新型基因重组人白细胞介素-2(125ser-rIL-2)的Ⅱ期临床研究

目的 :新型基因重组人白细胞介素 2 (12 5ser rIL 2 )的临床应用范围 ,确定 12 5ser rIL 2对某些实体瘤 ,恶性胸腹水的疗效及人体的毒副作用 ,研究最适合的给药途径和治疗剂量。方法 :分别应用 12 5ser rIL 2经胸、腹腔注射 ,静脉滴注治疗5 4例中晚期恶性肿瘤患者。结果 :CR 2例 ,PR 12例 ,总缓解率为 2 5 9%。主要有效病种为恶性胸腹水 ,恶性黑色素瘤 ,肠癌和胃癌 ,其中胸腹腔注射的有效率为 4 0 7% ,静脉注射的有效率为 11 1%。免疫指标CD3、CD4治疗后升高 ,CD8治疗后下降 ,但无统计学差异 ,NK细胞治疗后升高 ,由 4 89上升到 6 2 8(P <0 0 5 )。治疗中主要不良反应为寒颤、发热、肌肉酸痛 ,未出现严重不良反应。结论 :12 5ser rIL 2具有一定的抗肿瘤作用 ,在本组应用的剂量范围内未出现严重不良反应

A phase Ⅱ study of the new gene-recombinant interleukin-2 in cancer patients

Objective:To develop the clinical application of gene recombined human interlukine 2(125ser rIL 2). Methods:54 patients with advanced malignant tumor were treated with 125ser rIL 2 in different ways such as thorax, abdomen or vein injection. Results:2 patients achieved complete response. 12 patients were partial response. The overall response rate was 25 9%. The diseases with satisfied response rate were pleuroperitoneal effusion, malignant melanoma, gastrointestinal cancer. The response rate in pleuroperitoneal effusion was 40 7%. The response rate in vein injection was 11 1%. CD3, CD4 rose and CD8 declined after treatment. But the result has no statistical difference. NK cell rose from 4 89 to 6 28.( P <0 05). The main side effect were chill, fever, myalgia. Serious toxic side effect was not observed. Conclusion:125ser rIL 2 has some anti tumor effect, serious toxic side effect was not observed in this group.