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目的 探讨特异性免疫抑制剂鼠抗人CD3 T淋巴细胞单克隆抗体 (CD3 单抗 )对重型再生障碍性贫血 (SAA)的临床疗效。方法 13例SAA患者中位数年龄 2 2岁 ,既往未经特殊治疗者4例 ,既往治疗无效的 9例中 ,加环孢素≥ 3个月者 4例 ;给药方法 :CD3 单抗 5mg静脉滴注 ,日 1次 ,连用 10d为一疗程。结果 共随访 3～ 15个月 ,骨髓象有 8例明显好转 ;外周血WBC平均升高 1 5 9× 10 9/L ,中性粒细胞升高 0 72× 10 9/L ,Hb升高 4 0 g/L ,血小板升高 4 7× 10 9/L(Р值均 <0 0 1) ;其中 2例基本治愈 ,2例达缓解 ,7例明显进步 ,2例无效 ;T淋巴细胞亚群的变化 :CD4/CD8比值由1 12± 0 34上升至 1 4 2± 0 4 3、HLA DR的表达率由 ( 2 9 2± 13 3) %下降至 ( 15 2± 5 6 ) % (Р值均<0 0 1) ;体外培养患者外周血单个核细胞分泌下列淋巴因子含量的中位数值 (U/ml) :肿瘤坏死因子α、干扰素γ与白细胞介素 2分别由 2 6 7、784和 92降至 15 2、5 70和 5 1(Р值均 <0 0 1)。不良反应 :单抗治疗期间 ,全部病例均有发热 ,4例出现胸闷、呼吸困难 ,但无 1例死亡。结论 与其他常用的免疫抑制剂相比 ,CD3 单抗对SAA的临床疗效更快、有效率可能更高 ,且安全性较好 ;关于该单抗的长期疗效、远期不良作用 ,有待于积累更多
Objective To investigate the clinical efficacy of specific immunosuppressive murine monoclonal anti-human CD3 T lymphocyte monoclonal antibody (CD3 monoclonal antibody) on severe aplastic anemia (SAA). Methods Thirteen patients with SAA were enrolled in this study. The median age was 22 years. Four patients were previously treated without special treatment. Among the nine patients who had no previous treatment, 4 patients were treated with cyclosporine ≥ 3 months. Administration method: 5 mg Intravenous drip, day 1, once every 10d for a course of treatment. Results A total of 8 months follow-up was observed in 3 to 15 months. There was a significant improvement in 8 cases of bone marrow astrocytoma. WBC was increased by 15 59 × 10 9 / L in peripheral blood, while the neutrophil was increased by 72 × 10 9 / L and Hb was increased by 4 0 g / L and thrombocytopenia 4 7 × 10 9 / L, respectively (both, P0 <0.01). Two of them were basically cured, two were relieved, seven were significantly improved and two were ineffective. T lymphocyte subsets : The ratio of CD4 / CD8 increased from 12 ± 0 34 to 1 42 ± 0 43, and the expression rate of HLA DR decreased from (292 ± 13 3)% to (15 2 ± 5 6)% (P <0.01). The median of peripheral blood mononuclear cells (PBMCs) secreted the following lymphokines in vitro: tumor necrosis factor alpha, interferon gamma and interleukin 2 were respectively increased by 267, 784 and 92 dropped to 15 2,570 and 5 1 (Р values <0 0 1). Adverse reactions: during the course of monoclonal antibody treatment, all cases had fever, 4 cases of chest tightness, difficulty breathing, but none of them died. Conclusion Compared with other commonly used immunosuppressive agents, CD3 monoclonal antibody has a faster and more effective clinical response to SAA, its efficiency may be higher and its safety is better. Long-term curative effect of this monoclonal antibody has long-term adverse effects and needs to be accumulated More