■通过对食品和药物管理局不良事件报告系统(FAERS)的分析,我们探讨了与秋水仙碱和他汀类药物联合使用引起的肌病相关的不良反应(ADR)的信号强度,并深入了解了这些肌病相关ADR的特点.
■我们从FAERS数据库中提取了秋水仙碱和他汀类药物联合使用导致肌病患者不良反应的相关数据。该分析是在2004年1月至2023年12月期间进行的,使用报告的优势比(ROR)和信息成分(IC)方法评估肌肉相关的ADR信号。
■共有18,386例他汀类药物肌病相关不良反应报告,348秋水仙碱肌病相关不良反应,收集到461例因两者联合所致的肌肉相关不良反应;他汀类药物肌毒性事件的最强信号是坏死性肌炎(ROR50.47,95%CL41.74-61.01;IC3.7095%CL3.25-4.08);秋水仙碱肌毒性事件的最强信号是中毒性肌病(ROR32.50,95%CL5.89%CL1.51);他汀类药物联合秋水仙碱的最强信号是中毒性肌病(ROR159.85,95%CL111.60-228.98;IC7.2295%CL3.59-5.9);当两种药物按照秋水仙碱联合氟伐他汀的顺序联合使用时,肌肉相关的不良反应信号是有意义的(ROR187.38,95%CL96.68-363.17;IC6.9995%与colsim95%CL25.25-35.85;IC4.8095%CL3.96-5.12);秋水仙碱联合瑞舒伐他汀(ROR25.73,95%CL20.16-32.83;IC4.5995%CL3.38-4.98)与秋水仙碱联合阿托伐他汀(ROR25.73,95%CL22.33-29.66;IC4.5995%CL3.97-4.91其次是秋水仙碱联合普伐他汀(ROR13.67,95%CL9.17-20.37;IC3.7395%CL1.87-4.47),而洛伐他汀或匹伐他汀没有产生信号。
■当秋水仙碱和他汀类药物单独或联合使用时,会发生类似的不良反应;然而,这些反应的强度可能不同。为了最大限度地降低药物相互作用的风险,具有较少潜在相互作用的他汀类药物,比如洛伐他汀,匹伐他汀,还有普伐他汀,应该选择,在使用过程中应密切监测与肌病相关的指标和症状。
UNASSIGNED: Through an analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS), we explored the signal strength of adverse reactions (ADRs) related to myopathy caused by the combination of colchicine and statins and gained insight into the characteristics of these myopathy related ADRs.
UNASSIGNED: We extracted data from the FAERS database about ADRs in individuals with myopathy resulting from the combination of colchicine and statins. The analysis was conducted for the period spanning from January 2004 to December 2023 using the reported odds ratio (ROR) and information component (IC) methods to assess muscle-related ADR signals.
UNASSIGNED: A total of 18,386 reports of statin myopathy-associated adverse reactions, 348 colchicine myopathy-associated adverse reactions, and 461 muscle-associated adverse reactions due to the combination of the two were collected; the strongest signals of statin myotoxicity events were for necrotizing myositis (ROR 50.47, 95% CL 41.74-61.01; IC 3.70 95% CL 3.25-4.08); the strongest signal for colchicine myotoxicity events was toxic myopathy (ROR 32.50, 95% CL 19.74-53.51; IC 4.97 95% CL 1.89-5.10), and the strongest signal for statins combined with colchicine was toxic myopathy (ROR 159.85, 95% CL 111.60-228.98; IC 7.22 95% CL 3.59-5.9); muscle-related adverse reactions signals were meaningful when the two drugs were combined in the order of colchicine combined with fluvastatin (ROR 187.38, 95% CL 96.68-363.17; IC 6.99 95% CL 1.65-5.68); colchicine combined with simvastatin in 135 cases (ROR 30.08. 95% CL 25.25-35.85; IC 4.80 95% CL 3.96-5.12); and colchicine combined with rosuvastatin (ROR 25.73, 95% CL 20.16-32.83; IC 4.59 95% CL 3.38-4.98) versus colchicine combined with atorvastatin (ROR 25.73, 95% CL 22.33-29.66; IC 4.59 95% CL 3.97-4.91) with almost identical signal intensity, followed by colchicine combined with pravastatin (ROR 13.67, 95% CL 9.17-20.37; IC 3.73 95% CL 1.87-4.47), whereas no signals were generated for lovastatin or pitavastatin.
UNASSIGNED: Similar ADRs can occur when colchicine and statins are used individually or in combination; however, the strength of these reactions may differ. To minimize the risk of drug interactions, statins with less potential interactions, such as lovastatin, pitavastatin, and pravastatin, should be chosen, and myopathy-related indices and symptoms should be closely monitored during use.