文摘
婴儿和学龄前儿童的最佳剂量的氟替卡松加沙美特罗尚不清楚。本研究的目的是评估的bronchoprotective效果不同剂量氟替卡松加沙美特罗使用methacholine-induced喘息儿童年龄< 4岁。4岁以下儿童反复喘息的历史经历了两个7天内乙酰甲胆碱的挑战。前一个小时每个挑战他们进行预处理以双盲的方式使用metered-dose吸入器和Babyhaler垫片。安慰剂是一个挑战之前,和25、50或100 microg氟替卡松加沙美特罗之前。剂量和治疗的顺序都是随机的。醋甲胆碱引起喘息的挑衅浓度(PCwheeze)是测量每一次。研究终止当发生喘息或动脉氧饱和度(Sa, o2)跌至91%以下。42岁的孩子入学,33岁完成了研究。两人拒绝挑战测试,两次失败的返回和五个发达上呼吸道感染或两次测试之间的喘息。 The mean (range) age of the population was 27 (8-46) months. Ratios of PCwheeze between treatment and placebo challenges were calculated for each dosage group. The treatment/placebo ratios (95% confidence intervals) were 1.2 (0.6-2.4) for 25 microg, 2.5 (1.4-4.6) for 50 microg (p<0.01), and 4.0 (2.1-7.4) (p<0.001) for 100 microg doses. In recurrently wheezy children aged <4 yrs a single dose of salmeterol between 25 and 100 microg has a dose-dependent effect on methacholine-induced wheeze, and this is significantly different from placebo at 50 and 100 microg. This study suggests that the Babyhaler effectively delivers salmeterol to children <4 yrs of age and that doses between 50-100 microg are efficacious.