Abstract：
The purpose of this study was to evaluate the effect of 8 months of treatment with itraconazole on airway wall thickness in patients with severe persistent asthma. It was a double-blind, randomized, placebo-controlled clinical trial (IRCT20091111002695N9). Seventy-five subjects with severe persistent asthma received itraconazole (100 mg), prednisolone (5 mg), or placebo twice a day for eight months in three treatment groups (n=25 in each group). The primary objective was to improve the right upper lobe apical segmental bronchus (RB1) wall thickness percentage measured by high-resolution computed tomography scan of the lungs. Other morphometric measurements of RB1, asthma control test (ACT) score, presence of wheezing, dyspnea severity, rate of asthma exacerbation, fractional exhaled nitric oxide (FeNO), and expiratory volume in 1 second (FEV1) were set as the secondary outcomes. Wall thickness percentage reduced significantly from 46% to 43.7% from pre- to post-treatment in the itraconazole-treated subjects. Similarly, lumen area and radius increased significantly in both the prednisolone and itraconazole groups. Itraconazole led to a significant improvement in wheezing, dyspnea severity, FEV1, ACT score, and FeNO. Although prednisolone was also effective in improving pulmonary function tests and ACT scores, it was associated with significantly more side effects than itraconazole. Long-term treatment with itraconazole resulted in a significant reduction in bronchial wall thickness and improvements in clinical findings and pulmonary function tests. Thus, itraconazole could be a helpful add-on treatment option for severe persistent asthma patients to achieve better disease control.
摘要：
目的评价伊曲康唑治疗8个月对重度持续性哮喘患者气道壁厚度的影响。这是一个双盲，随机化，安慰剂对照临床试验（IRCT20091111002695N9）。75名患有严重持续性哮喘的受试者接受了伊曲康唑（100mg），泼尼松龙（5毫克），或安慰剂每天两次，共八个月（每组n=25）。主要目的是改善通过高分辨率计算机断层扫描测量的右上叶顶段支气管（RB1）壁厚百分比肺部。RB1的其他形态测量，哮喘控制测试（ACT）评分，喘息的存在，呼吸困难的严重程度，哮喘恶化率，呼出气一氧化氮（FeNO），将1秒呼气容积(FEV1)作为次要结局.在伊曲康唑治疗的受试者中，壁厚百分比从治疗前后的46％显着降低至43.7％。同样，泼尼松龙和伊曲康唑组的管腔面积和半径均显着增加。伊曲康唑导致喘息的显着改善，呼吸困难的严重程度，FEV1,ACT得分,和FeNO。尽管泼尼松龙在改善肺功能检查和ACT评分方面也有效，其副作用明显多于伊曲康唑。长期使用伊曲康唑治疗可显著减少支气管壁厚度，改善临床表现和肺功能检查。因此，对于重度持续性哮喘患者,伊曲康唑可能是一种有帮助的附加治疗选择,以实现更好的疾病控制.
