| アブストラクト | OBJECTIVE: Neuroleptic malignant syndrome (NMS) is a rare but potentially life-threatening reaction associated with dopamine antagonists, particularly typical antipsychotics. Despite the relatively low incidence of NMS linked to atypical antipsychotics (AAPs), there is a notable lack of extensive real-world studies investigating this condition. METHODS: This study utilizes data from the FDA Adverse Event Reporting System (FAERS) from 2004 to 2024, employing disproportionality analysis to explore the association between fourteen commonly prescribed AAPs and NMS. Multivariate logistic regression was conducted to identify risk factors for mortality related to NMS. RESULTS: We analyzed 79,980 primary suspected adverse drug event (ADE) reports for NMS, revealing a slight male predominance and a median age of 48 years (Interquartile Range [IQR]: 31-64). Patients were primarily located in Europe and the United States. Ziprasidone exhibited the strongest pharmacovigilance signal (Reporting Odds Ratio [ROR] = 3.09; 95 % confidence interval [CI]: 2.97-3.21), while lurasidone showed the lowest signal strength (ROR = 1.58; 95 % CI: 1.52-1.65). The median time to onset of NMS was 42 days (IQR: 9-328.25). Significant mortality risk factors included age >/= 65 years (Odds Ratio [OR] = 4.45; 95 % CI: 3.33-5.95), Parkinson's disease (OR = 32.69; 95 % CI: 14.75-72.46), and malignant hyperthermia (OR = 25.23; 95 % CI: 8.62-73.83), with an area under the curve (AUC) of 0.877. CONCLUSION: This study provides vital pharmacovigilance insights regarding NMS related to AAPs, enhancing the understanding of its clinical implications. |
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| ジャーナル名 | Journal of affective disorders |
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| Pubmed追加日 | 2025/5/27 |
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| 投稿者 | He, Jinhao; Luo, Xuehu; Li, Cong; Zhong, Wei; Sun, Mo; Zhang, Chenning |
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| 組織名 | Department of Pharmacy, The Third Affiliated Hospital of Chengdu Medical College,;Chengdu Pidu District People's Hospital, Chengdu 611730, Sichuan, China.;School of Biological Sciences, Georgia Institute of Technology, Atlanta, GA;30332, USA.;Department of Pharmacy, Xiangyang No.1 People's Hospital, Hubei University of;Medicine, Xiangyang 441000, Hubei, China; National Key Laboratory on Technologies;for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture,;Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China. Electronic;address: zhangcn1118@163.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40419159/ |
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