硝酸芬替康唑凝胶阴道刺激性研究

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。

Study on the Vaginal Irritation of Fenticonazole Nitrate Gel

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.