원저 : 신장 이식환자에서 사이클로스포린 연질 젤라틴 캡슐제제와 Microemulsion제제의 임상적 비교

A new microemulsion formulation of cycloporine(CsA) has been recently used in Korean renal transplants. We compared the clinical effect and the trough levels of microemulsion cyclosporine(M-CsA) as opposed to conventional CsA in soft gelatine capsule(C-CsA). In the study for hospitalized post-operative patients, 58 patients were divided into two groups; the C-CsA(control) group(n=23) received C-CsA, and the M-CsA group(n=28) received M-CsA after transplantation. In the study for stable OPD patients, 32 patients were dividecl into two groups. The C-CsA(control) group(n=l6) did not change the type of CsA and continued C-CsA medication after Sep. 1994, M-CsA group(n=l6) switched from C-CsA to M-CsA in Sep. 1995. In postoperative hospitialized patients, mean trough levels were not different between the two groups with CsA dosage (9mg/kg - 5mg/kg), although the M-CsA group had higher trough levels with 10mg/Kg CsA dosage than the control group. In OPD patients, there was no significant change in CsA dosage in both groups during the 6 month period. Mean trough levels, 6 months after conversion, were lower in the M-CsA group than in the control group. In the M-CsA group who received the same dose as a preconversion dose, mean trough levels at 2, 3, 4, 5, 6 months were lower than the preconversion level, although control groups had lower trough levels only at 5 months. Serum creatinine levles were significantly decreased in the M-CsA OPD patients. From these results, we couldnt find a dose saving effect of M-CsA in our patients, it is much desirable to study the pharmacokinetics of M-CsA and C-CsA in Korean renal transplants.