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首页> 外文期刊>Pediatric critical care medicine: a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies >ENHANCE: results of a global open-label trial of drotrecogin alfa (activated) in children with severe sepsis.
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ENHANCE: results of a global open-label trial of drotrecogin alfa (activated) in children with severe sepsis.

机译：增强：在患有严重脓毒症的儿童中进行drotrecogin alfa（活化）全球开放标签试验的结果。

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OBJECTIVE: To gather additional 28-day all-cause mortality data and safety information for pediatric patients with severe sepsis who received drotrecogin alfa (activated) (DrotAA). DESIGN AND SETTING: Single-arm, open-label, multicentered study conducted in 59 study sites in 15 countries. PATIENTS: One-hundred eighty-eight children (term newborn to <18 yrs old) with severe sepsis were consecutively enrolled in the study. INTERVENTION: Administration of DrotAA, 24 microg/kg/hr for 96 hrs. MAIN OUTCOME MEASURES: Four-day and 28-day all-cause mortality, safety information, and protein C levels. RESULTS:: One-hundred eighty-seven patients completed the study. The 4-day mortality rate was 7.0%, and the 28-day mortality rate was 13.4%. At baseline, 57.6% of patients were severely deficient in protein C (a level < or = 40% of normal). There was a statistically significant association between increased 28-day mortality and decreased end-of-infusion protein C levels (p < .001), greater number of baseline organ dysfunctions (p < .001), and greater baseline ventilator use (p = .03). Bleeding was the most significant complication observed. Serious bleeding events (including anemia without a bleeding source) were experienced by 27.7% of patients (n = 52). Six of the serious bleeding events (3.2%) were considered related to administration of DrotAA. During infusion, serious bleeding events with an identified source of bleeding were experienced by 5.9% of patients (n = 11). Central nervous system bleeding was experienced by 2.7% (n = 5). Two of the intracranial hemorrhages were fatal and occurred postinfusion. CONCLUSIONS: Without a placebo control, no efficacy conclusions are possible. Subgroups at higher risk of death were identified, and the change in protein C level from baseline was predictive of survival. The most significant complication observed was bleeding. Risk factors for serious bleeding appear to be multiple organ failure, thrombocytopenia, and coagulopathy.
机译：目的：收集接受drodrocogin alfa（活化）（DrotAA）治疗的严重脓毒症儿科患者的其他28天全因死亡率数据和安全性信息。设计与地点：在15个国家/地区的59个研究地点进行的单臂，开放标签，多中心研究。患者：一百八十八名患有严重脓毒症的儿童（足月新生儿至<18岁）已连续入选该研究。干预：给予DrotAA，24微克/千克/小时，持续96小时。主要观察指标：4天和28天全因死亡率，安全性信息和C蛋白水平。结果：一百八十七名患者完成了研究。 4天死亡率为7.0％，而28天死亡率为13.4％。在基线时，有57.6％的患者严重缺乏C蛋白（水平<或=正常水平的40％）。在28天的死亡率增加和输注结束时的蛋白C水平降低（p <.001），基线器官功能障碍的数量增加（p <.001）和基线呼吸机的使用增加之间有统计学意义的关联（p = .03）。出血是观察到的最重要的并发症。 27.7％的患者经历了严重的出血事件（包括无出血源的贫血）（n = 52）。严重出血事件中有六个（3.2％）被认为与DrotAA的给药有关。在输注过程中，有5.9％的患者经历了严重的出血事件，并带有确定的出血源（n = 11）。中枢神经系统出血发生率为2.7％（n = 5）。两次颅内出血是致命的，并在输注后发生。结论：如果没有安慰剂对照，就不可能得出疗效结论。确定了较高死亡风险的亚组，并且蛋白质C水平相对于基线的变化可预测生存。观察到的最重要的并发症是出血。严重出血的危险因素似乎是多器官功能衰竭，血小板减少和凝血病。

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