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2018—2022年河北省人乳头瘤病毒疫苗上市后安全性监测分析

Post-marketing surveillance analysis of human papillomavirus vaccine safety in Hebei province from 2018 to 2022

    摘要
  • 摘要:
    目的 分析河北省2018—2022年人乳头瘤病毒（HPV）疫苗疑似预防接种异常反应（AEFI）的发生特征，评价该疫苗的安全性。
    方法 通过中国疾病预防控制信息系统AEFI监测模块收集河北省2018年1月1日—2022年12月31日HPV疫苗接种后的AEFI个案，描述性分析AEFI发生特征和报告发生率。
    结果 2018—2022年河北省共报告HPV疫苗AEFI个案128例，年均报告发生率为3.03/10万剂，HPV2、HPV4和HPV9的AEFI报告发生率分别为2.39/10万剂、3.61/10万剂和3.38/10万剂，HPV2的AEFI报告发生率低于HPV4（χ2=3.931，P<0.05）；HPV2、HPV4、HPV9一般反应报告发生率分别为2.22/10万剂、2.63/10万剂和2.74/10万剂，局部红肿、发热的报告发生率均高于局部硬结（χ2=12.500、5.918，P均<0.05）；异常反应报告发生率分别为0.11/10万剂、0.60/10万剂和0.55/10万剂，HPV4和HPV9的异常反应发生率均高于HPV2（χ2=5.763、4.705，P均<0.05）。HPV疫苗所有AEFI个案均已治愈或好转，总体转归情况良好。
    结论 河北省接种的HPV疫苗AEFI报告发生率均在可接受范围内，总体安全性良好。

     

    Abstract:
    Objective To analyze the characteristics of adverse events following immunization (AEFI) with human papillomavirus (HPV) vaccines in Hebei province from 2018 to 2022 and to evaluate the safety of these vaccines.
    Methods AEFI cases following HPV vaccination in Hebei province from January 1, 2018, to December 31, 2022, were collected through the AEFI surveillance module of the Chinese Center for Disease Control and Prevention Information System. Descriptive analysis was conducted on the characteristics and reported incidence of AEFI.
    Results A total of 128 HPV vaccine AEFI cases were reported in Hebei province from 2018 to 2022, with an average annual reported incidence of 3.03/100 000 doses. The reported incidences of AEFI for the bivalent, quadrivalent, and 9-valent HPV vaccines (HPV2, HPV4, and HPV9, respectively) were 2.39/100 000 doses, 3.61/100 000 doses, and 3.38/100 000 doses, respectively. The AEFI reporting rate for HPV2 was lower than that for HPV4 (χ2=3.931, P<0.05). The reported incidences of general vaccine reactions for HPV2, HPV4, and HPV9 were 2.22/100 000 doses, 2.63/100 000 doses, and 2.74/100 000 doses, respectively. The reported incidences of local redness and swelling and fever were both higher than that of local induration (χ2=12.500, 5.918, both P<0.05). The reported incidences of rare reactions were 0.11/100 000 doses, 0.60/100 000 doses, and 0.55/100 000 doses for HPV2, HPV4, and HPV9, respectively. The incidence of vaccine reactions for both HPV4 and HPV9 were higher than that for HPV2 (χ2=5.763, 4.705, both P<0.05). All AEFI cases related to HPV vaccines recovered or improved, with a good overall outcome.
    Conclusions The reported incidences of AEFI for HPV vaccines in Hebei province were within acceptable limits, indicating good overall safety.

     

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