| アブストラクト | OBJECTIVE: Cardiac therapy drugs are widely used in the treatment of heart disease. However, the concern regarding adverse events (AEs) of cardiac therapy drugs have been rising. This study aimed to analyse cardiac therapy drug-related AEs using the Jinan adverse event reporting system (JAERS) database mining and conduct a comprehensive evaluation to provide safe medication information for patients. DESIGN: Retrospective observational study. SETTING: In this study, cardiac therapy drug-related AEs were detected using the JAERS database from January 2000 to March 2022. METHODS: Reports of cardiac therapy drug-related AEs were extracted from JAERS database, and the basic information of patients, reports and common AEs were analysed. Four disproportionality analysis methods, proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), Medicines and Healthcare products Regulatory Agency (MHRA), were used to detect cardiac therapy drug-related signals. We further checked whether the detected signals exist on drug labels in China and two developed countries, the USA and Japan. RESULTS: In total, 168 314 AEs were reported, of which 4788 were associated with cardiac therapy drugs. Using the PRR, ROR, MHRA and BCPNN method, we detected 52 signals, 52 signals, 33 signals and 43 signals, respectively. Among the 52 signals, 14 were not included on the drug labels of China. One (isosorbide mononitrate-head bilges) was not included on the drug labels of the three countries. CONCLUSION: We identified 14 new cardiac therapy drug signals that did not appear on drug labels in China and 1 new signal that did not appear on drug labels in 3 counties. A causal link between cardiac therapy drugs and AEs should be evaluated in further studies. |
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| ジャーナル名 | BMJ open |
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| 投稿日 | 2023/1/21 |
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| 投稿者 | Guan, Yuyao; Qi, Yingmei; Zheng, Lei; Yang, Jing; Zhang, Mingzhu; Zhang, Qiuhong; Ji, Lei |
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| 組織名 | Department of Pharmacy, Shandong University Affiliated Shandong Provincial Third;Hospital, Jinan, Shandong, China jilei2022022022@163.com zhangqiuhong2222@163.com;guanxiaoyao0815@163.com.;Jinan Adverse Drug Reactions and Medical Device Adverse Event Monitoring Center,;Jinan, Shandong, China.;Hospital, Jinan, Shandong, China.;Jinan, Shandong, China jilei2022022022@163.com zhangqiuhong2222@163.com;Shandong Provincial Key Laboratory of Applied Microbiology, Ecology Institute,;Qilu University of Technology, Jinan, Shandong, China jilei2022022022@163.com;zhangqiuhong2222@163.com guanxiaoyao0815@163.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36669842/ |
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