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作者对35例晚期恶性肿瘤病人进行了重组γ干扰素(rIFN-γ)的Ⅰ期临床研究,以观察其静脉滴注时的毒性反应。35例病人中,8例肾癌、16例胃肠道癌、6例头颈部癌,其余为肺癌(2)、乳癌(2)和肉瘤(1)。病人分成6个剂量组,每次静脉滴注0.5、1、2、4、6或8×10~6IU/m~2的rIFN-γ,每周2次,1个疗程为28天,连续治疗2个疗程以上。临床观察结果证实:rIFN-γ的毒性作用与其他干扰素相似。主要的临床毒性反应是急性发热、寒战等流感样症状,严重程度和发生率与剂量无关。作者认为IFN-γ是很强的单核细胞活化因子,肿瘤坏死因子或白细胞介素等生物反应调节素可能介导其毒性作
The authors conducted a phase I clinical study of recombinant interferon-gamma (rIFN-[gamma]) in 35 patients with advanced malignant tumors to observe the toxicity of intravenous infusion. Of the 35 patients, 8 had renal cell carcinoma, 16 had gastrointestinal cancer, 6 had head and neck cancer, and the remaining had lung cancer (2), breast cancer (2), and sarcoma (1). Patients were divided into 6 dose groups, each intravenously infused with 0.5, 1, 2, 4, 6 or 8×10-6 IU/m 2 rIFN-γ, 2 times per week, 1 course for 28 days, continuous treatment More than 2 courses. Clinical observations confirmed that the toxicity of rIFN-γ was similar to that of other interferons. The main clinical toxicities were acute fever, chills and other flu-like symptoms, and the severity and incidence were independent of the dose. The authors believe that IFN-γ is a strong monocyte-activating factor, and biological response regulators such as tumor necrosis factor or interleukin may mediate its toxicity.