Effects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial
Effects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial
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DOI：
10.1097/01.ccm.0000051515.56179.e1
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发表时间：
2003-03-01
影响因子：
8.8
通讯作者：
Bernard, GR
中科院分区：
文献类型：
--
作者：
Vincent, JL;Angus, DC;Bernard, GR
目的：评估使用和不使用屈曲霉素阿尔法(活性)治疗的严重脓毒症患者的发病率。IDesign：一项前瞻性、随机、双盲、安慰剂对照、多中心、3期试验(PROWESS)的次级终点分析。设置：I I国家的164家医疗机构。共有1,690名患有严重败血症的成人患者。96小时输注阿糖胞苷(活化的)(人重组活化蛋白C)或安慰剂。连续28天测量心血管、呼吸、肾脏、血液和肝脏器官系统的序贯器官衰竭评估(SOFA)评分。在这段时间内，接受屈曲可净阿尔法(激活)治疗的患者的平均心血管SOFA评分显著低于安慰剂患者(p=.022)。与安慰剂组相比，服用屈曲霉金阿尔法(激活剂)的患者心血管功能障碍(p=.009)和呼吸功能障碍(p=.009)的缓解速度显著加快(p=.009)，血液器官功能障碍的发生时间显著减慢(p=.041)。在28天的生存者中，两组患者的发病率没有显著差异。在一项大型的3期临床试验中，与安慰剂相比，屈曲霉金阿尔法(激活)在器官功能方面有显著改善，该试验表明，对严重脓毒症患者的死亡率有好处。
Objective: To assess morbidity in patients with severe sepsis managed with and without drotrecogin alfa (activated). IDesign: Analysis of secondary end points in a prospective, randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (PROWESS).Setting., A total of 164 medical institutions in I I countries.Patients. A total of 1,690 consecutive adult patients with severe sepsis.Interventions. A 96-hr infusion of drotrecogin alfa (activated) (human recombinant activated protein C) or placebo.Measurements and Main Results. Sequential Organ Failure Assessment (SOFA) scores for cardiovascular, respiratory, renal, hematologic, and hepatic organ systems were measured for 28 days. Mean cardiovascular SOFA scores were significantly lower for patients treated with drotrecogin alfa (activated) compared with placebo patients over this time period (p = .022). Drotrecogin alfa (activated)-treated patients also showed significantly faster resolution of cardiovascular (p = .009) and respiratory (p = .009) dysfunction and significantly slower onset of hematologic organ dysfunction (p = .041) compared with placebo patients for days 1 to 7. No significant differences in morbidity were observed between treatment groups among 28-day survivors.Conclusion. Drotrecogin alfa (activated) demonstrated significant improvements in organ function compared with placebo in a large phase 3 clinical trial that has shown a mortality benefit in patients with severe sepsis.