激素的必要性。
 

（杨冬 审校）
AnnAllergyAsthmaImmunol. 2015Oct9.pii:S1081-1206(15)00593-1.doi:10.1016/j.anai.2015.09.007. [Epub ahead of print]
 

Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma.
 

Meltzer EO1, Pearlman DS2, Eckerwall G3, Uryniak T4, DePietro M5, Lampl K4.
 

Abstract
BACKGROUND:Budesonide is approved for delivery using a nebulized solution and dry-powder inhaler, but its use through a pressurized metered-dose inhaler (pMDI) in pediatric patients with asthma has not been determined.
OBJECTIVE:To examine the efficacy and safety of 160 μg twice daily of budesonide through a pMDI vs placebo in children 6 to younger than 12 years with asthma and a demonstrated need for inhaled corticosteroids.
METHODS:A 6-week, international, multicenter, double-blinded, parallel-group, phase 2 study randomized 304 pediatric patients (mean age, 9 years; 21.7% <8 years) 1:1 to 160 μg (80 μg × 2 inhalations) twice daily of budesonide through a pMDI or placebo after a 7- to 21-day run-in period. The primary efficacy end point was change from baseline in morning peak expiratory flow (PEF); safety end points included adverse events, vital signs, and discontinuations.
RESULTS:Budesonide treatment significantly improved morning PEF vs placebo; mean treatment effect (budesonide vs placebo) was 13.6 L/min (P < .0001). Budesonide also showed significant improvements vs placebo for forced expiratory volume in 1 second, evening PEF, forced expiratory flow at 25% to 75% of pulmonary volume, reliever medication use, nighttime awakenings, awakenings with reliever use, and percentage of patients with at least 15- and at least 30-L/min increase in morning PEF from baseline. The numbers of patients experiencing adverse events and discontinuations were smaller in the budesonide than in the placebo group. No serious adverse events were reported.
CONCLUSION:Budesonide at 160 μg twice daily through a pMDI was generally well tolerated and significantly improved lung function, symptoms, rescue medication use, and nighttime awakenings vs placebo in children 6 to younger than 12 years with asthma and a demonstrated need for inhaled corticosteroids.
 

AnnAllergyAsthmaImmunol. 2015Oct9.pii:S1081-1206(15)00593-1.doi:10.1016/j.anai.2015.09.007. [Epub ahead of print]