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Article(id=1320442608304902429, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1320442558581424898, articleNumber=null, orderNo=null, doi=10.11847/zgggws1146675, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1734019200000, receivedDateStr=2024-12-13, revisedDate=1739808000000, revisedDateStr=2025-02-18, acceptedDate=1756224000000, acceptedDateStr=2025-08-27, onlineDate=1792747650457, onlineDateStr=2026-10-23, pubDate=1770652800000, pubDateStr=2026-02-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792747650457, onlineIssueDateStr=2026-10-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792747650457, creator=13701087609, updateTime=1792747650457, updator=13701087609, issue=Issue{id=1320442558581424898, tenantId=1146029695717560320, journalId=1319373219989389464, year='2026', volume='42', issue='2', pageStart='129', pageEnd='256', issueExtLink='null', onlineDate='null', pubDate='1770652800000', pubDateStr='2026-02-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792747638602, creator='13701087609', updateTime=1792748118043, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1320444569574031427, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1320442558581424898, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1320444569578225732, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1320442558581424898, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=239, endPage=244, ext={EN=ArticleExt(id=1320442608518811934, articleId=1320442608304902429, tenantId=1146029695717560320, journalId=1319373219989389464, language=EN, title=Herpes zoster vaccination and adverse event surveillance in Pudong New Area, Shanghai, 2020–2024, columnId=1320427686514770171, journalTitle=Chinese Journal of Public Health, columnName=Survey and Report, runingTitle=null, highlight=null, articleAbstract=
Objective

To examine the vaccination status of herpes zoster vaccine (HZV) and adverse events following immunization (AEFIs), thus providing evidence for the vaccination of HZV.

Methods

Two sets of data relevant to HZV vaccination in Pudong New Area of Shanghai from August 1, 2020 to July 31, 2024 were collected for statistical analysis, including information on HZV vaccination from the Pudong Immunization Program Integrated Management Cloud Platform and on AEFIs registered in the China Information System for Disease Control and Prevention.

Results

During the study period, 37 103 doses of HZV were totally vaccinated and 1 107 AEFIs were registered, with a reported AEFI incidence of 298.36/10 000 doses, 99.73% of which were common adverse reactions. The reported AEFI incidence of recombinant zoster vaccine (RZV) was 315.56/10 000 doses, which was higher than that (27.11/10 000 doses) of zoster vaccine live (ZVL). Among the receivers of RZV, females had higher reported AEFI incidence than males (348.58/10 000 doses vs. 254.05 /10 000 doses; χ2 = 23.412, P < 0.001). The individuals of 50–59 years old had higher reported AEFI incidence than those of 60–69 years old and 70 years old (342.86 /10 000 doses vs. 304.07 /10 000 doses and 259.53 /10 000 doses, respectively; χ2 = 9.574, P = 0.008). In addition, the reported AEFI incidence of the first dose was higher than that of the second dose (483.26/10 000 doses vs. 123.25/10 000 doses; χ2 = 369.000, P < 0.001).

Conclusions

The reported HZV-related AEFIs were mainly common adverse reactions in Pudong New area, with no serious adverse reaction reported, which suggest good safety of HZV.

, authors=Wenmin LIU, Cuiping ZHOU, Dandan YANG, Laibao YANG, authorsList=Wenmin LIU, Cuiping ZHOU, Dandan YANG, Laibao YANG, authorCompany=null, correspAuthors=Laibao YANG, authorNote=null, correspAuthorsNote=
YANG Laibao, E-mail:
, copyrightStatement=Copyright © 2026 Chinese Journal of Public Health. All rights reserved., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1320442608833384735, articleId=1320442608304902429, tenantId=1146029695717560320, journalId=1319373219989389464, language=CN, title=2020—2024年上海市浦东新区带状疱疹疫苗接种及疑似预防接种异常反应监测结果分析, columnId=1320427686770622717, journalTitle=中国公共卫生, columnName=调查报告与分析, runingTitle=null, highlight=null, articleAbstract=
目的

分析上海市浦东新区带状疱疹疫苗接种情况及疑似预防接种异常反应（AEFI）监测结果，为人群接种带状疱疹疫苗提供科学依据。

方法

收集2020年8月1日—2024年7月31日，上海市浦东新区免疫规划综合管理云平台中带状疱疹疫苗的接种信息和中国疾病预防控制信息系统疑似预防接种异常反应（AEFI）监测信息进行统计分析。

结果

上海市浦东新区带状疱疹疫苗累计接种37 103剂次，发生AEFI 1 107例，报告发生率298.36/万剂次，99.73%为一般反应。其中重组带状疱疹疫苗AEFI报告发生率315.56/万剂次，高于带状疱疹减毒活疫苗报告发生率（27.11/万剂次）。接种重组带状疱疹疫苗的受种者中，女性不良反应报告发生率（348.58/10万剂次）高于男性（254.05/10万剂次）（χ2=23.412，P<0.001）；50～59岁（342.86/万剂次）不良反应报告发生率高于60～69岁（304.07/10万剂次）和≥70岁（259.53/10万剂次）（χ2=9.574，P =0.008）；第1剂次不良反应报告发生率（483.26/10万剂次）高于第2剂次（123.25/10万剂次）（χ2=369.000，P<0.001）。

结论

上海市浦东新区使用的带状疱疹疫苗AEFI报告以一般反应为主，尚未发现严重异常反应，具有较好的安全性。

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刘文敏（1990—），主管医师，本科，研究方向：疫苗免疫与监测

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杨来宝，Email：
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Clin Immunol, 2016, 169: 16-27., articleTitle=null, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1320442609055682848, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, xref=null, ext=[AuthorCompanyExt(id=1320442609068265761, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, companyId=1320442609055682848, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Immunology, Shanghai Pudong New Area Center for Disease Control and Prevention (Shanghai Pudong New Area Health Supervision Institute), Shanghai 200136, China), AuthorCompanyExt(id=1320442609076654370, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, companyId=1320442609055682848, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=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）免疫科，上海 200136)])], figs=[ArticleFig(id=1320442613283541317, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, language=EN, label=Tab.1, caption=

Two types of HZV vaccination in Pudong New Area from August 1, 2020 to July 31, 2024

, figureFileSmall=null, figureFileBig=null, tableContent=
项目ZVL（减毒）RZV（CHO细胞）合计
剂次数构成比/%剂次数构成比/%剂次数构成比/%
性别
　男性84438.1412 39935.5413 24335.69
　女性1 36961.8622 49164.4623 86064.31
年龄/岁
　40～4926612.02——2660.71
　50～5967230.3715 57544.6416 24743.79
　60～6986439.0414 30641.0015 17040.89
　≥7041118.57500914.36542014.61
剂次
　第1剂次2 213100.0018 58253.2620 79556.05
　第2剂次16 30846.7416 30843.95
合计2 213100.0034 890100.0037 103100.00
), ArticleFig(id=1320442613363233094, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, language=CN, label=表1, caption=

2020年8月1日—2024年7月31日上海市浦东新区2种HZV接种情况

, figureFileSmall=null, figureFileBig=null, tableContent=
项目ZVL（减毒）RZV（CHO细胞）合计
剂次数构成比/%剂次数构成比/%剂次数构成比/%
性别
　男性84438.1412 39935.5413 24335.69
　女性1 36961.8622 49164.4623 86064.31
年龄/岁
　40～4926612.02——2660.71
　50～5967230.3715 57544.6416 24743.79
　60～6986439.0414 30641.0015 17040.89
　≥7041118.57500914.36542014.61
剂次
　第1剂次2 213100.0018 58253.2620 79556.05
　第2剂次16 30846.7416 30843.95
合计2 213100.0034 890100.0037 103100.00
), ArticleFig(id=1320442613447119175, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, language=EN, label=Tab.2, caption=

Reported incidence of RZV (CHO cell) adverse reaction symptoms in receivers of different ages and genders (n, /10 000 doses)

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应性别χ2值P值年龄/岁χ2值P值
男性女性50～5960～69≥70
发热/℃246（198.40）569（252.99）10.440<0.001403（258.75）324（226.48）88（175.68）12.0000.002
　37.1～37.522（17.74）54（24.01）1.4440.23033（21.19）33（23.07）10（19.96）0.2100.900
　37.6～38.5197（158.88）440（195.63）6.0220.014315（202.25）253（176.85）69（137.75）9.2390.010
　≥38.627（21.78）75（33.35）3.6710.05555（35.31）38（26.56）9（17.97）4.5060.105
红肿/cm66（53.23）248（110.27）29.154<0.001150（96.31）122（85.28）42（83.85）1.2650.531
　≤2.536（29.03）142（63.14）18.313<0.00186（55.22）64（44.74）28（55.90）1.8880.389
　2.6～5.028（22.58）90（40.02）7.2070.00754（34.67）52（36.35）12（23.96）1.7500.417
　>5.02（1.61）16（7.11）4.6900.03010（6.42）6（4.19）2（3.99）0.8710.647
硬结/cm19（15.32）71（31.57）8.1970.00439（25.04）40（27.96）11（21.96）0.5810.748
　≤2.516（12.90）52（23.12）4.2880.03832（20.55）27（18.87）9（17.97）0.1770.915
　2.6～5.03（2.42）16（7.11）3.2360.0724（2.57）13（9.09）2（3.99）6.0490.049
　>5.00（0.00）3（1.33）1.6540.1983（1.93）0（0.00）0（0.00）4.840 a0.089
乏力32（25.81）119（52.91）13.624<0.00189（57.14）46（32.15）16（31.94）12.550.002
肌痛22（17.74）71（31.57）5.7460.01751（32.74）33（23.07）9（17.97）4.2870.117
食欲不振12（9.68）22（9.78）0.0010.97619（12.20）13（9.09）2（3.99）2.7290.255
瘙痒2（1.61）14（6.22）3.7080.05410（6.42）6（4.19）0（0.00）3.4900.175
头痛头晕6（4.84）13（5.78）0.1300.7187（4.49）11（7.69）1（2.00）2.6770.262
嗜睡4（3.23）20（8.89）3.7330.05315（9.63）8（5.59）1（2.00）3.7980.150
其他症状17（13.71）24（10.67）0.6290.42820（12.84）16（11.18）5（9.98）0.3300.848
总不良反应315（254.05）784（348.58）23.412<0.001534（342.86）435（304.07）130（259.53）9.5740.008
), ArticleFig(id=1320442613535199560, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, language=CN, label=表2, caption=

不同年龄、性别RZV（CHO细胞）不良反应症状报告发生率分析（n，/万剂次）

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应性别χ2值P值年龄/岁χ2值P值
男性女性50～5960～69≥70
发热/℃246（198.40）569（252.99）10.440<0.001403（258.75）324（226.48）88（175.68）12.0000.002
　37.1～37.522（17.74）54（24.01）1.4440.23033（21.19）33（23.07）10（19.96）0.2100.900
　37.6～38.5197（158.88）440（195.63）6.0220.014315（202.25）253（176.85）69（137.75）9.2390.010
　≥38.627（21.78）75（33.35）3.6710.05555（35.31）38（26.56）9（17.97）4.5060.105
红肿/cm66（53.23）248（110.27）29.154<0.001150（96.31）122（85.28）42（83.85）1.2650.531
　≤2.536（29.03）142（63.14）18.313<0.00186（55.22）64（44.74）28（55.90）1.8880.389
　2.6～5.028（22.58）90（40.02）7.2070.00754（34.67）52（36.35）12（23.96）1.7500.417
　>5.02（1.61）16（7.11）4.6900.03010（6.42）6（4.19）2（3.99）0.8710.647
硬结/cm19（15.32）71（31.57）8.1970.00439（25.04）40（27.96）11（21.96）0.5810.748
　≤2.516（12.90）52（23.12）4.2880.03832（20.55）27（18.87）9（17.97）0.1770.915
　2.6～5.03（2.42）16（7.11）3.2360.0724（2.57）13（9.09）2（3.99）6.0490.049
　>5.00（0.00）3（1.33）1.6540.1983（1.93）0（0.00）0（0.00）4.840 a0.089
乏力32（25.81）119（52.91）13.624<0.00189（57.14）46（32.15）16（31.94）12.550.002
肌痛22（17.74）71（31.57）5.7460.01751（32.74）33（23.07）9（17.97）4.2870.117
食欲不振12（9.68）22（9.78）0.0010.97619（12.20）13（9.09）2（3.99）2.7290.255
瘙痒2（1.61）14（6.22）3.7080.05410（6.42）6（4.19）0（0.00）3.4900.175
头痛头晕6（4.84）13（5.78）0.1300.7187（4.49）11（7.69）1（2.00）2.6770.262
嗜睡4（3.23）20（8.89）3.7330.05315（9.63）8（5.59）1（2.00）3.7980.150
其他症状17（13.71）24（10.67）0.6290.42820（12.84）16（11.18）5（9.98）0.3300.848
总不良反应315（254.05）784（348.58）23.412<0.001534（342.86）435（304.07）130（259.53）9.5740.008
), ArticleFig(id=1320442613623279945, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, language=EN, label=Tab.3, caption=

Reported incidence of RZV (CHO cell) adverse reactions at different doses (n, /10 000 doses)

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应剂次合计χ2值P值
第1剂次第2剂次
发热/℃659（354.64）156（95.66）815（233.59）255.360<0.001
　37.1～37.557（30.67）19（11.65）76（21.78）14.462<0.001
　37.6～38.5518（278.76）119（72.97）637（182.57）205.221<0.001
　≥38.684（45.21）18（11.04）102（29.23）34.785<0.001
红肿/cm262（141.00）52（31.89）314（90.00）115.937<0.001
　≤2.5151（81.26）27（16.56）178（51.02）71.643<0.001
　2.6～5.096（51.66）22（13.49）118（33.82）37.548<0.001
　>5.015（8.07）3（1.84）18（5.16）6.5430.011
硬结/cm63（33.90）27（16.56）90（25.80）10.159<0.001
　≤2.546（24.76）22（13.49）68（19.49）5.6660.017
　2.6～5.016（8.61）3（1.84）19（5.45）7.3160.007
　>5.01（0.54）2（1.23）3（0.86）0.013 a0.489
乏力116（62.43）35（21.46）151（43.28）33.823<0.001
肌痛80（43.05）13（7.97）93（26.66）40.208<0.001
食欲不振29（15.61）5（3.07）34（9.74）14.030<0.001
瘙痒14（7.53）2（1.23）16（4.59）7.5390.006
头痛头晕14（7.53）5（3.07）19（5.45）3.1860.074
嗜睡21（11.3）3（1.84）24（6.88）11.311<0.001
其他症状32（17.22）9（5.52）41（11.75）10.133<0.001
总不良反应898（483.26）201（123.25）1 099（314.99）369.000<0.001
), ArticleFig(id=1320442613702971722, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, language=CN, label=表3, caption=

不同剂次RZV（CHO细胞）不良反应症状报告发生率（n，/万剂次）

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不良反应剂次合计χ2值P值
第1剂次第2剂次
发热/℃659（354.64）156（95.66）815（233.59）255.360<0.001
　37.1～37.557（30.67）19（11.65）76（21.78）14.462<0.001
　37.6～38.5518（278.76）119（72.97）637（182.57）205.221<0.001
　≥38.684（45.21）18（11.04）102（29.23）34.785<0.001
红肿/cm262（141.00）52（31.89）314（90.00）115.937<0.001
　≤2.5151（81.26）27（16.56）178（51.02）71.643<0.001
　2.6～5.096（51.66）22（13.49）118（33.82）37.548<0.001
　>5.015（8.07）3（1.84）18（5.16）6.5430.011
硬结/cm63（33.90）27（16.56）90（25.80）10.159<0.001
　≤2.546（24.76）22（13.49）68（19.49）5.6660.017
　2.6～5.016（8.61）3（1.84）19（5.45）7.3160.007
　>5.01（0.54）2（1.23）3（0.86）0.013 a0.489
乏力116（62.43）35（21.46）151（43.28）33.823<0.001
肌痛80（43.05）13（7.97）93（26.66）40.208<0.001
食欲不振29（15.61）5（3.07）34（9.74）14.030<0.001
瘙痒14（7.53）2（1.23）16（4.59）7.5390.006
头痛头晕14（7.53）5（3.07）19（5.45）3.1860.074
嗜睡21（11.3）3（1.84）24（6.88）11.311<0.001
其他症状32（17.22）9（5.52）41（11.75）10.133<0.001
总不良反应898（483.26）201（123.25）1 099（314.99）369.000<0.001
), ArticleFig(id=1320442615355527499, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, language=EN, label=Tab.4, caption=

Reported AEFIs at different occurrence intervals

, figureFileSmall=null, figureFileBig=null, tableContent=
发生时间间隔/hRZV（CHO细胞）ZVL（减毒）合计
例数构成比/%例数构成比/%例数构成比/%
<2499490.28466.6799890.15
24～<48887.99233.33908.13
≥48191.7300.00191.72
合计1 101100.006100.001 107100.00
), ArticleFig(id=1320442615443607884, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442608304902429, language=CN, label=表4, caption=

不同发生时间间隔AEFI报告发生情况

, figureFileSmall=null, figureFileBig=null, tableContent=
发生时间间隔/hRZV（CHO细胞）ZVL（减毒）合计
例数构成比/%例数构成比/%例数构成比/%
<2499490.28466.6799890.15
24～<48887.99233.33908.13
≥48191.7300.00191.72
合计1 101100.006100.001 107100.00
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2020—2024年上海市浦东新区带状疱疹疫苗接种及疑似预防接种异常反应监测结果分析
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刘文敏 , 周翠萍 , 杨丹丹 , 杨来宝 *, *
中国公共卫生 | 调查报告与分析 2026,42(2): 239-244
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中国公共卫生 |调查报告与分析 2026 , 42 (2) : 239 -244
2020—2024年上海市浦东新区带状疱疹疫苗接种及疑似预防接种异常反应监测结果分析
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刘文敏, 周翠萍, 杨丹丹, 杨来宝*, *
作者信息
  • 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）免疫科，上海 200136
通讯作者:
杨来宝，Email：
作者简介:

刘文敏（1990—），主管医师，本科，研究方向：疫苗免疫与监测

Herpes zoster vaccination and adverse event surveillance in Pudong New Area, Shanghai, 2020–2024
Wenmin LIU, Cuiping ZHOU, Dandan YANG, Laibao YANG
Affiliations
  • Department of Immunology, Shanghai Pudong New Area Center for Disease Control and Prevention (Shanghai Pudong New Area Health Supervision Institute), Shanghai 200136, China
    • Corresponding Author:
    YANG Laibao, E-mail:
出版时间: 2026-02-10 doi: 10.11847/zgggws1146675
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摘要
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目的

分析上海市浦东新区带状疱疹疫苗接种情况及疑似预防接种异常反应（AEFI）监测结果，为人群接种带状疱疹疫苗提供科学依据。

方法

收集2020年8月1日—2024年7月31日，上海市浦东新区免疫规划综合管理云平台中带状疱疹疫苗的接种信息和中国疾病预防控制信息系统疑似预防接种异常反应（AEFI）监测信息进行统计分析。

结果

上海市浦东新区带状疱疹疫苗累计接种37 103剂次，发生AEFI 1 107例，报告发生率298.36/万剂次，99.73%为一般反应。其中重组带状疱疹疫苗AEFI报告发生率315.56/万剂次，高于带状疱疹减毒活疫苗报告发生率（27.11/万剂次）。接种重组带状疱疹疫苗的受种者中，女性不良反应报告发生率（348.58/10万剂次）高于男性（254.05/10万剂次）（χ2=23.412，P<0.001）；50～59岁（342.86/万剂次）不良反应报告发生率高于60～69岁（304.07/10万剂次）和≥70岁（259.53/10万剂次）（χ2=9.574，P =0.008）；第1剂次不良反应报告发生率（483.26/10万剂次）高于第2剂次（123.25/10万剂次）（χ2=369.000，P<0.001）。

结论

上海市浦东新区使用的带状疱疹疫苗AEFI报告以一般反应为主，尚未发现严重异常反应，具有较好的安全性。

带状疱疹疫苗  /  重组带状性疱疹疫苗  /  接种疫苗  /  疑似预防接种不良反应  /  安全性  /  上海市浦东新区
Objective

To examine the vaccination status of herpes zoster vaccine (HZV) and adverse events following immunization (AEFIs), thus providing evidence for the vaccination of HZV.

Methods

Two sets of data relevant to HZV vaccination in Pudong New Area of Shanghai from August 1, 2020 to July 31, 2024 were collected for statistical analysis, including information on HZV vaccination from the Pudong Immunization Program Integrated Management Cloud Platform and on AEFIs registered in the China Information System for Disease Control and Prevention.

Results

During the study period, 37 103 doses of HZV were totally vaccinated and 1 107 AEFIs were registered, with a reported AEFI incidence of 298.36/10 000 doses, 99.73% of which were common adverse reactions. The reported AEFI incidence of recombinant zoster vaccine (RZV) was 315.56/10 000 doses, which was higher than that (27.11/10 000 doses) of zoster vaccine live (ZVL). Among the receivers of RZV, females had higher reported AEFI incidence than males (348.58/10 000 doses vs. 254.05 /10 000 doses; χ2 = 23.412, P < 0.001). The individuals of 50–59 years old had higher reported AEFI incidence than those of 60–69 years old and 70 years old (342.86 /10 000 doses vs. 304.07 /10 000 doses and 259.53 /10 000 doses, respectively; χ2 = 9.574, P = 0.008). In addition, the reported AEFI incidence of the first dose was higher than that of the second dose (483.26/10 000 doses vs. 123.25/10 000 doses; χ2 = 369.000, P < 0.001).

Conclusions

The reported HZV-related AEFIs were mainly common adverse reactions in Pudong New area, with no serious adverse reaction reported, which suggest good safety of HZV.

herpes zoster vaccine  /  recombinant zoster vaccine  /  vaccination  /  adverse events following immunization  /  safety  /  Pudong Shanghai
刘文敏, 周翠萍, 杨丹丹, 杨来宝. 2020—2024年上海市浦东新区带状疱疹疫苗接种及疑似预防接种异常反应监测结果分析. 中国公共卫生, 2026 , 42 (2) : 239 -244 . DOI: 10.11847/zgggws1146675
Wenmin LIU, Cuiping ZHOU, Dandan YANG, Laibao YANG. Herpes zoster vaccination and adverse event surveillance in Pudong New Area, Shanghai, 2020–2024[J]. Chinese Journal of Public Health, 2026 , 42 (2) : 239 -244 . DOI: 10.11847/zgggws1146675
正文
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带状疱疹（herpes zoster, HZ）是由潜伏性水痘–带状疱疹病毒 （varicella-zoster Virus, VZV） 感染再激活和复制引起的感染性皮肤病[1]。HZ通常以疼痛性皮区水疱疹为特征，可引起系列并发症，最常见并发症为带状疱疹后神经痛（postherpetic neuralgia, PHN）[1–2]。研究表明，5%～30% HZ患者可能并发PHN， PHN是一种持续的、使人衰弱的一种神经性综合征，一些患者疼痛可持续数月至数年，严重影响患者的生活质量和精神健康[3–5]。接种带状疱疹疫苗（herpes zoster vaccine, HZV）是预防HZ及其并发症最有效的措施。重组带状疱疹疫苗（recombinant zoster vaccine, RZV）和带状疱疹减毒活疫苗（zoster vaccine live, ZVL）分别于2019年5月和2023年1月获得国家药品监督管理局批准上市[6–7]。国内针对2种HZV疫苗上市后人群安全性评价研究较少[8]。本研究对2020年8月1日—2024年7月31日，上海市浦东新区接种HZV疑似预防接种异常反应（adverse events following immunization, AEFI）监测数据进行分析，为HZV接种安全性评价提供参考依据。结果报告如下。
1　资料与方法
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1.1　资料来源
HZV的接种信息来源于上海市浦东新区免疫规划综合管理云平台；HZV接种后AEFI监测数据来源于中国疾病预防控制信息系统。统计范围为2020年8月1日—2024年7月31日。本研究已获上海市浦东新区疾病预防控制中心医学伦理委员会审批（PDCDCLL–20200801–001）。
1.2　疫苗情况
上海市浦东新区使用的HZV有两种，一种是GlaxoSmithKline Biologicals SA公司生产的RZV（CHO细胞），接种对象为≥50岁人群，间隔2个月接种2剂次；一种是长春百克生物科技股份公司生产的ZVL（减毒）。接种对象为≥40岁人群，接种1剂次。两种HZV均为单人份规格，0.5 mL/支，肌内注射。2020年8月1日上海市浦东新区开始使用RZV（CHO细胞），2023年8月1日上海市浦东新区开始使用ZVL（减毒）。
1.3　AEFI定义与分类
根据《全国疑似预防接种异常反应监测方案》[9]，AEFI是指预防接种后发生怀疑与预防接种有关的反应或事件。AEFI 按发生原因分为不良反应（包括一般反应和异常反应）、偶合症、心因性反应、疫苗质量事故、接种事故。
1.4　统计分析
采用Excel 2007软件建立数据库，对AEFI报告数、报告发生率、临床诊断、剂次、发生时间间隔等情况进行描述性统计分析。AEFI报告发生率=AEFI报告数/疫苗接种剂次数×10万剂次数。应用SPSS 21.0软件进行统计学分析。率间比较采用χ2检验或Fisher精确概率法。检验水准α=0.05（双侧）。
2　结　果
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2.1　浦东新区HZV接种情况（表1）
2020年8月1日—2024年7月31日，浦东新区共接种HZV 37 103剂次，其中ZVL（减毒）接种2 213剂次，RZV（CHO细胞）接种34 890剂次；男性13 243（35.69%）剂次，女性23 860（64.31%）剂次，男女比例0.56:1，平均年龄为（ 61.21±7.60）岁；第1剂次接种20 795（56.05%）剂次，第2剂次接种16 308（43.95%）剂次。
2.2　浦东新区HZV安全性分析
2.2.1　AEFI报告情况
2020年8月1日—2024年7月31日，浦东新区共接种各类疫苗10 386 225剂次，报告总AEFI 24 213例，报告发生率23.31/万剂次。其中一般反应22 307例（92.13%，21.48/万剂次），异常反应587例（2.42%，0.57/万剂次）；无疫苗质量和接种事故。HZV的受种者共报告AEFI 1 107例，占总AEFI4.57%，报告发生率298.36/万剂次。其中一般反应1 104例（99.73%，297.55/万剂次）；RZV（CHO细胞）1101例，报告发生率315.56/万剂次，其中一般反应1 098例（99.73%，314.90/万剂次），异常反应、偶合症和心因性反应各1例（0.09%，0.29/万剂次）。ZVL（减毒）接种后报告AEFI 6例，均为一般反应，报告发生率为27.11/万剂次。RZV（CHO细胞）AEFI报告发生率高于ZVL（减毒），差异有统计学意义（χ2=59.818，P<0.001）。
2.2.2　不同年龄和性别RZV（CHO细胞）不良反应比较（表2）
1 099例不良反应中，男性315例，报告发生率254.11/万剂次，女性784例，报告发生率348.69/万剂次，女性报告发生率高于男性，差异有统计学意义（P<0.001）；发热、红肿、硬结、乏力和肌痛，女性报告发生率高于男性，差异有统计学意义（P<0.05）；50～59岁报告发生率最高，≥70岁报告发生率最低，不同年龄组差异有统计学意义（P=0.008）；50～59岁发热、乏力报告发生率最高，不同年龄组差异有统计学意义（P<0.05）。
2.2.3　不同剂次RZV（CHO细胞）不良反应比较（表3）
不良反应中第1剂次报告898例，报告发生率483.26/万剂次，第2剂次报告201例，报告发生率123.25/万剂次，第1剂次报告发生率高于第2剂次，差异有统计学意义（P<0.001）。发热、红肿、硬结、乏力、肌痛等症状第1剂次报告发生率高于第2剂次，差异有统计学意义（P<0.05）。
2.2.4　AEFI发生时间间隔分布（表4）
998例（90.15%）AEFI发生在<24 h，其中RZV（CHO细胞）报告的1 101例中，<24 h发生994例（90.28 %），24～<48 h发生88例（7.99%），≥48 h发生19例（1.73%）；ZVL（减毒）报告的6例中，<24 h发生4例（66.67 %）。
3　讨　论
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HZ是一种全球性重大疾病，发病与年龄增长有关，普通人群患HZ的终生风险为30%，50岁后风险急剧增加，≥50岁人群HZ全球发病率为5.23/1 000人年～10.9/1 000人年[10–11]。在中国，HZ未纳入常规系统监测，相关流行病学研究相对较少，≥50岁人群HZ发病率为2.9/1 000人年～6.89/1 000人年，≥60岁人群HZ发病率高达11.69/1 000人年。有证据表明，HZ发病率随着时间的推移而增加[12–13]。接种HZV是预防HZ最有效的措施。研究表明，中国HZV接种率较低，2022年全国≥60岁人群接种率仅为0.10%[14]，而接种后不良反应是影响人群接种意愿的重要原因之一[15]。本研究旨在通过对2020年8月1日—2024年7月31日上海市浦东新区接种HZV AEFI监测数据进行分析，探讨HZV的安全性，为提高HZV接种率提供科学依据。
上海市浦东新区各类疫苗接种后总AEFI报告发生率为23.31/万剂次，而HZV 报告发生率为298.36/万剂次，明显高于年均报告发生率。分析可能原因为：（1）上海市浦东新区接种HZV的受种者中，94.04%接种的是RZV（CHO细胞），RZV（CHO细胞）的AS01B佐剂系统可能会增强人体反应原性，增加注射部位疼痛和其他不良反应的发生[16]。（2）HZV作为国家非免疫规划疫苗，遵循自愿自费的接种原则，意愿接种的受种者经济情况、受教育程度和对疫苗的认知高于一般人群，更加关注疫苗接种和接种后身体健康情况，轻微反应亦能及时发现、上报，提高了AEFI的报告率。本次研究中RZV（CHO细胞）接种后AEFI报告发生率（315.56/万剂次）高于ZVL（减毒）（27.11/万剂次），这与国外HZV不良反应研究结果一致[17]。可能与RZV（CHO细胞）中所含佐剂增强人体反应有关，亦不能排除与ZVL（减毒）使用时间短、接种剂次较少，AEFI报告还不够完整有关。
研究结果显示，接种RZV（CHO细胞）后女性不良反应报告发生率高于男性，接种后女性接种部位症状和全身反应发热、乏力报告发生率明显高于男性，这与国外RZV（CHO细胞）不良反应研究相近[18–19]。可能原因：（1）生理、基因、性激素等差异，导致女性的先天性和适应性免疫反应强于男性，更易发生炎症和接种后不良反应[20]；（2）相较于男性，女性内心更加细腻，更容易关注接种后身体情况，更倾向于报告健康问题和不良反应。年龄分布，50～59岁不良反应报告发生率高于60～69岁和≥70岁年龄组，这与国外RZV（CHO细胞）不良反应研究相近[18–19]。可能原因：（1）随着年龄的增长，免疫细胞活性降低，T细胞受体多样性减退，免疫反应物质减少，免疫系统功能下降，对传染病的保护及疫苗反应降低[21–22]。（2）随着年龄增长，老年人对疼痛和轻微症状的耐受性可能更高，更不易报告接种后轻微反应[18]。（3）中国疫苗接种后AEFI监测仍以被动监测方式为主，需受种者前往接种门诊或电话报告，报告渠道不便利，年龄越大，轻微反应越会选择不报。
研究结果显示，RZV（CHO细胞）接种第1剂次不良反应报告发生率高于第2剂次，这与国内卜哲妮等[23]对RZV（CHO细胞）的研究相近，但与RZV（CHO细胞）全球临床研究及佐剂的研究结果（第2剂次不良反应发生率高于第1剂次）相反[24–25]。可能原因：（1）第1剂次接种后受种者更加关注接种后身体反应，报告轻微反应意愿较高，第2剂次接种后出现轻微反应或与第1剂次类似的反应则易被忽视，更倾向选择不报或延报。（2）疫苗接种前门诊医生会对受种者进行健康问询，受种者在接种第2剂次时因被问询更易回忆、倾诉第1剂次接种后发生的不良反应；第2剂次接种后发生不良反应因缺乏同等机会则易被忽视，导致接种后不良反应报告偏移。（3）第1剂次接种后出现不良反应，受种者可能因担心自身健康选择不接种第2剂次。因此，应进一步加强疫苗知识宣教，提高居民疫苗接种知识素养，鼓励居民接种疫苗和报告接种后不良反应，同时拓宽疫苗接种后不良反应报告渠道，提高不良反应报告渠道的可及性，尽量避免不良反应的迟报和漏报。
本次研究中，HZV接种后报告的不良反应主要以接种部位症状和发热、乏力等一般反应为主，大多发生在接种后24 h内。结果提示，接种门诊在严格遵循规范流程，实施常规接种并切实完成接种后30 min留观工作的基础上，需进一步强化受种者接种后 24 h内自我健康状况观察的宣教，让受种者准确掌握自我健康观察和不良反应处置的要点与方法，进而保障接种的安全，提升接种后不良反应监测的全面性与及时性。
综上所述，上海市浦东新区HZV接种后AEFI报告发生率高于年均AEFI报告发生率，但以一般反应为主，未发现严重不良反应表明，上海市浦东新区接种的HZV安全性良好。同时本研究也有与其他研究者结果的不同之处。提示应探索更加全面、无偏的方式开展HZV AEFI监测研究，准确监测HZV不良反应特征。

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doi: 10.11847/zgggws1146675
  • 接收时间：2024-12-13
  • 首发时间：2026-10-23
  • 出版时间：2026-02-10
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  • 收稿日期：2024-12-13
  • 修回日期：2025-02-18
  • 录用日期：2025-08-27
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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）免疫科，上海 200136

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Number of
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Number of
species		 占总种数比例
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total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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