Bisgaard Hans, Le Roux Pascal, Bjåmer Ditlef, Dymek Andrzej, Vermeulen Jan H, Hultquist Christer
Danish Pediatric Asthma Center, Department of Pediatrics, Copenhagen University Hospital, Gentofte, DK-2900 Copenhagen, Denmark.
Chest. 2006 Dec;130(6):1733-43. doi: 10.1378/chest.130.6.1733.
A fixed combination of long-acting beta(2)-agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations vs ICS alone in children. This 12-month, double-blind, randomized study in 341 children (age range, 4 to 11 years) with asthma uncontrolled on ICS investigated whether a novel regimen using budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy [SMART]) [Symbicort; AstraZeneca R&D, Lund, Sweden] could reduce exacerbations.
Patients received SMART (budesonide/formoterol 80/4.5 microg qd maintenance plus additional inhalations for symptom relief), budesonide/formoterol 80/4.5 microg qd for maintenance (fixed combination), or higher-dose budesonide 320 microg qd (fixed-dose budesonide). Blinded as-needed medication (terbutaline 0.4 microg) was provided in both fixed-dose groups.
SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p = 0.02) and fixed-dose combination (p < 0.001). Rates of exacerbation requiring medical intervention were reduced by 70 to 79% with SMART vs fixed-dose budesonide and fixed-dose combination (0.08/patient vs 0.28/patient and 0.40/patient, respectively; both p < 0.001). Mild exacerbation days and awakenings were significantly lower with SMART; yearly growth improved by 1.0 cm vs fixed-dose budesonide (p < 0.01).
The SMART regimen using budesonide/formoterol for both maintenance and as-needed symptom relief reduces the exacerbation rate compared with both fixed-dose combination and higher fixed-dose ICS alone in children with asthma.
在儿童中，长效β2受体激动剂（LABA）与吸入性糖皮质激素（ICS）的固定组合从未被证明相较于单独使用ICS能减少哮喘发作。这项针对341名4至11岁使用ICS但哮喘控制不佳的儿童进行的为期12个月的双盲随机研究，调查了一种使用布地奈德/福莫特罗进行维持和缓解治疗的新方案（信必可维持和缓解治疗[SMART]）[信必可；阿斯利康研发公司，瑞典隆德]是否能减少发作次数。
患者接受SMART方案（布地奈德/福莫特罗80/4.5微克每日一次维持治疗加额外吸入以缓解症状）、布地奈德/福莫特罗80/4.5微克每日一次用于维持治疗（固定组合）或更高剂量的布地奈德320微克每日一次（固定剂量布地奈德）。两个固定剂量组均提供盲法按需使用药物（特布他林0.4微克）。
与固定剂量布地奈德（p = 0.02）和固定剂量组合（p < 0.001）相比，SMART方案延长了首次发作的时间。与固定剂量布地奈德和固定剂量组合相比，SMART方案使需要医疗干预的发作率降低了70%至79%（分别为0.08/患者、0.28/患者和0.40/患者；p均< 0.001）。SMART方案组的轻度发作天数和觉醒次数显著更低；与固定剂量布地奈德相比，年生长量提高了1.0厘米（p < 0.01）。
在哮喘儿童中，使用布地奈德/福莫特罗进行维持治疗和按需缓解症状的SMART方案与固定剂量组合及单独使用更高固定剂量ICS相比，可降低发作率。
