免疫程序调整前后某市无细胞百白破疫苗疑似预防接种异常反应发生情况对比研究

doi:10.19803/j.1672-8629.20260386

摘要/Abstract

摘要： 目的分析免疫程序调整前后安阳市百日咳-白喉-破伤风联合疫苗（百白破疫苗,DTaP）疑似预防接种异常反应（AEFI）发生情况,为减少AEFI发生提供参考。方法通过中国疾病预防控制信息系统收集2024年1月1日—2025年12月31日安阳市DTaP AEFI病例,通过河南省免疫规划信息管理系统收集同期疫苗接种数据。使用描述性流行病学方法分析AEFI报告情况及发生特征。结果免疫程序调整前,安阳市DTaP AEFI报告发生率为829.46/10万剂,一般反应、异常反应报告发生率分别为828.65/10万剂、0.81/10万剂;免疫程序调整后,DTaP AEFI报告发生率为882.78/10万剂,一般反应、异常反应报告发生率分别为882.21/10万剂、0.57/10万剂,调整前后AEFI报告发生率差异无统计学意义（χ²=2.419,P=0.120）。免疫程序调整前后,随接种剂次增多,发热、局部红肿、局部硬结报告发生率均升高（P<0.001）;随接种至反应发生时间间隔延长,局部红肿、局部硬结占比增加。结论免疫程序调整后,安阳市DTaP AEFI仍以一般反应为主,异常反应罕见,疫苗安全性良好,但仍需继续规范接种服务,加强AEFI监测。

关键词: 百白破疫苗, 免疫程序, 疑似预防接种异常反应, 监测, 安全性

Abstract: Objective To analyze the surveillance data of adverse events following immunization (AEFI) with diphtheria, tetanus and acellular pertussis combined vaccine (DTaP) in Anyang before and after adjustment of the immunization schedule so as to provide references for reducing the incidence of AEFI. Methods Using the Chinese Disease Control and Prevention Information System, the AEFI reports of DTaP in Anyang from January 1, 2024 to December 31, 2025. were collected. Data on DTaP vaccines during the same period was collected via the Henan Provincial Immunization Program Information Management System. The reporting rates and clinical characteristics of AEFI of DTaP vaccines were analyzed and compared. Results Before the adjustment, the reported incidence rate of DTaP AEFI in Anyang was 829.46 per 100 000 doses, and those of common or abnormal reactions were 828.65 per 100 000 doses and 0.81 per 100 000 doses, respectively, compared with 882.78 per 100 000 doses, 882.21 per 100 000 doses and 0.57 per 100 000 doses after the adjustment. There were no significant differences in the reported incidence of AEFI before and after the adjustment(χ²=2.419,P=0.120). Before and after the vaccination program was updated, the reporting rates of fever, local redness and swelling, and local induration rose significantly with the increase in vaccination doses (P<0.001). With the extended time interval between vaccination and onset of adverse events, the proportions of local redness and swelling, and local induration increased. Conclusion Since the immunization schedule was updated, AEFI of DTaP in Anyang is mostly common reactions, and abnormal ones are rare. DTaP vaccines are relatively safe. However, vaccination needs to be standardied and AEFI monitoring enhanced.

Key words: Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine(DTaP), Immunization Schedule, Adverse Events Following Immunization(AEFI), Surveillance, Safety

中图分类号:

R978
R994.11

张萍, 贾飞飞. 免疫程序调整前后某市无细胞百白破疫苗疑似预防接种异常反应发生情况对比研究[J]. 中国药物警戒, 2026, 23(10): 1153-1157.

Zhang Ping, Jia Feifei. Comparison of adverse events following immunization with diphtheria, tetanus and acellular pertussis combined vaccine in a city before and after adjustment of the immunization schedule[J]. Chinese Journal of Pharmacovigilance, 2026, 23(10): 1153-1157.

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