他汀类药物相关不良反应的信号挖掘与评价——基于美国OpenFDA公共数据开放项目的数据挖掘研究
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摘要
目的:挖掘他汀类药物(普伐他汀、洛伐他汀、辛伐他汀、氟伐他汀、瑞舒伐他汀、阿托伐他汀)的安全警戒信号,从不良反应(ADR)信号角度比较6种药物在安全性上的差异。方法:采用报告比值比(ROR)法对2004年1月1日至2017年1月1日的FDA公共数据开放项目数据库中他汀药物的肌肉、肝胆、肾脏以及神经4个系统的重点ADR报告进行风险信号挖掘。结果:在此期间OpenFDA数据库的ADR报告数为7 108 870例,他汀类药物的ADR报告数为295 810例。辛伐他汀和氟伐他汀的肌肉系统风险信号强度相对其他药物更高,洛伐他汀和普伐他汀的肌肉系统风险信号强度相对较低。氟伐他汀发生肝胆、肾脏系统ADR的系统风险信号强度相对其他药物更高,洛伐他汀的肝胆、肾脏系统风险信号强度相对较低。氟伐他汀的神经系统风险信号相对其他药物更低。结论:本文分析比较了他汀类药物的ADR信号风险。对Open FDA进行数据挖掘可以了解他汀类药物的ADR情况,为该类药物的安全使用提供预警。
Objective: To mine and evaluate the adverse drug reaction signals of statins( pravastatin,lovastatin,simvastatin,fluvastatin,rosuvastatin and atorvastatin) and determine the rank-order of the association.Methods: To assess the muscular,hepatobiliary,renal and nervous system adverse drug reactions( ADR),the reporting odds ratio( ROR) method was used for quantitative detection of signals from the data in the FDA public data program( OpenFDA) during 2004-2017. Results: Based on 7 108 870 ADR cases from OpenFDA,295 810 statin-associated ADR cases were retrieved. Muscular system ADR signals were stronger for simvastatin and fluvastatin than other stains. Hepatobiliary and renal system ADR signals were stronger for fluvastatin than other stains. Nervoussystem ADR signals were weaker for fluvastatin than other stains. Conclusion: The latest information about statinassociated ADR herein is summarized for signal detection. Data mining of the OpenFDA is useful for examining ADR signals and can provide useful early-warning of drug safety.
Objective: To mine and evaluate the adverse drug reaction signals of statins( pravastatin,lovastatin,simvastatin,fluvastatin,rosuvastatin and atorvastatin) and determine the rank-order of the association.Methods: To assess the muscular,hepatobiliary,renal and nervous system adverse drug reactions( ADR),the reporting odds ratio( ROR) method was used for quantitative detection of signals from the data in the FDA public data program( OpenFDA) during 2004-2017. Results: Based on 7 108 870 ADR cases from OpenFDA,295 810 statin-associated ADR cases were retrieved. Muscular system ADR signals were stronger for simvastatin and fluvastatin than other stains. Hepatobiliary and renal system ADR signals were stronger for fluvastatin than other stains. Nervoussystem ADR signals were weaker for fluvastatin than other stains. Conclusion: The latest information about statinassociated ADR herein is summarized for signal detection. Data mining of the OpenFDA is useful for examining ADR signals and can provide useful early-warning of drug safety.
引文
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[10] LIN SF,CHAN A. Statin-related myopathy[J]. J Taiwan Pharmacy,2011,27(2):116-120.
[11] HARGREAVES DIP,DUNCAN AJ,HEALES SJR,et al. The effect of Hmg-Coa reductase inhibitors on coenzyme Q10[J].Drug Safety,2005,28(8):659-676.
[12] BAYS H. Statin safety:an overview and assessment of the data-2005[J]. Am J Cardiol,2006,97(8A):6C-26C.
[13] COHEN DE,ANANIA FA,CHALASANI N. An assessment of statin safety by hepatologists[J]. Am J Cardiol,2006,97(8A):77C-81C.
[14] SWIGER KJ,MANALAC RJ,BLAHA MJ,et al. Statins,mood,sleep,and physical function:a systematic review[J]. Eur J Clin Pharmacol,2014,70(12):1413-1422.
[2] DUMOUCHEL W. Bayesian data mining in large frequency tables,with an application to the FDA spontaneous reporting system[J]. Amer Statist,1999,53(3):177-190.
[3]彭媛,王程程,唐利,等.西格列汀上市后致皮肤不良反应的信号挖掘与评价[J].中国药房,2014,25(2):156-158.
[4] KADOYAMA K,MIKI I,TAMURA T,et al. Adverse event profiles of 5-fluorouracil and capecitabine:data mining of the public version of the FDA adverse event reporting system,aers,and reproducibility of clinical observations[J]. Int J Med Sci,2012,9(1):33-39.
[5] KOSE E,UNO K,HAYASHI H. Evaluation of the expression profile of extrapyramidal symptoms due to antipsychotics by data mining of Japanese adverse drug event report(Jader)database[J]. Yakugaku Zasshi,2017,137(1):111-120.
[6] BROWN WV. Safety of statins[J]. Curr Opin Lipidol,2008,19(6):558-562.
[7] DAVIDSON MH,CLARK JA,GLASS LM,et al. Statin safety:an appraisal from the adverse event reporting system[J]. Am J Cardiol,2006,97(8A):32C-43C.
[8]侯永芳,王玲,郭秀花,等.信号检测在药品不良反应监测系统中的应用[J].中国药物警戒,2012,9(9):539-541.
[9]他汀类药物安全性评价工作组.他汀类药物安全性评价专家共识[J].中华心血管病杂志,2014,42(11):890-894.
[10] LIN SF,CHAN A. Statin-related myopathy[J]. J Taiwan Pharmacy,2011,27(2):116-120.
[11] HARGREAVES DIP,DUNCAN AJ,HEALES SJR,et al. The effect of Hmg-Coa reductase inhibitors on coenzyme Q10[J].Drug Safety,2005,28(8):659-676.
[12] BAYS H. Statin safety:an overview and assessment of the data-2005[J]. Am J Cardiol,2006,97(8A):6C-26C.
[13] COHEN DE,ANANIA FA,CHALASANI N. An assessment of statin safety by hepatologists[J]. Am J Cardiol,2006,97(8A):77C-81C.
[14] SWIGER KJ,MANALAC RJ,BLAHA MJ,et al. Statins,mood,sleep,and physical function:a systematic review[J]. Eur J Clin Pharmacol,2014,70(12):1413-1422.