摘要
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
Objective: To Observe the toxicity and adverse reactions of IL-2 gene-modified allogenic gastric cancer cell line to far-advanced gastric cancer patients.Methods: A specific clinical trial was conducted in eight far-advanced gastric cancer patients using the IL-2 gene-modified gastric cancer cell line as an adjunctive measure of therapy. The cells were inactivated by irradiation (100 Gray) and were cryopreserved for producing the vaccine. The immunization was administered subcutaneously in a dose of 1×10 7 at the 1st, 7 th , 15 th , 28 th and 58 th day. The toxicity and adverse reactions were evaluated by the WHO criteria. Results: Seven of the 8 patients completed the immunization. The side-effects of the treatment consisted of mild to moderate fever, redness and swelling at the site of injection. The treatment was stopped in one patient after the third injection due to high fever and acute urticaria. Other adverse reactions including allergic shock, bone marrow depression and disturbance of hepatorenal functions were not observed during the immunization. Conclusions: This trial demonstrates the feasibility, safety and potential therapeutic effects of vaccination of gastric cancer patients with allogenic, gene-modified gastric cancer cell line.
出处
《外科理论与实践》
2002年第3期201-204,共4页
Journal of Surgery Concepts & Practice
基金
国家自然科学基金资助项目 (39470 792 )
国家"86 3"高科技资助项目 (Z2 0 0 1 0 4)
