他汀类药物的使用与认知能力下降、糖尿病及癌症之间的关系

中国临床药理学与治疗学 ›› 2014, Vol. 19 ›› Issue (10): 1132-1138.

他汀类药物的使用与认知能力下降、糖尿病及癌症之间的关系

蒋朋利¹, 吴晶¹, 孙鹤^{1, 2}

¹ 天津大学药物科学与技术学院,天津 300072;
² 天津天士力集团,天津 300410

收稿日期:2013-07-25 修回日期:2014-09-02 出版日期:2014-10-26 发布日期:2014-10-29
通讯作者: 孙鹤,男,博士,教授,博士生导师,研究方向:药政管理与临床药理。Tel: 022-27892883 E-mail: henrysunusa@gmail.com
作者简介:蒋朋利,女,硕士研究生,研究方向:药事管理。Tel: 022-27892883 E-mail: aflyingsoul@aliyun.com

Association of cognitive decline, diabetes mellitus and cancer with statins use: gaining insight through the FDA pharmacovigilance database

JIANG Peng-li¹, WU Jing¹, SUN He^{1, 2}

1School of Pharmaceutical Science and Technology, Tianjin University, Tianjin 300072, China;
² Tianjin Tasly Group, Tianjin 300410, China

Received:2013-07-25 Revised:2014-09-02 Online:2014-10-26 Published:2014-10-29

摘要/Abstract

摘要： 目的基于美国食品药品监督管理局不良反应自发呈报系统数据库探讨他汀类药物的使用与认知能力下降,糖尿病及癌症之间的统计学关系。方法利用国际上常用的不良反应信号挖掘算法,成比例报告比值法(PRR),报告比值比法(ROR),贝叶斯判别区间递进神经网络法(BCPNN),伽玛泊松缩减法(GPS),对不良反应自发呈报系统数据库进行大规模的数据挖掘。结果在分析他汀类药物与认知能力下降之间的关系中,4种不良反应信号挖掘算法的信号检测值分别为 2.03、2.03、0.80 和 1.77,即PRR、ROR、BCPNN检测到他汀类药物的使用可能会导致患者的认知能力下降,具体到每一种他汀类药物,PRR、ROR、BCPNN均检测到阿托伐他汀的使用可能会导致患者的认知能力下降,PRR和ROR检测到氟伐他汀的使用可能会导致患者的认知能力下降;在分析他汀类药物与糖尿病之间的统计学关系中,4种不良反应信号挖掘算法的信号检测值分别为 2.35、2.42、1.09 和 2.12,即PRR、ROR、BCPNN、GPS均检测到他汀类药物的使用可能会诱发糖尿病,具体到每一种他汀类药物,PRR、ROR、BCPNN均检测到辛伐他汀,阿托伐他汀和洛伐他汀的使用可能诱发糖尿病;在分析他汀类药与癌症之间的统计学关系中,4种不良反应信号检测算法的信号检测值分别为 0.90、0.89、-0.17 和 1.00,即PRR、ROR、BCPNN、GPS均没有发现他汀类药物的使用可能会引发癌症。结论美国食品药品监督管理局不良反应自发呈报系统数据库是探索他汀类药物的使用与认知能力下降,糖尿病和癌症之间关系的有力工具,他汀类药物的后续临床研究应密切关注与他汀类药物有关的不良反应。

关键词: 他汀类药物, 认知能力下降, 糖尿病, 癌症, 不良反应, 药物警戒

Abstract: AIM: To analyze the association between statins use and cognitive decline, diabetes mellitus and cancer through the US Food and Drug Administration (FDA) Adverse Event Reporting System (AERS). METHODS: Widely used pharmacovigilance tools were adopted for quantitative detection of signals, i.e. drug-associated adverse events, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the Bayesian confidence propagation neural network (BCPNN) and the gamma possion shrinker (GPS). RESULTS: As for the association between statins use and cognitive decline, results of four algorithms are respectively 2.03,2.03,0.80,1.77, PRR,ROR and BCPNN were indicative of a definite risk, especially for atorvastatin and fluvastatin; as for the association between statin use and diabetes mellitus, results of four algorithms are respectively 2.35,2.42,1.09,2.12, PRR,ROR,BCPNN and GPS were all indicative of a definite risk, especially for simvastatin, atorvastatin and lovastatin; as for the association between statin use and cancer, results of four algorithms are respectively 0.90,0.89,-0.17,1.00, PRR,ROR,BCPNN and GPS all found no convincing evidence for risk of cancer after statins use. CONCLUSION: Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statins-associated cognitive decline, diabetes mellitus and cancer. The data strongly suggest the necessity of well-organized clinical studies with respect to statins-associated adverse events.

Key words: statins, cognitive decline, diabetes mellitus, cancer, adverse event, pharmacovigilance

中图分类号:

R972⁺.6

蒋朋利, 吴晶, 孙鹤. 他汀类药物的使用与认知能力下降、糖尿病及癌症之间的关系[J]. 中国临床药理学与治疗学, 2014, 19(10): 1132-1138.

JIANG Peng-li, WU Jing, SUN He. Association of cognitive decline, diabetes mellitus and cancer with statins use: gaining insight through the FDA pharmacovigilance database[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2014, 19(10): 1132-1138.

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