[Evaluation of the safety of diphtheria, tetanus and acellular pertussis containing combination vaccines in Chengdu, 2015-2019]

Objective: To evaluate the safety of diphtheria, tetanus and acellular pertussis (DTaP) containing combination vaccines used in Chengdu. Methods: The AEFI reports data of DTaP vaccine, DTaP-Haemophilus influenza type b combined vaccine (DTaP-Hib) and DTaP-inactivated poliovirus-Hib combined vaccine (DTaP-IPV-Hib) in Chengdu from 2015 to 2019 were collected through the national immunization management system. Description epidemiological method was used to analyze the data. Results: From 2015 to 2019, a total of 8 234 cases of AEFI of DTaP containing combination vaccines were reported in Chengdu, with a reported incidence of 194.55/100 000 doses, including 7 897 cases of common adverse reaction (168.59 per 100 000) and 234 cases of rare adverse reaction (5.53 per 100 000). The DTaP vaccine reported 4 240 cases AEFI (140.63 per 100 000), the DTaP-Hib vaccine reported 2 490 cases AEFI (399.09 per 100 000) and the DTaP-IPV-Hib vaccine reported 1 504 cases AEFI (253.49 per 100 000). All the three vaccines had the highest incidence for the booster doses; the rare adverse reaction were mainly Anaphylactic Reaction (6.27 per 100 000). Conclusions: The AEFI monitor system had high sensitivity, and the rare adverse reaction rate was extremely low, all the vaccines had good safety profiles. The Thrombocytopenic purpura and Laryngeal Edema should be paid more attention to.

目的： 评价成都市含无细胞百日咳、白喉和破伤风（DTaP）成分的联合疫苗预防接种安全性。 方法： 通过中国免疫规划信息管理系统疑似预防接种异常反应（AEFI）监测模块，收集2015—2019年成都市报告的DTaP-b型流感嗜血杆菌疫苗（DTaP-Hib）以及DTaP-灭活脊髓灰质炎-b型流感嗜血杆菌疫苗（DTaP-IPV/Hib）报告AEFI的病例，对其进行描述流行病学分析。 结果： 2015—2019年成都市接种含DTaP成分联合疫苗4 232 248剂，报告AEFI共8 234例，报告发生率194.55/10万剂，其中一般反应为7 897例（186.59/10万剂），异常反应为234例（5.53/10万剂）；DTaP报告AEFI共4 240例，报告发生率为140.63/10万剂，DTaP-Hib报告AEFI共2 490例，报告发生率为399.09/10万剂，DTaP-IPV/Hib报告AEFI共1 504例，报告发生率为253.49/10万剂。基础免疫（1、2、3剂）报告发生率86.94/10万剂，加强免疫（4剂）报告发生率548.67/10万剂，加强免疫报告发生率高于基础免疫（P<0.001）；异常反应以过敏性皮疹为主，报告发生率6.27/10万剂。 结论： 成都市3种含DTaP成分疫苗的AEFI监测敏感性高，异常反应发生率低，安全性良好。.

Keywords: Diphtheria-tetanus-acellular pertussis vaccines; Safety; Surveillance; Vaccination.