口服脊髓灰质炎活疫苗(OPV)猴体神经毒力试验国内外病理学检定结果分析

Pathological Evaluation of Neurovirulence Tests of OPV in Monkeys at Home and Abroad

根据荷兰国立公共卫生与环境保护研究所（NIPHEP）和昆明医学生物学研究所的要求，英国国家生物制品标准和检定所Marsden教授，在1994～1996年，按WHO推荐的方法，对昆明医学生物学研究所OPV猴体神经毒试验的病理切片进行复检。经复检4批毒种，9批疫苗和8批参考品的结果完全符合WHO要求，但两处病变记分不完全一致，而接种部位和中脑部位的选择，麻痹的和阳性的猴数的计算，针迹部位病变的判定和复试标准等，尚需进一步改进。

On request of National Institute of Public Health and Envir0mental Protection(NIPHEP,Netherlands)and Institute of Medical Biology(IMB,China),Professor Marsden from National Institute for Biological Standards and Control(NIBSC,England)had givenhistopathological evaluations of the sections of neurovirulence tests of OPV in monkeys fromIMB for 3 times during 1994～1996 at NIPHEP.Four lots of seeds,9 lots of OPV and 8 lotsof references were evaluated.The results fully fitted in with WHO’s requirements,but themarks for the pathologic changes were not fully in agreement with that awarded by IMB.Thechose of inocu1ation and midbrain sites,calculation of para1ytic and poitive monkeys,judgement of pathologic change at injectng site and the standard for retest should be further improved.