患有囊性纤维化慢性感染Pseudomonas aeruginosa的患者的阿齐思罗米:一个随机对照试验
Lisa Saiman1, Bruce C Marshall, Nicole Mayer-Hamblett
1Department of Pediatrics, Columbia University College of Physicians and Surgeons, New York, NY 10032-3784, USA. ls5@columbia.edu
JAMA
|October 2, 2003
概括
阿齐思罗米改善了肺功能,减少了囊性纤维化患者的恶化. 这种宏类抗生素为那些患有慢性 Pseudomonas aeruginosa 感染的人提供了潜在的治疗选择.
科学领域:
- 肺部病理学 肺部病理学
- 传染性疾病 传染性疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 囊性纤维化 (CF) 肺部疾病的治疗包括抗生素,粘菌剂和抗炎药.
- 宏类抗生素对CF患者显示出潜在的益处.
研究的目的:
- 调查在囊性纤维化 (CF) 患者中使用阿齐思罗米和肺功能之间的关联.
- 评估阿齐思罗米在患有慢性 Pseudomonas aeruginosa 感染的 CF 患者的疗效和安全性.
主要方法:
- 一个多中心,随机,双盲,安慰剂受控试验.
- 185名CF患者 (年龄≥6岁,P. aeruginosa感染,FEV1≥30%) 接受了168天的口服阿兹罗米辛或安慰剂治疗.
- 主要结局:FEV1的变化;次要结局:肺部恶化和体重增加.
主要成果:
- 阿齐思罗米辛组显示FEV1显著增加 (0.097 L对比0.003 L,P=.009).
- 在阿齐思罗米辛组观察到肺部恶化风险降低 (HR=0.65,P=.03) 和体重增加 (0.7公斤,P=.02).
- 恶心,腹和喘息的发病率增加在阿齐思罗米辛组报告.
结论:
- 阿齐思罗米治疗与CF患者改善的临床结果有关.
- 在患有慢性P. aeruginosa感染的CF患者 (≥6岁) 时,考虑使用阿兹罗米辛.
- 在这种患者群体中,阿齐思罗米显示出有利的风险-益处概况.
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