成人用吸附精制白喉破伤风二联类毒素人体反应及血清学效果观察

为了解成人用吸附精制白喉破伤风二联类毒素 (成人白破二联 )的人体反应及血清学效果 ,于 1999年 3月在北京市朝阳区5所小学对 2 14名小学一年级学生随机分为两组 ,分别接种北京生物制品研究所 (北京所 )、上海生物制品研究所 (上海所 )生产的成人白破二联。人体反应观察结果显示 :接种北京所疫苗 2 4小时全身中、强反应发生率为 2 2 5 % ,局部反应发生率 <7% ;接种上海所疫苗局部与全身中、强反应发生率均 <7%。用间接血凝法检测免疫前后配对血清白喉、破伤风抗毒素含量显示 :北京所疫苗人群免疫后白喉、破伤风抗体较免疫前≥ 4倍增长率分别为 98 9%、96 6 % ,成功率均为 10 0 0 % ;上海所疫苗人群免疫后白喉、破伤风抗体较免疫前≥ 4倍增长率分别为 93 2 %、98 8% ,成功率分别为 97 7%、10 0 0 %。观察结果表明 ,在小学一年级学生中使用上海所生产的成人白破二联是安全有效的。另外 ,根据本次观察 ,免疫前白喉抗体仍保持在较高水平 ,而破伤风抗体已下降至较低水平 ,提示有必要继续观察小学一年级学生加强免疫后血清白喉抗体消退情况 ,并据此考虑是否取消北京市初中一年级白喉类毒素加强免疫 ,同时将高三、中专、技校毕业班和外地进京大学一年级学生的白喉类毒素加强免疫改为成人白破二联免疫

Observation on the Side Effect and Serological Effect of Adult-type Tetanus-Diphtheria Combined Vaccine (Td)

Side effect and serological effect were observed in 214 primary school children who were inoculated with one dose (0.5ml) adult-type tetanus-diphtheria combined vaccine (Td) in March 1999. The vaccines used were produced by Beijing TianTan Biological Products CO.LTD and Shanghai Institute of Biological Products, Ministry of Health. The observation on side effect showed that the rate of moderate and severe systemic reaction of the cluster who were inoculated with vaccine from Beijing Institute was 22.5%, the local reaction rate was <7%, while both the rates of systemic and local reaction of the cluster who were inoculated with the vaccine from Shanghai Institute were below 7%. The serological effect of the paired sera showed that after injecting the vaccine from Beijing Institute, the positive rates of anti-diphtheria, anti-tetanus toxin with a 4-foldrise or more were 98.9%, 96.6% respectively, the successful rates were all 100%; after injecting with vaccine from Shanghai Institute, the positive rates of anti-diphtheria, anti-tetanus toxin with a 4-foldrise or more were 93.2%, 98.8% respectively, the successful rates were 97.7%, 100%. Summing up the results above, the inoculation of Td produced by Shanghai Institute in primary school children is safe and effective. Some other data acquired from this observation showed that before the Td booster immunization, the anti-diphtheria toxin level remained high in primary school pupils, but the anti-tetanus toxin level was low. According to this, it is necessary to lunch Td immunization continually in first grade primary shool pupils. We also suggest to cancel the anti-diphtheria revaccination in junior middle schools and change it into diphtheria-tetanus combined booster immunization to the students of the graduate classes of senior middle schools, the technical schools and the freshmen coming from other provices.