Effect of Azithromycin on Lung Function and Pulmonary Exacerbations in Children with Post-infectious Bronchiolitis Obliterans. A Double-blind, Placebo-controlled Trial

Claudio Castaños, Felix Salin Maximiliano, Luciana Pereyra Carla, Veronica Aguerre, Belen Lucero Maria, Gabriela Bauer, Brenda Zylbersztajn, Leonor Leviled, Hebe González Pena
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Abstract

Introduction: Acute lower respiratory infection (ALRI) of viral etiology is a frequent consultation in pediatrics. Post-infectious bronchiolitis obliterans (PIBO) is a rare and potentially severe disorder following ALRI, characterized by partial or complete obstruction of the small airways by inflammatory tissue. There is evidence that macrolides reduce morbidity and mortality in diffuse panbronchiolitis, which may have similar inflammatory and obstructive components. We hypothesized that the effect of azithromycin (AZ) may improve lung function and reduce pulmonary exacerbations in PIBO. Methods Study design: A double-blind, randomized, placebo-controlled trial. Patients: We enrolled patients with PIBO followed-up at the Pulmonology department between 5 years to 18 years. Treatment regimen: The patients were randomized to receive active drug or placebo three times a week. Clinical evaluation: Clinical evaluation, pulse oximetry, lung function, and 6-min walk test were performed before and after study initiation and at 1, 3, and 6 months. CT scan and a quality of life questionnaire were performed at the beginning and the end of the Study. Results: 29 patients, 15 in G1 (10 males) and 14 in G2 (7 males) were included. There were no significant differences in FVC, FEV1, TLC, RV, or sGaw between the treatment group and controls. In addition, no significant differences were observed in exacerbations, quality of life questionnaire, or HRCT scan scores. Conclusion: No differences were observed between the groups. Further studies are necessary to allow us to find a better treatment, as azithromycin does not seem to be efficacious.
阿奇霉素对感染后支气管炎闭塞症儿童肺功能和肺部恶化的影响。双盲安慰剂对照试验
导言:病毒性急性下呼吸道感染(ALRI)是儿科的常见病。感染后阻塞性支气管炎(PIBO)是继 ALRI 之后出现的一种罕见且潜在的严重疾病,其特点是炎症组织部分或完全阻塞小气道。有证据表明,大环内酯类药物可降低弥漫性全细支气管炎的发病率和死亡率,而全细支气管炎可能具有类似的炎症和阻塞成分。我们假设,阿奇霉素(AZ)的作用可能会改善 PIBO 患者的肺功能并减少肺部恶化。方法 研究设计:双盲、随机、安慰剂对照试验。患者:我们招募了在肺科随访 5 至 18 年的 PIBO 患者。治疗方案:患者随机接受活性药物或安慰剂治疗,每周三次。临床评估:在研究开始前后以及1、3和6个月时进行临床评估、脉搏血氧仪、肺功能和6分钟步行测试。在研究开始和结束时进行 CT 扫描和生活质量问卷调查。结果:共纳入 29 名患者,其中 G1 15 名(10 名男性),G2 14 名(7 名男性)。治疗组和对照组的 FVC、FEV1、TLC、RV 或 sGaw 均无明显差异。此外,在病情恶化、生活质量问卷或 HRCT 扫描评分方面也未观察到明显差异。结论治疗组与对照组之间未发现差异。由于阿奇霉素似乎没有疗效,因此有必要开展进一步研究,以便找到更好的治疗方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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