Dantal J, Ninin E, Hourmant M, Boeffard F, Cantarovich D, Giral M, Wijdenes J, Soulillou J P, Le Mauff B
Diaclone, Besançon, Nantes, France.
Transplantation. 1996 Nov 27;62(10):1502-6. doi: 10.1097/00007890-199611270-00020.
B-F5, a mouse IgG1 anti-CD4 MoAb, was used in recipients of a first cadaveric kidney allograft. Eighteen patients received 30 mg/day MoAb with a quadruple sequential therapy. All but one kidney were functioning at 6 months, with a mean serum creatinine of 153 micromol/L. However, 50% of the patients had an acute rejection episode within the first three months, and most of the early episodes (i.e., < 1 month) occurred in patients with low levels of circulating MoAb. The biological analysis showed a strong depleting effect on the CD4+ cell counts, a saturation by the MoAb of the remaining circulating CD4+ cells, and no detectable immunization against B-F5. Although the biological parameters indicate an action of B-F5 in vivo, the clinical data associated with poor MoAb bioavailability suggest the need for an improved pharmacokinetic behavior of the MoAb to determine its use for prophylaxis of early rejection.
B-F5是一种小鼠IgG1抗CD4单克隆抗体，用于首次尸体肾移植受者。18例患者接受了每日30毫克单克隆抗体的四联序贯治疗。除1例肾脏外，其余所有肾脏在6个月时均功能良好，平均血清肌酐为153微摩尔/升。然而，50%的患者在最初三个月内发生了急性排斥反应，且大多数早期反应（即<1个月）发生在循环单克隆抗体水平较低的患者中。生物学分析显示对CD4+细胞计数有强烈的耗竭作用，单克隆抗体使剩余循环CD4+细胞饱和，且未检测到针对B-F5的免疫反应。尽管生物学参数表明B-F5在体内有作用，但与单克隆抗体生物利用度差相关的临床数据表明，需要改善单克隆抗体的药代动力学行为，以确定其用于预防早期排斥反应的用途。
