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[Oral enzyme therapy for chronic hepatitis C--a retrospective analysis].

BACKGROUND AND OBJECTIVE
Data from a randomized trial in hepatitis C infected Egyptian patients suggest that the oral intake of the enzyme preparation Phlogenzym results in a significant reduction of aminotransferase levels and is equally effective to the therapy with interferon alpha. In our study, we investigated whether comparable effects can be found in daily practice in German patients.


PATIENTS AND METHODS
We retrospectively evaluated the aminotransferase levels of all patients with chronic hepatitis C who were treated with Phlogenzym at a dose of 6 tablets/day in our outpatient department between 1998 and 2003. Inclusion criteria for the study were treatment duration >3 weeks and elevated alanine-aminotransferase (ALT)levels 6 months prior to and at the beginning of the treatment with Phlogenzym. Liver cirrhosis Child B or C, interferon therapy within the last 3 months before treatment with Phlogenzym and alcohol intake >30 g/day were exclusion criteria.


RESULTS
22 patients were included into the analyses. The mean duration of treatment with Phlogenzym was 77 +/- 41 days. ALT, aspartate-aminotransferase (AST) and gamma glutamyl transpeptidase (GGT) levels did not change significantly during treatment. Fitting a generalized linear model, we estimated that a hypothetical patient who started with a baseline value of 50 U/I after 90 days of treatment ends up in an ALT level of 52 U/I (95%-CI:27-77 U/I), an AST level of 51 U/I (35-67 U/I) and a GGT level of 42 U/I (22-61 U/I). 5 out of 22 patients had to stop treatment because of side effects.


CONCLUSION
6 tablets Phlogenzym per day do not seem to reduce permanently elevated aminotransferases in patients with chronic hepatitis C.