Pizzichini Marcia M M, Kerstjens Huib A M, Pizzichini Emilio
Pol Arch Med Wewn. 2015;125(11):859-66. doi: 10.20452/pamw.3168. Epub 2015 Oct 30.
Anticholinergic bronchodilators such as tiotropium, a potent long-acting drug, are central to the symptomatic treatment of chronic obstructive pulmonary disease. Its role in asthma treatment has been recently investigated. This review critically evaluates documented evidence of clinical trials and assesses the therapeutic implications of anticholinergic drugs in asthma management. So far, the results of 10 Phases II and III randomized controlled trials evaluating the effect of adding tiotropium to the treatment of mild-to-moderate or severe asthma have been published. These trials had a duration of 4 to 52 weeks and involved 3368 subjects with mild-to-moderate asthma and 1019 subjects with severe asthma [corrected]. Also, 1 systematic review and 6 meta-analyses have appraised the results of published and unpublished trials investigating the role of tiotropium in asthma. The results of the trials in mild to moderate asthma showed that adding tiotropium to inhaled corticosteroids (ICSs) was not inferior to adding long-acting β2-agonists (LABAs). In addition, the safety and efficacy of tiotropium were similar to those of salmeterol. The results of studies on severe asthma showed that adding tiotropium to a treatment with high doses of an ICS plus LABA results in further improvement in lung function, increases the time to the first severe exacerbation of asthma and to worsening of asthma, and improves asthma control. Except for dry mouth, the safety profile of tiotropium was similar to placebo both in moderate and in severe asthma. Adding tiotropium to an ICS or ICS plus LABA improves lung function, symptoms, and asthma control, and in severe asthma, it increases the time to exacerbations, with good safety profile. The effect seems independent of baseline characteristics such as age, level of bronchial obstruction, smoking status, allergic status, and bronchial reversibility.
抗胆碱能支气管扩张剂，如噻托溴铵这种强效长效药物，是慢性阻塞性肺疾病症状治疗的核心药物。其在哮喘治疗中的作用最近得到了研究。本综述批判性地评估了临床试验的记录证据，并评估了抗胆碱能药物在哮喘管理中的治疗意义。到目前为止，已发表了10项评估在轻度至中度或重度哮喘治疗中添加噻托溴铵效果的II期和III期随机对照试验结果。这些试验为期4至52周，涉及3368名轻度至中度哮喘患者和1019名重度哮喘患者[校正后]。此外，1项系统评价和6项荟萃分析评估了已发表和未发表的研究噻托溴铵在哮喘中作用的试验结果。轻度至中度哮喘试验结果表明，在吸入性糖皮质激素（ICS）中添加噻托溴铵并不比添加长效β2受体激动剂（LABA）差。此外，噻托溴铵的安全性和有效性与沙美特罗相似。重度哮喘研究结果表明，在高剂量ICS加LABA治疗中添加噻托溴铵可进一步改善肺功能，延长首次严重哮喘发作和哮喘恶化的时间，并改善哮喘控制。除口干外，噻托溴铵在中度和重度哮喘中的安全性与安慰剂相似。在ICS或ICS加LABA中添加噻托溴铵可改善肺功能、症状和哮喘控制，在重度哮喘中，可延长发作时间，安全性良好。这种效果似乎与年龄、支气管阻塞程度、吸烟状况、过敏状态和支气管可逆性等基线特征无关。
