Derom Eric, Brusselle Guy G, Joos Guy F
Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
Int J Chron Obstruct Pulmon Dis. 2016 Dec 13;11:3163-3177. doi: 10.2147/COPD.S92840. eCollection 2016.
Tiotropium-olodaterol, formulated in the Respimat soft-mist inhaler, is an inhaled fixed-dose combination (FDC) of a long-acting muscarinic antagonist (LAMA) and a long-acting β-agonist (LABA), commercialized under the name of Spiolto or Stiolto. The efficacy of tiotropium-olodaterol 5-5 μg once daily in adult patients with COPD was documented in eleven large, multicenter trials of up to 52 weeks duration. Tiotropium-olodaterol 5-5 μg not only improved spirometric values to a significantly greater extent than placebo but also resulted in statistically significant beneficial effects on dyspnea, markers of hyperinflation, use of rescue medication, health-related quality of life, and exercise endurance. Improvements exceeded the minimal clinically important difference (MCID) for forced expiratory volume in 1 second (FEV), dyspnea, and quality of life. Differences between tiotropium-olodaterol 5-5 μg and the respective monocomponents were statistically significant for FEV, dyspnea, markers of hyperinflation, use of rescue medication, and health-related quality of life, but did not reach the MCID. However, dual bronchodilatation significantly increased the number of patients who exceeded the MCID for dyspnea and quality of life. Moreover, tiotropium-olodaterol 5-5 μg was significantly more effective than salmeterol-fluticasone (FDC) twice daily at improving pulmonary function. Differences between tiotropium-olodaterol and other LAMA/LABA FDCs were not observed for FEV or other efficacy markers. Therefore, tiotropium-olodaterol is a valuable option in the treatment of COPD patients who remain symptomatic under monotherapy.
噻托溴铵-奥达特罗采用Respimat软雾吸入器剂型，是一种长效毒蕈碱拮抗剂（LAMA）和长效β受体激动剂（LABA）的吸入性固定剂量复方制剂，商品名为思力华能倍乐或杰润。在11项持续时间长达52周的大型多中心试验中，记录了噻托溴铵-奥达特罗5-5μg每日一次用于慢性阻塞性肺疾病（COPD）成年患者的疗效。噻托溴铵-奥达特罗5-5μg不仅比安慰剂更显著地改善了肺功能测定值，而且在呼吸困难、肺过度充气标志物、急救药物使用、健康相关生活质量和运动耐力方面产生了具有统计学意义的有益效果。改善程度超过了1秒用力呼气容积（FEV₁）、呼吸困难和生活质量的最小临床重要差异（MCID）。噻托溴铵-奥达特罗5-5μg与各自的单一组分在FEV₁、呼吸困难、肺过度充气标志物、急救药物使用和健康相关生活质量方面的差异具有统计学意义，但未达到MCID。然而，双重支气管扩张显著增加了超过呼吸困难和生活质量MCID的患者数量。此外，噻托溴铵-奥达特罗5-5μg在改善肺功能方面比沙美特罗-氟替卡松（固定剂量复方制剂）每日两次显著更有效。在FEV₁或其他疗效标志物方面，未观察到噻托溴铵-奥达特罗与其他LAMA/LABA固定剂量复方制剂之间的差异。因此，对于在单药治疗下仍有症状的COPD患者，噻托溴铵-奥达特罗是一种有价值的治疗选择。
