Gossett K A, Barbolt T A, Cornacoff J B, Zelinger D J, Dean J H
Department of Toxicology, Sterling Winthrop Pharmaceuticals Research Division, Rensselaer, New York 12144.
Toxicol Pathol. 1993;21(1):46-53. doi: 10.1177/019262339302100106.
Recombinant human interleukin 4 (rhuIL-4) is a candidate for the treatment of refractory cancer based on its potential to enhance immune function. Recombinant human IL-4 was administered subcutaneously at 0, 1, 5, or 25 micrograms/kg/day for 28 days with a 14-day recovery to male and female cynomolgus monkeys as part of the preclinical safety evaluation. Clinical pathologic changes related to treatment with rhuIL-4 were evidence of consumptive coagulopathy, erythrocyte fragmentation, lymphocytosis, and lymphocyte morphologic changes indicative of marked antigenic or mitogenic stimulation, mild eosinophilia and neutrophilia, hypoalbuminemia, hypocholesterolemia, and hypertriglyceridemia. Based on data obtained after the 14-day recovery period, the clinical pathologic changes associated with rhuIL-4 administration were considered to be reversible.
重组人白细胞介素4（rhuIL-4）因其具有增强免疫功能的潜力，是难治性癌症治疗的候选药物。作为临床前安全性评估的一部分，以0、1、5或25微克/千克/天的剂量对雄性和雌性食蟹猴皮下注射重组人IL-4，持续28天，随后恢复14天。与rhuIL-4治疗相关的临床病理变化表现为消耗性凝血病、红细胞破碎、淋巴细胞增多，以及淋巴细胞形态学变化，提示存在明显的抗原性或有丝分裂原刺激，轻度嗜酸性粒细胞增多和中性粒细胞增多、低白蛋白血症、低胆固醇血症和高甘油三酯血症。根据14天恢复期后获得的数据，与rhuIL-4给药相关的临床病理变化被认为是可逆的。
