细胞因子诱导的杀伤细胞对肿瘤病人体内淋巴细胞活化的影响  

Evaluation of cytokine-induced killer cells in activating iymphocytes of tumorbearing patients in vivo

作　　者：吴擘颈 徐建民[1] 吴直江[2] 高奇蓉[2] 孙汛[2] 李锋[1] 邹善华[1] 

机构地区：[1]复旦大学附属中山医院血液科,上海200032 [2]中国科学院上海生命科学研究院,上海200032

出　　处：《中国新药与临床杂志》2007年第10期797-800,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：上海市科学技术委员会生物医药重大科技攻关项目(05DZ19313)

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WHO2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。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 phase Ⅰ anti- tumor clinical trial for CIK ceils in tumor-bearing patients. The mononuclear cell induced CIK ceils 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 ceils was 20.1 × 10^9. 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 phase Ⅰ clinical trial. Besides the direct anti-tumor activity, CIK ceils might have enhanced anti-tumor effects by activating T-lymphocytes in vivo.

关 键 词：免疫疗法 T淋巴细胞 杀伤细胞 临床试验 Ⅰ期 细胞因子诱导的杀伤细胞 

分 类 号：R979.1[医药卫生—药品] R969.4[医药卫生—药学]