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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 evaluate the safety of Adsorbed Diphtheria Tetanus and Whole Cell Pertussis Combined Vaccine (DTwP). Methods Clinical responses were observed in healthy children ≥ 3 months of age after inoculation of DTwP, with a focus on 19 740 persons. Results The incidence of total adverse reaction was 21.90% after DTwP inoculation, and 21.18% and 23.40% in basic and booster immunization respectively. Including fever, inflamed induration rate was 19.15%, 13.51%, the reaction intensity is mainly weak reaction. The incidence of other systemic and local reactions are low. With the increase of vaccination times, the incidence of side effects also increased, and there are some regional differences, but different batch DTwP difference is small. Conclusion There is some systemic and local adverse reactions after inoculation of DTwP in a large range of infants. The safety of DTwP should be improved from the aspects of improving vaccine production process and so on.