接种吸附全细胞百日咳-白喉-破伤风联合疫苗的安全性评价

Safety Evaluation on the Immunization with Adsorbed Diphtheria,Tetanus and Whole Cell Pertussis Combined Vaccine

目的对接种吸附全细胞百日咳-白喉-破伤风联合疫苗(Adsorbed Diphtheria,Tetanus and Whole Cell Pertussis Combined Vaccine,DTwP)的安全性进行评价。方法对≥3月龄健康儿童接种DTwP后观察临床反应,重点观察19 740人次。结果接种DTwP后总副反应发生率为21.90%,基础免疫和加强免疫的副反应发生率分别为21.18%和23.40%。其中发热、红肿硬结发生率分别为19.15%、13.51%,反应强度主要是弱反应。其它全身和局部反应的发生率均较低。随着接种针次的增加,副反应发生率也随之增高,并存在一定的区域差异,但不同批次DTwP差异较小。结论在较大范围婴儿群体中接种DTwP后,存在一定的全身和局部副反应,应着重从改进疫苗生产工艺等方面来提高DTwP安全性。

Objective To assess the safety of DTwP vaccine. Method Infants who were 3 and above months age inoculated with DTwP were investigated. Total 19740 infants were investigated. Results The total incidence rate of AEFI was 21.90%. The rate of routine immunization and booster immunization were 21.18% and 23.40% respectively. The occurrence rate of fever and swell nodule were 19.06% and 13.51% respectively, most of reactions were mild. Except fever and swell nodule, other reactions were low. The occurrence rate could rise with injections doses. Region differences existed, but there was little diversity among difference lots. Conclusions The safety assesment was carried out on adverse reactions of DTwP among large scale infants. The results showed that some AEFI with DTwP occurred. Development of production process and other relative proceeding should be improved so as to enhance safety of vaccine.