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他汀类药物与肝损伤风险:一项基于人群的病例对照研究。

Statins and the risk of liver injury: a population-based case-control study.

作者信息

Chen Guan-Lin, Hsiao Fei-Yuan, Dong Yaa-Hui, Shen Li-Jiuan, Wu Fe-Lin Lin

机构信息

Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.

出版信息

Pharmacoepidemiol Drug Saf. 2014 Jul;23(7):719-25. doi: 10.1002/pds.3646. Epub 2014 May 14.

Abstract

OBJECTIVE

This case-control study investigated the association between statin use and liver injury using Taiwan's National Health Insurance Research Database.

METHODS

Our study subjects included 4165 cases (patients who had been admitted with a primary diagnosis of liver injury between 2002 and 2009) and 16 660 age-matched, sex-matched and index date-matched controls. Multivariable conditional regression models were used to estimate the association between statin use and liver injury.

RESULTS

Users of statins were not associated with risk of liver injury (adjusted odds ratio [aOR] 1.04; 95% confidence interval [0.90-1.19]) when compared with nonusers. Nevertheless, a higher dose of statin (≥1 defined daily dose; aOR 1.55 [1.14-2.11]) and use of rosuvastatin before event of liver injury (aOR 1.38 [1.03-1.85]) were significantly associated with liver injury.

CONCLUSIONS

This population-based study extends previous evidence by exploring the potential association between statins use and risk of liver injury. Overall, we found that statin was not associated with risk of liver injury. Nevertheless, special concern should be paid to those who used statin ≥1 defined daily dose and rosuvastatin.

摘要

目的

本病例对照研究利用台湾全民健康保险研究数据库,调查他汀类药物使用与肝损伤之间的关联。

方法

我们的研究对象包括4165例病例(2002年至2009年间因肝损伤为主诊断入院的患者)以及16660例年龄、性别和索引日期匹配的对照。采用多变量条件回归模型来估计他汀类药物使用与肝损伤之间的关联。

结果

与未使用者相比,他汀类药物使用者与肝损伤风险无关(校正比值比[aOR]为1.04;95%置信区间[0.90 - 1.19])。然而,更高剂量的他汀类药物(≥1限定日剂量;aOR为1.55[1.14 - 2.11])以及在肝损伤事件发生前使用瑞舒伐他汀(aOR为1.38[1.03 - 1.85])与肝损伤显著相关。

结论

这项基于人群的研究通过探索他汀类药物使用与肝损伤风险之间的潜在关联,扩展了先前的证据。总体而言,我们发现他汀类药物与肝损伤风险无关。然而,对于使用≥1限定日剂量他汀类药物和瑞舒伐他汀的患者应给予特别关注。

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