口服脊髓灰质炎减毒活疫苗猴体神经毒力试验参考品合格标准的统计分析

Statistical analysis of the standard of reference viruses for monkey neurovirulence test in oral poliomyelitis vaccine(OPV)

验证口服脊髓灰质炎减毒活疫苗的猴体神经毒力试验参考品合格标准是否发生改变及其对疫苗猴体神经毒力试验检测结果的影响.按照WHO推荐的猴体神经毒力中枢神经系统病理学检定方法,统计分析了1996～2002年中猴体神经毒力试验三个型参考品各五批以上的实验数据.并对Ⅰ、Ⅱ、Ⅲ型参考品的病变好发部位腰、颈、脑的病变分数进行了比较.结果表明,Ⅰ、Ⅱ型参考品合格标准上、下限及C值有所下降;Ⅲ型参考品合格标准上、下限及C值略有升高.从病理学记分结果显示,三型参考品在腰、颈、脑部的致病力存在着差异;Ⅲ型参考品的致病变力向颈、脑部位扩散的指数明显增大.Ⅰ、Ⅱ型参考品合格标准对疫苗猴体神经毒力试验合格界线趋于严格,而Ⅲ型参考品猴体神经毒力病变指数由腰部向颈、脑部蔓延趋势的增大导致病变扩散指数和强度指数增大,从而使Ⅲ型参考品合格标准对疫苗的猴体神经毒力试验合格界线范围趋大,有可能对Ⅲ型疫苗制品合格率增大.

To validate the qualified criterion of the reference viruses for monkey neurovirulence test of OPV and observe the affect of OPV neurovirulence test by the changes of the qualified criterion. According to the neurovirulence proceeding recommended by WHO, more than 5 batches of three types WHO reference viruses were analyzed from 1996 to 2002 and the related lesion tissues were obsen,ed. The range of qualified standard for upper limit and lower limit and the C value of type Ⅰ、Ⅱ is decreased slightly, while the range of qualified standard for upper limit and lower limit and the C value of type Ⅲ is increased slightly. The results of pathology score revealed that the three types reference viruses had some differences in relation to neurovirulence in lumbar, cervical enlargement and brain. The neurovirulence index of type Ⅲ reference product was apparently increased towards lumbar and cervical enlargement. The range of qualified standard of type Ⅰ、Ⅱ reference viruses was becoming stricter in monkey neurovirulence test of vaccine seed strains. However, the index of monkey neurovirulence lesion for type Ⅲ reference viruses began to increase the trend in spreading from waist part to neck and brain, which made both index of pathological expanding and intensity begin to increase, thereby the related qualified borderline range has enlarged and the qualified rates for three types of vaccine have increased too.