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[2015 - 2019年成都市含白喉、破伤风和无细胞百日咳联合疫苗的安全性评估]

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

作者信息

Li L, Yang R P, Cai J, Zheng J H

机构信息

Expanded Program Immunization Department of Chengdu Center for Disease Control and Prevention, Chengdu 610041, China.

出版信息

Zhonghua Yu Fang Yi Xue Za Zhi. 2020 Sep 6;54(9):958-962. doi: 10.3760/cma.j.cn112150-20200417-00593.

DOI:10.3760/cma.j.cn112150-20200417-00593
PMID:32907285
Abstract

To evaluate the safety of diphtheria, tetanus and acellular pertussis (DTaP) containing combination vaccines used in Chengdu. 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. 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). 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.

摘要

评估成都地区使用的含白喉、破伤风和无细胞百日咳(DTaP)联合疫苗的安全性。通过国家免疫规划管理系统收集2015年至2019年成都地区DTaP疫苗、DTaP-乙型流感嗜血杆菌结合疫苗(DTaP-Hib)和DTaP-灭活脊髓灰质炎病毒-Hib联合疫苗(DTaP-IPV-Hib)的疑似预防接种异常反应(AEFI)报告数据。采用描述性流行病学方法对数据进行分析。2015年至2019年,成都地区共报告含DTaP联合疫苗AEFI 8234例,报告发生率为194.55/10万剂次,其中一般不良反应7897例(168.59/10万),罕见不良反应234例(5.53/10万)。DTaP疫苗报告AEFI 4240例(140.63/10万),DTaP-Hib疫苗报告AEFI 2490例(399.09/10万),DTaP-IPV-Hib疫苗报告AEFI 1504例(253.49/10万)。三种疫苗加强免疫剂次的AEFI发生率均最高;罕见不良反应主要为过敏反应(6.27/10万)。AEFI监测系统敏感性高,罕见不良反应发生率极低,所有疫苗安全性良好。应重点关注血小板减少性紫癜和喉头水肿。

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