在移植后用于BK病毒预防的利沃素:一项随机临床试验
Greg A Knoll1, Atul Humar2, Dean Fergusson3
1Division of Nephrology, Kidney Research Centre, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada2Clinical Epidemiology Program, Ottawa Hospital Research Institute, and Department of Epidemiology and Community Medicine, University of O.
JAMA
|November 16, 2014
概括
在移植患者中,利沃撒并没有预防BK病毒病. 这种抗生素还增加了耐药感染和肌炎的风险,表明它不适合预防BK病毒感染.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 病毒学 病毒学
- 免疫学 免疫学 免疫学
背景情况:
- BK病毒感染是移植后的一个主要并发症,导致移植失败的高率.
- 目前的管理策略缺乏预防或治疗BK病毒感染的选择.
- 昆类抗生素在体外对BK病毒表现出抗病毒活性,但预防的临床疗效仍未得到证实.
研究的目的:
- 评估levofloxacin在预防移植接受者的BK病毒病的疗效.
- 评估叶黄素对二次结局的影响,包括BK病毒病,排斥和移植存活率.
主要方法:
- 一个双盲,安慰剂受控的随机试验与154名脏移植接受者进行.
- 参与者接受了为期3个月的勒沃素 (500毫克/天) 或安慰剂,从移植后5天内开始.
- 主要终点是通过定量实时PCR在一年内检测BK病毒病的时间.
主要成果:
- 在乐沃克素 (29%) 和安慰剂 (33.3%) 组之间没有观察到BK病毒病发病率的显著差异 (HR,0.91;P=.58).
- 二次结局,包括BK病毒病和异种移植存活率,在两组之间也没有显著差异.
- 列沃素组显示出抗药性感染的发病率较高 (58.3%对33.3%),肌炎的增加趋势 (7.9%对1.3%).
结论:
- 早期启动为期3个月的勒沃弗洛克萨辛疗程并不能预防移植患者的BK病毒病.
- 列沃素使用与不良事件的风险增加有关,包括细菌耐药性和潜在的肌炎.
- 这些发现不支持使用勒沃素预防移植后的BK病毒感染.
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