PDF(Pubmed)
Abstract：
OBJECTIVE: The use of cefoperazone/sulbactam (CPZ/SAM) could commonly cause vitamin K-dependent coagulation disorders and even hemorrhage sometimes. However, there is a lack of prediction tools estimating the risk for this. This study aimed at developing and internally validating a model for predicting CPZ/SAM-associated coagulation disorders in Chinese inpatients.
METHODS: A case-control study was conducted in 11,092 adult inpatients admitted to a Chinese general hospital between 2020 and 2021 and treated with CPZ/SAM. Patients with CPZ/SAM-associated coagulation disorders were identified through the Adverse Drug Events Active Surveillance and Assessment System-II and subsequent manual evaluation. Controls were selected from eligible patients who didn\'t develop coagulation disorders after CPZ/SAM therapy, with a 1:1 propensity score matching. The final predictors were obtained by univariable and multivariable logistic regression analyses. Internal validation and calibration for the model were performed using 1000 bootstrap resamplings.
RESULTS: 258 patients were identified as CPZ/SAM-associated coagulation disorders in 2184 patients eligible for inclusions and exclusions and the incidence was 11.8%. A final population of 252 cases and 252 controls was included for model development and validation. Malnutrition (OR = 2.41 (1.56-3.77)), history of recent bleeding (OR = 1.95 (1.32-2.90)), treatment duration (OR = 1.10 (1.07-1.14)), combination with carbapenems (OR = 4.43 (1.85-11.88)), and serum creatinine (OR = 1.01 (1.00-1.01)) were identified as final predictors. The model showed good discrimination, calibration, and clinical practicality, with the validated area under the receiver operating characteristic curve being 0.723 (0.683-0.770).
CONCLUSIONS: The model with good performance quantifies the risk for CPZ/SAM-associated coagulation disorders, and may support individual assessment and interventions to mitigate the risk after external validation.
METHODS: A case-control study was conducted in 11,092 adult inpatients admitted to a Chinese general hospital between 2020 and 2021 and treated with CPZ/SAM. Patients with CPZ/SAM-associated coagulation disorders were identified through the Adverse Drug Events Active Surveillance and Assessment System-II and subsequent manual evaluation. Controls were selected from eligible patients who didn\'t develop coagulation disorders after CPZ/SAM therapy, with a 1:1 propensity score matching. The final predictors were obtained by univariable and multivariable logistic regression analyses. Internal validation and calibration for the model were performed using 1000 bootstrap resamplings.
RESULTS: 258 patients were identified as CPZ/SAM-associated coagulation disorders in 2184 patients eligible for inclusions and exclusions and the incidence was 11.8%. A final population of 252 cases and 252 controls was included for model development and validation. Malnutrition (OR = 2.41 (1.56-3.77)), history of recent bleeding (OR = 1.95 (1.32-2.90)), treatment duration (OR = 1.10 (1.07-1.14)), combination with carbapenems (OR = 4.43 (1.85-11.88)), and serum creatinine (OR = 1.01 (1.00-1.01)) were identified as final predictors. The model showed good discrimination, calibration, and clinical practicality, with the validated area under the receiver operating characteristic curve being 0.723 (0.683-0.770).
CONCLUSIONS: The model with good performance quantifies the risk for CPZ/SAM-associated coagulation disorders, and may support individual assessment and interventions to mitigate the risk after external validation.
摘要：
目的：使用头孢哌酮/舒巴坦（CPZ/SAM）通常可引起维生素K依赖性凝血功能紊乱，有时甚至出血。然而,缺乏估计风险的预测工具。本研究旨在开发和内部验证预测中国住院患者CPZ/SAM相关凝血障碍的模型。
方法：对2020年至2021年在中国综合医院接受CPZ/SAM治疗的11,092例成人住院患者进行了病例对照研究。通过药物不良事件主动监测和评估系统-II和随后的手动评估来鉴定患有CPZ/SAM相关凝血障碍的患者。对照组选自CPZ/SAM治疗后未出现凝血功能紊乱的合格患者，1：1的倾向得分匹配。通过单变量和多变量逻辑回归分析获得最终预测因子。使用1000次自举重新采样进行模型的内部验证和校准。
结果：在符合纳入和排除的2184例患者中，258例患者被确定为CPZ/SAM相关凝血障碍，发生率为11.8%。最终包括252个病例和252个对照的群体用于模型开发和验证。营养不良（OR=2.41（1.56-3.77）），近期出血病史（OR=1.95（1.32-2.90）），治疗持续时间（OR=1.10（1.07-1.14）），与碳青霉烯类抗生素组合（OR=4.43（1.85-11.88）），和血清肌酐（OR=1.01（1.00-1.01））被确定为最终预测因子。该模型显示出良好的鉴别力，校准,和临床实用性，接收器工作特性曲线下的验证面积为0.723（0.683-0.770）。
结论：性能良好的模型量化了CPZ/SAM相关凝血障碍的风险，并可能支持个人评估和干预措施，以减轻外部验证后的风险。
方法：对2020年至2021年在中国综合医院接受CPZ/SAM治疗的11,092例成人住院患者进行了病例对照研究。通过药物不良事件主动监测和评估系统-II和随后的手动评估来鉴定患有CPZ/SAM相关凝血障碍的患者。对照组选自CPZ/SAM治疗后未出现凝血功能紊乱的合格患者，1：1的倾向得分匹配。通过单变量和多变量逻辑回归分析获得最终预测因子。使用1000次自举重新采样进行模型的内部验证和校准。
结果：在符合纳入和排除的2184例患者中，258例患者被确定为CPZ/SAM相关凝血障碍，发生率为11.8%。最终包括252个病例和252个对照的群体用于模型开发和验证。营养不良（OR=2.41（1.56-3.77）），近期出血病史（OR=1.95（1.32-2.90）），治疗持续时间（OR=1.10（1.07-1.14）），与碳青霉烯类抗生素组合（OR=4.43（1.85-11.88）），和血清肌酐（OR=1.01（1.00-1.01））被确定为最终预测因子。该模型显示出良好的鉴别力，校准,和临床实用性，接收器工作特性曲线下的验证面积为0.723（0.683-0.770）。
结论：性能良好的模型量化了CPZ/SAM相关凝血障碍的风险，并可能支持个人评估和干预措施，以减轻外部验证后的风险。
