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目的 :评估同种异型 (HLA A2 +)IL 2基因工程化人胃癌细胞瘤苗 (HG 1/IL 2 )治疗晚期胃癌的毒副作用及临床安全性。方法 :应用基因工程技术 ,以逆转录病毒载体介导将人IL 2cDNA转导入人胃癌细胞株MKN 45 ,经10 0Gy60Co照射灭活后 ,制备成基因工程化胃癌细胞瘤苗 (HG 1/IL 2 )。 2 0 0 1年 4月～ 2 0 0 1年 7月 ,对 8例晚期胃癌病人施行HG 1/IL 2瘤苗治疗。以 5次接种为一疗程 ,接种时间分别在第 1、8、15、2 9和第 5 8天 ,每次于一侧腹股沟和对侧腋部皮下多点注射 1× 10 7个细胞。每次接种后严格观察毒副反应 ,并在治疗开始前一周和治疗结束后进行临床评估 ,同时进行凝血功能、血液生化学、肿瘤标记物及相关免疫指标检测。结果 :除 1例在第 3次接种后 ,因高热和全身性荨麻疹而终止试验外 ,余均顺利完成治疗。接种后低热和注射局部红肿、酸胀感是最常见的反应。治疗前后未观察到病人血液学、凝血功能、肝肾功能、血清标志物等指标的明显异常。部分病人治疗后血清转铁蛋白、IgG、IgA、IgM、IL 2等体液免疫指标和CD3 、CD4 、CD8等细胞免疫指标有一定程度升高。结论 :在密切观察的前提下 ,HG 1/IL 2基因工程化胃癌细胞瘤苗应用于晚期胃癌的辅助治疗是安全可行的
PURPOSE: To evaluate the toxic side effects and clinical safety of allogenic (HLA A2 +) IL2 genetically engineered human gastric cancer cell vaccine (HG1 / IL2) in the treatment of advanced gastric cancer. METHODS: Human IL-2 cDNA was transduced into human gastric cancer cell line MKN 45 by retroviral vector and genetically engineered gastric cancer cell vaccine (HG 1 / IL 2 ). From April 2001 to July 2001, 8 patients with advanced gastric cancer were treated with HG 1 / IL 2 tumor vaccine. Five inoculations were given as a course of inoculation. On the 1st, 8th, 15th, 2nd, 9th, and 58th days of inoculation, 1 × 10 7 cells were subcutaneously injected on one side of the groin and contralateral axilla. Toxic side effects were observed after each inoculation, and clinical evaluation was performed one week before treatment and after the treatment was completed. Blood coagulation, blood biochemistry, tumor markers and related immune indexes were also tested. Results: Except one case after the third inoculation, the test was terminated due to high fever and generalized urticaria. All the patients were successfully treated. Low temperature after inoculation and injection of local swelling, soreness is the most common reaction. Before and after treatment, hematology, coagulation, liver and kidney function, serum markers and other indicators were not observed. Some patients after treatment, serum transferrin, IgG, IgA, IgM, IL 2 and other humoral immune indicators and CD3, CD4, CD8 and other cellular immune indicators have increased to some extent. Conclusion: It is safe and feasible to use adjuvant HG 1 / IL 2 genetically engineered gastric cancer cell vaccine for advanced gastric cancer under close observation