Novembre E, Frongia G F, Veneruso G, Vierucci A
Department of Pediatrics, Ospedale A. Meyer, Florence, Italy.
Pediatr Allergy Immunol. 1994 May;5(2):107-10. doi: 10.1111/j.1399-3038.1994.tb00226.x.
Nedocromil sodium (Ned) 4 mg, sodium cromoglycate (SCG) 10 mg, and placebo were compared for their efficacy in preventing exercise-induced asthma. Nineteen asthmatic children aged six to 15 years performed a treadmill exercise test before and 20' after a single dose of drug in a double-blind trial. Both active drugs performed significantly better than placebo; in fact the exercise challenge resulted in a mean maximum fall in FEV1 of 26.1 +/- 14.9% after placebo, but only of 14.6 +/- 11.5% after SCG (P < 0.05), and 11.0 +/- 12.4% after Ned (p < 0.01). Measurements of PEFR gave similar results, while the effect of treatment on FEF 25-75 was significant for Ned alone (p < 0.05). Direct comparison between Ned and SCG at different time points demonstrated significant differences in FEV1 at 1 min (p < 0.05) with a better overall performance of Ned. In individual patients, complete protection was provided in 9 patients with SCG, in 14 patients with Ned and in 2 with placebo. No side effects were observed. This study suggests that at the dosages used there are only slight differences between SCG and Ned activity in the prevention of exercise-induced asthma.
比较了奈多罗米钠(Ned)4毫克、色甘酸钠(SCG)10毫克和安慰剂预防运动诱发性哮喘的疗效。在一项双盲试验中,19名6至15岁的哮喘儿童在单剂量药物服用前和服用后20分钟进行了跑步机运动试验。两种活性药物的表现均显著优于安慰剂;事实上,运动激发试验后,安慰剂组FEV1平均最大下降26.1±14.9%,而SCG组仅为14.6±11.5%(P<0.05),Ned组为11.0±12.4%(P<0.01)。呼气峰流速(PEFR)测量结果相似,而治疗对FEF 25-75的影响仅对Ned有显著意义(P<0.05)。Ned和SCG在不同时间点的直接比较显示,1分钟时FEV1存在显著差异(P<0.05),Ned的总体表现更好。在个体患者中,SCG使9名患者得到完全保护,Ned使14名患者得到完全保护,安慰剂使2名患者得到完全保护。未观察到副作用。该研究表明,在所使用的剂量下,SCG和Ned在预防运动诱发性哮喘方面的活性仅有轻微差异。