• 1. 四川大學(xué)華西醫(yī)院泌尿外科,成都,6100412. 四川大學(xué)華西醫(yī)院中國循證醫(yī)學(xué)中心3. 四川大學(xué)華西醫(yī)院內(nèi)分泌科;

目的 　評價他克莫司與環(huán)孢素A對腎移植術(shù)后急慢性排斥反應(yīng)發(fā)生率和人/腎存活率的療效差異.
方法 　計算機(jī)檢索MEDLINE (1989～2004.11)、EMBASE (1989～2004.11)、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(CBM)(1998～2004.11)及Cochrane圖書館2004年第4期;手工檢索與腎移植相關(guān)的 lt;中華器官移植雜志 gt;等8種中文雜志.納入腎移植術(shù)后使用他克莫司與環(huán)孢素比較的隨機(jī)對照試驗,對納入研究的方法學(xué)質(zhì)量(隨機(jī)方法,分配隱藏,盲法)進(jìn)行評價.用Revman4.2.7軟件進(jìn)行統(tǒng)計分析.
結(jié)果 　共納入18個隨機(jī)對照試驗,包括3 738例患者.Meta分析結(jié)果顯示,與環(huán)孢素A相比,他克莫司減少了腎移植術(shù)后急性排斥反應(yīng)發(fā)生率,其6月及12月的RR(95%CI)分別為0.65 (0.56,0.75) 和0.70 (0.54,0.92);減少了慢性排斥反應(yīng)的發(fā)生率,其合并后的RR(95%CI)為0.65 (0.47,0.89);降低了排斥反應(yīng)的病理分級,移植腎穿刺活檢BanffⅠ級及Banff(Ⅱ+Ⅲ)級的RR(95%CI)分別為1.64 (1.08,2.49)和0.75 (0.63,0.89).術(shù)后使用他克莫司或環(huán)孢素A,5年內(nèi)患者生存率差別無統(tǒng)計學(xué)意義,其6月、12月、2年、3年和5年的RR(95%CI)分別為1.01 (0.99,1.02)、1.00 (0.99,1.02)、1.01 (0.97,1.05)、1.00 (0.97,1.03) 和0.97 (0.88,1.07);移植腎5年內(nèi)存活率差異也不明顯,其6月、12月、2年、3年和5年的RR(95%CI)分別為1.04 (1.01,1.07)、1.03 (1.00,1.06)、0.99 (0.91,1.07)、1.04 (0.99,1.09) 和1.04 (0.90,1.21).
結(jié)論 　他克莫司抗急慢性排斥反應(yīng)的作用優(yōu)于環(huán)孢素A,但并不能提高腎移植術(shù)后人/腎存活率.

引用本文： 李旭東,吳泰相,蘇 斌,楊宇如,李 亞,王 莉,盧一平. 腎移植術(shù)后他克莫司與環(huán)孢素A抗排斥反應(yīng)效果的系統(tǒng)評價. 中國循證醫(yī)學(xué)雜志, 2005, 05(3): 206-215. doi: 復(fù)制

1. 王祥慧, 唐孝達(dá). 普樂可復(fù)預(yù)防同種腎移植排斥反應(yīng)的研究[J]. 中華器官移植雜志, 2000; 21(2) : 117～118.
2. 于立新, 劉小友, 孫煦勇, 杜傳福, 付紹杰, 徐健. 腎移植術(shù)后長期應(yīng)用他克莫司的臨床觀察[J]. 中華器官移植雜志, 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. 1. 王祥慧, 唐孝達(dá). 普樂可復(fù)預(yù)防同種腎移植排斥反應(yīng)的研究[J]. 中華器官移植雜志, 2000; 21(2) : 117～118.
  2. 2. 于立新, 劉小友, 孫煦勇, 杜傳福, 付紹杰, 徐健. 腎移植術(shù)后長期應(yīng)用他克莫司的臨床觀察[J]. 中華器官移植雜志, 2003; 24(6): 361～363.
  3. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 17. Mayer AD. Four-year follow-up of the European Tacrolimus Multicenter Renal Study[J]. Transplant Proc, 1999; 31(7A): 27S-28S.
  18. 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. 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. 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. 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. 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. 23. US Renal Transplantation Mycophenolate Mofetil Study Group. Mycophenolate Mofetil in cadaveric renal transplantation[J]. Am J kidney Diease, 1999; 34(2): 296-303.