Yin Yi, Jiang Jie, Jin Youpeng
Department of Pediatric Intensive Care Unit, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong Province, People's Republic of China.
Sci Rep. 2025 Mar 26;15(1):10499. doi: 10.1038/s41598-025-95700-9.
Rhabdomyolysis is a potentially fatal adverse reaction mainly caused by certain medications. Few real-world studies have shown a clear association between atypical antipsychotics and rhabdomyolysis. This study aimed to evaluate the association between atypical antipsychotics and rhabdomyolysis using the FDA Adverse Event Report System (FAERS) database. The data were obtained from the FAERS database from January 1, 2004 to December 31, 2023. To identify potential risk signals from the FAERS database, a disproportionality analysis was conducted using the reporting odds ratio (ROR) and corresponding 95% confidence intervals (CIs) with p-values adjusted via Bonferroni correction. The time to onset, hospitalization rate, and mortality of atypical antipsychotics associated rhabdomyolysis were also investigated. A total of 2360 rhabdomyolysis case reports from the FAERS database were considered. Quetiapine had the greatest proportion (27.75%). Olanzapine had the highest positive signal values of rhabdomyolysis. Statistically significant rhabdomyolysis RORs (95% CI) for atypical antipsychotics were (in descending order): olanzapine 4.02 (3.72-4.35), quetiapine 3.81 (0.53-27.6), ziprasidone 2.76 (2.19-3.49), risperidone 2.12 (1.91-2.35), aripiprazole 2 (1.8-2.21), clozapine 1.47 (1.31-1.64). In the time to onset analysis, all atypical antipsychotics associated rhabdomyolysis had early failure type characteristics, the risk of rhabdomyolysis occurrence would be gradually decreased over time. Our study highlights the importance of vigilant patient monitoring following the prescription of atypical antipsychotics to reduce the risk of rhabdomyolysis. It is necessary to monitor serum creatinine kinase (CK) level early, especially during dose adjustment or initiation of new atypical antipsychotics. This research may provide a valuable information for patients, clinicians, and others concerned with the safety of atypical antipsychotics, and optimize clinical practice.
横纹肌溶解症是一种主要由某些药物引起的潜在致命不良反应。很少有真实世界研究表明非典型抗精神病药物与横纹肌溶解症之间存在明确关联。本研究旨在使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库评估非典型抗精神病药物与横纹肌溶解症之间的关联。数据取自2004年1月1日至2023年12月31日的FAERS数据库。为了从FAERS数据库中识别潜在风险信号，采用报告比值比（ROR）和相应的95%置信区间（CIs）进行不成比例分析，并通过Bonferroni校正调整p值。还调查了非典型抗精神病药物相关横纹肌溶解症的发病时间、住院率和死亡率。共考虑了FAERS数据库中的2360例横纹肌溶解症病例报告。喹硫平的占比最大（27.75%）。奥氮平的横纹肌溶解症阳性信号值最高。非典型抗精神病药物的横纹肌溶解症ROR（95%CI）具有统计学意义的（按降序排列）：奥氮平4.02（3.72 - 4.35）、喹硫平3.81（0.53 - 27.6）、齐拉西酮2.76（2.19 - 3.49）、利培酮2.12（1.91 - 2.35）、阿立哌唑2（1.8 - 2.21）、氯氮平1.47（1.31 - 1.64）。在发病时间分析中，所有非典型抗精神病药物相关横纹肌溶解症均具有早期发病类型特征，横纹肌溶解症发生风险会随时间逐渐降低。我们的研究强调了在开具非典型抗精神病药物处方后对患者进行密切监测以降低横纹肌溶解症风险的重要性。有必要早期监测血清肌酸激酶（CK）水平，尤其是在剂量调整或开始使用新的非典型抗精神病药物期间。本研究可能为患者、临床医生及其他关注非典型抗精神病药物安全性的人员提供有价值的信息，并优化临床实践。
