Midtvedt K, Tafjord A B, Hartmann A, Eide T C, Holdaas H, Nordal K P, Draganov B, Sødal G, Leivestad T, Fauchald P
Department of Internal Medicine, National Hospital, University of Oslo, Norway.
Transplantation. 1996 Jul 15;62(1):38-42. doi: 10.1097/00007890-199607150-00008.
Rejection episodes in renal allograft recipients are usually efficiently treated with high doses of intravenous methylprednisolone. Rejection therapy with OKT3 is often reserved for steroid-resistant episodes. However, the optimal dose of OKT3 in the treatment of steroid-resistant rejection is not known. Therefore, we randomized renal transplant recipients with steroid-resistant rejection to treatment with a standard daily intravenous dose of either 5 mg of OKT3 (n=15) or 2.5 mg of OKT3 (n=15) for 10 days. Circulating T cells (measured as CD2+ cells) were adequately and equally depleted in the two groups. Three grafts were lost due to rejection within the first 3 months following OKT3 administration, one in the 2.5 mg OKT3 group and two in the 5 mg OKT3 group. Two nonimmunologic graft losses occurred in the 2.5 mg OKT3 group. Median serum creatinine values were not different between the two groups, neither at the start (median values: 200 micormol/L in the 5 mg OKT3 group vs. 188 micromol/L in the 2.5 mg group) nor immediately after OKT3 rescue therapy (202 micromol/L vs. 185 micromol/L, respectively). Eight cytomegalovirus infections occurred in each group. Two re-rejection episodes occurred in the 5 mg OKT3 group and one occurred in the 2.5 mg OKT3 group. All responded to treatment. Function of the remaining grafts estimated by serum creatinine after a mean long-term follow-up of 18 months (range, 6-36 months) revealed no differences (185 micromol/L in the 5 mg OKT3 group vs. 170 micromol/L in the 2.5 mg OKT3 group). We conclude that OKT3 treatment of steroid-resistant rejections in renal transplant recipients is equally effective in daily doses of 2.5 mg and 5 mg with respect to reversal rate and long-term outcome.
肾移植受者的排斥反应通常用大剂量静脉注射甲基强的松龙进行有效治疗。OKT3用于抗类固醇排斥反应的治疗通常保留给对类固醇耐药的情况。然而，OKT3治疗类固醇耐药性排斥反应的最佳剂量尚不清楚。因此，我们将患有类固醇耐药性排斥反应的肾移植受者随机分为两组，一组每天静脉注射标准剂量5毫克OKT3（n = 15），另一组每天静脉注射标准剂量2.5毫克OKT3（n = 15），治疗10天。两组中循环T细胞（以CD2 +细胞衡量）均得到充分且同等程度的清除。在OKT3给药后的前3个月内，有3个移植物因排斥反应而丢失，其中2.5毫克OKT3组有1个，5毫克OKT3组有2个。2.5毫克OKT3组发生了2例非免疫性移植物丢失。两组的血清肌酐中位数在开始时（中位数：5毫克OKT3组为200微摩尔/升，2.5毫克组为188微摩尔/升）以及OKT3挽救治疗后即刻（分别为202微摩尔/升和185微摩尔/升）均无差异。每组均发生了8例巨细胞病毒感染。5毫克OKT3组发生了2例再次排斥反应，2.5毫克OKT3组发生了1例再次排斥反应。所有患者对治疗均有反应。平均长期随访18个月（范围6 - 36个月）后，根据血清肌酐评估的其余移植物功能显示无差异（5毫克OKT3组为185微摩尔/升，2.5毫克OKT3组为170微摩尔/升）。我们得出结论，对于肾移植受者中类固醇耐药性排斥反应的治疗，就逆转率和长期结果而言，每天2.5毫克和5毫克剂量的OKT3同样有效。
