2017-2024年浦东新区人乳头瘤病毒疫苗不良反应监测
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上海市浦东新区疾病预防控制中心(上海市浦东新区卫生健康监督所)

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浦东新区卫生健康委员会重点学科(PWZxk2022-25);浦东新区卫生健康委员会学科带头人培养计划(PWRd2020-14);浦东新区疾病预防控制中心课题(PDCDC-2021-05)


Surveillance of Adverse Reactions to Human Papillomavirus Vaccine in Pudong New Area, 2017-2024
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Shanghai Pudong New Area Center for Disease Control and Prevention (Shanghai Pudong New Area Health Supervision Institute), Pudong, Shanghai

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Key Discipline of the Pudong New Area Health Commission (PWZxk2022-25); Discipline Leader Cultivation Program of the Pudong New Area Health Commission (PWRd2020-14); Research Project of the Pudong New Area Center for Disease Control and Prevention (PDCDC-2021-05)

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    摘要:

    摘要:目的 探讨2017-2024年上海市浦东新区人乳头瘤病毒(human papilloma virus,HPV)疫苗不良反应情况,为上市后HPV疫苗安全性评价提供科学依据。方法 收集2017-2024年浦东新区HPV疫苗疑似预防接种异常反应(adverse events following immunization,AEFI)监测数据,分析HPV疫苗接种后AEFI报告发生率。结果 2017-2024 年浦东新区共接种HPV疫苗1436659剂次,出现AEFI 1610例,总体AEFI 报告发生率为112.07/10万剂次其中一般反应、异常反应、心因性反应、偶合症的报告数分别为1 578例(109.84/10万剂次)、24例(1.67/10万剂次)、5例(0.35/10万剂次)和3例(0.21/10万剂次)。2价、4价、9价HPV疫苗的AEFI报告数分别为208例(193.30/10万剂次)、457例(107.10/10万剂次)、945例(104.72/10万剂次)。2017-2024年期间,2价、4价、9价HPV最高不良反应报告发生率分别为530.50/10万剂次、190.56/10万剂次、194.38/10万剂次。不同类型HPV疫苗的AEFI报告发生率差异有统计学意义(P< 0.05)。2价液体西林、2价液体预充、4价液体预充、9价液体西林、9价液体预充AEFI报告例数分别是53例(101.90/10万剂次)、155例(278.82/10万剂次)、457例(107.10/10万剂次)、41例(198.26/10万剂次)、904例(102.53/10万剂次)。2价和9价HPV疫苗中不同规格疫苗的AEFI报告发生率差异均有统计学意义(P< 0.05)。HPV疫苗AEFI发生最集中时间段为接种后0~0.5d,为854例(59.44/10万剂次),不同类型HPV疫苗的AEFI发生时间分布差异有统计学意义(P<0.05)。不同类型HPV疫苗的一般反应局部红肿症状分布差异有统计学意义(P< 0.05)。结论 HPV疫苗具有较低的不良反应发生率,应继续加强HPV疫苗接种后不良反应的监测。

    Abstract:

    Abstract: Objective To explore the situation of HPV vaccine adverse reactions in Pudong New Area, Shanghai, from 2017 to 2024, and to provide scientific basis for the safety evaluation of HPV vaccine after marketing. Methods Data on suspected adverse events following immunization (AEFI) to HPV vaccines in Pudong New Area from 2017 to 2024 were collected to analyze the incidence of AEFI reports following HPV vaccination. Results From 2017 to 2024, a total of 1,436,659 doses of HPV vaccine were administered in Pudong New Area, with 1,610 AEFI cases reported. with an overall AEFI reporting rate of 112.07 per 100,000 doses administered. The respective numbers of reports for general reactions, abnormal reactions, psychogenic reactions, and coincidental events were 1,578 (109.84 per 100,000 doses), 24 (1.67 per 100,000 doses) , 5 cases (0.35 per 100,000 doses), and 3 cases (0.21 per 100,000 doses), respectively. The AEFI reports for bivalent, quadrivalent, and nonavalent HPV vaccines were 208 cases (193.30 per 100,000 doses administered), 457 cases (107.10 per 100,000 doses administered), and 945 cases (104.72 per 100,000 doses administered), respectively. During 2017-2024, the highest AEFI incidence rates for bivalent, quadrivalent, and nonavalent HPV vaccines were 530.50/100,000 doses, 190.56/100,000 doses, and 194.38/100,000 doses, respectively. Statistically significant differences in AEFI incidence rates were observed among different HPV vaccine types (P< 0.05). The number of AEFI reports for bivalent liquid penicillin, bivalent liquid pre-filled, quadrivalent liquid pre-filled, nonavalent liquid penicillin, and nonavalent liquid pre-filled vaccines were 53 cases (101.90 per 100,000 doses) , 155 cases (278.82 per 100,000 doses), 457 cases (107.10 per 100,000 doses), 41 cases (198.26 per 100,000 doses), and 904 cases (102.53 per 100,000 doses), respectively. The incidence rates of AEFI differed significantly among different dosage strengths of both the bivalent and nonavalent HPV vaccines (P < 0.05). The peak period for HPV vaccine-associated AEFI occurred within 0–0.5 days post-vaccination, with 854 cases (59.44/100,000 doses administered). The temporal distribution of AEFI varied significantly among different HPV vaccine types (P < 0.05) . The distribution of local redness and swelling as a common reaction differed significantly among HPV vaccine types (P<0.05). Conclusion: HPV vaccines exhibit a low incidence of adverse reactions, and post-vaccination adverse reaction monitoring should be strengthened. Conclusion HPV vaccine has a low incidence of AEFIs, and the monitoring of AEFIs after HPV vaccination should continue to be strengthened.

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  • 收稿日期:2025-12-15
  • 最后修改日期:2026-02-24
  • 录用日期:2026-03-17
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