[Presentation of an operational system for online collection and evaluation of data within the scope of drug trials and the detection of side effects].
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Biomedical subjects
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An "Intensive Drug Monitoring" System has been established in collaboration of the Departments of Internal Medicine, Biometrics and Pharmacology of the Medical College Hannover. It is based on the hypothesis-free collection of therapy data as well as clinical symptoms and chemical parameters which may be side-effects of drugs. The procedure is described in detail. The advantages of "Intensive Drug Monitoring" are emphasized. Such systems especially should be used to answer specified questions. Besides "Intensive Drug Monitoring" the necessity of "Spontaneous Monitoring" of adverse drug effects is argued.
Drug addicts admitted to the hospital had acute hepatitis in 44%, chronic hepatitis in 34%, toxic liver injury in 16%. About 50% of the patients with acute hepatitis were HAA positive. Patients with intravenous drug abuse acquired acute hepatitis after a mean period of 1.8 years. Acute hepatitis in drug addicts shows a prolonged course in the majority of the cases. Biochemically increases in serum bilirubin and transaminase levels are less pronounced as compared to non-addicted persons. 30-35% of the patients develop chronic hepatitis. Speed abuse promotes the tendency to cholestasis in acute episodes of liver disease. A toxic effect of the drug preparations upon the liver cells is assumed. Chronic hepatitis in drug addicts mainly develops from earlier acute hepatitis with prolonged course. In our material, the percentage of chronic hepatitis at present is 47.5%. Besides toxic effects, also repeated infections have to be discussed with regard the etiology and pathogenesis of the disease.
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