b型流感嗜血杆菌-破伤风类毒素结合疫苗与国产DTPw疫苗婴儿同时接种后的反应观察  

Adverse Reactions Induced by Simultaneous Immunization with Hib-TT Conjugate Vaccine and DTPw in Infants

作　　者：李凤祥[1] 李荣成[2] 李艳萍[2] 赵雷 唐海文 Hans L Bock 潘百斌 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]广西疾病预防控制中心 [3]葛兰素史克生物制品公司 [4]广西蒙山疾病预防控制中心

出　　处：《中国生物制品学杂志》2008年第9期803-805,共3页Chinese Journal of Biologicals

摘　　要：目的观察婴儿同时接种b型流感嗜血杆菌-破伤风类毒素(Hib-TT)结合疫苗与国产DTPw疫苗后的反应。方法按照开放、随机的原则,将472名11～17周龄的健康男女婴儿分为2组,即DTPw组(234名)和DTPw+Hib组(238名)。DTPw组接种0.5mlDTPw疫苗,DTPw+Hib组同时在不同部位接种0.5mlHib结合疫苗,2组分别于3、4、5月龄各接种1针。在免疫接种后4d内,观察2组接种对象所有症状(征集与非征集的)的发生情况,对接种当日和随后30d报告的非征集性不良反应进行记录,并进行统计学分析。结果在接种疫苗后4d内,DTPw+Hib组与DTPw组所有症状的发生率相似,分别为49.1%和46.0%;在31d内,2组中出现非征集症状的比例分别为9.9%和9.8%,其中上呼吸道感染和咽喉炎是最常见的非征集性症状;未报告严重不良反应。结论婴儿同时接种DTPw疫苗和Hib结合疫苗具有良好的安全性和耐受性。Objective To observe the adverse reactions induced by simultaneous immunization with Haemophilus influenzae type b（Hib）-tetanus（TT） conjugate vaccine and DTPw in infants in China. Methods A total of 472 healthy infants aged 11-17 weeks were subjected to an open and randomized study. Divide the infants into DTPw and DTPw ＋ Hib-TT groups randomly. The 238 infants in DTPw ＋ Hib-TT group were immunized simultaneously with 0. 5 ml of DTPw and 0. 5 ml of Hib-TT in separated site at ages of 3, 4 and 5 months, and the other 234 infants in DTPw group with 0.5 ml of DTPw alone. Observe the solicited and unsolicited adverse reactions within 4 d and record the unsolicited adverse reactions reported within 30 d after each immunization for statistical analysis. Results The incidences of adverse reactions with in 4 d after immunization in DTPw ＋ Hib-TT and DTPw groups were 49. 1% and 46% respectively, which showed no significant difference. However, the incidences of unsolicited adverse reactions, prominent with upper respiratory infection and pharyngitis, within 30 d in the two groups were 9. 9% and 9. 8% respectively. No severe adverse reaction was reported. Conclusion The simultaneous immunization with Hib-TT and DTPw was safe and well-tolerant.

关 键 词：B型流感嗜血杆菌 破伤风类毒素 结合疫苗 DTPw疫苗 接种反应 

分 类 号：R392-33[医药卫生—免疫学] R311[医药卫生—基础医学]