アブストラクト | BACKGROUND: The main purpose of this study is to observe and detect adverse reactions to the combination of topotecan, bevacizumab and cyclophosphamide, to learn more about possible adverse drug reactions (ADRs) and to help doctors make the right medication decisions and treatment plans. RESEARCH DESIGN AND METHODS: Adverse event signals were detected and quantified using data from the U.S. Food and Drug Administration's Adverse Event Reporting System using reporting ratios, proportions of reports (PRR), Bayesian Confidence Propagation Neural Networks (BCPN), and empirical Bayesian Geometric Mean (EBGM). Subgroup analyses were performed to compare adverse events associated with topotecan alone. RESULTS: The analysis of FAERS data revealed a total of 1,789 primary suspected adverse events (PS AEs) linked to topotecan. The Weibull shape parameter (beta) for females was lower than for males across all age groups, indicating a potentially higher susceptibility to the adverse effects of topotecan in female patients. CONCLUSIONS: This study proved several expected and new adverse drug reactions associated with the combination of topotecan, bevacizumab, and cyclophosphamide. While some ADRs, such as neutropenia and anemia, align with the known adverse profile of topotecan, the detection of novel signals, including potential gender-based differences in drug response, warrants further investigation. |
ジャーナル名 | Expert opinion on drug safety |
Pubmed追加日 | 2025/4/2 |
投稿者 | Chen, Huihui; Zhuang, Guobiao; Hong, Shihao; Wu, Jing |
組織名 | Department of Obstetrics and Gynecology, Ninghai Maternal and Child Health;Hospital, Ningbo, China.;Assisted Reproduction Unit, Department of Obstetrics and Gynecology, Sir Run Run;Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.;Zhejiang University; Zhejiang Provincial Clinical Research Center for Obstetrics;and Gynecology, Hangzhou, China.;Zhejiang Key Laboratory of Precise Protection and Promotion of Fertility,;Hangzhou, China. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40172256/ |