Chinese Journal of Tissue Engineering Research ›› 2010, Vol. 14 ›› Issue (18): 3408-3411.doi: 10.3969/j.issn.1673-8225.2010.18.044

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Clinical efficacy and safety of conversion from cyclosporine A to tacrolimus-based regimen for different pathological types of chronic allograft nephropathy patients

Gao Sen1, Gao Yi1, Liu Yong-guang2, Liu Ding2, Guo Ying2   

  1. 1 Department of Hepatobiliary Surgery, Zhujiang Hospital, Southern Medical University, Guangzhou   510282, Guangdong Province, China
    2 Center for Organ Transplantation, Zhujiang Hospital, Southern Medical University, Guangzhou   510282, Guangdong Province, China
  • Online:2010-04-30 Published:2010-04-30
  • Contact: Guo Ying, Doctor, Associate professor, Center for Organ Transplantation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, Guangdong Province, China guohanjing001@163.com
  • About author:Gao Sen★, Studying for master’s degree, Department of Hepatobiliary Surgery, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, Guangdong Province, China nfygaosen@sina. com
  • Supported by:

     the Natural Science Foundation of Guangdong Province, No.06024438*

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Abstract:

BACKGROUND: Recent studies have suggested that conversion from cyclosporine A (CsA) to tacrolimus (FK 506)-based regimen can improve renal allograft function and survival rate. But little is known about whether the conversion from CsA to tacrolimus(FK 506) plus mycophenolate mofetil (MMF)-based regimen exhibits the same or similar clinical efficacy.
OBJECTIVE: To investigate the clinical efficacy and safety of converting CsA to FK506 plus MMF in treatment of different types of chronic allograft nephropathy (CAN).
DESIGN, TIME AND SETTING: An observational and controlled trial was performed at the Center for Organ Transplantation, Zhujiang Hospital, Southern Medical University from January 2005 to October 2007.
PARTICIPANTS: Fifteen-nine enrolled patients received CsA-based regimen after renal allografting. Following pathological confirm and typing, all patients were assigned to two groups: CAN with chronic rejection (CR, n = 31) and CAN without chronic rejection (non-CR, n = 28). FK 56 was purchased from Fujisawa Pharmaceutical Company, Ltd., Japan. MMF was sourced from Shanghai Roche Pharmaceutical Co., Ltd., China.
METHODS: When patients were diagnosed CAN, the CsA regimen was conversed to FK506 plus MMF regimen. FK506 initiated at a dose of 0.08 mg/kg per day and then was adjusted to achieve steady-state whole blood trough levels of approximately 5-8 µg/L. MMF was used at a fixed dosage, 1.0 g/d, twice a day, only if relative adverse events occurred. All patients were followed up at least 6 months. 
MAIN OUTCOME MEASURES: Serum creatinine(Scr), total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL), 24-h proteinuria, glomerular filtration rate (GFR), and complications.
RESULTS: All initial 59 patients were included in the final analysis. At 6 months after regimen conversion, the levels of Scr, TC, TG, LDL, and 24-hour proteinuria were significantly reduced in non-CR, in particular CR, groups, compared with prior to conversion (P < 0.05). GFR was markedly increased in both the CR and non-CR groups (P < 0.05). In the CR group, 20 patients obtained improved results, 7 got stable results, and 4 showed ineffective results. The effective rate of regimen conversion was 64.5% and 32.1% in the CR and non-CR groups, respectively, and significant difference existed between the two groups (P < 0.05). Compared with prior to conversion, the incidence of hypertension and hyperlipemia was significantly decreased after regimen conversion (P < 0.05). There was no significant difference in diabetes mellitus, opportunistic infection, and malignancy between prior to and after regimen conversion.
CONCLUSION: FK506 plus MMF-based regimen can markedly improve the function of renal graft of CAN, in particular CR, patients. 
 

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