吸入性类固醇/长效β2受体激动剂联合制剂可使成年哮喘患者的肺功能在24小时内得到改善。
Inhaled steroid/long-acting beta 2 agonist combination products provide 24 hours improvement in lung function in adult asthmatic patients.
作者信息
Lötvall Jan, Langley Stephen, Woodcock Ashley
机构信息
Department of Internal Medicine/Respiratory Medicine and Allergology, Sahlgrenska Academy, Göteborg University, Sweden.
出版信息
Respir Res. 2006 Aug 18;7(1):110. doi: 10.1186/1465-9921-7-110.
BACKGROUND
The combination of inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA) is recommended by treatment guidelines for the treatment of persistent asthma. Two such combination products, salmeterol/fluticasone propionate (SFC, Seretide GSK, UK) and formoterol/budesonide (FBC, Symbicort, AstraZeneca, UK) are commercially available.
OBJECTIVES
The purpose of these studies was to evaluate and compare the duration of bronchodilation of both combination products up to 24 hours after a single dose.
METHODS
Two randomised, double blind, placebo-controlled, crossover studies were performed. Study A was conducted in 33 asthmatic adults receiving 400-1200 mcg of budesonide or equivalent. Serial forced expiratory volume in one second (FEV1) was measured over 24 hours to determine the duration of effect of both SFC (50/100 mcg) and FBC (4.5/160 mcg). Study B was conducted in 75 asthmatic adults receiving 800-1200 mcg of budesonide or equivalent and comprised a 4 week run-in of 400 mcg bd Becotide followed by 4 weeks treatment with either SFC 50/100 mcg bd or FBC 4.5/160 mcg bd taken in a cross-over manner. Serial 24-hour FEV1 was measured after the first dose and the last dose after each 4-weeks treatment period to determine the offset of action of each treatment.
RESULTS
In study A, a single inhalation of SFC and FBC produced a sustained bronchodilation at 16 hours with an adjusted mean increase in FEV1 from pre-dose of 0.22 L (95% CI 0.19, 0.35 L) for SFC and 0.25 L (95% CI 0.21, 0.37 L) for FBC, which was significantly greater than placebo for both treatments (-0.05 L; p < 0.001). In study B, the slope of decline in FEV1 from 2-24 hours post dose was -16.0 ml/hr for SFC and -14.2 ml/hr for FBC. The weighted mean AUC over 24 hours was 0.21 Lxmin and 0.22 Lxmin and mean change from pre-dose FEV1 at 12 hours was 0.21 L for SFC and 0.20 L for FBC respectively
CONCLUSION
Both SFC and FBC produced a similar sustained bronchodilator effect which was prolonged beyond 12 hours post dose and was clearly measurable at 24 h.
背景
吸入性糖皮质激素（ICS）与长效β2受体激动剂（LABA）联合使用是持续性哮喘治疗指南所推荐的治疗方法。两种此类联合产品，沙美特罗/丙酸氟替卡松（SFC，舒利迭，葛兰素史克公司，英国）和福莫特罗/布地奈德（FBC，信必可，阿斯利康公司，英国）已上市销售。
目的
这些研究的目的是评估和比较两种联合产品单次给药后长达24小时的支气管扩张持续时间。
方法
进行了两项随机、双盲、安慰剂对照、交叉研究。研究A纳入了33名接受400 - 1200微克布地奈德或等效药物的成年哮喘患者。在24小时内连续测量一秒用力呼气容积（FEV1），以确定SFC（50/100微克）和FBC（4.5/160微克）两种药物的作用持续时间。研究B纳入了75名接受800 - 1200微克布地奈德或等效药物的成年哮喘患者，包括4周的400微克每日两次必可酮导入期，随后以交叉方式进行4周的SFC 50/100微克每日两次或FBC 4.5/160微克每日两次治疗。在每次4周治疗期的首剂和末剂给药后测量连续24小时的FEV1，以确定每种治疗的作用消退情况。
结果
在研究A中，单次吸入SFC和FBC后，16小时时支气管扩张持续存在，SFC给药前FEV1调整后平均增加0.22升（95%可信区间0.19，0.35升），FBC为0.25升（95%可信区间0.21，0.37升），两种治疗的增加均显著大于安慰剂（-0.05升；p < 0.001）。在研究B中，给药后2 - 24小时FEV1下降斜率SFC为-16.0毫升/小时，FBC为-14.2毫升/小时。24小时加权平均曲线下面积分别为0.21升·分钟和0.22升·分钟，12小时时相对于给药前FEV1的平均变化SFC为0.21升，FBC为0.20升。
结论
SFC和FBC均产生了相似的持续性支气管扩张作用，给药后作用持续超过12小时，在24小时时仍可明显测量到。
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