抗菌疗法对成年人患有异常性肺纤维化病的住院或死亡的影响:CleanUP-IPF随机临床试验
Fernando J Martinez1, Eric Yow2, Kevin R Flaherty3
1New York Presbyterian Hospital/Weill Cornell Medicine, New York.
用co- trimoxazole或doxycycline进行的抗菌治疗没有改善异常性肺纤维化患者的结果. 这项研究表明这些抗生素对治疗这种肺病没有好处.
科学领域:
- 肺病学
- 传染性疾病
- 临床试验
背景情况:
- 肺部微生物群的变化与异常性肺纤维化 (IPF) 的进展有关.
- 作为IPF的潜在治疗方法,正在研究抗菌疗法.
研究的目的:
- 评估抗菌药物治疗改善异常性肺纤维化患者的临床结果的有效性.
- 评估co- trimoxazole或doxycycline对非选择性呼吸道住院或所有原因死亡的时间影响.
主要方法:
- 这是一项实用性,随机化,无盲目的临床试验,涉及35个美国地区的513名IPF患者.
- 患者接受了通常的治疗加上抗菌药物 (co- trimoxazole或doxycycline) 或仅接受通常的治疗.
- 主要终点是第一个非选择性呼吸系统住院时间或全因死亡率.
主要成果:
- 这项研究因徒劳而提前终止. 在抗菌药物组和常规治疗组之间,主要终点没有显著差异 (调整后HR为1. 04;P=0. 83).
- 在抗菌组中,腹和皮疹等不良反应更为频繁.
- 对于初级终点,没有发现co- trimoxazole和doxycycline之间的显著相互作用.
结论:
- 在患有异常性肺纤维化的成年人中,添加co- trimoxazole或doxycycline在常规治疗中并没有显著改善临床结果.
- 目前的证据不支持使用这些特定的抗生素治疗异常性肺纤维化.
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