Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Department of Pulmonary Medicine, University Hospital of Zürich, Zürich, Switzerland.
Ann Am Thorac Soc. 2021 Dec;18(12):2018-2026. doi: 10.1513/AnnalsATS.202103-266OC.
Patients with idiopathic pulmonary fibrosis (IPF) frequently suffer from chronic cough that is difficult to treat, which substantially affects their quality of life. Azithromycin has been demonstrated to relieve chronic cough in some populations; however, this has not been investigated in patients with IPF. To determine the safety and efficacy of azithromycin for the treatment of chronic cough in patients with IPF. In a double-blind randomized controlled crossover trial, patients with IPF underwent two 12-week intervention periods (azithromycin 500 mg three times per week or placebo three times per week). The primary outcome was the change in cough-related quality of life as measured by the Leicester Cough Questionnaire (LCQ). Secondary outcomes included cough severity as measured by the Visual Analog Scale (VAS), health-related quality of life as assessed by the St. George's Respiratory Questionnaire, and objective cough frequency as measured by audiovisual readings from 24-hour respiratory polygraphy. Twenty-five patients were randomized (23 men, 2 women); 20 patients completed the study. The mean (standard deviation [SD]) age was 67 (8) years, the mean (SD) forced vital capacity was 65 (16) percent predicted, and the diffusing capacity of the lung for carbon monoxide was 43 (16) percent predicted. The mean (SD) baseline LCQ scores were 11.7 (3.7) and 11.3 (3.3) for the azithromycin period and the placebo period, respectively, and the corresponding mean (SD) cough VAS scores were 5.6 (2.3) and 5.8 (2.1). There was no significant change in the LCQ score or the VAS score with azithromycin or with placebo. Similarly, there was no significant difference between the azithromycin period and the placebo period for change in polygraphy-measured cough frequency. Gastrointestinal adverse effects were more frequent with azithromycin than with placebo (diarrhea, 43% vs. 5%; = 0.03). This randomized controlled trial does not support the use of low-dose azithromycin for chronic cough in patients with IPF.Clinical trial registered with www.clinicaltrials.gov (NCT02173145).
特发性肺纤维化（IPF）患者常患有慢性咳嗽，难以治疗，这极大地影响了他们的生活质量。阿奇霉素已被证明可缓解某些人群的慢性咳嗽，但尚未在 IPF 患者中进行研究。
确定阿奇霉素治疗 IPF 患者慢性咳嗽的安全性和疗效。
在一项双盲随机对照交叉试验中，IPF 患者接受了两个为期 12 周的干预期（阿奇霉素 500mg，每周 3 次或安慰剂每周 3 次）。主要结局是莱斯特咳嗽问卷（LCQ）测量的咳嗽相关生活质量的变化。次要结局包括咳嗽严重程度（视觉模拟量表[VAS]）、健康相关生活质量（圣乔治呼吸问卷）和 24 小时呼吸多导睡眠图的视听读数测量的客观咳嗽频率。
25 名患者被随机分配（23 名男性，2 名女性）；20 名患者完成了研究。平均（标准差[SD]）年龄为 67（8）岁，平均（SD）用力肺活量为 65（16）%预测值，一氧化碳弥散量为 43（16）%预测值。阿奇霉素期和安慰剂期的平均（SD）LCQ 评分分别为 11.7（3.7）和 11.3（3.3），相应的平均（SD）咳嗽 VAS 评分分别为 5.6（2.3）和 5.8（2.1）。阿奇霉素或安慰剂治疗后 LCQ 评分或 VAS 评分均无显著变化。同样，多导睡眠图测量的咳嗽频率变化在阿奇霉素期和安慰剂期之间也没有显著差异。阿奇霉素组胃肠道不良反应比安慰剂组更常见（腹泻，43% vs. 5%；=0.03）。
这项随机对照试验不支持在 IPF 患者中使用低剂量阿奇霉素治疗慢性咳嗽。临床试验注册于 www.clinicaltrials.gov（NCT02173145）。
