Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reactions
Section snippets
Materials and Methods
The study received prior approval from the Newcastle upon Tyne Joint Ethics Committee. The Committee on Safety of Medicines obtained consent from the physicians and pharmacists within the Northern Region who had reported suspected hepatic ADRs, between 1992–1996, to divulge patients' names and clinical details. The reporting doctors were requested to obtain prior consent from patients. During 1997–1998, the case records for each patient were obtained and were systematically reviewed for the
Results
Out of 188 hepatotoxic reactions received between 1992–1996, 181 reports were traced. Excluding two duplicate reports and 24 GP reports, where consent from the reporting doctor could not be obtained, 155 reports were reviewed. Of these reports, 138 patients had case records available for review. Follow-up liver function tests were available 0–2555 days (median 118 days) post-reaction. After a review of their case notes, three further patients who acquired chronic hepatitis C following the
Discussion
The clinical diagnostic scale (CDS) was developed and validated in a single centre using a random sample of 50 cases of suspected, drug-induced liver injury, with the classification of these 50 cases by three clinicians used as the “gold standard” (3). In our study, the CDS has been compared with a more objective and widely accepted standard - the international consensus criteria - using a larger group of suspected hepatic ADRs. These criteria have been used previously by us to define and
Acknowledgements
This work was supported in part by the EUROHEPATOX Biomed Programme of the European Union (contract: BMH4-CT96-0658). We are grateful to Vivian Snaith for secretarial support.
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