Treatment of renal allograft rejection with T10B9.1A31 or OKT3 - Final analysis of a phase II clinical trial
Treatment of renal allograft rejection with T10B9.1A31 or OKT3 - Final analysis of a phase II clinical trial
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DOI：
10.1097/00007890-199707270-00017
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发表时间：
1997-07-27
期刊：
影响因子：
6.2
通讯作者：
Skeeters, LJ
中科院分区：
文献类型：
--
作者：
Waid, TH;Lucas, BA;Skeeters, LJ
背景。单克隆抗体OKT3治疗急性同种异体肾移植排斥反应已被证明优于多克隆抗血清治疗。迄今为止，只有OKT3在逆转排斥危机中表现出一致的功效。从1989年到1993年，肯塔基大学进行了一项比较单克隆抗体T10B9.1A31 （T10B9）与OKT3治疗同种异体肾移植受体急性细胞排斥反应的II期试验。我们收集了178名可能有资格进入研究的患者的数据；48例从未排斥，9例拒绝，13例不能活检，16例接受甲基强的松龙治疗，11例接受抗胸腺细胞球蛋白或OKT3治疗。共有81名患者参加了这项研究，其中76人能够接受评估。活检证实急性排斥反应的患者随机分配T10B9或OKT3治疗至少10天。在人口统计学上，T10B9组和OKT3组之间没有差异。接受T10B9的患者4年精算移植存活率为87%，接受OKT3的患者为79%，接受两种单克隆抗体的患者为89% （P=0.55）。4年生存率T10B9为94%，OKT3为100%，两种单克隆抗体均为89% （P=0.45）。在1、6、12、24和36个月时，各组的平均肌酐没有差异。细胞因子肾病较少(P
Background. Treatment of acute renal allograft rejection with the monoclonal antibody (mAb) OKT3 has been shown to be superior to treatment with polyclonal antisera. To date, only OKT3 has demonstrated consistent efficacy in reversing rejection crisis.Methods. From 1989 to 1993, a phase II trial comparing the mAb T10B9.1A31 (T10B9) with OKT3 for treatment of acute cellular rejection in renal allograft recipients was done at the University of Kentucky. We collected data from 178 patients potentially eligible to enter the study; 48 never rejected, 9 refused, 13 could not be biopsied, 16 received methylprednisolone, and 11 received antithymocyte globulin or OKT3. Altogether, 81 patients entered the study, 76 of whom were able to be evaluated. Patients with biopsy-confirmed acute rejection were randomly assigned to T10B9 or OKT3 for at least 10 days.Results. Demographically, there was no difference between the T10B9 or OKT3 cohorts. Actuarial graft survival at 4 years was 87% for patients receiving T10B9, 79% for those receiving OKT3, and 89% for those receiving both mAbs (P=0.55). Patient survival at 4 years was 94% for T10B9, 100% for OKT3, and 89% for both mAbs (P=0.45). Mean creatinines of the cohorts were no different at 1, 6, 12, 24, and 36 months. There was less cytokine nephropathy (P