【摘要】 目的:探讨细胞因子诱导的杀伤细胞(CIK细胞)临床应用的安全性和CIK细胞对肿瘤病人体内淋巴细胞活化的影响。方法:进行CIK细胞抗肿瘤Ⅰ期临床试验,21例恶性肿瘤病人采集外周血单个核细胞诱导CIK细胞,按CIK细胞静脉滴注(静滴)剂量分为4个治疗组观察不良反应,并测定静滴前后病人外周血淋巴细胞活化相关表面标志。结果:21例恶性肿瘤病人中未出现导致研究中断的严重不良反应,CIK细胞最大耐受剂量20.1×10~9个,观察到WHO 2级发热5例,一过性白细胞减少2例,均能迅速恢复正常;CIK细胞静滴后,病人外周血淋巴细胞表面CD25、CD38、CD69表达均有明显上调,P<0.01。结论:Ⅰ期临床试验表明CIK细胞临床应用不良反应轻微,除了直接杀伤作用外还可能活化体内T淋巴细胞从而增强抗肿瘤活性。更多还原

【Abstract】 AIM:To evaluate the clinical safety and discuss the activation effect of cytokine-induced killer(CIK)cells on lymphocytes of tumor-bearing patients.METHODS:This study was a phaseⅠanti- tumor clinical trial for CIK cells in tumor-bearing patients.The mononuclear cell induced CIK cells of the peripheral blood were prepared from 21 tumor-bearing patients,and then distributed into four therapeutic groups with different doses for observing adverse reactions,through measuring activation signs of peripheral blood lymphocyte surface markers before and after CIK intravenous infusion.RESULTS:No severe adverse reactions leading to abruption of the study occurred in all 21 subjects.The highest tolerance dose for CIK cells was 20.1×109.Five patients with WHO-grade-2 fever and two patients with transient leukocytopenia were observed but all of them recovered sooner or later uneventfully.Surface expressions CD25,CD38 and CD69 of subjects’ peripheral blood lymphocytes were up-regulated significantly after CIK intravenous infusion(P<0.01). CONCLUSION:CIK cells are safe with minor adverse reactions during phaseⅠclinical trial.Besides the direct anti-tumor activity,CIK cells might have enhanced anti-tumor effects by activating T-lymphocytes in vivo.更多还原