Cyclosporine microemulsion C2 monitoring in Chinese heart transplant recipients

Abstract

Objective To evaluate the safety and reliability of cyclosporine microemulsion (Neoral) C2monitoring in Chinese heart transplant recipients. Methods 107 stable heart transplant recipients treated with Neoral, mycopherolate mofetil and steroids were randomly divided into twogroups. Drug concentrations were supervised by different target levels in different groups. Bloodchemistry parameters reflecting heart, liver and renal function were examined. Results The incidenceof hepatoxicity in group Co and group C2 was 25.0%(13/52) and 10.0%(5/50), and the nephroto-xicity rate was 5.8% (3/52) and 8.0% (4/50), respectively. The acute rejection rate was 11.5%(6/52) in group Co and 6.0%(3/51)) in group Ca, respectively. The results of Neoral C0-C2monito-ring displayed that the difference was not statistically significant in Co levels between rejection andnonrejection [(0.133±0.078) μnol/L vs (0.131±0.074) txmol/13 (P0.05), while the differencein C2levels was significant F(0.516±0.217)/anol/L vs (0.659±0.296) μnol/L] (P<0.05). Therewas also no statistically significant difference in C0 levels between the recipients with side-effects andthose without side-effects [(0.133±0.075)μmol/L vs (0.131±0.073)μmol/L] (P0.05), butstatistically significant difference was found in Ca levels [(0.719±0.288) tanol/L vs (0.579±0.271)μmol/L] (P<0.05). Conclusion Cyclosporine Ca monitoring is a more sensitive predictor not only foracute rejection but also for side-effects in stable Chinese heart transplant recipients. Key words: Heart transplantation; Cyclosporine; Drug monitoring