艾硕特抗菌露对阴道黏膜刺激的实验研究

Irritation of Esawt Microbicide Gel on vaginal mucosa

目的研究艾硕特抗菌露(Esawt Microbicide Gel,EMG)对实验兔阴道黏膜刺激性,以评估其产品使用的安全性。方法测试两个不同批次产品,实验动物为雌性新西兰大耳白兔12只,随机分为四组,两个对照组和两个实验组,每组三只,对照组用生理盐水。对动物进行阴道黏膜刺激试验,并对每只动物阴道黏膜的上、中、下段做组织病理学检查;分析比较实验组与对照组动物各部位受刺激评分数据以及动物受刺激反应的个体差异,用Hotelling T2检验,从动物受刺激后有无反应考虑,用精确概率法做两组间比较。结果按阴道黏膜刺激强度分级标准艾硕特抗菌露的两个不同批次产品均为极轻刺激性;统计分析表明,受试物对动物刺激后,对照组与实验组受刺激后反应情况相似,其反应率差异均无统计学意义,试验中存在动物个体差异。结论艾硕特抗菌露是一种安全、稳定的产品;由于动物存在个体差异,以及活体试验操作过程中可能存在的操作误差,因此对实验结果作必要的统计学分析,对获得科学结论是十分必要的。

Objective To evaluate the safety of Esawt Microbicide Gel（tin） （EMG） on rabbit vaginal mucosa. Methods 12 female New Zealand rabbits were randomly divided into 4 even groups, including 2 experimental groups with EMG and 2 control group with saline. Pathological examinations were performed on the upper, medial and lower section of vagina. The irritation scores of vagina sections were observed. Results The irritation for the experimental group was significantly different from that for the control group. Conclusion The results indicated that Esawt Microbicide Gel may be a stable and safe product.