A pharmacovigilance study on platinum associated cholangitis based on the FDA adverse event reporting system
摘要
Some clinical studies have found that some patients develop cholangitis after using platinum drugs. However, whether there is a correlation between platinum drugs and the occurrence of cholangitis remains controversial. This study aims to determine the association between platinum drugs and cholangitis by exploring the FAERS database.
MethodReports of platinum-related cholangitis in the FAERS database from the first quarter of 2004 to the second quarter of 2024 were collected and analyzed. Disproportional analysis, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM) algorithms, is used in data mining to quantify the signals of platinum-related cholangitis.
ResultsFurther analysis of different platinum drugs showed that the use of three types of platinum drugs, oxaliplatin, cisplatin and carboplatin, is all associated with the occurrence of cholangitis. Among female patients who used platinum-based drugs, the use of each of the three platinum-based drugs was significantly correlated with the occurrence of cholangitis. However, among male patients who used platinum-based drugs, a correlation with the occurrence of cholangitis was only observed for oxaliplatin use. In addition, patients with carboplatin induced cholangitis had the highest hospitalization rate, and patients with oxaliplatin induced cholangitis had the highest mortality rate.
ConclusionThe results of this study confirm that there is a strong correlation between the use of platinum drugs and the occurrence of cholangitis. Furthermore, this conclusion has also been confirmed in the female population using platinum-based drugs. We also found that patients with oxaliplatin-related cholangitis had the highest mortality rate and patients with carboplatin-related cholangitis had the highest hospitalization rate.