Busse W W, Middleton E, Storms W, Dockhorn R J, Chu T J, Grossman J, Weiler J M, Bronsky E A, Mansfield L E, Bell T D, Hemsworth G R, Perhach J L, D'Eletto T A, Dam A
Department of Medicine, University of Wisconsin, Madison 53792, USA.
Am J Respir Crit Care Med. 1996 Jan;153(1):122-7. doi: 10.1164/ajrccm.153.1.8542104.
The objective of this double-blind trial was to evaluate the corticosteroid-sparing effect of azelastine in patients with chronic bronchial asthma. A total of 193 subjects received either 6 mg of azelastine twice per day or placebo (in a 2:1 ratio) in combination with beclomethasone dipropionate (6 to 16 inhalations per day). The number of daily inhalations of the corticosteroid was reduced until maximum reduction or elimination was achieved. Patients then entered a 12-wk maintenance period, during which patients were maintained on their lowest possible dose of inhaled corticosteroid. Compared with placebo, the azelastine group had a statistically significantly greater overall median reduction in inhaled corticosteroids (4.9 puffs/day for azelastine versus 3.1 puffs/day for placebo; p < or = 0.010) during the maintenance period. The azelastine group also had a statistically significantly higher percentage of patients with reductions of > or = 50% and > or = 75% from the baseline level (53 and 31%, respectively, for azelastine versus 34 and 14%, respectively, for placebo; p < or = 0.028). The results demonstrated that azelastine, 6 mg twice per day, can reduce the need for inhaled corticosteroids in patients with chronic bronchial asthma and not lead to a deterioration in pulmonary function.
这项双盲试验的目的是评估氮卓斯汀对慢性支气管哮喘患者的糖皮质激素节省效应。共有193名受试者接受每日两次6毫克氮卓斯汀或安慰剂（比例为2:1），并联合丙酸倍氯米松（每日6至16喷）治疗。糖皮质激素的每日喷数逐渐减少，直至达到最大减少量或完全停用。然后患者进入为期12周的维持期，在此期间患者维持使用尽可能低剂量的吸入性糖皮质激素。与安慰剂组相比，在维持期，氮卓斯汀组吸入性糖皮质激素的总体中位数减少量在统计学上显著更大（氮卓斯汀组为每日4.9喷，安慰剂组为每日3.1喷；p≤0.010）。氮卓斯汀组中吸入性糖皮质激素较基线水平减少≥50%和≥75%的患者百分比在统计学上也显著更高（氮卓斯汀组分别为53%和31%，安慰剂组分别为34%和14%；p≤0.028）。结果表明，每日两次6毫克的氮卓斯汀可减少慢性支气管哮喘患者对吸入性糖皮质激素的需求，且不会导致肺功能恶化。
