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研究生:陳孟吟
研究生(外文):Meng-Yin Chen
論文名稱:B型肝炎患者中Statins藥物使用和急性肝炎住院風險之探討
論文名稱(外文):The association between Statins use and risk of hospitalization for acute hepatitis in patients with HBV infection
指導教授:陳保中陳保中引用關係
指導教授(外文):Pau-Chung Chen
口試委員:賴榮年何文照
口試委員(外文):Jung-Nein LaiWen-Chao Ho
口試日期:2013-06-04
學位類別:碩士
校院名稱:國立臺灣大學
系所名稱:職業醫學與工業衛生研究所
學門:醫藥衛生學門
學類:公共衛生學類
論文種類:學術論文
論文出版年:2013
畢業學年度:101
語文別:英文
論文頁數:24
中文關鍵詞:急性肝炎statins類藥物B型肝炎
外文關鍵詞:acute hepatitisstatinsHBV
相關次數:
  • 被引用被引用:0
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  • 收藏至我的研究室書目清單書目收藏:0
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。


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.


CONTENTS
中文摘要 i
ABSTRACT ii
INTRODUCTION 1
METHODS 3
Data Sources 3
Identification of Study Cohort 4
Statins Exposure 4
Definition of outcome 6
Potential Confounders 7
Statistical Analysis 8
RESULTS 9
DISCUSSION 11
CONCLUSIONS 15
REFERENCES 16


REFERENCES
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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.
6. Tsan YT, Lee CH, Wang JD, Chen PC. Statins and the risk of hepatocellular carcinoma in patients with hepatitis B virus infection. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2012;30(6):623-30.
7. Lai MN, Wang SM, Chen PC, Chen YY, Wang JD. Population-based case-control study of Chinese herbal products containing aristolochic acid and urinary tract cancer risk. Journal of the National Cancer Institute 2010;102(3):179-86.
8. WHO Collaborating Center for Drugs Statis-tics Methodology: ATC Index with DDDs 2003.Oslo N, WHO, 2003.
9. Nielsen SF, Nordestgaard BG, Bojesen SE. Statin use and reduced cancer-related mortality. The New England journal of medicine 2012;367(19):1792-802.
10. Lee CH, Wang JD, Chen PC. Increased risk of hospitalization for acute hepatitis in patients with previous exposure to NSAIDs. Pharmacoepidemiology and drug safety 2010;19(7):708-14.
11. Brewer HB. benefit-risk assessment of Rosuvastatin 10 to 40 milligrams. The American journal of cardiology 2003;92(4):23-29.
12. Bruckert E, Hayem G, Dejager S, Yau C, Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients--the PRIMO study. Cardiovascular drugs and therapy / sponsored by the International Society of Cardiovascular Pharmacotherapy 2005;19(6):403-14.
13. Goh IX, How CH, Tavintharan S. Cytochrome P450 drug interactions with statin therapy. Singapore Med J 2013;54(3):131-5.
14. Lee CH, Wang JD, Chen PC. Case-crossover study of hospitalization for acute hepatitis in Chinese herb users. Journal of gastroenterology and hepatology 2008;23(10):1549-55.
15. Armitage J. The safety of statins in clinical practice. Lancet 2007;370(9601):1781-90.
16. Kashani A, Phillips CO, Foody JM, Wang Y, Mangalmurti S, Ko DT, et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation 2006;114(25):2788-97.
17. Sgro C, Clinard F, Ouazir K, Chanay H, Allard C, Guilleminet C, et al. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology 2002;36(2):451-5.
18. Rosenson RS. Current overview of statin-induced myopathy. The American journal of medicine 2004;116(6):408-16.
19. Smith CC, Bernstein LI, Davis RB, Rind DM, Shmerling RH. Screening for statin-related toxicity: the yield of transaminase and creatine kinase measurements in a primary care setting. Archives of internal medicine 2003;163(6):688-92.
20. Zhang H, Plutzky J, Turchin A. Discontinuation of statins in routine care settings. Annals of internal medicine 2013;159(1):75-6.
21. Zhang H, Plutzky J, Skentzos S, Morrison F, Mar P, Shubina M, et al. Discontinuation of statins in routine care settings: a cohort study. Annals of internal medicine 2013;158(7):526-34.
22. Bernal W, Auzinger G, Dhawan A, Wendon J. Acute liver failure. Lancet 2010;376(9736):190-201.



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