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首页> 外文期刊>Transplantation: Official Journal of the Transplantation Society >Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group.
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Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group.

机译:霉酚酸酯用于预防原发性尸体肾脏同种异体移植受体的急性排斥反应。美国肾脏移植麦考酚酸酯研究小组。

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摘要

Mycophenolate mofetil (MMF), a new immunosuppressant that selectively inhibits proliferation of T and B lymphocytes, may reduce the frequency and severity of acute graft rejection. Acute graft rejection is the leading cause of graft loss in cadaveric renal transplantation. The purpose of this randomized, double-blind, multicenter study was to evaluate the efficacy and safety of MMF for the prevention of acute rejection episodes in adult patients during the first 6 months after renal transplantation. A total of 499 patients who were to receive a primary cadaveric renal allograft as their first transplant were randomized to receive MMF 1.0 g b.i.d. (MMF 2 g treatment group), MMF 1.5 g b.i.d. (MMF 3 g treatment group), or azathioprine 1-2 mg/kg/day. CsA, corticosteroids, and antithymocyte globulin (ATGAM) were administered as part of a quadruple sequential induction protocol. The primary efficacy endpoint was biopsy-proven rejection or treatment failure (defined as graft loss, death, or premature withdrawal from the study for any reason) during the first 6 months after transplant. All enrolled patients were included in the primary analyses of efficacy on the basis of intent to treat. The 495 patients who received study drug were included in the safety and secondary efficacy analyses. Biopsy-proven acute rejection episodes or treatment failure occurred in 47.6% of patients in the azathioprine group compared with 31.1% (P = 0.0015) and 31.3% (P = 0.0021) of patients in the MMF 2 g and 3 g treatment groups, respectively. Time to first biopsy-proven rejection episode or treatment failure was significantly longer for MMF 2 g versus azathioprine (P = 0.0036) and MMF 3 g versus azathioprine (P = 0.0006). First biopsy-proven rejection alone occurred in 38.0% of patients who received azathioprine compared with 19.8% and 17.5% of patients who received MMF 2 g and 3 g, respectively. Patients in the azathioprine group received a greater number of full courses of antirejection treatment as compared with the MMF 2 g and MMF 3 g groups (44.5%, 24.8%, and 21.1%, respectively). The use of antilymphocyte agents to treat rejection was greater in the azathioprine group (20.1%) compared with the MMF 2 g group (10.3%) and the MMF 3 g group (5.4%). At 6 months after transplant, graft and patient survival were similar in all 3 treatment groups.(ABSTRACT TRUNCATED AT 400 WORDS)
机译:霉酚酸酯(MMF)是一种选择性抑制T和B淋巴细胞增殖的新型免疫抑制剂,可降低急性移植排斥的频率和严重程度。急性移植排斥是尸体肾移植中移植损失的主要原因。这项随机,双盲,多中心研究的目的是评估MMF预防肾移植后最初6个月内成年患者急性排斥反应的有效性和安全性。总共499例接受首次尸体移植的尸体肾脏患者被随机分配接受1.0 g b.i.d的MMF。 (MMF 2 g治疗组),MMF 1.5 g b.i.d. (MMF 3 g治疗组)或硫唑嘌呤1-2 mg / kg /天。 CsA,皮质类固醇和抗胸腺细胞球蛋白(ATGAM)作为四次顺序诱导方案的一部分进行管理。主要功效终点是活检证实的排斥或治疗失败(定义为移植物丢失,死亡或出于任何原因从研究中退出),在移植后的前6个月内。根据治疗意图,所有入组患者均纳入疗效初步分析。 495名接受研究药物的患者被纳入安全性和次要疗效分析。硫唑嘌呤组47.6%的患者发生了活检证实的急性排斥反应或治疗失败,而MMF 2 g和3 g治疗组的患者分别为31.1%(P = 0.0015)和31.3%(P = 0.0021)。 。 MMF 2 g相对于硫唑嘌呤(P = 0.0036)和MMF 3 g相对于硫唑嘌呤(P = 0.0006)的首次活检证实的排斥发作或治疗失败的时间明显更长。接受硫唑嘌呤治疗的患者中,只有38.0%的患者经首次活检证实是排斥反应,而分别接受2 g和3 g MMF的患者分别为19.8%和17.5%。与MMF 2 g和MMF 3 g组相比,硫唑嘌呤组的患者接受了更多的全程抗排斥治疗(分别为44.5%,24.8%和21.1%)。与MMF 2 g组(10.3%)和MMF 3 g组(5.4%)相比,硫唑嘌呤组(20.1%)使用抗淋巴细胞药物治疗排斥的比例更高。移植后6个月,所有3个治疗组的移植物和患者存活率均相似(摘要截短为400字)

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