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目的]确定重组人肿瘤坏死因子衍生物(rhTNFα DK2)的人体可耐受剂量范围或最大耐受剂量 ,观察其毒性表现。[方法]设计6个剂量组 ,每组3例 ,以30万IU/m2 为初始剂量 ,按60、90、120、150和200万IU/m2 剂量渐次递增 ,受试病人在2小时内静脉滴注250ml药液 ,每日1次 ,连续7天。[结果]20例肿瘤病人入组 ,除2例因故出组外 ,其余18例均按计划完成试验。临床观察到的主要毒副反应为畏冷、寒战、发热、血压异常、白细胞下降及骨肌肉酸痛等 ,多属Ⅰ级可逆反应(WHO分级) ,未发现有Ⅲ级以上毒性反应 ,毒性反应发生的程度和发生率与剂量无明显相关 ,全部病人的肝肾功能和尿常规在用药前后均在正常值范围内。[结论]200万IU/m2(含200万IU/m2)以下的剂量对人体都是可耐受的安全剂量。
Objective] To determine the human tolerable dose range or the maximum tolerated dose of recombinant human tumor necrosis factor derivative (rhTNFα DK2) and observe its toxicity. [Method] Six dose groups were designed, with 3 patients in each group. The initial dose was 30, 000 IU / m2, and the dose was 60, 90, 120, 150 and 2 million IU / Instil 250ml liquid, 1 day, for 7 days. [Results] Twenty cases of cancer patients were enrolled in the study. Except for 2 cases, the remaining 18 cases were completed according to plan. Clinical observations of the main toxic side effects of chills, chills, fever, abnormal blood pressure, leukopenia and muscle soreness, etc., are mostly Ⅰ grade reversible reaction (WHO classification), did not find Ⅲ grade toxicity, toxicity occurred The degree and incidence of dose and no significant correlation, all patients with liver and kidney function and urine before and after treatment in the normal range. [Conclusion] The dosage of 2 million IU / m2 (including 2 million IU / m2) is safe to the human body.