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为考核冻干卡介苗(BCG)的质量,对上海市普陀区、江苏省南京市新生儿接种不同批号冻干BCG的临床反应及免疫效果进行了观察。结果显示:接种不同批号BCG后均无腋下淋巴结肿大等副反应;两地各组新生儿阳转率为98%~100%,不同地区新生儿接种同一批BCG,因个体差异等因素导致结核菌素纯蛋白衍化物(T-PPD)硬结平均直径的差异有显著的统计学意义(t=5537~10.951。P<001);而不同批号BCG之间由于活菌数不同,与对照BCG的PPD试验的硬结平均直径比较,差异也各不相同(t=0.142~4.054,P<0.05或>0.05);卡痕阳性率高于94.59%,PPD试验与卡痕反应判定的符合率为94.81%。
To evaluate the quality of freeze-dried BCG, the clinical response and immunological effects of different batches of freeze-dried BCG in Putuo District of Shanghai and Nanjing City of Jiangsu Province were observed. The results showed that there was no adverse reactions such as axillary lymph node enlargement after inoculation of different batch BCGs. The positive rate of newborns in each group was 98% -100%. The newborns in different regions were vaccinated with the same batch of BCG due to individual differences and other factors The average diameter of tuberculin pure protein derivative (T-PPD) was significantly different (t = 5537 ~ 10.951.P <001). However, due to the different number of viable BCG, (T = 0.142 ~ 4.054, P <0.05 or> 0.05). The positive rate of card marks was higher than 94.59%. The PPD test and the kerf reaction The coincidence rate of the judgment is 94.81%.