Sepsis-3标准对脓毒症患者诊断价值的多中心前瞻性观察性临床研究

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目的:探讨Sepsis-3标准对脓毒症患者的诊断价值。方法:选择2017年9月至2018年8月江苏省6家医院重症医学科连续收治的感染或怀疑感染的成人患者。将纳入患者分为4组,A组Sepsis-1及Sepsis-3标准都符合,B组只符合Sepsis-1标准,C组只符合Sepsis-3标准,D组Sepsis-1及Sepsis-3标准均不符合。记录患者的年龄、性别、基础疾病、诊断及感染来源,入住重症监护病房(ICU)24 h内生命体征、全身炎症反应综合征(SIRS)评分、序贯器官衰竭评分(SOFA)、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)、快速序贯器官衰竭评分(qSOFA),ICU住院时间、总住院时间、28 d病死率等临床数据,将上述收集数据按分组进行比较分析。绘制SOFA、qSOFA、SIRS评分预测患者28 d病死率的受试者工作特征曲线(ROC),并计算ROC曲线下面积(AUC),使用约登指数筛检各评分预测脓毒症患者28 d病死率的最佳截断值及其对应的敏感度和特异度。结果:共纳入527例感染或怀疑感染的患者,其中A组324例,B组113例,C组22例,D组68例,其28 d病死率分别为38.9%、17.7%、31.8%、11.8%,组间比较差异具有统计学意义(n P<0.05),SIRS评分分别为3(1)、2(1)、1(0)、1(0)分,APACHEⅡ评分分别为17(10)、11(10)、15(8)、12(8)分,qSOFA评分分别为2(1)、1(1)、1(1)、1(2)分,SOFA评分分别为8(6)、1(0)、7(4)、1(0)分,4组间比较差异均具有统计学意义(均n P<0.05)。ROC曲线分析SOFA、qSOFA、SIRS评分预测患者28 d病死率的价值,结果显示,SOFA评分的AUC和95%可信区间优于qSOFA评分和SIRS评分〔0.71(0.66~0.76)比0.59(0.55~0.64)、0.57(0.51~0.62),均n P<0.01〕。根据约登指数,SOFA、qSOFA、SIRS评分预测脓毒症患者28 d病死率最佳截断值分别为7、2和2分,其敏感度分别为69.4%、60.1%、53.6%,特异度分别为61.8%、76.2%、51.1%。n 结论:Sepsis-3标准在诊断及预测脓毒症患者28 d病死率方面优于Sepsis-1标准。qSOFA可作为早期ICU床边快速筛选高死亡风险脓毒症患者的工具。“,”Objective:To explore the value of Sepsis-3 standard in diagnosis of patients with sepsis.Methods:Patients who were infected or suspected of infection in intensive care unit (ICU) of six hospitals in Jiangsu Province from September 2017 to August 2018 were enrolled. They were divided into four groups: group A was in accordance with Sepsis-1 and Sepsis-3, group B only met the Sepsis-1 standard, group C only met the Sepsis-3 standard, and both Sepsis-1 and Sepsis-3 standard did not match in group D. The age, gender, underlying disease, diagnosis and source of infection, vital signs within 24 hours of ICU, systemic inflammatory response syndrome (SIRS) score, sequential organ failure assessment (SOFA) score, acute physiology and chronic health evaluation Ⅱ(APACHEⅡ) score, quick sequential organ failure assessment (qSOFA) score, the length of ICU stay, total hospitalization time, 28-day mortality rate, etc. were recorded. The above collected data were compared and analyzed in groups, and the receiver operating characteristic (ROC) curves of each scoring standard were drawn and calculated. The area under the ROC curve (AUC), and the n Youden index of each score was calculated to predict the optimal cut-off value of 28-day mortality in patients with sepsis and its corresponding sensitivity and specificity.n Results:A total of 527 patients with infection or suspected infection were enrolled in the study, including 324 patients in group A, 113 patients in group B, 22 patients in group C, 68 patients in group D, and 28-day mortality were 38.9%, 17.7%, 31.8%, and 11.8%, respectively, and there was statistically significant difference among four groups (n P < 0.05). The SIRS scores of the A, B, C, D groups were 3 (1), 2 (1), 1 (0), 1 (0), APACHEⅡ scores were 17 (10), 11 (10), 15 (8), 12 (8), qSOFA score were 2 (1), 1 (1), 1 (1), 1 (2), SOFA scores were 8 (6), 1 (0), 7 (4), 1 (0), respectively, there were statistically significant differences among four group (all n P < 0.05). Values of SOFA, qSOFA and SIRS scores were evaluated by ROC to predict the value of 28-day mortality. The results showed that AUC and 95% confidence interval of SOFA score was superior to qSOFA score and SIRS score [0.71 (0.66-0.76) vs. 0.59 (0.55-0.64), 0.57 (0.51-0.62), both n P < 0.01]. According to the n Youden index, the best cut-off values for the 28-day mortality of SOFA, qSOFA and SIRS scores for sepsis were 7, 2 and 2, respectively, and the sensitivity was 69.4%, 60.1%, 53.6%, the specificity was 61.8%, 76.2%, 51.1%, respectively.n Conclusions:The Sepsis-3 standard is superior to the Sepsis-1 standard in the diagnosis and prediction of 28-day mortality in patients with sepsis. qSOFA can be used as an early tool for rapid screening of patients with high-risk sepsis in the ICU bedside.
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