B型肝炎患者中Statins藥物使用和急性肝炎住院風險之探討

The association between Statins use and risk of hospitalization for acute hepatitis in patients with HBV infection

陳孟吟(Meng-Yin Chen)

指導教授 ： 陳保中

國立臺灣大學/公共衛生學院/職業醫學與工業衛生研究所/碩士(2013年)

https://doi.org/10.6342/NTU.2013.03055

摘要

中文摘要
背景與目的
Statins藥物常運用於預防心血管疾病，但這類藥物有可能增加肝毒性以及肌肉毒性的風險。B型肝炎患者是急性肝炎的易感受族群。然而statins藥物用於B型肝炎患者的安全性仍不清楚。因此，本研究目的在於探討B型肝炎患者中statins藥物與因急性肝炎住院風險。
材料與方法
我們利用1999年到2010年的台灣全國健康保險資料庫建立本研究的B型肝炎研究世代。以Cox proportional hazards regression去計算危險比(hazard ratios)和95%信賴區間去探討B型肝炎患者使用statins藥物與急性肝炎之安全性。
結果
共有255,344 B型肝炎患者納入本研究，其中有283(0.11%)人於一年內因急性肝炎住院，在本研究族群中發生率為每十萬人年中有110.9，族群中有127,672 (50%)人使用statins藥物。經過校正可能的干擾因子，發現使用statins藥物並沒有影響一年內急性肝炎住院的發生，無論在不同的時間、劑量以及再次使用statins藥物者。
結論
無論在考慮累積劑量、藥物種類、再次使用statins藥物者，本研究未發現B型肝炎患者中使用statins藥物與急性肝炎住院相關性。B型肝炎患者使用statins藥物可能不會增加肝損傷的風險。

關鍵字

急性肝炎 ； statins類藥物 ； B型肝炎

並列摘要

ABSTRACT
Background
Statins are commonly used to prevent coronary heart disease and stroke, but they may increase the risk of hepatotoxicity and muscle toxicity. Hepatitis B virus (HBV) infected patients are more susceptible to acute hepatitis. However, the safety of statins use in patients with HBV infection is unclear. The purpose of this study was to investigate the association between statins use and risk of hospitalizations related to acute hepatitis in patients with HBV infection.
Patients and Methods
Ours study was a population-based retrospective cohort study. We used a nationwide data of HBV-infected patient from 1999 to 2010 from the Taiwanese National Health Insurance database. Cox proportional hazards regression was used to calculate the hazard ratios (HRs) and 95% CIs for the association between statins use and the occurrence of acute hepatitis in the HBV-infected study cohort.
Results
A total of 255,344 HBV-infected patients were included in the study cohort. Of these patients, 127,672 (50%) had used statins, and 283 (0.11%) were diagnosed with acute hepatitis within one year and incident rate of acute hepatitis in patients with HBV infection was 110.9 per 100000 person-years. After controlling for potential confounders, no association of acute hepatitis between statins user and non-statin user was found in different follow-up periods and doses within one year. Furthermore, no association with acute hepatitis between statin re-user and non-statin user in different follow-up periods was found.
Conclusions
Among patients with HBV infection, statins use may be not association with acute hepatitis regardless of larger cumulative dose, drug class of statins, re-user.
Statins given to HBV-infection patients may not associate with severe liver injury.

並列關鍵字

acute hepatitis ； statins ； HBV

參考文獻

1. Lewis JH, Mortensen ME, Zweig S, Fusco MJ, Medoff JR, Belder R. Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease: Results of a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Hepatology 2007;46(5):1453-63.

2. Bjornsson E JE, Kalaitzakis E. Hepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing. Journal of hepatology 2012;56(2):374-80.

3. http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm (Accessed on February 28. February 28, 2012.

4. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomised placebocontrolled trial. The Lancet 2002;360(9326):7-22.

5. Charles EC, Olson KL, Sandhoff BG, McClure DL, Merenich JA. Evaluation of cases of severe statin-related transaminitis within a large health maintenance organization. The American journal of medicine 2005;118(6):618-24.