Serious asthma exacerbations in asthmatics treated with high-dose formoterol
Serious asthma exacerbations in asthmatics treated with high-dose formoterol
复制标题
DOI：
10.1378/chest.124.1.70
复制
发表时间：
2003-07-01
期刊：
影响因子：
9.6
通讯作者：
Meyer, RJ
中科院分区：
文献类型：
--
作者：
Mann, M;Chowdhury, B;Meyer, RJ
目的：回顾福莫特罗(Foradil Aerolizer；，Novartis PharmPharmticals，瑞士巴塞尔)治疗哮喘患者的3项前瞻性、随机、安慰剂对照、双盲临床研究。资料来源：提交给美国食品和药物管理局(FDA)的临床研究，支持福莫特罗在美国上市。结果：定期服用福莫特罗24杯的患者比服用安慰剂的患者有更多的严重哮喘加重。在第一项研究中，接受福莫特罗治疗的135名成年患者中有4名(3%)出现了严重的哮喘恶化，而服用安慰剂的136名患者中没有一名出现严重的哮喘恶化。在第二项研究中，服用福莫特罗的136名患者中有5名(3.7%)出现了严重的哮喘加重，与之相比，服用安慰剂的141名患者中有2名(1.4%)。在第三项研究中，171名接受福莫特罗治疗的儿童患者(6.4%)发生了严重的哮喘加重，与176名接受安慰剂治疗的儿童患者相比，I I组发生了严重的哮喘加重。结论：经常使用大剂量吸入福莫特罗(24杯，2次)可能与更频繁的严重哮喘加重有关。
Objective: To review three prospective, randomized, placebo-controlled, double-blind clinical studies of formoterol (Foradil Aerolizer;, Novartis Pharmaceuticals; Basel, Switzerland) at dosages of 12 mug and 24 mug bid for the treatment of patients with asthma.Data sources: Clinical studies submitted to the US Food and Drug Administration in support of the approval of Foradil Aerolizer for marketing in the United States.Results: More patients treated regularly with formoterol, 24 mug bid, had a serious asthma exacerbation than did patients who had been treated with placebo. In the first study, 4 of 135 adult patients (3%) who had been treated with formoterol, 24 mug bid, had a serious asthma exacerbation compared to none of 136 placebo-treated patients. In the second study, 5 of 136 patients (3.7%) treated with formoterol, 24 mug bid, had a serious asthma exacerbation compared to 2 of 141 placebo-treated patients (1.4%). In the third study, I I of 171 pediatric patients (6.4%) treated with formoterol, 24 mug bid, had a serious asthma exacerbation compared to none of 176 placebo-treated patients.Conclusion: Regular use of high-dose inhaled formoterol (24 mug bid) may be associated with more frequent serious asthma exacerbations.