关键词: 巴利昔单抗, 肾移植, 肝移植, 运用信息成分法, 报告比值比, 神经系统疾病, 眼器官疾病

Abstract: Objective To explore the adverse event signals of basiliximab after kidney transplantation and liver transplantation, and to assess the safety of its clinical applications by finding some new suspicious signals of adverse events. Methods By adopting two signal mining methods-the information component (IC) method and the reporting odds ratio (ROR) method- and based on the proportion imbalance approach, the adverse events of basiliximab collected between January 1, 2004 and June 30, 2024 were retrieved from the FDA's Adverse Event Reporting System (FAERS) database. Results A total of 92 suspicious positive signals were identified for basiliximab after kidney transplantation, involving 26 system-organ classes (SOCs), compared with 27 after liver transplantation, involving 23 SOCs. Increased serum creatinine, fever, anemia, decreased platelet count, increased blood glucose, decreased blood pressure and other adverse reactions were consistent with the conditions specified in the instructions of basiliximab. After excluding the adverse reactions related to kidney transplantation itself, decreased lymphocyte count, increased white blood cell count and neutrophil count, elevated alanine aminotransferase, higher levels of blood lactate dehydrogenase, higher aspartate aminotransferase, abnormal liver function, lymphocyte infiltration, chest discomfort, diffuse intravascular coagulation, neurotoxicity after renal transplantation and other new suspicious signals of adverse events not mentioned in drug labels were found. New suspicious signals of adverse events after liver transplantation, such as shock, pleural effusion and elevated C-reactive protein, were detected after the possible adverse reactions of liver transplantation itself were excluded. Conclusion Rigorous monitoring is critical when basiliximab is used clinically. Special attention needs to be paid not only to suspicious adverse event signals that are left unmentioned in instructions, such as nervous system diseases, ocular diseases and thrombotic diseases caused by hypercoagulability after kidney transplantation, but also to new and serious suspected adverse event signals such as shock and pleural effusion after liver transplantation.

Key words: Basiliximab, Kidney Transplantation, Liver Transplantation, Information Component (IC) Method, Reporting Odds Ratio (ROR) Method, Neurological Disorders, Ocular Diseases