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6 BETA-HYDROXYCORTISOL IN HUMAN URINE

Objective



Some drugs, administered to humans, have the capacity to induce the production of enzymes in much larger amounts than normally. The enzyme induction capacity is determined in pharmacological studies since it can represent either a benefit or a potential danger for the tested drug. In humans, induction processes can be explored using different exogenous or endogenous substances. These last compounds such as plasma gamma glutamyltransferase, urinary glucaric acid or urinary 6 beta-hydroxycortisol are particularly interesting. 6 beta-hydroxycortisol is a polar, unconjugated metabolite of cortisol which is dependent on the cytochrome P-450IIIA3 activity. Its urinary excretion is considered as a good test to evaluate inductive effects of drugs in humans and has been demonstrated to be clearly increased in subjects treated by inducers such as phenobarbital or rifampicin.

The project consists of an interlaboratory study of urinary 6 beta-hydroxycortisol determination, using an immunoenzymatic technique (ELISA) more rapid and more sensitive than other existing methods. High performance liquid chromatography (HPLC) will be used as a "reference method". It is probable that a reference material adapted to the immunoenzymatic method will be considered in the future.

STATUS

The project started in July 1990. The results of a first intercomparison of measurements of urinary 6 beta-hydroxycortisol yielded a satisfactory analytical variation (4-12% day to day coefficient of variation) for ELISA method. However significant differences were observed between the results obtained by ELISA and HPLC respectively. Additional work for method comparison was recommended.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

Centre du Médicament
Address

Nancy
France

Participants (14)

"De Wever" Hospital
Netherlands
Address

Heerlen
Centre Hospitalier Universitaire Jean Minjoz
France
Address

25030 Besançon
Centre Hospitalier Universitaire Necker
France
Address

Paris
Department of Pharmacology
Denmark
Address

Copenhagen
Facultad de Medicina
Spain
Address

Sevilla
Facultad de Medicina
Spain
Address

Badajoz
Faculty of Medical Sciences
Portugal
Address

Lisbonne
Hoechst AG
Germany
Address

Frankfurt
Institut de Pathologie
Belgium
Address

Liège
Kantonsspital
Switzerland
Address

St.gallen
Laboratoire d'Analyses Médicales
Luxembourg
Address

Luxembourg
Ospedale Niguarda Ca Granda
Italy
Address
Via F. Sforza 35
20100 Milano
Trinity College
Ireland
Address

Dublin
University of Birmingham
United Kingdom
Address
Edgbaston
B15 2TT Birmingham