• 1.四川大學(xué)華西醫(yī)院移植工程和移植免疫實(shí)驗(yàn)室（成都 610041） 2.四川大學(xué)華西醫(yī)院循證醫(yī)學(xué)與臨床流行病學(xué)中心 3.蘭州大學(xué)循證醫(yī)學(xué)中心（蘭州 730000） 4.四川大學(xué)華西醫(yī)院泌尿外科;

目的 　評(píng)價(jià)腎移植術(shù)后從新三聯(lián)免疫抑制方案中撤出激素的安全性和有效性。
方法 　計(jì)算機(jī)檢索MEDLINE（1966～2005.9)、OVID（1966～2004）、EMBASE（1984～2004）、Cochrane圖書館（2005年第4期）、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)（1990～2005.9）。手工檢索《中華器官移植雜志》（1995～2005）等7種中文雜志。納入腎移植術(shù)后環(huán)孢A（CsA）/他克莫司（Tac）+霉酚酸酯（MMF）+激素（新三聯(lián)）方案中激素撤出的隨機(jī)對(duì)照試驗(yàn)（RCT）：包括激素撤出組與持續(xù)應(yīng)用激素的對(duì)照組。納入研究的方法學(xué)質(zhì)量按Cochrane Reviewer’s Handbook 4.2.5隨機(jī)對(duì)照試驗(yàn)的質(zhì)量標(biāo)準(zhǔn)評(píng)價(jià)。統(tǒng)計(jì)分析采用RevMan 4.2.7版軟件。
結(jié)果 　共納入9個(gè)RCT，1 681例受者（SW/SC：845/836），隨訪時(shí)間6～12個(gè)月。在CsA/Tac+MMF+激素治療方案中，CsA 和Tac對(duì)急性、慢性排斥的發(fā)生、病人和移植物存活率的影響均無統(tǒng)計(jì)學(xué)差異，Meta分析顯示：① 試驗(yàn)組急性排斥發(fā)生率比對(duì)照組約高2倍，主要為Banff Ⅰ級(jí)。② 移植物、病人存活率和慢性排斥發(fā)生率兩組均無統(tǒng)計(jì)學(xué)差異。③ 激素撤出可以降低泌尿系、單純皰疹病毒和念珠菌機(jī)會(huì)性感染的發(fā)生頻次；巨細(xì)胞病毒和敗血癥感染兩組發(fā)生頻次比較均無統(tǒng)計(jì)學(xué)差異。
結(jié)論 　在腎移植術(shù)后3個(gè)月內(nèi)從新三聯(lián)免疫抑制劑方案中撤出激素：① 會(huì)增加Banff Ⅰ級(jí)急性排斥發(fā)生率，但對(duì)中、重度急性排斥發(fā)生率無影響；② 激素撤出不影響移植物、病人存活率和慢性排斥發(fā)生率；③ 可降低機(jī)會(huì)性感染和泌尿系感染發(fā)生頻次，但不影響CMV感染和敗血癥的發(fā)生頻次。為預(yù)防嚴(yán)重感染，在足量免疫抑制劑治療方案中撤出激素值得考慮，臨床醫(yī)生可權(quán)衡利弊，個(gè)體化用藥。

引用本文： 譚繼英,趙 娜,吳泰相,楊克虎,田金徽,劉雅麗,王 莉,孫 鑫,盧一平,李幼平. 腎移植術(shù)后新三聯(lián)免疫抑制治療中激素撤出的安全性和有效性的系統(tǒng)評(píng)價(jià). 中國(guó)循證醫(yī)學(xué)雜志, 2006, 06(4): 273-281. doi: 復(fù)制

1. Puig i Mari JM. Induction treatment with mycophenolate mofetil, cyclosporine, and low-dose steroids with subsequent early withdrawal in renal transplant patients: results of the Spanish Group. Spanish Group of the CellCept Study. Transplant Proc, 1999; 31(6): 2256-2258.
2. Hricik DE, O’Toole MA, Schulak JA, et al. Steroid-free immunosuppression in cyclosporine-treated renal transplant recipients: a meta-analysis. J Am Soc Nephrol, 1993; 4(6): 1300-1305.
3. Kasiske BL, Chakkera HA, Louis TA, et al. A meta-analysis of immunosuppression withdrawal trials in renal transplantation. J Am Soc Nephrol, 2000; 11(10): 1910-1917.
4. Pascual J, Quereda C, Zamora J, et al. Steroid withdrawal in renal transplant patients on triple therapy with a calcineurin inhibitor and mycophenolate mofetil: a meta-analysis of randomized, controlled trials. Transplantation, 2004; 78(10): 1548-1556.
5. Squifflet JP, Vanrenterghem Y, van Hooff JP, et al. Safe withdrawal of corticosteroids or mycophenolate mofetil: results of a large, prospective, multicenter, randomized study. Transplant Proc, 2002; 34(5): 1584-1586.
6. Vanrenterghem Y, van Hooff JP, Squifflet JP, et al. Minimization of immunosuppressive therapy after renal transplantation: results of a randomized controlled trial. Am J Transplant, 2005; 5(1): 87-95.
7. Ahsan N, Hricik D, Matas A, et al. Prednisone withdrawal in kidney transplant recipients on cyclosporine and mycophenolate mofetil--a prospective randomized study. Steroid Withdrawal Study Group. Transplantation, 1999; 68(12): 1865-1874.
8. Vanrenterghem Y, Lebranchu Y, Hene R, et al. Double-blind comparison of two corticosteroid regimens plus mycophenolate mofetil and cyclosporine for prevention of acute renal allograft rejection. Transplantation, 2000; 70(9): 1352-1359.
9. Boletis JN, Konstadinidou I, Chelioti H, et al. Successful withdrawal of steroid after renal transplantation. Transplant Proc, 2001; 33(1-2): 1231-1233.
10. Nowacka-Cieciura E, Durlik M, Cieciura T, et al. Steroid withdrawal after renal transplantation--risks and benefits. Transplant Proc, 2002; 34(2):560-563.
11. Smak Gregoor PJ, de Sevaux RG, Ligtenberg G, et al. Withdrawal of cyclosporine or prednisone six months after kidney transplantation in patients on triple drug therapy: a randomized, prospective, multicenter study. J Am Soc Nephrol, 2002; 13(5): 1365-1373.
12. . Sola E, Alferez MJ, Cabello M, et al. Low-dose and rapid steroid withdrawal in renal transplant patients treated with tacrolimus and mycophenolate mofetil. Transplant Proc, 2002 ; 34(5): 1689-1690.
13. . Laftavi MR, Stephan R, Stefanick B, et al. Randomized prospective trial of early steroid withdrawal compared with low-dose steroids in renal transplant recipients using serial protocol biopsies to assess efficacy and safety. Surgery, 2005; 137(3): 364-371.
  1. 1. Puig i Mari JM. Induction treatment with mycophenolate mofetil, cyclosporine, and low-dose steroids with subsequent early withdrawal in renal transplant patients: results of the Spanish Group. Spanish Group of the CellCept Study. Transplant Proc, 1999; 31(6): 2256-2258.
  2. 2. Hricik DE, O’Toole MA, Schulak JA, et al. Steroid-free immunosuppression in cyclosporine-treated renal transplant recipients: a meta-analysis. J Am Soc Nephrol, 1993; 4(6): 1300-1305.
  3. 3. Kasiske BL, Chakkera HA, Louis TA, et al. A meta-analysis of immunosuppression withdrawal trials in renal transplantation. J Am Soc Nephrol, 2000; 11(10): 1910-1917.
  4. 4. Pascual J, Quereda C, Zamora J, et al. Steroid withdrawal in renal transplant patients on triple therapy with a calcineurin inhibitor and mycophenolate mofetil: a meta-analysis of randomized, controlled trials. Transplantation, 2004; 78(10): 1548-1556.
  5. 5. Squifflet JP, Vanrenterghem Y, van Hooff JP, et al. Safe withdrawal of corticosteroids or mycophenolate mofetil: results of a large, prospective, multicenter, randomized study. Transplant Proc, 2002; 34(5): 1584-1586.
  6. 6. Vanrenterghem Y, van Hooff JP, Squifflet JP, et al. Minimization of immunosuppressive therapy after renal transplantation: results of a randomized controlled trial. Am J Transplant, 2005; 5(1): 87-95.
  7. 7. Ahsan N, Hricik D, Matas A, et al. Prednisone withdrawal in kidney transplant recipients on cyclosporine and mycophenolate mofetil--a prospective randomized study. Steroid Withdrawal Study Group. Transplantation, 1999; 68(12): 1865-1874.
  8. 8. Vanrenterghem Y, Lebranchu Y, Hene R, et al. Double-blind comparison of two corticosteroid regimens plus mycophenolate mofetil and cyclosporine for prevention of acute renal allograft rejection. Transplantation, 2000; 70(9): 1352-1359.
  9. 9. Boletis JN, Konstadinidou I, Chelioti H, et al. Successful withdrawal of steroid after renal transplantation. Transplant Proc, 2001; 33(1-2): 1231-1233.
  10. 10. Nowacka-Cieciura E, Durlik M, Cieciura T, et al. Steroid withdrawal after renal transplantation--risks and benefits. Transplant Proc, 2002; 34(2):560-563.
  11. 11. Smak Gregoor PJ, de Sevaux RG, Ligtenberg G, et al. Withdrawal of cyclosporine or prednisone six months after kidney transplantation in patients on triple drug therapy: a randomized, prospective, multicenter study. J Am Soc Nephrol, 2002; 13(5): 1365-1373.
  12. 12. . Sola E, Alferez MJ, Cabello M, et al. Low-dose and rapid steroid withdrawal in renal transplant patients treated with tacrolimus and mycophenolate mofetil. Transplant Proc, 2002 ; 34(5): 1689-1690.
  13. 13. . Laftavi MR, Stephan R, Stefanick B, et al. Randomized prospective trial of early steroid withdrawal compared with low-dose steroids in renal transplant recipients using serial protocol biopsies to assess efficacy and safety. Surgery, 2005; 137(3): 364-371.