白喉和/或破伤风类毒素在单价疫苗及联合疫苗中免疫原性效力评估的实验研究
Experimental study on estimating the immunogenic potency of diphtheria and/or tetanus toxoids in monovaccines and associated vaccines.
作者信息
Durbacă S, Andronescu C, Diaconescu A
机构信息
Cantacuzino Institute, Bucharest, Romania.
出版信息
Roum Arch Microbiol Immunol. 1996 Apr-Jun;55(2):119-31.
The results obtained using the "classical" active immunoprotection tests on guinea pigs, biometrically interpreted by the regression analysis in "PROBIT" systems revealed that the biopreparations of the Cantacuzino Institute meet the validity conditions related to the parallelism of the "slopes" enabling the calculation of ED50 and of the relative potencies against the reference preparations. The results also showed that the relative potencies of the biopreparations tested by the two methodologies were very close. The geometrical means and the geometrical standard deviations of the titrers obtained in mice pointed to the similarity of the values following inoculation of the Cantacuzino Institute preparations on the one hand and of the international reference preparation on the other.
使用“经典”主动免疫保护试验在豚鼠身上获得的结果，通过“概率单位”系统中的回归分析进行生物统计学解释，结果表明，坎塔库齐诺研究所的生物制剂符合与“斜率”平行性相关的有效性条件，从而能够计算ED50以及与参考制剂相比的相对效力。结果还表明，两种方法测试的生物制剂的相对效力非常接近。在小鼠身上获得的滴度的几何平均值和几何标准差表明，一方面接种坎塔库齐诺研究所制剂后的值与另一方面接种国际参考制剂后的值相似。
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