摘要目的 建立离体兔眼实验方法,评价此实验的预测力和可靠性.方法 参照欧洲替代方法验证中心推荐的离体兔眼实验方法并结合具体条件,建立适合本实验室的离体兔眼实验方法.同步采用离体兔眼实验和兔眼刺激实验对26种受试物的眼刺激性进行检测,对2种实验分级结果的一致性和可靠性进行统计分析.结果 离体兔眼实验对26种受试物的眼刺激性分级结果与兔眼刺激实验分级结果具有较高的等级相关性(Spearman R=0.943,P=0.000;Gamma=1.000,P=0.000)及分级一致性(Kappa=0.799,P=0.000),2种实验方法分级结果的差异无统计学意义(McNemar Bowker W=5.00,P＝0.172);3次离体兔眼实验结果重复性良好(F=0.439,P=0.646).结论 本实验室成功建立了离体兔眼实验的实验方法,可以作为兔眼实验的一种替代方法.

abstractsObjective To develop and evaluate the method of isolated rabbit eye (IRE) test. Methods The method of IRE test was developed based on the ECVAM protocol for rabbit enucleated eye test which was modified to adapt the specific settings of our laboratory.Twenty-six chemicals were then tested in both in vitro IRE and in vivo Draize tests.Statistical analysis was conducted to determine the relevance of the IRE test compared with the data generated in the Draize test. Results The rank correlation (Spearman R=0.943,P=0.000;Gamma=1.000, P=0.000) and class concordance (Kappa=0.799, P=0.000) were fairly well between IRE test and Draize test for 26 reference chemicals. No statistical difference was found between the classification of IRE test and of Draize test (McNemar-Bowker JP=5.00, P=0.172). The 3 IRE tests showed reliable reproducibility(F=0.439, P=0.646). Conclusion IRE test is established successfully for in vitro testing of eye irritation as an alternative method of Draize test.