Department of Pulmonology, Martini Hospital, Groningen, the Netherlands.
Clin Drug Investig. 2010;30(7):439-51. doi: 10.2165/11533420-000000000-00000.
Inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) combinations are the preferred maintenance therapy for adult asthma patients uncontrolled by ICS alone. Supporting data are largely from mixed populations of adolescents and adults, although ICS/LABA combinations are not approved for adolescents in all countries. This analysis evaluates overall asthma control in asthma patients aged >or=16 years receiving ICS/LABA combinations.
This was a post hoc analysis of asthma patients aged >or=16 years in a randomized, double-blind/open-label extension, parallel-group study. Patients received fixed maintenance-dose budesonide/formoterol (Symbicort Turbuhaler), fixed maintenance-dose salmeterol/fluticasone propionate (Seretide/Advair/Adoair Diskus) or adjustable maintenance-dose budesonide/formoterol. Patients used terbutaline or salbutamol for as-needed reliever medication. The primary efficacy variable was the odds of having a well controlled asthma week during the randomized treatment period.
ICS/LABA regimens were well tolerated and efficacious, and the odds for achieving a well controlled asthma week did not differ between groups in this sub-analysis. The number of exacerbations was similar between fixed-dose regimens; however, there were trends toward fewer exacerbations requiring hospitalization/emergency room treatment in the fixed- and adjustable maintenance-dose budesonide/formoterol groups (three and two events, respectively) than in the fixed-dose salmeterol/fluticasone propionate group (eight events). Improvements in forced expiratory volume in 1 second (FEV(1)) were small but significantly greater with fixed-dose budesonide/formoterol versus fixed-dose salmeterol/fluticasone propionate.
This post hoc analysis supports the use of ICS/LABA combinations in adults aged >or=16 years.
对于不能仅用吸入型皮质激素（ICS）控制的成人哮喘患者，ICS/长效β2-激动剂（LABA）联合制剂是首选的维持治疗药物。支持数据主要来自青少年和成人的混合人群，尽管并非所有国家都批准 ICS/LABA 联合制剂用于青少年。该分析评估了接受 ICS/LABA 联合制剂治疗的年龄大于等于 16 岁的哮喘患者的总体哮喘控制情况。
这是一项随机、双盲/开放标签扩展、平行组研究中年龄大于等于 16 岁的哮喘患者的事后分析。患者接受固定维持剂量布地奈德/福莫特罗（Symbicort Turbuhaler）、固定维持剂量沙美特罗/氟替卡松丙酸酯（Seretide/Advair/Adoair Diskus）或可调维持剂量布地奈德/福莫特罗治疗。患者按需使用特布他林或沙丁胺醇作为缓解药物。主要疗效变量是随机治疗期间达到良好控制哮喘周的几率。
ICS/LABA 方案具有良好的耐受性和疗效，在本亚分析中，各组之间达到良好控制哮喘周的几率没有差异。固定剂量方案的哮喘加重次数相似；然而，与固定剂量沙美特罗/氟替卡松丙酸酯组（8 次）相比，固定剂量和可调维持剂量布地奈德/福莫特罗组（分别为 3 次和 2 次）的需要住院/急诊治疗的哮喘加重次数有减少的趋势。第 1 秒用力呼气量（FEV1）的改善虽小，但固定剂量布地奈德/福莫特罗组明显大于固定剂量沙美特罗/氟替卡松丙酸酯组。
这项事后分析支持在年龄大于等于 16 岁的成人中使用 ICS/LABA 联合制剂。
