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Drugs. 2015 May;75(7):809-16. doi: 10.1007/s40265-015-0393-y.
Tiotropium bromide (Spiriva®) solution for inhalation via the Respimat® Soft Mist™ inhaler is a long-acting anticholinergic agent approved in the EU for the add-on maintenance treatment of asthma in adults currently receiving maintenance therapy with an inhaled corticosteroid (ICS) (≥800 µg budesonide per day or equivalent) and a long-acting β2-adrenergic agonist (LABA) and who have experienced at least one severe exacerbation in the previous year. Tiotropium Respimat® added to maintenance ICS/LABA treatment significantly improved lung function after 6 months' treatment and extended the time to the first asthma exacerbation in two well-designed, replicate, phase III trials in patients with poorly controlled asthma despite treatment with an ICS (≥800 µg budesonide/day or equivalent) and a LABA. Tiotropium Respimat® was also associated with a reduced incidence of severe asthma exacerbations and an increase in the median time to asthma worsening. The drug was well tolerated in asthma patients throughout 48 weeks' treatment, with a generally similar incidence of serious adverse events in tiotropium Respimat® and placebo treatment groups. Thus, in patients with poorly controlled asthma despite receiving high-dose ICS and a LABA, tiotropium Respimat® provides a valuable treatment option.
噻托溴铵(思力华®)溶液经 Respimat® Soft Mist™吸入器吸入为长效抗胆碱能药物,在欧盟批准用于添加维持治疗成人哮喘,患者当前接受吸入皮质激素(ICS)(每日≥800μg布地奈德或等效剂量)和长效β2-激动剂(LABA)维持治疗,且在过去一年中经历至少一次严重加重。噻托溴铵 Respimat®添加至 ICS/LABA 维持治疗显著改善肺功能,在两项设计良好、复制的 III 期试验中,患者尽管接受 ICS(每日≥800μg布地奈德或等效剂量)和 LABA 治疗但哮喘控制不佳,治疗 6 个月后改善,且首次哮喘加重时间延长。噻托溴铵 Respimat®还降低严重哮喘加重发生率,增加哮喘恶化的中位时间。在 48 周治疗期间,哮喘患者对药物耐受良好,噻托溴铵 Respimat®和安慰剂治疗组严重不良事件发生率相似。因此,在接受高剂量 ICS 和 LABA 治疗但哮喘控制不佳的患者中,噻托溴铵 Respimat®提供了一种有价值的治疗选择。