阿福莫特罗和沙美特罗治疗慢性阻塞性肺疾病:一年的安全性和耐受性评价
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Donohue JF, Hanania NA, Sciarappa KA, Goodwin E, Grogan DR, Baumgartner RA, Hanrahan JP
阿福莫特罗和沙美特罗治疗慢性阻塞性肺疾病:一年的安全性和耐受性评价
中华医学杂志2008年4月号;2(2):37-48。doi: 10.1177 / 1753465808089455。
- PubMed ID
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19124357 (在PubMed］
- 摘要
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引言:长期使用长效β 2受体激动剂(LABAs)的安全性已引起关注。对arformoterol(50微克每日一次)和沙美特罗(42微克BID)的安全性进行了超过12个月的COPD受试者评估。该研究还检查了这些药物耐受性的发生情况，即使用12个月后，气道功能改善是否减弱或加重频率是否增加。方法:纳入COPD患者(平均FEV1 1.2 L，预测~41%)，随机接受雾化吸入阿福莫特罗50微克QD (n = 528)或沙美特罗42微克BID (MDI;N = 265)，这是一项前瞻性、多中心、开放标签、12个月的试验。在整个研究期间，我们评估了不良事件、COPD加重和短效支气管扩张剂的使用频率。同时检查肺功能。结果:在接受治疗的受试者中，服用阿福莫特罗(90.5%)和沙美特罗(88.3%)的不良事件发生率相似。震颤在arformoterol治疗组(13.4%)比沙美特罗治疗组(1.1%)更常见。arformoterol和沙美特罗在12个月内COPD加重的频率没有增加(0-13周:分别为15.7%和11.7%; weeks 39-52: 10.0% and 9.4%, respectively). Supplemental ipratropium bromide and rescue racemic albuterol use decreased for both groups by 0.8 to 1.5 actuations/day, decreases that remained stable throughout the 52-week study. Mean predose (trough) FEV1 improved for arformoterol and salmeterol at week 13 (7.1% +/- 17.0 and 7.6% +/- 17.8, respectively) and the improvement continued at week 52 (5.9% and 6.2%, respectively). Mean peak percent predicted postdose FEV1 over the course of the 52-week study declined by about 2% for both treatments, but throughout was higher for arformoterol than for salmeterol. CONCLUSION: In this trial, both arformoterol 50 microg QD and salmeterol 42 microg BID were well tolerated in patients with COPD. Both LABAs produced effective bronchodilation and their use was not associated with the development of clinically meaningful tolerance over a 1-year treatment period.
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