The Effectiveness of Tacrolimus and Cyclosporine A after Renal Transplantation: A Systematic Review_Chinese Journal of Evidence-Based Medicine

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1.Department of Urology; West China Hospital; Sichuan University; Chengdu 610041; China2.Chinese Evidence Based Medicine Center; West China Hospital; Sichuan University; Chengdu 610041; China3.Department of Endocrine; West China Hospital; Sichuan University; Chengdu 610041; China;

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Keywords：

Tacrolimus; Cyclosporine A; Renal transplantation; Systematic review; Meta analyses

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Objective 　To evaluate the effectiveness of tacrolimus and cyclosporine A on acute rejection, chronic rejection and survival rate of patient and graft after renal transplantation.
Methods 　We searched MEDLINE (1989 to Nov.2004), EMBASE (1989 to Nov.2004), The Chinese Biomedical Database (CBM) (1998 to Nov.2004), Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2004) and handsearched 8 Chinese journals. Trials comparing tacrolimus with cyclosporine A after renal transplantation were included. The quality of included studies such as randomization, blinding, allocation concealment was evaluated and meta-analysis was performed using RevMan 4.2.7 software.
Results 　Eighteen studies involving 3 738 patients were included. Tacrolimus was more effective in decreasing the incidence of acute rejection and chronic rejection than that of cyclosporine A with RR 0.65, 95％CI 0.56 to 0.75 at the end of 6 months; with RR 0.70, 95％CI 0.54 to 0.92 at the end of 12 months for number of patients of acute rejection. The pooled RR was 0.65 (95％CI 0.47 to 0.89) for number of patients of chronic rejection. Tacrolimus could reduce the severity of acute rejection. The relative risks of pathologic grade BanffⅠand Banff (Ⅱ＋Ⅲ) were 1.64 (95％CI 1.08 to 2.49) and 0.75 (95％CI 0.63 to 0.89) respectively. But there was no significant difference on the survival rate of patient and graft within 5 years between the two groups. The relative risk of 6, 12, 24, 36 and 60 months were 1.01 (95％CI 0.99 to 1.02), 1.00 (95％CI 0.99 to 1.02), 1.01 (95％CI 0.97 to 1.05), 1.00 (95％CI 0.97 to 1.03) and 0.97 (95％CI 0.88 to 1.07) respectively for the survival rate of patient and 1.04 (95％CI 1.01 to 1.07), 1.03 (95％CI 1.00 to 1.06), 0.99 (95％CI 0.91 to 1.07), 1.04 (95％CI 0.99 to 1.09) and 1.04 (95％CI 0.90 to 1.21) respectively for the survival rate of grafts.
Conclusions 　On acute rejection and chronic rejection, tacrolimus is more effective than cyclosporine A, but there is no difference in the graft or patient survival rate.

Citation： LI Xu dong,WU Tai xiang,SU Bin,YANG Yu ru,LI Ya,WANG Li,LU Yi ping. The Effectiveness of Tacrolimus and Cyclosporine A after Renal Transplantation: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2005, 05(3): 206-215. doi: Copy

1.	王祥慧, 唐孝达. 普乐可复预防同种肾移植排斥反应的研究[J]. 中华器官移植杂志, 2000; 21(2) : 117～118.
2.	于立新, 刘小友, 孙煦勇, 杜传福, 付绍杰, 徐健. 肾移植术后长期应用他克莫司的临床观察[J]. 中华器官移植杂志, 2003; 24(6): 361～363.
3.	Charpentier B, Rostaing L, Berthoux F, Lang P, Civati G, Touraine JL, Squifflet JP, Vialtel P, Abramowicz D. A three-arm study comparing immediate tacrolimus therapy with Antithymocyte globulin induction therapy followed by Tacrolimus or Cyclospoine A in adult Renal transplant recipients[J]. Transplantation, 2003; 75(6): 844-851.
4.	Margreiter R. Efficacy and safety of tacrolimus compared with ciclosporin microemulsion in renal transplantation: a randomised multicentrestudy[J]. Lancet, 2002; 359(9 308): 741-746.
5.	Trompeter R, Filler G, Webb NJ, Watson AR, Milford DV, Tyden G, Grenda R, Janda J, Hughes D, Ehrich JH, Klare B, Zacchello G, Bjorn Brekke I, McGraw M, Perner F, Ghio L, Balzar E, Friman S, Gusmano R, Stolpe J. Randomized trial of tacrolimus versus cyclosporin microemulsion in renal transplantation[J]. Pediatr Nephrol, 2002; 17(3): 141-149.
6.	White SA, Jain S, Williams ST, Doughman T, Hayes P, Murphy G, Veitch PS, Horsburgh T. Randomized trial comparing neoral and tacrolimus immunousuppression for recipients of renal transplants procured from different donor groups[J]. Transplant Proc, 2000; 32(3): 600.
7.	Xu D, Tang XD. Tacrolimus vs CyA Neoral in combination with MMF and steroids after cadaveric renal transplantation[J]. Transplant Proc, 2000; 32(3): 1 702-1 703.
8.	Campos HH, Abbud Filho M, Brazilian Tacrolimus Study Group. One-year follow-up of a Brazilian randomized multicenter study comparing tacrolimus versus cyclosporine in kidney transplantation[J]. Transplant Proc, 2002; 34(5): 1 656-1 658.
9.	Abou-Jaoude MM, Irani-Hakime N, Ghantous I, Najm R, Afif C, Almawi WY. Cyclosporine microemulsion (Neoral) versus tacrolimus (FK506) as maintenance therapy in kidney transplant patients[J]. Transplant Proc, 2003; 35(7): 2 748-2 749.
10.	Gonwa T, Johnson C, Ahsan N, Alfrey EJ, Halloran P, Stegall M, Hardy M, Metzger R, Shield C 3rd, Rocher L, Scandling J, Sorensen J, Mulloy L, Light J, Corwin C, Danovitch G, Wachs M, VanVeldhuisen P, Leonhardt M, Fitzsimmons WE. Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: results at three years[J]. Transplantation, 2003; 75(12): 2048-2053.
11.	Vincenti F, Jensik SC, Filo RS, Miller J, Pirsch J. A long-term comparison of tacrolimus (FK506) and Cyclosporine in kidney transplantation:evidence for improved allograft survival at five years[J]. Transplantation, 2002; 73(5): 775-782.
12.	Montagnino G, Kramer BK, Arias M. Efficacy and safety of tacrolimus compared with cyclosporine microemulsion in kidney transplantation: twelve-month follow-up[J]. Transplant Proc, 2002; 34(5): 1 635-1 637.
13.	Toz H, Sen S, Sezis M, Duman S, Ozkahya M, Ozbek S. Comparison of tacrolimus and cyclosporin in renal transplantation by the protocol biopsies[J]. Transplant Proc, 2004; 36(1): 134-136.
14.	Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation[J]. Transplantation,1997; 63(7): 977-983.
15.	Wang XH, Tang XD. The prospective randomize study on prevention of cadaveric renal allograft rejection by Tacrolimus (FK506)[J]. Chin J Organ Transpant, 2000; 21(2): 117-118.
16.	Yu LX, Liu XY, Sun XY, Du CF, Fu SJ, Xu J. Long-term evaluation of FK506 based immunosuppressive therapy in kidney transplantation[J]. Chin J Organ Transpant, 2003; 24(6) : 361-363.
17.	Mayer AD. Four-year follow-up of the European Tacrolimus Multicenter Renal Study[J]. Transplant Proc, 1999; 31(7A): 27S-28S.
18.	Vincenti F. Tacrolimus (FK 506) in kidney transplantation: five-year survival results of the U.S. multicenter, randomized, comparative trial[J]. Transplant Proc, 2001; 33(1-2): 1 019-1 020.
19.	Jensik SC. Tacrolimus (FK 506) in kidney transplantation: three-year survival results of the US multicenter, randomized, comparative trial[J]. Transplant Proc,1998; 30(4): 1 216-1 218.
20.	Yu L, Wang Y, Fu SJ, Cheng XJ. Clinical experience with Prograf (tacrolimus, FK 506) in Chinese patients after renal transplantation[J]. Transplant Proc, 2000; 32(7): 1 709-1 710.
21.	Ferguson R. Acute rejection episodes: Best predictor of long-term primary cadaveric renal transplant survival[J]. Clin Transplant, 1994; 8(3 Pt 2): 328-331.
22.	Gjertson DW, Cecka JM, Terasaki PI. The relative effects of FK506 and cyclosporine on short- and long-term kidney graft survival[J]. Transplantation, 1995; 60(12): 1 384-1 384.
23.	US Renal Transplantation Mycophenolate Mofetil Study Group. Mycophenolate Mofetil in cadaveric renal transplantation[J]. Am J kidney Diease, 1999; 34(2): 296-303.

1. 王祥慧, 唐孝达. 普乐可复预防同种肾移植排斥反应的研究[J]. 中华器官移植杂志, 2000; 21(2) : 117～118.
2. 于立新, 刘小友, 孙煦勇, 杜传福, 付绍杰, 徐健. 肾移植术后长期应用他克莫司的临床观察[J]. 中华器官移植杂志, 2003; 24(6): 361～363.
3. Charpentier B, Rostaing L, Berthoux F, Lang P, Civati G, Touraine JL, Squifflet JP, Vialtel P, Abramowicz D. A three-arm study comparing immediate tacrolimus therapy with Antithymocyte globulin induction therapy followed by Tacrolimus or Cyclospoine A in adult Renal transplant recipients[J]. Transplantation, 2003; 75(6): 844-851.
4. Margreiter R. Efficacy and safety of tacrolimus compared with ciclosporin microemulsion in renal transplantation: a randomised multicentrestudy[J]. Lancet, 2002; 359(9 308): 741-746.
5. Trompeter R, Filler G, Webb NJ, Watson AR, Milford DV, Tyden G, Grenda R, Janda J, Hughes D, Ehrich JH, Klare B, Zacchello G, Bjorn Brekke I, McGraw M, Perner F, Ghio L, Balzar E, Friman S, Gusmano R, Stolpe J. Randomized trial of tacrolimus versus cyclosporin microemulsion in renal transplantation[J]. Pediatr Nephrol, 2002; 17(3): 141-149.
6. White SA, Jain S, Williams ST, Doughman T, Hayes P, Murphy G, Veitch PS, Horsburgh T. Randomized trial comparing neoral and tacrolimus immunousuppression for recipients of renal transplants procured from different donor groups[J]. Transplant Proc, 2000; 32(3): 600.
7. Xu D, Tang XD. Tacrolimus vs CyA Neoral in combination with MMF and steroids after cadaveric renal transplantation[J]. Transplant Proc, 2000; 32(3): 1 702-1 703.
8. Campos HH, Abbud Filho M, Brazilian Tacrolimus Study Group. One-year follow-up of a Brazilian randomized multicenter study comparing tacrolimus versus cyclosporine in kidney transplantation[J]. Transplant Proc, 2002; 34(5): 1 656-1 658.
9. Abou-Jaoude MM, Irani-Hakime N, Ghantous I, Najm R, Afif C, Almawi WY. Cyclosporine microemulsion (Neoral) versus tacrolimus (FK506) as maintenance therapy in kidney transplant patients[J]. Transplant Proc, 2003; 35(7): 2 748-2 749.
10. Gonwa T, Johnson C, Ahsan N, Alfrey EJ, Halloran P, Stegall M, Hardy M, Metzger R, Shield C 3rd, Rocher L, Scandling J, Sorensen J, Mulloy L, Light J, Corwin C, Danovitch G, Wachs M, VanVeldhuisen P, Leonhardt M, Fitzsimmons WE. Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: results at three years[J]. Transplantation, 2003; 75(12): 2048-2053.
11. Vincenti F, Jensik SC, Filo RS, Miller J, Pirsch J. A long-term comparison of tacrolimus (FK506) and Cyclosporine in kidney transplantation:evidence for improved allograft survival at five years[J]. Transplantation, 2002; 73(5): 775-782.
12. Montagnino G, Kramer BK, Arias M. Efficacy and safety of tacrolimus compared with cyclosporine microemulsion in kidney transplantation: twelve-month follow-up[J]. Transplant Proc, 2002; 34(5): 1 635-1 637.
13. Toz H, Sen S, Sezis M, Duman S, Ozkahya M, Ozbek S. Comparison of tacrolimus and cyclosporin in renal transplantation by the protocol biopsies[J]. Transplant Proc, 2004; 36(1): 134-136.
14. Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation[J]. Transplantation,1997; 63(7): 977-983.
15. Wang XH, Tang XD. The prospective randomize study on prevention of cadaveric renal allograft rejection by Tacrolimus (FK506)[J]. Chin J Organ Transpant, 2000; 21(2): 117-118.
16. Yu LX, Liu XY, Sun XY, Du CF, Fu SJ, Xu J. Long-term evaluation of FK506 based immunosuppressive therapy in kidney transplantation[J]. Chin J Organ Transpant, 2003; 24(6) : 361-363.
17. Mayer AD. Four-year follow-up of the European Tacrolimus Multicenter Renal Study[J]. Transplant Proc, 1999; 31(7A): 27S-28S.
18. Vincenti F. Tacrolimus (FK 506) in kidney transplantation: five-year survival results of the U.S. multicenter, randomized, comparative trial[J]. Transplant Proc, 2001; 33(1-2): 1 019-1 020.
19. Jensik SC. Tacrolimus (FK 506) in kidney transplantation: three-year survival results of the US multicenter, randomized, comparative trial[J]. Transplant Proc,1998; 30(4): 1 216-1 218.
20. Yu L, Wang Y, Fu SJ, Cheng XJ. Clinical experience with Prograf (tacrolimus, FK 506) in Chinese patients after renal transplantation[J]. Transplant Proc, 2000; 32(7): 1 709-1 710.
21. Ferguson R. Acute rejection episodes: Best predictor of long-term primary cadaveric renal transplant survival[J]. Clin Transplant, 1994; 8(3 Pt 2): 328-331.
22. Gjertson DW, Cecka JM, Terasaki PI. The relative effects of FK506 and cyclosporine on short- and long-term kidney graft survival[J]. Transplantation, 1995; 60(12): 1 384-1 384.
23. US Renal Transplantation Mycophenolate Mofetil Study Group. Mycophenolate Mofetil in cadaveric renal transplantation[J]. Am J kidney Diease, 1999; 34(2): 296-303.

Chinese Journal of Evidence-Based Medicine

The Effectiveness of Tacrolimus and Cyclosporine A after Renal Transplantation: A Systematic Review

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