患有囊性纤维化症儿童的长期阿齐思罗米辛:一个随机的,安慰剂控制的交叉试验
A Equi1, I M Balfour-Lynn, A Bush
1Department of Paediatric Respiratory Medicine, Royal Brompton Hospital, London, UK.
Lancet (London, England)
|October 18, 2002
概括
在患有囊性纤维化症的儿童中,阿齐思罗米对肺功能产生了适度的益处. 这种抗生素可能会减少CF患者口服抗生素疗程的需要.
科学领域:
- 肺部病理学 肺部病理学
- 儿科 儿科 儿科
- 药理学 药理学是指药理学的学科.
背景情况:
- 阿齐思罗米是一种宏类抗生素,具有抗炎性质.
- 试点研究表明,在囊性纤维化 (CF) 患者中,阿齐思罗米具有潜在的临床益处.
研究的目的:
- 在患有囊性纤维化症的儿童中正式评估阿齐思罗米的疗效.
主要方法:
- 一个为期15个月的随机,双盲,安慰剂控制的交叉试验,涉及41名患有CF的儿童 (8-18岁).
- 患者接受了阿兹罗密辛或安慰剂6个月,随后进行了2个月的洗,然后跨越.
- 主要结局是1秒强迫呼气量 (FEV1) 的相对差异;次要结局包括炎症标志物,运动测试和抗生素使用.
主要成果:
- FEV1的中位数相对差异为5.4%,有利于阿齐思罗米辛 (p=0.059).
- 需要服用口服抗生素的疗程在阿齐思罗米组显著减少 (p=0.005).
- 没有观察到炎症标志物,运动耐受性或主观幸福感的显著变化.
结论:
- 对于那些对常规疗法没有反应的CF儿童,需要进行4-6个月的阿齐思罗米试验.
- 阿齐思罗米在CF中所带来的益处的确切机制仍未确定.
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