Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all the antigen and antibody of HBV are negative | Hepatitis B Virus surface antigen (HBsAg), Hepatitis B Virus surface antibody (HBsAb), Hepatitis B Virus e antigen (HBeAg), Hepatitis B Virus e antibody (HBeAb), Hepatitis B Virus core antibody (HBcAb) are all negative. | ||
| HBV infection history | One or more of HBsAb,HBeAb, HBcAb are positive, while HBsAg and HBeAg are negative. If only HBsAb is positive, the history of HBV vaccination need to be excluded. |
| |
| HBV carriers | One or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBV infection history | Other | HBV infection history or HBV carriers |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes of alanine transaminase (ALT, U/L) | The peak increases of ALT from baseline to follow-up | one month, three months, six months |
| number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN) | one month, three months, six months |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with alanine transaminase (ALT) increasing over the ULN | one month, three months, six months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients diagnosied as coronary heart disease (CHD) at hospitalization receive long-term statin treatment, with or without HBV infection history.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhijian Yang, Doctor | Contact | +83 13809030208 | zhijianyangnj@njmu.edu.cn | |
| Haoyu Meng, Master | Contact | +86 15805167259 | 15805167259@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhijian Yang, Doctor | First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15198967 | Background | Bellosta S, Paoletti R, Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation. 2004 Jun 15;109(23 Suppl 1):III50-7. doi: 10.1161/01.CIR.0000131519.15067.1f. | |
| 17400325 | Background | Ekstedt M, Franzen LE, Mathiesen UL, Holmqvist M, Bodemar G, Kechagias S. Statins in non-alcoholic fatty liver disease and chronically elevated liver enzymes: a histopathological follow-up study. J Hepatol. 2007 Jul;47(1):135-41. doi: 10.1016/j.jhep.2007.02.013. Epub 2007 Mar 8. |
| Label | URL |
|---|---|
| Click here for more information about this study | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| 17542767 | Background | Segarra-Newnham M, Parra D, Martin-Cooper EM. Effectiveness and hepatotoxicity of statins in men seropositive for hepatitis C virus. Pharmacotherapy. 2007 Jun;27(6):845-51. doi: 10.1592/phco.27.6.845. |
| 18654866 | Background | Balmer ML, Dufour JF. Treatment of hypercholesterolemia in patients with primary biliary cirrhosis might be more beneficial than indicated. Swiss Med Wkly. 2008 Jul 26;138(29-30):415-9. doi: 10.4414/smw.2008.12311. |
| 16581333 | Background | Cohen DE, Anania FA, Chalasani N; National Lipid Association Statin Safety Task Force Liver Expert Panel. An assessment of statin safety by hepatologists. Am J Cardiol. 2006 Apr 17;97(8A):77C-81C. doi: 10.1016/j.amjcard.2005.12.014. Epub 2006 Feb 3. |
| 16496329 | Background | Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095. |
| 20041146 | Background | Lu J, Zhou Y, Lin X, Jiang Y, Tian R, Zhang Y, Wu J, Zhang F, Zhang Y, Wang Y, Bi S. General epidemiological parameters of viral hepatitis A, B, C, and E in six regions of China: a cross-sectional study in 2007. PLoS One. 2009 Dec 24;4(12):e8467. doi: 10.1371/journal.pone.0008467. |
| 21129795 | Result | Zhang Q, Yang Z. Can statins be used safely in coronary heart disease patients of hepatitis B virus carriers? Int J Cardiol. 2011 Jan 21;146(2):291. doi: 10.1016/j.ijcard.2010.10.087. Epub 2010 Dec 3. No abstract available. |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |