신이식환자에서 산디문 뉴오랄로 전환후 효과 및 안정성에 관한 20주간의 추적보고

Abstract

Recently a new formulation of CsA(Sandimmun Neoral), based on microemulsion technology, has been developed and became available. This improved galenic technology allows more predictable and consistent absorption, thus minimizing inter-patient and intra-patient variability and permitting a more predictable whole blood CsA concentration. The objectives of this study are 1) to assess that safety and tolerability are comparable in stable renal transplant patients when switched from Sandimmun to Sandimmun Neoral and 2) to assess the ability of Sandimmun Neoral to maintain CsA blood trough levels in the predefined therapeutic window. A total of 48 stable renal transplant patients from our hospital were entered. These patients had to have stable graft function under CsA based immunosuppression and at least 6 months have passed since their first graft. After a two week run-in phase, patients were randomized in a 4 : 1 ratio to switch to Sandimmun Neoral on a 1 : 1 dose level basis or continue Sandimmun for a 20 week period respectively. The results of our research are as following: 1) There was no differences between the groups in terms of sex, age and time interval between transplantation and entry of the study. 2) Mean CsA blood level in Sandimmun control group was fluctuated with about 22.9% width of increment or decrement during study period. However, in Sandimmun Neoral group, mean blood level was steady increased to 17.5% comparing that of time of study entry, which made the required dose 13.3% lower at 20th week. 3) Serum creatinine did not change significantly through the entire study period in both groups. 4) Episodes of infection and occurrence of liver dysfunction in both groups were comparable. There was no episodes of acute rejection requiring treatment in both groups. The tolerability and safety of Sandimmun Neoral is equivalent to that of Sandimmun. And lower doses of Sandimmun Neoral than of conventional Sandimmun were required because of a better absorption of Sandimmun Neoral to achieve a predefined therapeutic CsA concentration.