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xiaowanzi9新虫 (正式写手)
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| Organs affected by doxycycline administration in both rats and Cynomolgus monkeys were the stomach and thyroid. In rats, both the glandular and non-glandular stomachs were affected. Effects in the rat non-glandular stomach included spongiosis at the limiting ridge, submucosal inflammation, hyperkeratosis and increased incidence of epithelial hyperplasia but these findings are not discussed further here as the non-glandular stomach does not have a counterpart in humans. From clinical experience, doxycycline is known to be irritant to the gastric and oesophageal mucosas. At 600 mg/kg/day in the 13 week rat study, focal erosion in the glandular stomach was of sufficient severity to cause or contribute to death in 2 animals but it was not observed at lower doses. Other changes in the glandular stomach included increased mucus producing cells/mucus production, observed in both rats and monkeys, and submucosal inflammation and eosinophilic chief cells, observed only in rats. In rats, other parts of the gastrointestinal tract (small and large intestines) were also affected, which may have been due to changes in intestinal flora. At doses ≥400 mg/kg/day (13 week study), diffuse mucosal hyperplasia was observed in both the duodenum and caecum and, additionally, villus hypertrophy was observed in the caecum. The NOEL for gastrointestinal lesions was 25 mg/kg/day in rats (ERAUC 2) and 30 mg/kg/day in monkeys (ERAUC 2.5 based on the 1 year study). |
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| 在大鼠和猕猴，受使用多西环素影响的器官是胃和甲状腺。在大鼠中，胃的腺体和非腺体腺部分都受到影响。在大鼠胃的非腺体部分的影响包括海绵层水肿，主要限于脊、粘膜下炎症、角化过度和上皮增生发病率增加等。但因为人没有胃非腺体所对应的结构，因此这里对这些发现不做进一步论述。根据临床经验，多西环素是胃和食管粘膜已知的刺激物。在600毫克/千克/天持续13周的大鼠研究中，在2只动物，腺胃的侵蚀足够严重，可以引起动物死亡或是动物死亡的原因。但较低剂量时并未观察到。在腺胃其他的变化包括，粘液分泌细胞增多/粘液生产增多，这在大鼠和猴中都出现；以及粘膜下炎症和嗜酸性主细胞，仅见于大鼠观察。在大鼠，胃肠道的其他部分（小肠和大肠）也受到影响，这可能是由于改变了肠道菌群。在剂量≥400毫克/千克/天（13周研究）时，在十二指肠和盲肠均出现弥漫性粘膜增生。此外，盲肠出现绒毛肥大。未观察到胃肠损伤效应的剂量分别是：大鼠（ERAUC2）25毫克/千克/天、猴（ERAUC2.5根据1年的研究）30毫克/公斤/天的。 |
2楼2014-10-20 10:14:18
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3楼2014-10-20 11:40:52