CAJ | 학술논문

目的：观察大鼠重组人碱性成纤维细胞生长因子（rhbFGF ）的毒性反应，提供毒性反应的靶器官及其损伤的可逆性，确定无毒反应剂量，为临床安全用药提供参考。方法：实验分4组，即溶剂对照组及8，32和128 μ g/L给药组，各组试验动物分别在15，30 d和停药后30 d活杀，中和抗体检测在20和25 d 各活杀6只动物。分别观察外周血各项指标，血清生化10项指标及血清中大鼠抗人rhbFGF抗体滴度等。结果：128 μg/(kg.d)肌内注射30 d，其主要毒性表现为外周血红细胞数和血红蛋白含量降低。病理检查显示，肾小球内细胞核大的足细胞数目增多，胞体增大，胞浆内出现大小不等的空泡，胸骨皮质及骨小梁较对照组略有增粗等。结论：128 μg/(kg.d)是rhbFGF的明显中毒剂量，主要毒性靶器官是肾脏。3 2 μg/(kg.d)剂量可产生轻度的毒性反应，而 8 μg/(kg.d)剂量无明显毒性作用，为受试药安全剂量。
목적：관찰대서중조인감성성섬유세포생 장인자（rhbFGF ）적독성반응，제공독성반응적파기관급기손상적가역성，학정무독반응제량，위림상안전 용약제공삼고。방법：실험분4조，즉용제대조조급8，32화128 μ g/L급약조，각조시험동물분별재15，30 d화정약후30 d활살，중화항체검측재20화25 d 각활 살6지동물。분별관찰외주혈각항지표，혈청생화10항지표급혈청중대서항인rhbFGF항체적 도등。결과：128 μg/(kg.d)기내주사30 d，기주요독성표현위외 주혈홍세포수화혈홍단백함량강저。병리검사현시，신소구내세포핵대적족세포수목증다， 포체증대，포장내출현대소불등적공포，흉골피질급골소량교대조조략유증조등。결론：128 μg/(kg.d)시rhbFGF적명현중독제량，주요독성파기관시신장。3 2 μg/(kg.d)제량가산생경도적독성반응，이 8 μg/(kg.d)제량무명현독성작용，위수시 약안전제량。
Objectives:In order to determine the non-toxicic do se of rhbFGF,its toxicity in rats was studied.Methods;Wistar rats were divided into 4 groups,including 3 active groups［receiving 8,32 or 128μg/( kg.d) rhbFGF respectively］and 1 control group.After 30 da ys,the peripheral blood parameters,10 biochemical parameters,and the rats'serum titer of rhbFGF antibody were observed.Results:After intramuscular injection of 128μg/(kg.d) rhbFGF for 30 days,the peripheral red cell counting and hemoglobin content were decreased.Pathological examination indicated that t he glomerular podocytes increased and body cells enlarged,vacuoles of various si zes appeared in cytoplasm and the sternum cortex and bone trabecula were thicked slightly in comparison with control.Conclusions:The non-toxicic and safe dose for rhbFGF is 8μg/(kg.d).