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Drugs. 2016 Jan;76(1):135-46. doi: 10.1007/s40265-015-0527-2.
Tiotropium/olodaterol (Stiolto™ Respimat®, Spiolto™ Respimat®) is a fixed-dose combination of the long-acting antimuscarinic agent tiotropium bromide (hereafter referred to as tiotropium) and the long-acting β2-adrenoreceptor agonist olodaterol delivered via the Respimat® Soft Mist™ inhaler. It is indicated for the maintenance treatment of airflow obstruction in adults with COPD. Several randomized, phase III studies of 6-52 weeks' duration evaluated the efficacy of once-daily tiotropium/olodaterol in patients with GOLD stage 2-3 or 2-4 COPD. Tiotropium/olodaterol maintenance therapy improved lung function to a greater extent than the individual components or placebo and provided clinically meaningful improvements in health-related quality of life and dyspnoea in 12- and 52-week studies. Tiotropium/olodaterol consistently improved 24-h lung function in 6-week studies, providing greater benefits than the monotherapies, placebo or twice-daily fixed-dose fluticasone propionate/salmeterol. Inspiratory capacity and exercise endurance were also improved with tiotropium/olodaterol following 6 or 12 weeks' treatment. The tolerability profile of tiotropium/olodaterol in the phase III studies was generally similar to that of the component monotherapies. The most common adverse events and serious adverse events during 52 weeks' therapy were respiratory in nature, with COPD exacerbation, unsurprisingly, reported most frequently with tiotropium/olodaterol and component monotherapies. Although additional data assessing the effect of tiotropium/olodaterol on exacerbations and comparative studies with other recommended therapies are needed to definitively position tiotropium/olodaterol, current evidence indicates that tiotropium/olodaterol is a useful treatment option for patients with COPD.
噻托溴铵/奥达特罗（思力华® Respimat®，全再乐® Respimat®）是长效抗毒蕈碱药物噻托溴铵（以下简称噻托溴铵）与长效β2-肾上腺素能受体激动剂奥达特罗以固定剂量组合，通过 Respimat® Soft Mist™吸入器给药。该药用于治疗慢性阻塞性肺疾病（COPD）成人患者的气流阻塞维持治疗。几项为期 6-52 周的随机、III 期研究评估了噻托溴铵/奥达特罗每日一次治疗 GOLD 2-3 期或 2-4 期 COPD 患者的疗效。噻托溴铵/奥达特罗维持治疗在 12 周和 52 周研究中较单一成分或安慰剂更显著改善肺功能，且在健康相关生活质量和呼吸困难方面有临床意义的改善。噻托溴铵/奥达特罗在 6 周研究中持续改善 24 小时肺功能，提供的益处大于单药治疗、安慰剂或每日两次固定剂量丙酸氟替卡松/沙美特罗。噻托溴铵/奥达特罗治疗 6 或 12 周后也改善吸气量和运动耐力。III 期研究中噻托溴铵/奥达特罗的耐受性概况通常与单一成分治疗相似。52 周治疗期间最常见的不良事件和严重不良事件为呼吸系统，COPD 加重也在意料之中，噻托溴铵/奥达特罗和各单一成分治疗报告最多。尽管需要更多评估噻托溴铵/奥达特罗对加重事件的影响以及与其他推荐疗法的对比研究来明确定位噻托溴铵/奥达特罗，但目前的证据表明，噻托溴铵/奥达特罗是 COPD 患者的一种有用治疗选择。
