The toxicity of Prednisolone farnesylate (PNF) gel, a synthetic glucocorticoid, was investigated in the Beagle dog. PNF gel was administered percutaneously at doses of 0.2, 0.8 and 3.2 mg/kg/day for 13 weeks, then the drug was withdrawn for 5 weeks to evaluate the reversibility. In addition, 2 mg/kg/day prednisolone gel (PN gel), which is approximate to 3.2 mg/kg/day PNF gel in prednisolone molarity, was also administered for comparison. The results are summarized as follows: 1. No deaths were observed in any of the PNF gel test groups or the PN gel group, nor were there any abnormal findings in the clinical signs of the animals. 2. In the hematology, a tendency toward a decrease in the lymphocyte ratio was observed in males from the PNF gel 0.8 mg/kg/day and above groups. In the PN gel group, a significant decrease or a tendency toward a decrease in the lymphocyte ratio was observed, as well as an increase in the white blood cell count in some animals. 3. In the blood biochemistry, a significant decrease or a tendency toward a decrease in total cholesterol and phospholipid was observed in males from the PNF gel 3.2 mg/kg/day group and a tendency toward an increase in triglyceride in females from the PNF gel 3.2 mg/kg/day group was observed. In the PN gel group, a tendency toward an increase in AIP activity, a tendency toward an increase in triglyceride were observed. 4. In the histological examinations, a decrease in the weight of the thymus and adrenal glands, vacuolation of hepatocytes in the middle zone of the liver, atrophy of zona fasciculata of the adrenal glands, hypertrophy of zona glomeruli, swelling of cortical cells of zona faciculate and atrophy of the thymus were observed in the PNF gel 0.8 mg/kg/day and above groups. In the PN gel group, atrophy of submandibular lymph nodes and mesenteric lymph nodes was observed in addition to the same changes as observed in the PNF gel groups. Furthermore, thinning, atrophy or a decrease in the weight of the adrenal glands was also observed both in the PNF gel 3.2 mg/kg/day group and the PN gel group at the end of the 5-week recovery period. 5. As described above, a decrease in the lymphocyte ratio, in the weight of the thymus and adrenal glands and vacuolation of hepatocytes were observed in the PNF gel 0.8 mg/kg/day and above groups.(ABSTRACT TRUNCATED AT 400 WORDS)

译文

在Beagle犬中研究了合成糖皮质激素法呢酸泼尼松龙 (PNF) 凝胶的毒性。PNF凝胶以0.2、0.8和3.2 mg/kg/天的剂量经皮给药13周,然后撤回药物5周以评估可逆性。此外,还施用2 mg/kg/天的泼尼松龙凝胶 (PN凝胶),其在泼尼松龙摩尔浓度中约为3.2 mg/kg/天的PNF凝胶,以进行比较。研究结果总结如下: 1.在任何PNF凝胶测试组或PN凝胶组中均未观察到死亡,动物的临床体征也没有任何异常发现。2.在血液学中,从PNF凝胶0.8 mg/kg/天及以上组的男性中观察到淋巴细胞比率下降的趋势。在PN凝胶组中,观察到淋巴细胞比率显着降低或趋于降低,并且某些动物的白细胞计数增加。3.在血液生物化学中,在PNF凝胶3.2 mg/kg/天组的男性中观察到总胆固醇和磷脂的显着降低或趋于降低,而在PNF凝胶3.2 mg/kg/天组的女性中观察到甘油三酯的增加趋势。在PN凝胶组中,观察到AIP活性增加的趋势,甘油三酸酯增加的趋势。4.在组织学检查中,胸腺和肾上腺的重量减少,肝脏中间区域的肝细胞空泡化,肾上腺束状带萎缩,肾小球带肥大,在0.8 mg/kg/天及以上的PNF凝胶中观察到透明带皮质细胞肿胀和胸腺萎缩。在PN凝胶组中,除了与PNF凝胶组相同的变化外,还观察到下颌下淋巴结和肠系膜淋巴结的萎缩。此外,在5周恢复期结束时,在PNF凝胶3.2 mg/kg/天组和PN凝胶组中也观察到肾上腺变薄、萎缩或重量减少。5.如上所述,在0.8毫克/千克/天及以上的PNF凝胶中观察到淋巴细胞比率、胸腺和肾上腺重量的降低以及肝细胞的空泡化。(摘要截短于400字)

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