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目的 :考察重组人表皮生长因子 (rhEGF)对健康人体及烧伤患者的药物不良反应。方法 :健康志愿者3 2例 ,rhEGF剂量由小到大依次为 14 0 ,2 80 ,70 0 ,14 0 0IU ,进行随机分组试验 ,同部位同剂量连续 3次给药 ,观察 1周 ;志愿受试烧伤患者 3 3例 ,在常规治疗的基础上按上述分组及给药剂量 ,连续用药 15d。结果 :rhEGF对正常人皮肤及烧伤患者创面无明显的刺激性 ,无致敏作用 ,抗原试验均为阴性。仅有 1例健康受试者自觉局部痒感和 1例烧伤患者创面用药时有一过性的轻微疼痛。体征及各项生化指标均无明显改变 ,受试患者创面愈合后期未见组织过度增生现象。结论 :rhEGF外用安全剂量范围较大 ,不良反应轻微 ,人体对其具有较好的耐受性。
Objective: To investigate the adverse effects of recombinant human epidermal growth factor (rhEGF) on healthy human and burn patients. Methods: Thirty-two healthy volunteers were randomly divided into two groups. The doses of rhEGF were 14 0, 280, 70 0, 140 0 IU randomly. The rats were randomly divided into three groups, 33 cases of burn patients, on the basis of conventional treatment according to the above group and dose, continuous medication 15d. Results: rhEGF had no obvious irritation and no sensitization on the skin of normal people and burn patients. The antigen test was negative. Only one healthy volunteer had consciously localized itching and one patient with burns had transient mild pain when wound dressing. Signs and biochemical indicators were no significant changes in the wound healing of patients with no evidence of excessive tissue hyperplasia. Conclusion: rhEGF topical safe dose range, minor adverse reactions, the human body has its better tolerance.