Galant S P, Lawrence M, Meltzer E O, Tomasko M, Baker K A, Kellerman D J
Adult and Pediatric Allergy and Clinical Immunology, Orange, California, USA.
Ann Allergy Asthma Immunol. 1996 Aug;77(2):112-8. doi: 10.1016/S1081-1206(10)63496-5.
The inhaled corticosteroid, fluticasone propionate, was compared with the oral bronchodilator theophylline in the maintenance treatment of asthma.
The objective of the present study was to compare the efficacy and safety of twice-daily inhaled fluticasone propionate, 50 micrograms, and fluticasone propionate, 100 micrograms, with that of theophylline in the maintenance treatment of mild-to-moderate asthma.
In this randomized, double-blind, placebo-controlled, parallel-group study, 353 adult and adolescent patients with asthma inadequately controlled with inhaled beta-agonist therapy alone received fluticasone propionate, 50 micrograms, or fluticasone propionate, 100 micrograms, by metered-dose inhaler; theophylline capsules; or placebo twice daily for 12 weeks. Only inhaled albuterol was permitted as needed for acute symptoms.
Both fluticasone propionate groups had a significantly greater probability of remaining in the study (ie, meeting asthma stability criteria) than did either the theophylline or placebo group (P < or = .008); 39% and 51% in the theophylline and placebo groups, respectively, were withdrawn due to lack of treatment efficacy compared with 14% and 21% in the fluticasone propionate, 50 micrograms, and fluticasone propionate, 100 micrograms, groups. Both fluticasone propionate groups experienced significantly greater improvement in FEV1 and PEF compared with patients in the theophylline or placebo group (P < or = .004). The incidence of potentially drug-related adverse events was significantly greater in the theophylline group (25%) than in the placebo group (11%) (P = .031), while there were no differences between placebo and fluticasone propionate, 50 micrograms, (18%) or fluticasone propionate 100 micrograms, (22%).
Twice daily treatment with inhaled fluticasone propionate 50 micrograms or 100 micrograms was significantly more effective than theophylline in the treatment of mild-to-moderate asthma.
在哮喘维持治疗中，对吸入性皮质类固醇丙酸氟替卡松与口服支气管扩张剂茶碱进行了比较。
本研究的目的是比较每日两次吸入50微克丙酸氟替卡松、100微克丙酸氟替卡松与茶碱在轻度至中度哮喘维持治疗中的疗效和安全性。
在这项随机、双盲、安慰剂对照、平行组研究中，353例仅通过吸入β-激动剂治疗控制不佳的成年和青少年哮喘患者，通过定量吸入器接受50微克丙酸氟替卡松或100微克丙酸氟替卡松治疗；茶碱胶囊；或安慰剂，每日两次，共12周。仅在出现急性症状时按需使用吸入沙丁胺醇。
与茶碱组或安慰剂组相比，两个丙酸氟替卡松组留在研究中的可能性（即符合哮喘稳定标准）显著更高（P≤0.008）；茶碱组和安慰剂组分别有39%和51%因治疗无效而退出，而50微克丙酸氟替卡松组和100微克丙酸氟替卡松组分别为14%和21%。与茶碱组或安慰剂组患者相比，两个丙酸氟替卡松组的第一秒用力呼气容积（FEV1）和呼气峰值流速（PEF）均有显著更大改善（P≤0.004）。茶碱组潜在药物相关不良事件的发生率（25%）显著高于安慰剂组（11%）（P = 0.031），而安慰剂与50微克丙酸氟替卡松组（18%）或100微克丙酸氟替卡松组（22%）之间无差异。
每日两次吸入50微克或100微克丙酸氟替卡松治疗轻度至中度哮喘的效果显著优于茶碱。
