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目的观察重组人角质细胞生长因子-2(recombination human keratinocyte growth factor-2,rhKGF-2)对兔眼的长期毒性。方法 32只新西兰白兔,随机分为对照组及高(2 000 mg·L-1)、中(500 mg·L-1)、低(125 mg·L-1)剂量组,每组8只,连续滴眼给药重组人角质细胞生长因子-2,每天6次,每2 h给药1次,单眼给药0.1 m L,给药4周,停药后恢复2周。观察一般药物反应及眼部症状,检测动物血液学、血液生化学和组织病理学等指标。结果除了中高剂量组分别有7例和8例眼部有少量类似眼屎的黏性分泌物及高剂量组有3例出现睑结膜充血呈鲜红色外,其他动物眼部未见与给药相关的明显异常变化;体质量、进食量、体温、心电图、尿液、血液学、凝血、血液生化学、骨髓细胞、脏器质量、脏器系数和病理学检查均未见明显与给药相关的异常变化。结论本试验选用3个剂量分别为有效剂量浓度的5、20和80倍,并未对新西兰白兔产生明显毒性,说明该剂量对新西兰白兔眼部用药是安全的。
Objective To observe the long-term toxicity of recombinant human keratinocyte growth factor-2 (rhKGF-2) to rabbit eyes. Methods Thirty-two New Zealand white rabbits were randomly divided into control group and high dose (2 000 mg · L -1), medium dose (500 mg · L -1) and low dose (125 mg · L -1) , Continuous administration of recombinant human keratinocyte growth factor-2, 6 times a day, once every 2 h administration, monocular administration of 0.1 m L, for 4 weeks, withdrawal after recovery for 2 weeks. Observe the general drug reactions and ocular symptoms, detection of animal hematology, blood biochemistry and histopathology and other indicators. Results In addition to the medium and high dose groups were 7 cases and 8 cases of eye with a small amount of gum-like viscous secretions and high-dose group, 3 cases appeared conjunctival congestion was bright red, the other animals did not see the eyes and administration-related Obvious abnormal changes; no obvious drug-related abnormalities were found in body weight, food intake, body temperature, electrocardiogram, urine, hematology, blood coagulation, blood biochemistry, bone marrow cells, organ quality, organ coefficient and pathological examination Variety. CONCLUSION: Three doses of 5, 20 and 80 times higher than the effective dose were used in this study. No significant toxicity was observed in New Zealand White rabbits, indicating that this dose is safe for ocular administration in New Zealand white rabbits.