目的  对治疗用卡介苗毒性试验和脾激活试验进行方法学验证。方法  分别用治疗用卡介苗、皮内注射用卡介苗或生理氯化钠溶液处理小鼠，通过每天观察处理小鼠的体重变化和健康状况并打分来进行毒性试验，通过计算处理小鼠的脾指数来进行脾激活试验。使用NCSS软件对检测结果进行方差分析，考察试验方法的精密度和中间精密度。结果  操作人员和时间变化对毒性试验和脾激活试验的检测结果没有影响。结论  治疗用卡介苗毒性试验和脾激活试验均具有可重复性和精密性，可用于治疗用卡介苗的安全性和有效性检测。

Objective  To validate the toxicity test and the spleen activation test for detecting therapeutic BCG.  Methods   Mice were injected with therapeutic BCG, BCG for intradermal injection and normal saline, respectively. The toxicity test was conducted by observing weights and healths of treated mice and scoring every day, and the spleen activation test was conducted by calculating spleen index of treated mice. The statistical analysis of results was made by ANOVA with NCSS software. The precisions and intermediate precisions of two methods were investigated.  Results  The changes of operator and time had no effect on the results of the toxicity test and the spleen activation test.  Conlusions  Both the toxicity test and the spleen activation test for detecting therapeutic BCG have repeatability and precision, and can be used to determine the safety and effectiveness of therapeutic BCG.