| アブストラクト | BACKGROUND: Bortezomib, carfilzomib and ixazomib are the most common proteasome inhibitors (PIs) used to treat Multiple Myeloma (MM). We conducted a pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS), aiming to offer a reference for safe and reasonable clinical use. RESEARCH DESIGN AND METHODS: Adverse drug reaction (ADR) signals of bortezomib, carfilzomib and ixazomib were analyzed by statistical methods including Reporting Odds Ratio (ROR), Proportional Reporting Ratios (PRR), and Multi-item Gamma-Poisson Shrinker (MGPS). RESULTS: A total of 13,977, 8263 and 13296 ADRs of bortezomib, carfilzomib and ixazomib were analyzed respectively from the FAERS database. The most frequent adverse reaction signal for bortezomib was peripheral neuropathy; for carfilzomib, it was acute kidney injury; for ixazomib, it was vomiting. Then, a total of 43, 23 and 10 infection-related adverse events of bortezomib, carfilzomib and ixazomib were analyzed. The most common infection-related adverse event for bortezomib was cytomegalovirus infection; for carfilzomib, it was bacteremia; and for ixazomib, it was conjunctivitis. CONCLUSIONS: In real-world pharmacovigilance studies, PIs are associated with infection-related adverse events, which is crucial for the safe use of PIs in the treatment of MM. However, further research is needed to validate the hypotheses generated in this study. |
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