百日咳菌苗免疫力水平测定两种统计方法的比较

Comparative Studies on the Immunity of Pertussis Vaccine by Two Statistical Analysis Methods

利用生物统计软件对兰州生研所１２年间生产的１４７批百日咳菌苗原液的免疫力进行质反应平行线测定分析（平行线法），并与《中国生物制品规程》９５版中ＷｉｌｓｏｎＷｏｒｃｅｓｔｅｒ法（Ｗ－Ｗ）比较，结果表明，质反应平行线测定法的各剂量反应百分率落在经验区间内；ＥＤ５０可信限区间为０．０１６～０．０１４；相对效价９５％可信限区间为０７７５～０．６５５。按合格、不合格、复试三个水平对１４７批百日咳菌苗的免疫力进行了分析与评价。并以中国百日咳菌苗免疫力试验用参考品为对照，对待检菌苗的稳定性及实验一致性进行了质量检测，计得总体回归系数分别为１．５８７９（ｘ２＝６０．９０）和１．３８４９（ｘ２＝１６３．２４）；总体ＥＤ５０分别为０．０１４和０．０１５；待检菌苗总体相对效价０７１４，两法的ＥＤ５０值间及相对效价值间存在很好的相关性（ｒ＝０．８３７６及ｒ＝０．９９４０）。

The Immunity of 147 lots pertussis vaccine had been evaluated by probability method and Wilson Worcester method.The results shows that the ED 50 and relative Immunity between the two statistical analysis mathods were ralative eath other.