Onishi M, Ueda T, Omachi K, Honda T, Nomura M, Nagata R, Hamasu Y, Sumi N
Shin Nippon Biomedical Laboratories, Ltd., Kagoshima, Japan.
J Toxicol Sci. 1994 Nov;19 Suppl 3:405-27. doi: 10.2131/jts.19.supplementiii_405.
Five male and 5 female beagle dogs were orally given lactitol, a hepatic encephalopathy drug, for 52 weeks at doses of 0, 0.25, 1.25 or 6.25 g/kg/day. A 9 week recovery test was conducted after the discontinuation of the drug treatment. Soft stool, diarrhea, and vomiting were seen in the 1.25 and 6.25 g/kg groups. In the 6.25 g/kg group, bloody stool and increased water consumption were also observed. Urinalysis showed larger amount of the urine volume in the 6.25 g/kg group. The cecum weight of this group was increased without any morphological changes. There were no drug related effects on survival, body weight gain and food consumption. Electrocardiographic, ophthalmoscopic, hematologic and biochemical examinations failed to show any abnormalities related to the drug treatment. The above mentioned changes were satisfactorily reversible. Based on the results obtained, the NOAEL of this study was suggested to be 0.25 g/kg/day.
选用5只雄性和5只雌性比格犬，口服给予肝性脑病药物乳糖醇，剂量分别为0、0.25、1.25或6.25克/千克/天，持续52周。药物治疗停止后进行为期9周的恢复试验。在1.25和6.25克/千克组中观察到软便、腹泻和呕吐。在6.25克/千克组中，还观察到血便和饮水量增加。尿液分析显示6.25克/千克组的尿量较多。该组盲肠重量增加，但无任何形态学变化。对存活、体重增加和食物消耗没有药物相关影响。心电图、眼底镜、血液学和生化检查均未显示与药物治疗相关的任何异常。上述变化令人满意地可逆。根据所得结果，本研究的无观察到有害作用水平建议为0.25克/千克/天。
