噻托溴铵治疗哮喘时低于慢性阻塞性肺疾病治疗量
2016/02/23
摘要
虽然抗胆碱药物广泛应用于治疗慢性阻塞性肺疾病(COPD)且对治疗哮喘有潜在作用,但是他们并不是哮喘治疗的规范用药。已发表的研究(主要是短期和以异丙托溴铵与噻托溴铵为主用药的研究)呈现不同的功效。因此,吸入性抗胆碱药在哮喘治疗中的作用并不明确。本评论讨论和评论来自勃林格殷格翰提交给美国食品药品监督管理局的5个成人临床实验数据,以支持噻托溴铵通过吸入装置(思力华能倍乐)治疗哮喘。这些试验为允许噻托溴铵治疗哮喘提供了大量证据支持,推荐剂量为每天2.5ug。值得指出的是,在评估两种剂量2.5ug和5ug(COPD允许使用剂量)噻托溴铵对肺功能影响的试验中,每天2.5ug的思力华能倍乐整体治疗效果优于每天5ug的剂量,因此治疗哮喘时应选用低剂量。思力华能倍乐的批准使用意味着十多年来第一个治疗哮喘的新类药的诞生。思力华能倍乐以及其他正在研究的治疗哮喘的新方法有可能影响哮喘治疗指南。
(苏欣 审校)
Ann Am Thorac Soc. 2015 Dec 9. [Epub ahead of print]
Tiotropium Respimat is Effective for the Treatment of Asthma at a Dose Lower Than That for Chronic Obstructive Pulmonary Disease.
Chin SJ1, Durmowicz AG2, Chowdhury BA3.
Abstract
Anticholinergic drug products are not part of the current treatment paradigm for asthma, despite their widespread availability for chronic obstructive pulmonary disease (COPD) and interest in their use for asthma. Published study results, mostly of short duration and primarily with ipratropium and tiotropium, have revealed inconsistent efficacy results. Consequently, the role of inhaled anticholinergics in the treatment of asthma has been unclear. This commentary discusses and comments on data from five clinical trials in adults that were submitted by Boehringer Ingelheim to the US Food and Drug Administration to support approval of tiotropium delivered by the Respimat device (Spiriva Respimat) for the treatment of asthma. These trials provided substantial evidence that supported the approval of Spiriva Respimat at a recommended dose of 2.5 µg once daily for asthma. Notably, in trials which evaluated two doses of tiotropium, 2.5 µg and 5 µg (the dose approved for COPD), pulmonary function measures for Spiriva Respimat 2.5 µg once daily were better overall than those obtained for the 5 µg once daily dose, thus justifying selection of the lower dose for asthma. The approval of Spiriva Respimat signifies the first new class of drug approved for asthma in over a decade. The availability of Spiriva Respimat for asthma along with other novel therapies currently under development has the potential to impact asthma treatment guidelines.
Ann Am Thorac Soc. 2015 Dec 9. [Epub ahead of print]
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糠酸氟替卡松(FF)/维兰特罗(100/25 mcg或200/25mcg)或FF(100 mcg)在持续性哮喘中的效果比
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罗氟司特治疗哮喘的安全性数据:十项临床研究的汇总分析