亚斯科伯酸盐治疗毒症重症患者的器官功能障碍:第2b期ASTER试验
D Clark Files1, Michael A Matthay1, Lorraine B Ware1
1Wake Forest University School of Medicine (D. C. F., K. W. G., and C. M.), Winston-Salem, NC; the University of California, San Francisco (M. A. M. and S. F.), San Francisco, the University of California, Los Angeles (S. Y. C., G. W. H., and K. D. L.), Los Angeles, CA; the Vanderbilt University Medical Center (L. B. W. and W. H. S.), Nashville, TN; the Johns Hopkins Hospital (R. G. B.), Baltimore, MD; the University of Colorado (N. R. A. and A. G.), the Denver Health Medical Center (I. S. D.), Denver, CO; Intermountain Health (S. M. B.), the University of Utah (E. S. H.), Salt Lake City, UT; the Cleveland Clinic (A. D.), Cleveland, the University of Cincinnati (R. D. H.), Cincinnati, OH; the Massachusetts General Hospital (A. S. F., K. H., W. H., P. L., and B. T. T.), Boston; the Baystate Medical Center (M. A. T.), Springfield, MA; the Medical University of South Carolina (A. G.), Charleston, SC; the Oregon Health and Science University (C. L. H. and A. K.), the Maine Medical Center (R. R.), Portland, OR; the Mount Sinai Hospital (A. M.), New York, NY; the Harborview Medical Center (B. R. H. R.), University of Washington, Seattle, WA, the University of Pittsburgh Medical Center (D. M. Y.), Pittsburgh, PA; and the Virginia Commonwealth University (A. A. F.), Richmond, VA.
高剂量静脉注射亚斯科伯并没有改善血症和急性呼吸困扰综合征 (ARDS) 患者的器官支持无天. 然而,甲酸盐确实降低了炎症标志物,这表明在败血症和肺损伤方面具有潜在的益处.
科学领域:
- 关键护理医学 关键护理医学
- 药理学 药理学是指药理学的学科.
- 传染性疾病 传染性疾病
背景情况:
- 之前的第二阶段试验表明,高剂量静脉注射 Askorbate 对 ARDS 的潜在死亡率有好处.
- 然而,败血症试验没有证明临床益处,需要进一步调查.
研究的目的:
- 评估高剂量静脉注射 Askorbate 在改善有 ARDS 风险或患有 ARDS 的败血症患者的治疗结果方面的疗效.
- 评估亚酸盐对无器官支持日以及其他临床和生物终点的影响.
主要方法:
- 一个2b期多中心随机化安慰剂对照试验,涉及79名患有败血症和冲击或急性缺血性呼吸衰竭的参与者.
- 患者接受了阿斯科伯 (50毫克/公斤IV每6小时,持续5天) 或与之匹配的安慰剂.
- 主要结局是28日活了几天,没有呼吸,和循环器官支持.
主要成果:
- 该试验被提前终止,因为一项已发表的研究报告说,在败血症休克时,使用 Askorbate 增加了死亡率.
- 在没有器官支持的天中,在阿斯科尔酸盐和安慰剂组之间 (20.5 vs 19.0天,P = .528) 没有发现显著差异.
- 在阿斯科尔巴酸盐组中发现了降低90天全因死亡率的趋势 (15%对33%,P = .057),阿斯科尔巴酸盐显著降低了可溶性瘤亡因子受体1水平.
结论:
- 高剂量静脉注射 Askorbate 在血症和 ARDS 患者中没有改善无器官支持的日子.
- 在这项小型研究中,没有发现安全问题.
- 亚斯科伯酸盐显示,它减少了关键的生物炎症标志物,与败血症和肺损伤的不良结果有关.
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