关键词: 注射用头孢拉定, 报告比值比, 贝叶斯置信传播神经网络, 信号挖掘, 血尿症, 寒热不耐受

Abstract: Objective To analyze the adverse drug reaction (ADR) signals of cefradine for injection so as to provide a clinical reference for safe medication. Methods The ROR and BCPNN Methods were employed to mine and analyze signals in cefradine-related ICSRs collected between 2017 and 2023 by safety databases based on real-world data from medical institutions. Results A total of 268 cases were included, and a total of 15 overlapping signals were detected by both ROR and BCPNN Methods. Among them, there were 7 safety signals identified as expected ADR that were specified in package inserts, namely haematuria, injection-site pain, hypersensitivity, vomiting, nausea, abdominal discomfort and abdominal pain. Meanwhile there were 8 unexpected safety signals identified, including temperature intolerance, tachypnoea, chills, pallor, hypoaesthesia, swelling, dizziness and flushing. Conclusion When cefradine for injection is clinically used, dosage regimens should be determined based on the patient’s conditions. Special care has to be given to those patients who are male, or under 18 or taking a combination of drugs. Changes in urinary routine indexes and renal function should be monitored to prevent such ADR as haematuria. In addition, clinicians should provide pharmaceutical care and remain alert to unexpected potential risks in order to ensure the safety of patients.

Key words: Cefradine for Injection, ROR, BCPNN, Signal Mining, Haematuria, Temperature Intolerance