Long term effects of azithromycin in patients with cystic fibrosis: a double blind, placebo controlled trial
Long term effects of azithromycin in patients with cystic fibrosis: a double blind, placebo controlled trial
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DOI：
10.1136/thx.2005.057950
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发表时间：
2006-10-01
期刊：
影响因子：
10
通讯作者：
Jais, J-P
中科院分区：
文献类型：
--
作者：
Clement, A.;Tamalet, A.;Jais, J-P
背景：大环内酯类药物显示免疫调节作用，可能对慢性炎症性肺病有益。该研究的目的是证明长期使用阿奇霉素是否与囊性纤维化年轻患者的呼吸益处有关。方法：2001年10月至2003年6月进行多中心、随机、双盲、安慰剂对照试验。入组标准为年龄大于6岁，1秒用力呼气量(FEV1)≥40%。活性组给予250 mg或500 mg（体重，或>= 40 kg）口服阿奇霉素，每周3次，连续12个月。主要终点为FEV1的变化。结果：82例患者被随机分组，平均（SD）年龄11.0（3.3）岁，平均（SD） FEV1 85(22)%预测：阿奇霉素组40例，安慰剂组42例。19例患者感染铜绿假单胞菌。两组患者第12个月FEV1的相对变化无显著差异。阿奇霉素组肺加重次数（计数比0.50 (95% CI 0.32 ~ 0.79), p < 0.005），第一次肺加重前的时间（危险比0.37 (95% CI 0.22 ~ 0.63), p < 0.0001），以及口服抗生素的额外疗程数均显著减少，无论感染状态如何（计数比0.55 (95% CI 0.36 ~ 0.85), p < 0.01）。无严重不良事件报告。结论：年轻囊性纤维化患者长期使用低剂量阿奇霉素对肺部疾病表达有有益影响，甚至在感染铜绿假单胞菌之前。
Background: Macrolides display immunomodulatory effects that may be beneficial in chronic inflammatory pulmonary diseases. The aim of the study was to document whether long term use of azithromycin may be associated with respiratory benefits in young patients with cystic fibrosis.Methods: A multicentre, randomised, double blind, placebo controlled trial was conducted from October 2001 to June 2003. The criteria for enrolment were age older than 6 years and forced expiratory volume in 1 second (FEV1) of 40% or more. The active group received either 250 mg or 500 mg ( body weight, or >= 40 kg) of oral azithromycin three times a week for 12 months. The primary end point was change in FEV1.Results: Eighty two patients of mean (SD) age 11.0 (3.3) years and mean ( SD) FEV1 85 (22)% predicted were randomised: 40 in the azithromycin group and 42 in the placebo group. Nineteen patients were infected with Pseudomonas aeruginosa. The relative change in FEV1 at month 12 did not differ significantly between the two groups. The number of pulmonary exacerbations ( count ratio 0.50 (95% CI 0.32 to 0.79), p < 0.005), the time elapsed before the first pulmonary exacerbation ( hazard ratio 0.37 (95% CI 0.22 to 0.63), p < 0.0001), and the number of additional courses of oral antibiotics were significantly reduced in the azithromycin group regardless of the infectious status ( count ratio 0.55 ( 95% CI 0.36 to 0.85), p < 0.01). No severe adverse events were reported.Conclusion: Long term use of low dose azithromycin in young patients with cystic fibrosis has a beneficial effect on lung disease expression, even before infection with Pseudomonas aeruginosa.