Masoli M, Weatherall M, Holt S, Beasley R
Medical Research Institute of New Zealand, P O Box 10055, Wellington, New Zealand.
Thorax. 2005 Sep;60(9):730-4. doi: 10.1136/thx.2004.039180.
There is uncertainty as to the dose of inhaled corticosteroids (ICS) at which to start concomitant long acting beta agonist (LABA) treatment in patients with asthma not adequately controlled by ICS alone.
A meta-analysis was carried out of randomised, double blind clinical trials that compared the efficacy of adding salmeterol to moderate doses of ICS (fluticasone propionate 200 mug/day or equivalent) with increasing the ICS dose by at least twofold in symptomatic adult patients with asthma. The main outcome measures were the number of subjects withdrawn from the study due to asthma and the number of subjects with at least one moderate or severe exacerbation.
Twelve studies with a total of 4576 subjects met the inclusion criteria for the analyses. The number of subjects withdrawn due to asthma and with at least one moderate or severe exacerbation was higher in the high dose ICS group (odds ratios 1.58, 95% CI 1.12 to 2.24 and 1.35, 95% CI 1.10 to 1.66, respectively). For the secondary outcome variables (forced expiratory volume in 1 second, morning and evening peak expiratory flow, and daytime beta agonist use) there was significantly greater benefit in the salmeterol group.
This meta-analysis shows that the addition of salmeterol to moderate doses of ICS (fluticasone 200 mug/day or equivalent) in patients with asthma symptomatic at that dose results in significantly greater clinical benefit than increasing the dose of ICS by twofold or more.
对于仅使用吸入性糖皮质激素(ICS)无法充分控制病情的哮喘患者,开始联合长效β受体激动剂(LABA)治疗时ICS的起始剂量尚不确定。
对随机双盲临床试验进行荟萃分析,比较在有症状的成年哮喘患者中,将沙美特罗添加到中等剂量ICS(丙酸氟替卡松200μg/天或等效剂量)与将ICS剂量至少增加两倍的疗效。主要结局指标是因哮喘退出研究的受试者数量以及至少有一次中度或重度加重的受试者数量。
共有4576名受试者的12项研究符合分析的纳入标准。高剂量ICS组中因哮喘退出以及至少有一次中度或重度加重的受试者数量更高(优势比分别为1.58,95%置信区间1.12至2.24和1.35,95%置信区间1.10至1.66)。对于次要结局变量(1秒用力呼气量、早晚呼气峰值流速和日间β受体激动剂使用情况),沙美特罗组有显著更大的益处。
这项荟萃分析表明,对于在该剂量下有症状的哮喘患者,在中等剂量ICS(氟替卡松200μg/天或等效剂量)中添加沙美特罗比将ICS剂量增加两倍或更多可带来显著更大的临床益处。