Clinical outcomes during the first three months posttransplant in renal allograft recipients managed by C2 monitoring of cyclosporine microemulsion

被引:99
作者
Thervet, E
Pfeffer, P
Scolari, MP
Toselli, L
Pallardó, LM
Chadban, S
Pilmore, H
Connolly, J
Buchler, M
Schena, FP
Carreno, CA
Dandavino, R
Cole, E
机构
[1] Hop St Louis, Serv Nephrol & Transplantat Renale, F-75010 Paris, France
[2] Univ Oslo, Natl Hosp, Dept Surg, Oslo, Norway
[3] Policlin S Orsola, Ist Nefrol, Bologna, Italy
[4] CRAI Norte, Buenos Aires, DF, Argentina
[5] Hosp Univ Dr Peset, Valencia, Spain
[6] Monash Med Ctr, Clayton, Vic 3168, Australia
[7] Auckland Hosp, Dept Renal Med, Auckland, New Zealand
[8] Belfast City Hosp, Renal Unit, Belfast BT9 7AD, Antrim, North Ireland
[9] CHU Tours, Serv Nephrol & Tr 2, Tours, France
[10] Policlin Univ Bari, Dept Nephrol, Bari, Italy
[11] Bartolome Mitre, Sanat Mitre, Buenos Aires, DF, Argentina
[12] Hop Maison Neuve Rosemont, Montreal, PQ H1T 2M4, Canada
[13] Toronto Gen Hosp, Div Nephrol, Toronto, ON, Canada
关键词
D O I
10.1097/01.TP.0000089006.00653.64
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background. MO2ART (monitoring of 2-hr absorption in renal transplantation) is the first prospective, multicenter trial of cyclosporine (CsA) blood level 2 hr postdose (C-2) monitoring in de novo kidney recipients receiving CsA microemulsion (ME) (Neoral; Novartis, Basel, Switzerland). Efficacy and safety results from the first 3 months are presented here. Methods. MO2ART is a 12-month, open-label, randomized study involving 296 patients. In all patients, the dose of CsA-ME was adjusted to achieve protocol-defined C-2 targets of 1.6 to 2.0 mug/mL for the first month, with subsequent tapering. Randomization into two target groups occurred at 3 months. All patients received steroids and mycophenolate mofetil (89%) or azathioprine. For patients with delayed graft function, the protocol permitted reduced C-2 targets and prophylactic administration of antibodies. Results. At 3 months, overall incidence of biopsy-proven acute rejection was 11.5%. Median serum creatinine was 132 mumol/L. Patient and graft survival were 96.6% and 91.2%, respectively. C-2 levels greater than 1.6 mug/mL were achieved within 5 days by 60.6% of patients with immediate graft function and 19.5% of patients with delayed graft function. Prophylactic antibodies were used in 15% of the total population. Twenty-four patients (8.1%) experienced serious adverse events with a suspected relation to CsA, and 26 patients (8.8%) discontinued the study because of adverse events (n=15) or after a switch in immunosuppression after rejection episodes (n=11). Conclusions. Patient management by C2 monitoring resulted in a low incidence of biopsy-proven acute rejection in standard risk de novo kidney recipients, 85% of whom did not receive prophylactic antibodies. CsA-ME with C2 monitoring provides excellent short-term efficacy and safety among de novo renal transplant patients.
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页码:903 / 908
页数:6
相关论文
共 17 条
[1]  
Cantarovich M, 1998, CLIN TRANSPLANT, V12, P243
[2]   Clinical benefits of neoral C2 monitoring in the long-term management of renal transplant recipients [J].
Cole, E ;
Naham, N ;
Cardella, C ;
Cattran, D ;
Fenton, S ;
Hamel, J ;
O'Grady, C ;
Smith, R .
TRANSPLANTATION, 2003, 75 (12) :2086-2090
[3]   Neoral C2 monitoring in pediatric liver transplant recipients [J].
Dunn, S ;
Falkenstein, K ;
Cooney, G .
TRANSPLANTATION PROCEEDINGS, 2001, 33 (7-8) :3094-3095
[4]   Peak cyclosporine levels (Cmax) correlate with freedom from liver graft rejection -: Results of a prospective, randomized comparison of neoral and sandimmune for liver transplantation (NOF-8) [J].
Grant, D ;
Kneteman, N ;
Tchervenkov, J ;
Roy, A ;
Murphy, G ;
Tan, A ;
Hendricks, L ;
Guilbault, N ;
Levy, G .
TRANSPLANTATION, 1999, 67 (08) :1133-1137
[5]  
KAHAN BD, 1995, TRANSPLANTATION, V59, P505
[6]  
Kelles A, 1999, Pediatr Transplant, V3, P282, DOI 10.1034/j.1399-3046.1999.00058.x
[7]  
Keown P, 2002, AM J TRANSPLANT, V2, P148
[8]  
Keown P, 2001, TRANSPLANTATION, V72, P1024
[9]  
Keown PA, 2002, AM J TRANSPLANT, V2, P157
[10]   Improved clinical outcomes for liver transplant recipients using cyclosporine monitoring based on 2-hr post-dose levels (C2) [J].
Levy, G ;
Burra, P ;
Cavallari, A ;
Duvoux, C ;
Lake, J ;
Mayer, AD ;
Mies, S ;
Pollard, SG ;
Varo, E ;
Villamil, F ;
Johnston, A .
TRANSPLANTATION, 2002, 73 (06) :953-959