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首页> 外文期刊>Critical care : >Drotrecogin alfa (activated) in patients with severe sepsis presenting with purpura fulminans, meningitis, or meningococcal disease: a retrospective analysis of patients enrolled in recent clinical studies
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Drotrecogin alfa (activated) in patients with severe sepsis presenting with purpura fulminans, meningitis, or meningococcal disease: a retrospective analysis of patients enrolled in recent clinical studies

机译：严重败血症患者出现暴发性紫癜，脑膜炎或脑膜炎球菌病的Drotrecogin alfa（已激活）：对近期临床研究的患者的回顾性分析

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IntroductionWe report data from adult and pediatric patients with severe sepsis from studies evaluating drotrecogin alfa (activated) (DrotAA) and presenting with purpura fulminans (PF), meningitis (MEN), or meningococcal disease (MD) (PF/MEN/MD). Such conditions may be associated with an increased bleeding risk but occur in a relatively small proportion of patients presenting with severe sepsis; pooling data across clinical trials provides an opportunity for improving the characterization of outcomes.MethodsA retrospective analysis of placebo-controlled, open-label, and compassionate-use trials was conducted. Adult patients received infusions of either DrotAA or placebo. All pediatric patients (<18 years old) received DrotAA. 189 adult and 121 pediatric patients presented with PF/MEN/MD.ResultsFewer adult patients with PF/MEN/MD met cardiovascular (68.3% versus 78.8%) or respiratory (57.8% versus 80.5%) organ dysfunction entry criteria than those without. DrotAA-treated adult patients with PF/MEN/MD (n = 163) had an observed 28-day mortality rate of 19.0%, a 28-day serious bleeding event (SBE) rate of 6.1%, and an intracranial hemorrhage (ICH) rate of 4.3%. Six of the seven ICHs occurred in patients with MEN (three of whom were more than 65 years old with a history of hypertension). DrotAA-treated adult patients without PF/MEN/MD (n = 3,088) had an observed 28-day mortality rate of 25.5%, a 28-day SBE rate of 5.8%, and an ICH rate of 1.0%. In contrast, a greater number of pediatric patients with PF/MEN/MD met the cardiovascular organ dysfunction entry criterion (93.5% versus 82.5%) than those without. DrotAA-treated PF/MEN/MD pediatric patients (n = 119) had a 14-day mortality rate of 10.1%, an SBE rate of 5.9%, and an ICH rate of 2.5%. DrotAA-treated pediatric patients without PF/MEN/MD (n = 142) had a 14-day mortality rate of 14.1%, an SBE rate of 9.2%, and an ICH rate of 3.5%.ConclusionDrotAA-treated adult patients with severe sepsis presenting with PF/MEN/MD had a similar SBE rate, a lower observed 28-day mortality rate, and a higher observed rate of ICH than DrotAA-treated patients without PF/MEN/MD. DrotAA-treated pediatric patients with severe sepsis with PF/MEN/MD may differ from adults, because all three outcome rates (SBE, mortality, and ICH) were lower in pediatric patients with PF/MEN/MD.
机译：简介我们报告了来自严重败血症的成年和儿科患者的数据，这些研究来自评估drotrecogin alfa（活化）（DrotAA）并表现为暴发性紫癜（PF），脑膜炎（MEN）或脑膜炎球菌病（MD）（PF / MEN / MD）的研究。这种情况可能与出血风险增加有关，但发生在脓毒症严重的患者中相对较少。汇总临床试验中的数据可提供改善结局特征的机会。方法对安慰剂对照，开放标签和有同情心的试验进行回顾性分析。成年患者接受了DrotAA或安慰剂的输注。所有儿科患者（<18岁）均接受DrotAA。结果189例成人和121例儿科患者患有PF / MEN / MD，结果没有PF / MEN / MD的成人患者符合心血管（68.3％对78.8％）或呼吸道（57.8％对80.5％）器官功能障碍进入标准的人数较少。用DrotAA治疗的PF / MEN / MD成人患者（n = 163）观察到的28天死亡率为19.0％，28天严重出血事件（SBE）率为6.1％，颅内出血（ICH）率4.3％。七个ICH中有六个发生在MEN患者中（其中三个有65岁以上的高血压病史）。 DrotAA治疗的无PF / MEN / MD的成年患者（n = 3,088）观察到的28天死亡率为25.5％，28天SBE率为5.8％，ICH率为1.0％。相比之下，更多的PF / MEN / MD患儿符合心血管器官功能障碍的入院标准（93.5％比82.5％）。 DrotAA治疗的PF / MEN / MD小儿患者（n = 119）的14天死亡率为10.1％，SBE率为5.9％，ICH率为2.5％。无PF / MEN / MD的DrotAA治疗的儿科患者（n = 142）的14天死亡率为14.1％，SBE率为9.2％，ICH率为3.5％。与没有PF / MEN / MD的DrotAA治疗患者相比，PF / MEN / MD的患者SBE发生率相似，观察到的28天死亡率更低，ICH的观察率更高。 DrotAA治疗的严重败血症合并PF / MEN / MD的儿科患者可能与成人不同，因为这3个结局率（SBE，死亡率和ICH）在PF / MEN / MD的儿科患者中均较低。

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