| アブストラクト | OBJECTIVE: This study aims to analyze adverse drug events (ADE) related to romosozumab from the second quarter of 2019 to the third quarter of 2023 from FAERS database. METHODS: The ADE data related to romosozumab from 2019 Q2 to 2023 Q3 were collected. After data normalization, four signal strength quantification algorithms were used: ROR (Reporting Odds Ratios), PRR (Proportional Reporting Ratios), BCPNN (Bayesian Confidence Propagation Neural Network), and EBGM (Empirical Bayesian Geometric Mean). RESULTS: Screening for romosozumab-related AEs (adverse events) included 23 system organ categories (SOCs). PT (preferred terms) levels were screened for adverse drug reaction (ADR) signals. A total of 7055 reports with romosozumab as the primary suspect (PS) and 14,041 PTs induced by romosozumab as PS were identified. Common significant signals of general disorders and administration site conditions, musculoskeletal and connective tissue disorders have emerged. Specifically, unexpected AEs such as gastrointestinal disorder, respiratory, thoracic and mediastinal disorders also occur. Notably, fracture (n = 503, ROR = 107.8, PRR = 103.83, IC = 6.6, EBGM = 97.02) and bone density abnormal (n = 429, ROR = 343.65, PRR = 332.77, IC = 8.08, EBGM = 271.34) exhibited relatively high occurrence rates and signal strengths. CONCLUSION: Our study identifies potential new AE signals and provides broader data support for the safety of romosozumab. In clinical application, doctors are provided with a warning to closely monitor adverse reactions to support their rational use in diseases such as osteoporosis. |
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| ジャーナル名 | Aging clinical and experimental research |
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| Pubmed追加日 | 2025/1/14 |
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| 投稿者 | Liu, Luyu; Wu, Shaobo; Wei, Liangliang; Xia, Zhihao; Ji, Jiajia; Huang, Dageng |
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| 組織名 | Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an,;710054, Shaanxi, China.;Department of Orthopaedics, Lanzhou University Second Hospital, Lanzhou, 730030,;Gansu, China.;710054, Shaanxi, China. huangdageng@xjtu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39808360/ |
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