硝酸芬替康唑凝胶阴道刺激性研究

Study on the Vaginal Irritation of Fenticonazole Nitrate Gel

目的探讨硝酸芬替康唑凝胶按规定剂量给予兔阴道后对阴道的刺激性,为临床研究用药提供参考。方法选取新西兰兔8只,雌性,按体重随机分为两组,给药1次/d,连续7 d,末次给药后24 h处死动物,取阴道进行病理组织学检查。结果空白凝胶组4只动物阴道粘膜上皮细胞无明显变性、坏死,固有膜血管未见明显扩张充血,血管周围未见明显炎细胞浸润;硝酸芬替康唑组4只动物阴道黏膜固有层均见成纤维细胞增生,部分黏膜上皮脱落,并且1号阴道黏膜固有层见较多的坏死的中性粒细胞。结论连续给予硝酸芬替康唑阴道凝胶对阴道局部有一定的刺激性,有可能会引起部分阴道黏膜上皮脱落及局部水肿等炎症改变。

Objective To observe the vaginal irritation of Fenticonazole Nitrate Gel given to rabbit vaginal according to the pre-scribed dose, so as to provide a reference for the study of clinical medication. Methods 8 New Zealand female rabbits were ran-domly divided into two groups according to the weight. Fenticonazole Nitrate Gel was administrated to them q.d. for 7 d. The rab-bits were killed 24h after the last administration, and the vagina was taken for histopathological examination. Results In the 4 rab-bits of the blank gel contrast group, no obvious degeneration and necrosis was found in vaginal epithelial cells, no palpable dilata-tion and congestion was found in intrinsic membrane vascular and no obvious inflammatory cells infiltration was found around the vessels; but in the Fenticonazole Nitrate Gel group, fibroblast proliferation and some epithelial exfoliation were found in vaginal mucosa lamina propria of 4 rabbits, and many necrosis neutrophils were found in vaginal mucosa lamina propria of No. 1 rabbit. Conclusion Continuous administration of Fenticonazole Nitrate Gel has certain irritation on local vaginal, it may cause partial vaginal epithelial exfoliation, local edema and other inflammatory changes.