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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。
Objective: To investigate the safety of cytokine-induced killer cells (CIK cells) and the effect of CIK cells on lymphocyte activation in tumor patients. Methods: Phase I clinical trial of anti-tumor of CIK cells was performed. Peripheral blood mononuclear cells were collected from 21 patients with malignant tumor to induce CIK cells. The CIK cells were divided into 4 treatment groups according to the intravenous drip (IV) dosage, and the adverse reactions were observed. Before and after intravenous infusion of peripheral blood lymphocytes in patients with activation-related surface markers. Results: No serious adverse reactions were found in 21 malignant tumor patients. The maximum tolerated dose of CIK cells was 20.1 × 10 ~ 9. Five cases of WHO grade 2 fever and 2 cases of transient leukopenia were observed Quickly returned to normal. After CIK cells were intravenously dripped, the expression of CD25, CD38 and CD69 on peripheral blood lymphocytes of patients were significantly increased (P <0.01). Conclusion: Phase Ⅰ clinical trial shows that clinical application of CIK cells has mild adverse reactions. In addition to its immediate killing effect, it may activate T lymphocytes in vivo to enhance anti-tumor activity.