基于TOR-I的CNI撤除方案在腎移植術后免疫抑制治療中療效和安全性的Meta分析_《中國循證醫學雜志》

作者：

吳斌 ^1,2 , 吳逢波 ¹ , 于磊 ¹ , 李天平 ¹ ,  唐堯 ¹

1. 四川大學華西醫院藥劑科（成都 610041）；2. 四川大學華西藥學院（成都 610041）;

關鍵詞：

環孢素A 他克莫司西羅莫司伊維莫司腎移植 Meta 分析

DOI：

10.7507/1672-2531.20100088

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目的　評價腎移植術后鈣調蛋白阻滯劑（CNI）撤除后雷帕霉素受體阻滯劑（TOR-I）免疫抑制替代治療的療效和安全性。
方法　檢索MEDLINE、EMbase、SCI、CBM、Cochrane 圖書館及其他腎移植相關雜志，納入腎移植術后基于TOR-I 的CNI 撤除干預方案療效和安全性的隨機對照試驗。檢索時間為建庫至2009 年9 月。評價納入研究的方法學質量，采用RevMan 5.0 軟件進行Meta 分析。
結果　納入來自10 個RCT 的14 篇報道，A、B 級研究各5 個。分析結果顯示：急性排斥反應發生率1、2、4 年的RR（95%CI）值分別為1.64（1.19，2.27）、1.53（1.06，2.22）及1.21（0.73，1.98）；受者生存率1、2、4 年的RD（95%CI）值分別為– 0.01（– 0.02，0.01）、– 0.00（– 0.03，0.02）及0.03（– 0.01，0.08）；移植物生存率1、2、4 年的RD（95%CI）值分別為0.00（– 0.02，0.02）、0.00（– 0.03，0.04）及0.07（0.01，0.12）；腎小球濾過率WMD（95%CI）值為9.50（2.96，16.03）。
結論　基于當前證據，腎移植術后CNI 撤除后西羅莫司替代治療與CNI 持續治療相比能更好保護腎臟功能和提高移植物生存率，但對1 年急性排斥反應發生率增加、受者生存率無影響及4 年急性排斥反應發生率無影響。長期隨訪結果有待進一步研究證實。

引用本文： 吳斌,吳逢波,于磊,李天平,唐堯. 基于TOR-I的CNI撤除方案在腎移植術后免疫抑制治療中療效和安全性的Meta分析. 中國循證醫學雜志, 2010, 10(1): 33-39. doi: 10.7507/1672-2531.20100088 復制

1.	de Mattos AM, Olyaei AJ, Bennett WM. Nephrotoxicity of immunosuppressive drugs: long-term consequences and challenges for the future. Am J Kidney Dis, 2000, 35(2): 333-346.
2.	Webster AC, Lee VW, Chapman JR, et al. Target of rapamycin inhibitors (TOR-I; sirolimus and everolimus) for primary immunosuppression in kidney transplant recipients. Cochrane Database Syst Rev, 2006, 19(2): CD004290.
3.	Mulay AV, Hus sain N, Fergus son D, e t al . Calcineur i n Inhibitor Withdrawal from Sirolimus-Based Therapy in Kidney Transplantation: A Systematic Review of Randomized Trials. Am J Transplant, 2005, 5(7): 1748-1756.
4.	Johnson RW, Kreis H, Oberbauer R, et al. Sirolimus allows early cyclosporine withdrawal in renal transplantation resulting in improved renal function and lower blood pressure. Transplantation, 2001, 72(5): 777-786.
5.	Oberbauer R, Kreis H, Johnson RW, et al. Long-term improvement in renal function with sirolimus after early cyclosporine withdrawal in renal transplant recipients: 2-year results of the Rapamune Maintenance Regimen Study. Transplantation, 2003, 76(2): 364-370.
6.	Kreis H, Oberbauer R, Campistol JM, et al. Long-term benefits with sirolimus-based therapy after early cyclosporine withdrawal. J Am Soc Nephrol, 2004, 15(3): 809-817.
7.	Oberbauer R, Segoloni G, Campistol JM, et al. Early cyclosporine withdrawal from a sirolimus-based regimen results in better renal allograft survival and renal function at 48 months after transplantation. Transpl Int, 2005, 18(1): 22-28.
8.	Gonwa TA, Hricik DE, Brinker K, et al. Improved renal function in sirolimus-treated renal transplant patients after early cyclosporine elimination. Transplantation, 2002, 74(11): 1560-1567.
9.	Baboolal K. A phase III prospective, randomized study to evaluate concentration-controlled sirolimus (rapamune) with cyclosporine dose minimization or elimination at six months in de novo renal allograft recipients. Transplantation, 2003, 75(8): 1404-1408.
10.	Stallone G, Di Paolo S, Schena A, et al. Early withdrawal of cyclosporine A improves 1-year kidney graft structure and function in sirolimus-treated patients. Transplantation, 2003, 75(7): 998-1003.
11.	Grinyo JM, Campistol JM, Paul J, et al. Pilot randomized study of early tacrolimus withdrawal from a regimen with sirolimus plus tacrolimus in kidney transplantation. Am J Transplant, 2004, 4(8): 1308-1314.
12.	Morales JM, Grinyó JM, Campistol JM, et al. Improved renal function, with similar proteinuria, after two years of early tacrolimus withdrawal from a regimen of sirolimus plus tacrolimus. Transplantation, 2008, 86(4): 620-622.
13.	Watson CJ, Firth J, Williams PF, et al. A randomized controlled trial of late conversion from CNI-based to sirolimus-based immunosuppression following renal transplantation. Am J Transplant, 2005, 5(10): 2496-2503.
14.	Barsoum RS, Morsey AA, Iskander IR, et al. The Cairo kidney center protocol for rapamycin-based sequential immunosuppression in kidney transplant recipients: 2-year outcomes. Exp Clin Transplant, 2007, 5(2): 649-657.
15.	Smith MP, Newstead CG, Ahmad N, et al. Poor tolerance of sirolimus in a steroid avoidance regimen for renal transplantation. Transplantation, 2008, 85(4): 636-639.
16.	Lebranchu Y, Thierry A, Toupance O, et al. Efficacy on renal function of early conversion from cyclosporine to sirolimus 3 months after renal transplantation: concept study. Am J Transplant, 2009, 9(5): 1115-1123.
17.	Schena FP, Pascoe MD, Alberu J, et al. Conversion from calcineurin inhibitors to sirolimus maintenance therapy in renal allograft recipients: 24-month efficacy and safety results from the CONVERT trial. Transplantation, 2009, 87(2): 233-242.
18.	Oberbauer R. Protocol conversion from a calcineurin inhibitor based therapy to sirolimus. Transplantation, 2009, 87(8 Suppl): S7-10.
19.	Haller M, Oberbauer R. Calcineurin inhibitor minimization, withdrawal and avoidance protocols after kidney transplantation. Transpl Int, 2009, 22(1): 69-77.
20.	Webster A, Woodroffe RC, Taylor RS, et al. Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients. Cochrane Database Syst Rev, 2005, (4): CD003961.

1. de Mattos AM, Olyaei AJ, Bennett WM. Nephrotoxicity of immunosuppressive drugs: long-term consequences and challenges for the future. Am J Kidney Dis, 2000, 35(2): 333-346.
2. Webster AC, Lee VW, Chapman JR, et al. Target of rapamycin inhibitors (TOR-I; sirolimus and everolimus) for primary immunosuppression in kidney transplant recipients. Cochrane Database Syst Rev, 2006, 19(2): CD004290.
3. Mulay AV, Hus sain N, Fergus son D, e t al . Calcineur i n Inhibitor Withdrawal from Sirolimus-Based Therapy in Kidney Transplantation: A Systematic Review of Randomized Trials. Am J Transplant, 2005, 5(7): 1748-1756.
4. Johnson RW, Kreis H, Oberbauer R, et al. Sirolimus allows early cyclosporine withdrawal in renal transplantation resulting in improved renal function and lower blood pressure. Transplantation, 2001, 72(5): 777-786.
5. Oberbauer R, Kreis H, Johnson RW, et al. Long-term improvement in renal function with sirolimus after early cyclosporine withdrawal in renal transplant recipients: 2-year results of the Rapamune Maintenance Regimen Study. Transplantation, 2003, 76(2): 364-370.
6. Kreis H, Oberbauer R, Campistol JM, et al. Long-term benefits with sirolimus-based therapy after early cyclosporine withdrawal. J Am Soc Nephrol, 2004, 15(3): 809-817.
7. Oberbauer R, Segoloni G, Campistol JM, et al. Early cyclosporine withdrawal from a sirolimus-based regimen results in better renal allograft survival and renal function at 48 months after transplantation. Transpl Int, 2005, 18(1): 22-28.
8. Gonwa TA, Hricik DE, Brinker K, et al. Improved renal function in sirolimus-treated renal transplant patients after early cyclosporine elimination. Transplantation, 2002, 74(11): 1560-1567.
9. Baboolal K. A phase III prospective, randomized study to evaluate concentration-controlled sirolimus (rapamune) with cyclosporine dose minimization or elimination at six months in de novo renal allograft recipients. Transplantation, 2003, 75(8): 1404-1408.
10. Stallone G, Di Paolo S, Schena A, et al. Early withdrawal of cyclosporine A improves 1-year kidney graft structure and function in sirolimus-treated patients. Transplantation, 2003, 75(7): 998-1003.
11. Grinyo JM, Campistol JM, Paul J, et al. Pilot randomized study of early tacrolimus withdrawal from a regimen with sirolimus plus tacrolimus in kidney transplantation. Am J Transplant, 2004, 4(8): 1308-1314.
12. Morales JM, Grinyó JM, Campistol JM, et al. Improved renal function, with similar proteinuria, after two years of early tacrolimus withdrawal from a regimen of sirolimus plus tacrolimus. Transplantation, 2008, 86(4): 620-622.
13. Watson CJ, Firth J, Williams PF, et al. A randomized controlled trial of late conversion from CNI-based to sirolimus-based immunosuppression following renal transplantation. Am J Transplant, 2005, 5(10): 2496-2503.
14. Barsoum RS, Morsey AA, Iskander IR, et al. The Cairo kidney center protocol for rapamycin-based sequential immunosuppression in kidney transplant recipients: 2-year outcomes. Exp Clin Transplant, 2007, 5(2): 649-657.
15. Smith MP, Newstead CG, Ahmad N, et al. Poor tolerance of sirolimus in a steroid avoidance regimen for renal transplantation. Transplantation, 2008, 85(4): 636-639.
16. Lebranchu Y, Thierry A, Toupance O, et al. Efficacy on renal function of early conversion from cyclosporine to sirolimus 3 months after renal transplantation: concept study. Am J Transplant, 2009, 9(5): 1115-1123.
17. Schena FP, Pascoe MD, Alberu J, et al. Conversion from calcineurin inhibitors to sirolimus maintenance therapy in renal allograft recipients: 24-month efficacy and safety results from the CONVERT trial. Transplantation, 2009, 87(2): 233-242.
18. Oberbauer R. Protocol conversion from a calcineurin inhibitor based therapy to sirolimus. Transplantation, 2009, 87(8 Suppl): S7-10.
19. Haller M, Oberbauer R. Calcineurin inhibitor minimization, withdrawal and avoidance protocols after kidney transplantation. Transpl Int, 2009, 22(1): 69-77.
20. Webster A, Woodroffe RC, Taylor RS, et al. Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients. Cochrane Database Syst Rev, 2005, (4): CD003961.

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基于TOR-I的CNI撤除方案在腎移植術后免疫抑制治療中療效和安全性的Meta分析

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《中國循證醫學雜志》

基于TOR-I的CNI撤除方案在腎移植術后免疫抑制治療中療效和安全性的Meta分析

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