Abstract
介绍:在不同的慢性呼吸系统疾病中,使用大环内酯类抗生素阿奇霉素(AZI)的维持治疗正在增加。原发性睫状运动障碍(PCD),尽管PCD中没有明确的证据。
目的和目标:主要目的是确定AZI维持疗法对PCD呼吸道恶化的功效。次要目标是确定对肺功能,与健康相关的生活质量,微生物学和听力障碍的功效,并评估安全性。
Methods:该欧洲多中心,平行组,双盲,随机,安慰剂对照试验的确认诊断为7-50岁的PCD诊断患者。根据体重(≥40kg)或安慰剂,将参与者随机分配到AZI 250/500毫克,每周3次,持续6个月。
结果:A total of 90 participants were randomized - 49 assigned to AZI and 41 to placebo. The AZI group had significant lower rate of exacerbations (rate ratio 0.46, 95%CI: 0.27; 0.80, p=0.006) and pathogenic bacterial species in sputum (rate ratio 0.39, 95%CI: 0.24; 0.64, p=0.0002), compared to the placebo group. There was no significant difference between the treatment groups in lung function, hearing level, or Respiratory symptoms, Sinus symptoms and Ear & hearing symptoms on the quality of life measure. Gastrointestinal complaints were more common in the AZI group.
Conclusions:PCD中第一次对药物治疗的跨国随机对照试验表明,维持AZI 6个月是安全的,呼吸道加重的发生率降低了,痰液中的致病细菌物种速率降低到一半不到一半。
Footnotes
本文引用:欧洲呼吸杂志》上2019; 54: Suppl. 63, RCT5102.
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