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美国食品和药物管理局(FDA)首次批准美国Ortho药物公司生产的治疗用单克隆抗体OKT_3。OKT_3能附着于靠近T细胞受体的T—3位上,从而抑制T细胞的功能。肾脏移植时,T细胞会引起急性排斥反应,OKT_3通过抑制T细胞而抑制了排斥反应,但不抑制免疫系统的其它部分。FDA主要是根据去年的临床试验结果而批准使用此单克隆抗体的。一项试验表明,OKT_3能纠正94%的急性肾脏排斥反应,而传统的类固醇治疗的成功率仅是75%。另一项试验发现,OKT_3能纠正94例中90例
The U.S. Food and Drug Administration (FDA) approved for the first time the therapeutic monoclonal antibody OKT_3 produced by Ortho Pharmaceuticals in the United States. OKT_3 can be attached to the T-3 position near the T cell receptor, thereby inhibiting T cell function. T cells cause acute rejection in kidney transplants. OKT_3 suppresses rejection by inhibiting T cells but does not inhibit other parts of the immune system. FDA approved the use of this monoclonal antibody based primarily on the results of last year’s clinical trial. One trial showed that OKT_3 corrected 94% of acute kidney rejection, compared to 75% for traditional steroid therapy. Another trial found that OKT_3 corrected 90 of 94 patients