Ohno H, Crome S J, Furuhama K, Nomura M, Onodera T
Drug Safety Research Center, Developmental Research Laboratories, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan.
J Toxicol Sci. 1995 Oct;20 Suppl 1:67-85. doi: 10.2131/jts.20.supplementi_67.
Groups of 10 male and 10 female Crl: CD (SD) BR rats were given iodixanol, a radiographic contrast medium, by intravenous injection at dosage levels of 30, 100 or 300 mgI/kg/day for four weeks to evaluate its toxicity. An extra 5 rats of each sex were given 300 mgI/kg/day for 4 weeks and then retained for 4 weeks without treatment to assess recovery. No clinical signs indicative of a toxic effect of iodixanol were noted. No effects of treatment with iodixanol on bodyweight gains, food consumption, laboratory investigations, ophthalmoscopic examinations, organ weights, bone marrow smears or macroscopic pathology were noted. Treatment related changes were noted microscopically in the kidneys only. Minimal cytoplasmic vacuolation in the proximal tubules was noted in a proportion of rats given 100 mgI/kg/day and all rats given 300 mgI/kg/day at the end of the treatment period. This effect was noted not to be fully reversible during four weeks off dose although recovery did occur in some rats.
将10只雄性和10只雌性Crl:CD(SD)BR大鼠分为一组,通过静脉注射给予碘克沙醇(一种放射造影剂),剂量水平为30、100或300 mgI/kg/天,持续四周,以评估其毒性。另外每组5只不同性别的大鼠给予300 mgI/kg/天,持续4周,然后在不进行治疗的情况下保留4周以评估恢复情况。未观察到表明碘克沙醇有毒性作用的临床体征。未观察到碘克沙醇治疗对体重增加、食物消耗、实验室检查、眼底检查、器官重量、骨髓涂片或大体病理学有影响。仅在显微镜下观察到与治疗相关的肾脏变化。在治疗期结束时,给予100 mgI/kg/天的部分大鼠和给予300 mgI/kg/天的所有大鼠近端小管中均观察到最小程度的细胞质空泡化。尽管一些大鼠确实出现了恢复,但在停药四周期间,这种效应并未完全可逆。