» Articles » PMID: 38997770

Development and Internal Validation of a Model for Predicting Cefoperazone/sulbactam-associated Coagulation Disorders in Chinese Inpatients

Overview
Publisher Biomed Central
Specialty Pharmacology
Date 2024 Jul 12
PMID 38997770
Authors
Affiliations
Soon will be listed here.
Abstract

Background And Aim: 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.

Citing Articles

Characteristics, risk factors and a risk prediction model of tocilizumab-induced hypofibrinogenemia: a retrospective real-world study of inpatients.

Cai L, Wen X, Qiu Z, Fu A, Guo D, Zhu M BMC Pharmacol Toxicol. 2025; 26(1):5.

PMID: 39789607 PMC: 11721054. DOI: 10.1186/s40360-024-00827-6.

References
1.
Wu S, Wu G, Wu H . A Comparison of Coagulation Function in Patients Receiving Aspirin and Cefoperazone-Sulbactam With and Without Vitamin K: A Retrospective, Observational Study. Clin Ther. 2021; 43(12):e335-e345. DOI: 10.1016/j.clinthera.2021.10.005. View

2.
ROCKOFF S, Blumenfrucht M, Irwin Jr R, Eng R . Vitamin K supplementation during prophylactic use of cefoperazone in urologic surgery. Infection. 1992; 20(3):146-8. DOI: 10.1007/BF01704604. View

3.
Levi M, van der Poll T . Coagulation in patients with severe sepsis. Semin Thromb Hemost. 2015; 41(1):9-15. DOI: 10.1055/s-0034-1398376. View

4.
Naranjo C, Busto U, Sellers E, Sandor P, Ruiz I, Roberts E . A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981; 30(2):239-45. DOI: 10.1038/clpt.1981.154. View

5.
Abd-El-Gawad W, Abou-Hashem R, El Maraghy M, Amin G . The validity of Geriatric Nutrition Risk Index: simple tool for prediction of nutritional-related complication of hospitalized elderly patients. Comparison with Mini Nutritional Assessment. Clin Nutr. 2014; 33(6):1108-16. DOI: 10.1016/j.clnu.2013.12.005. View