Epidemiologic study of hepatoxic medications
2010
Hochschulschrift
Zugriff:
98
Background: Despite the increase in popularity of herbal products, there is growing concern over potential hepatoxic hazards caused by the Chinese herbal medicines (CHMs). Otherwise, case reports of hepatoxicity about new drugs (nimesulide, celecoxib and rofecoxib) seem to increase. The prevalence rates of viral hepatitis are very high in Taiwan. The reimbursement database of National Health Insurance (NHI) in Taiwan provided an opportunity for post-marketing surveillance. The epidemiology of adverse hepatic reaction remains poorly documented and hard to conduct. Our epidemiologic studies were interested in an attempt to determine the association between the use of CHMs or potential hepatoxic new drug and the risk of liver injury amongst the citizens of Taiwan. Thus, we conducted our study for three objectives; (1) our observational study was conducted to assess if case-control and case-crossover designs could be applied to detect the risk of hepatoxic drugs on liver injury in the automated databases.; (2) to determine the association between the use of CHMs and the risk of hospitalizations related to acute hepatitis amongst the citizens of Taiwan; (3) to determine the association between the use of cyclooxygenase2 (COX-2) selective inhibitors and the increased hospitalizations related to liver injury among the citizens of Taiwan. Methods: First design: the study was conducted on approximately 22 million people enrolled in Taiwan’s national health insurance database from January 1, 1997 to December 31, 2004. We applied case-control and case-crossover designs to assess the estimated risks of liver injury related to well-known hepatoxic drugs, including isoniazid, rifampicin, erythromycin, and diclofenac. We applied two designs by conditional logistic regression model to adjust for other hepatoxic drugs and co-morbidity. Second design: a case-crossover study was designed on 200,000 randomly selected individuals from the NHI Research Database who were then followed from 1997 to 2002. All medications taken in the 30- and 60-day periods prior to hospitalization were explored and compared with four control periods (the 180- and 360-day periods prior to and after the hospitalization). A conditional logistic regression model was then constructed to determine the odds of CHM being prescribed during these risk periods. Third design: we conducted to determine the association between the use of hepatoxic NSAIDs and increased hospitalizations related to acute hepatitis. We applied two kinds of models to analyze by uni-directional and bi-directional case-crossover designs during the 28 days exposure periods and performed conditional logistic regression models. Results and conclusions: First, the adjusted odds ratios of hospitalized liver injury patients during the 30-day exposure window showed similar and significant increases for hepatoxic drugs by the case-control and case-crossover designs. The risk of admission with liver injury related to hepatoxic drugs could be assessed by both designs based on automated databases. Second, after adjustment for conventional hepatotoxic drugs, Chinese herbal users revealed a slightly increased risk of acute hepatitis for nonviral, nonalcoholic acute hepatitis. We therefore recommend active surveillance for CHMs suspected with hepatotoxicity. Third, the odds ratios of celecoxib, nimesulide, dicofenac, ibuprofen and other hepatoxic NSAIDs were significantly increased. Our results provide evidence for an increased risk of hospitalization with acute hepatitis among hepatoxic NSAIDs including celecoxib users. Further mechanistic research is warranted in order to document celecoxib’s hepatotoxicity.
Titel: |
Epidemiologic study of hepatoxic medications
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Autor/in / Beteiligte Person: | Lee, Chang-Hsing ; 李長興 |
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Veröffentlichung: | 2010 |
Medientyp: | Hochschulschrift |
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