Nielsen L P, Dahl R
Department of Respiratory Diseases, Aarhus University Hospital, Aarhus, Denmark.
Am J Respir Crit Care Med. 2000 Dec;162(6):2053-7. doi: 10.1164/ajrccm.162.6.9912072.
Inhaled corticosteroids have become the mainstay treatment of bronchial asthma. However, simultaneous evaluations of efficacy and side effects are few. This study aimed to compare the relative effect of fluticasone propionate (FP) and budesonide (BUD) on bronchial responsiveness and endogenous cortisol secretion in adults with asthma. The study was double-blind and included 66 adults with asthma, who were randomized to FP (n = 33) or BUD (n = 33). Prestudy, all participants were clinically stable, using inhaled corticosteroids and hyperresponsive to methacholine. Eligible patients were randomized to three consecutive 2-wk periods with either FP 250 microg twice daily, FP 500 microg twice daily, and FP 1,000 microg twice daily, or BUD 400 microg twice daily, BUD 800 microg twice daily, and BUD 1,600 microg twice daily, delivered by Diskhaler and Turbuhaler, respectively. Before randomization and at the end of each treatment, bronchial methacholine PD(20), 24-h urinary cortisol excretion (24-h UC), plasma cortisol, serum osteocalcin, and blood eosinophils were determined. The relative PD(20) potency between FP and BUD was 2.51 (95% CI, 1.05-5.99; p < 0. 05), while the relative 24-h UC potency was 0.60 (95% CI, 0.44-0.83; p < 0.01). The differential therapeutic ratio (FP/BUD) based on PD(20) potency and 24-h UC was 4.18 (95% CI, 1.16-15.03; p < 0.05). The difference in systemic potency was also seen for plasma cortisol, serum osteocalcin, and blood eosinophils. Therapeutic ratio over a wide dose range, determined by impact on bronchial responsiveness and endogenous corticosteroid production, seems to favor FP.
吸入性糖皮质激素已成为支气管哮喘的主要治疗药物。然而,同时评估其疗效和副作用的研究较少。本研究旨在比较丙酸氟替卡松(FP)和布地奈德(BUD)对成年哮喘患者支气管反应性和内源性皮质醇分泌的相对影响。该研究为双盲研究,纳入了66例成年哮喘患者,随机分为FP组(n = 33)和BUD组(n = 33)。研究前,所有参与者临床病情稳定,使用吸入性糖皮质激素且对乙酰甲胆碱高反应。符合条件的患者随机分为连续3个2周疗程,分别给予每日2次FP 250μg、每日2次FP 500μg、每日2次FP 1000μg,或每日2次BUD 400μg、每日2次BUD 800μg、每日2次BUD 1600μg,分别通过Diskhaler和Turbuhaler吸入装置给药。在随机分组前及每个治疗疗程结束时,测定支气管乙酰甲胆碱PD(20)、24小时尿皮质醇排泄量(24-h UC)、血浆皮质醇、血清骨钙素和血嗜酸性粒细胞。FP和BUD之间的相对PD(20)效价为2.51(95%CI,1.05 - 5.99;p < 0.05),而相对24-h UC效价为0.60(95%CI,0.44 - 0.83;p < 0.01)。基于PD(20)效价和24-h UC的差异治疗比(FP/BUD)为4.18(95%CI,1.16 - 15.03;p < 0.05)。血浆皮质醇、血清骨钙素和血嗜酸性粒细胞在全身效价方面也存在差异。通过对支气管反应性和内源性皮质类固醇产生的影响确定的宽剂量范围内的治疗比似乎有利于FP。