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IL-4是一种多功能细胞因子,它可刺激由IL-2激活的T细胞的增殖。临床前试验表明IL-4可诱导肿瘤免疫并可排斥已形成的恶性肿瘤。 IL-4 Ⅰ期临床试验证实,IL-4最大耐受剂量达20μg/kg,其剂量限制性毒性反应包括:发热、体液潴留、鼻塞以及粘膜炎。本研究在总结IL-4 Ⅰ期临床试验经验的基础上,对IL-4治疗肾癌和转移性黑色素瘤进行了Ⅱ期临床试验。选择30例转移性黑色素瘤病人和19例晚期肾癌病人分别为两个 IL-4 Ⅱ期临床试验组。所有病人均患有可检测到的肿瘤,PS值为0或1,肝肾功能正常,无心脏病、肺病、脑转移、癫痫、胃溃疡或需糖皮质激素治疗疾病的
IL-4 is a multifunctional cytokine that stimulates the proliferation of T cells activated by IL-2. Preclinical studies have shown that IL-4 can induce tumor immunity and can reject already formed malignant tumors. IL-4 Phase I clinical trials confirmed that the maximum tolerated dose of IL-4 reached 20 μg / kg. Its dose-limiting toxicities include fever, fluid retention, nasal obstruction, and mucositis. In this study, based on the experience of Phase I clinical trial of IL-4, Phase II clinical trial of IL-4 on renal cell carcinoma and metastatic melanoma was conducted. Thirty patients with metastatic melanoma and 19 patients with advanced renal cancer were selected as two phase II clinical trials of IL-4. All patients had detectable tumors with PS values of 0 or 1, normal liver and kidney function, absence of heart disease, lung disease, brain metastasis, epilepsy, gastric ulcer or glucocorticoid-treated disease