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Abstract：
BACKGROUND: There is no reliable indicator that can assess the treatment effect of anticoagulant therapy for sepsis-associated disseminated intravascular coagulation (DIC) in the short term. The aim of this study is to develop and validate a prognostic index identifying 28-day mortality in septic DIC patients treated with antithrombin concentrate after a 3-day treatment.
METHODS: The cohort for derivation was established utilizing the dataset from post-marketing surveys, while the cohort for validation was acquired from Japan\'s nationwide sepsis registry data. Through univariate and multivariate analyses, variables that were independently associated with 28-day mortality were identified within the derivation cohort. Risk variables were then assigned a weighted score based on the risk prediction function, leading to the development of a composite index. Subsequently, the area under the receiver operating characteristic curve (AUROC). 28-day survival was compared by Kaplan-Meier analysis.
RESULTS: In the derivation cohort, 252 (16.9%) of the 1492 patients deceased within 28 days. Multivariable analysis identified DIC resolution (hazard ratio [HR]: 0.31, 95% confidence interval [CI]: 0.22-0.45, P < 0.0001) and rate of Sequential Organ Failure Assessment (SOFA) score change (HR: 0.42, 95% CI: 0.36-0.50, P < 0.0001) were identified as independent predictors of death. The composite prognostic index (CPI) was constructed as DIC resolution (yes: 1, no: 0) + rate of SOFA score change (Day 0 SOFA score-Day 3 SOFA score/Day 0 SOFA score). When the CPI is higher than 0.19, the patients are judged to survive. Concerning the derivation cohort, AUROC for survival was 0.76. As for the validation cohort, AUROC was 0.71.
CONCLUSIONS: CPI can predict the 28-day survival of septic patients with DIC who have undergone antithrombin treatment. It is simple and easy to calculate and will be useful in practice.
METHODS: The cohort for derivation was established utilizing the dataset from post-marketing surveys, while the cohort for validation was acquired from Japan\'s nationwide sepsis registry data. Through univariate and multivariate analyses, variables that were independently associated with 28-day mortality were identified within the derivation cohort. Risk variables were then assigned a weighted score based on the risk prediction function, leading to the development of a composite index. Subsequently, the area under the receiver operating characteristic curve (AUROC). 28-day survival was compared by Kaplan-Meier analysis.
RESULTS: In the derivation cohort, 252 (16.9%) of the 1492 patients deceased within 28 days. Multivariable analysis identified DIC resolution (hazard ratio [HR]: 0.31, 95% confidence interval [CI]: 0.22-0.45, P < 0.0001) and rate of Sequential Organ Failure Assessment (SOFA) score change (HR: 0.42, 95% CI: 0.36-0.50, P < 0.0001) were identified as independent predictors of death. The composite prognostic index (CPI) was constructed as DIC resolution (yes: 1, no: 0) + rate of SOFA score change (Day 0 SOFA score-Day 3 SOFA score/Day 0 SOFA score). When the CPI is higher than 0.19, the patients are judged to survive. Concerning the derivation cohort, AUROC for survival was 0.76. As for the validation cohort, AUROC was 0.71.
CONCLUSIONS: CPI can predict the 28-day survival of septic patients with DIC who have undergone antithrombin treatment. It is simple and easy to calculate and will be useful in practice.
摘要：
背景：没有可靠的指标可以在短期内评估抗凝治疗对脓毒症相关的弥散性血管内凝血（DIC）的治疗效果。这项研究的目的是开发和验证预后指数，以确定在3天治疗后接受抗凝血酶浓缩物治疗的脓毒症DIC患者的28天死亡率。
方法：推导队列是利用上市后调查的数据集建立的，而用于验证的队列是从日本全国脓毒症登记数据中获得的。通过单变量和多变量分析，在推导队列中确定了与28日死亡率独立相关的变量.然后根据风险预测函数为风险变量分配加权分数，导致综合指数的发展。随后，受试者工作特征曲线下面积(AUROC)。通过Kaplan-Meier分析比较28天存活。
结果：在派生队列中，1492例患者中有252例（16.9%）在28天内死亡。多变量分析确定DIC分辨率（风险比[HR]：0.31，95％置信区间[CI]：0.22-0.45，P<0.0001）和序贯器官衰竭评估（SOFA）评分变化率（HR：0.42，95％CI：0.36-0.50，P<0.0001）被确定为死亡的独立预测因子。综合预后指数（CPI）构建为DIC分辨率（是：1，否：0）+SOFA评分变化率（第0天SOFA评分-第3天SOFA评分/第0天SOFA评分）。当CPI高于0.19时,判定患者存活。关于派生队列，存活的AUROC为0.76。至于验证队列，AUROC为0.71。
结论：CPI可以预测接受抗凝血酶治疗的DIC脓毒症患者的28天生存率。它计算简单，易于计算，在实践中很有用。
方法：推导队列是利用上市后调查的数据集建立的，而用于验证的队列是从日本全国脓毒症登记数据中获得的。通过单变量和多变量分析，在推导队列中确定了与28日死亡率独立相关的变量.然后根据风险预测函数为风险变量分配加权分数，导致综合指数的发展。随后，受试者工作特征曲线下面积(AUROC)。通过Kaplan-Meier分析比较28天存活。
结果：在派生队列中，1492例患者中有252例（16.9%）在28天内死亡。多变量分析确定DIC分辨率（风险比[HR]：0.31，95％置信区间[CI]：0.22-0.45，P<0.0001）和序贯器官衰竭评估（SOFA）评分变化率（HR：0.42，95％CI：0.36-0.50，P<0.0001）被确定为死亡的独立预测因子。综合预后指数（CPI）构建为DIC分辨率（是：1，否：0）+SOFA评分变化率（第0天SOFA评分-第3天SOFA评分/第0天SOFA评分）。当CPI高于0.19时,判定患者存活。关于派生队列，存活的AUROC为0.76。至于验证队列，AUROC为0.71。
结论：CPI可以预测接受抗凝血酶治疗的DIC脓毒症患者的28天生存率。它计算简单，易于计算，在实践中很有用。
