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用长效支气管扩展剂治疗中度至重度慢性阻塞性肺病中的罗夫卢米拉斯:两项随机临床试验
Leonardo M Fabbri1, Peter M A Calverley, José Luis Izquierdo-Alonso
1University of Modena and Reggio Emilia, Modena, Italy.
Lancet (London, England)
|September 1, 2009
概括
在已经使用沙米特醇或提奥的中度至重度慢性阻塞性肺病 (COPD) 患者中,罗夫卢米拉斯特显著改善了肺功能. 这种固-4抑制剂为COPD管理提供了新的治疗选择.
科学领域:
- 肺部病理学 肺部病理学
- 药理学 药理学是指药理学的学科.
背景情况:
- 慢性阻塞性肺病 (COPD) 对患者的治疗途径有限.
- 作为固-4抑制剂的罗夫米拉斯的疗效和安全性已在中度至重度的慢性肺炎患者中进行研究,但未在同时使用长效吸入支气管扩展剂的患者中进行研究.
- 这项研究研究了罗米拉斯特对COPD患者肺功能的影响,这些患者已经接受了沙米特醇或.
研究的目的:
- 为了评估罗夫卢米拉斯特对中度至重度慢性肺炎患者肺功能的影响,这些患者同时接受沙米特醇或的治疗.
- 为了评估添加roflumilast到现有的支气管扩展剂治疗的安全性和有效性.
主要方法:
- 进行了两项双盲,多中心,门诊研究 (M2-127用沙米特醇,M2-128用铁).
- 患有中度至重度COPD的患者每天服用500微克或安慰剂的口服罗夫卢米拉斯特,持续24周,此外还需要服用处方沙米特醇或提奥.
- 主要终点是1秒内预支气管扩展剂强迫呼气体积的变化 (FEV1).
主要成果:
- 与安慰剂相比,罗夫米拉斯在沙米特醇组 (p<0.0001) 和80mL的tiotropium组 (p<0.0001) 中显著改善了预支气管扩展剂FEV1的平均值49mL.
- 在经 bronchodilator FEV1 和其他肺功能测量中也观察到类似的改善.
- 恶心,腹和体重减轻等不良事件在罗米拉斯特治疗中更频繁,导致患者戒断增加.
结论:
- 罗夫米拉斯特在用沙米特醇或提奥治疗的COPD患者的肺功能改善方面表现出有效性.
- 罗夫米拉斯特代表了一种潜在的新疗法选择,用于在现有支气管扩展剂治疗的患者中管理中度至重度的COPD.
- 可能需要进一步的研究来优化其使用和管理相关的不良事件.
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