Background: Platelets and coagulation factors are critical to stabilizing blood circulation, and the malfunction of either of them will lead to impaired hemostasis (clinically manifested as bleeding sometimes), which is defined as coagulopathy. As application of antibacterial becomes more and more extensive in clinics, the risk of coagulopathy associated with it is of increasing concern.
Objectives: This research aimed at exploring the regularity and characteristics of antibacterial-induced coagulopathy, to provide a reference for safe use of antibacterial in clinics.
Methods: We examined antibacterial-induced coagulopathy reports submitted to the adverse drug reactions(ADR) surveillance system of Chinese PLA, and reviewed demographic and clinical characteristics of the study group, primary suspect drug, therapies and outcomes of reports. Meanwhile, we detected signals on ADR with the method using the 95% confidence interval (CI) for the reporting odds ratio (RORCI) and the Bayesian Confidence Propagation Neural Network (BCPNN). All cases were divided into three subgroups, including coagulation dysfunction, thrombocytopenia, and coagulation dysfunction accompanied with thrombocytopenia, according to different mechanisms of coagulopathy.
Results: Most of patients were male (69.84%) and over 60 years old (76.98%). The majority (95.52%) of ADR occurred within 15 days after medication, and lasted for no more than 14 days (95.48%). Patients with coagulation dysfunction alongside thrombocytopenia got a higher risk of bleeding(P < 0.001). We confirmed association of coagulopathy and 13 antibacterial types. Cefoperazone, tigecycline, and linezolid showed the strongest signals, and related to both coagulation dysfuction and thrombocytopenia. Moreover, We found several signals unlisted in the instructions, such as cefoperazone-induced hypofibrinogenemia, tigecycline-induced thrombin time prolongation, and linezolid-induced prothrombin time prolongation. Among the study population, 85% was cured or got better after drug withdrawal or (and) supportive care.
Conclusions: There are many types of antibacterial drugs being related to coagulopathy, but surveillance and evaluation of bleeding risk should be focused on those associated with both coagulation dysfunction and thrombocytopenia. Coagulation indicators should be monitored on time in clinics, and once they getting abnormal, dosage regimen of antibacterial should be changed in time and supportive care was needed, to prevent the occurrence of serious bleeding events.
