Article(id=1323941356095283529, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1323941237702668764, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202502395, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1740326400000, receivedDateStr=2025-02-24, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793581816933, onlineDateStr=2026-11-02, pubDate=1765296000000, pubDateStr=2025-12-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793581816933, onlineIssueDateStr=2026-11-02, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793581816933, creator=13701087609, updateTime=1793581816933, updator=13701087609, issue=Issue{id=1323941237702668764, tenantId=1146029695717560320, journalId=1227665162245664772, year='2025', volume='52', issue='23', pageStart='4225', pageEnd='4416', issueExtLink='null', onlineDate='null', pubDate='1765296000000', pubDateStr='2025-12-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793581788707, creator='13701087609', updateTime=1793581887795, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1323941653374959780, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1323941237702668764, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1323941653374959781, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1323941237702668764, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=4390, endPage=4395, ext={EN=ArticleExt(id=1323941356405662026, articleId=1323941356095283529, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Comparative analysis of the incidence of adverse events following immunization before and after the adjustment of the poliomyelitis immunization schedule in Tianjin, columnId=1228016573156360233, journalTitle=Modern Preventive Medicine, columnName=Disease Control and Prevention, runingTitle=null, highlight=null, articleAbstract=
Objective

To compare and analyze the reported incidence of adverse events following immunization (AEFI) before and after the adjustment of the poliomyelitis immunization schedule in Tianjin.

Methods

We obtained AEFI case data and the vaccine doses for poliomyelitis vaccine from the Immunization Program Information System from May 2016 to December 2019(pre-adjustment) and from January 2020 to September 2024 (post-adjustment). Reported incidence rates were calculated and compared between the periods.

Results

Before the adjustment, the reported incidence rates of AEFI in Tianjin were 37.00 per 100 000 doses for bOPV and 50.52 per 100 000 doses for IPV, the incidence rates of common adverse reactions were 30.06 per 100 000 doses (bOPV) and 43.87 per 100 000 doses (IPV), while those of abnormal reactions were 5.26 per 100 000 doses(bOPV) and 5.32 per 100 000 doses (IPV). After the adjustment, the reported incidence rates of AEFI declined to 26.70 per 100 000 doses for bOPV and 33.13 for IPV per 100 000 doses, the incidence rates of common adverse reactions were 21.10 per 100 000 doses (bOPV) and 28.24 per 100 000 doses (IPV), and abnormal reactions were 4.62 per 100 000 doses (bOPV) and 3.57 per 100 000 doses (IPV). There were statistically significant differences in the reported incidence of AEFI before and after the adjustment (χ2=7.45, P<0.01; χ2=24.20, P<0.01).

Conclusion

After the adjustment to the immunization strategy of polio vaccine in Tianjin, AEFI reporting rates decreased, with rare serious adverse reactions and favorable overall safety.

, authors=Bai-hui GUO, Xiao-yan LUO, Yong-cheng LI, Di ZHU, authorsList=Bai-hui GUO, Xiao-yan LUO, Yong-cheng LI, Di ZHU, authorCompany=null, correspAuthors=Bai-hui GUO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, 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=1323941358997741901, articleId=1323941356095283529, tenantId=1146029695717560320, journalId=1227665162245664772, language=CN, title=天津市脊髓灰质炎疫苗免疫程序调整前后疑似预防接种异常反应发生率比较分析, columnId=1228016573844226129, journalTitle=现代预防医学, columnName=疾病预防控制, runingTitle=null, highlight=null, articleAbstract=
目的

比较分析天津市脊髓灰质炎疫苗免疫程序调整前后的疑似预防接种异常反应(adverse event following immunization,AEFI)报告发生率。

方法

从免疫规划信息系统收集2016年5月—2019年12月(免疫程序转换前)和2020年1月—2024年9月(免疫程序转换后)脊灰疫苗的AEFI个案数据,以及脊灰疫苗接种剂次数,计算报告发生率并进行分析和比较。

结果

脊灰疫苗免疫程序转换之前,天津市的bOPV、IPV的AEFI报告发生率分别为37.00/10万剂、50.52/10万剂,其中一般反应分别为30.06/10万剂、43.87/10万剂,异常反应分别为5.26/10万剂、5.32/10万剂;策略调整之后,bOPV、IPV AEFI报告发生率分别为26.70/10万剂、33.13/10万剂,其中一般反应分别为21.10/10万剂、28.24/10万剂,异常反应分别为4.62/10万剂、3.57/10万剂,调整前后的AEFI报告发生率均有统计学差异(χ2=7.45,P<0.01;χ2=24.20,P<0.01)。

结论

天津市脊灰疫苗的免疫程序调整后AEFI报告发生率均有所下降,严重异常反应报告发生率较低,总体安全性良好。

, authors=郭百慧, 骆晓艳, 李永成, 朱迪, authorsList=郭百慧, 骆晓艳, 李永成, 朱迪, authorCompany=null, correspAuthors=郭百慧, authorNote=

郭百慧(1995—),女,硕士,医师,研究方向:免疫规划

, correspAuthorsNote=
郭百慧,E-mail:
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郭百慧(1995—),女,硕士,医师,研究方向:免疫规划

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Vaccine, 2021, 39 (9): 1463-1471., articleTitle=Immunogenicity and safety of the inactivated poliomyelitis vaccine made from Sabin strains in a phase IV clinical trial for the vaccination of a large population, refAbstract=null)], funds=[Fund(id=1323941364118987129, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, awardId=null, language=CN, fundingSource=国家疾病预防控制局公共卫生人才培养支持项目, fundOrder=null, country=null)], companyList=[AuthorCompany(id=1323941359228428622, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, xref=null, ext=[AuthorCompanyExt(id=1323941359236817231, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, companyId=1323941359228428622, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Centers for Disease Control and Prevention, Tianjin 300000, China), AuthorCompanyExt(id=1323941359245205840, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, companyId=1323941359228428622, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市疾病预防控制中心,天津 300000)])], figs=[ArticleFig(id=1323941360880984427, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=EN, label=Figure 1, caption=Monthly distribution of reported AEFI cases for poliomyelitis vaccines in Tianjin, 2016—2024, figureFileSmall=mAu7vLuSNc1RlOxBD2mdag==, figureFileBig=feFmnVkf3hhQft5sNDCEXg==, tableContent=null), ArticleFig(id=1323941362600649068, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=CN, label=图1, caption=2016—2024 年天津市脊灰疫苗 AEFI 报告病例数的月分布, figureFileSmall=mAu7vLuSNc1RlOxBD2mdag==, figureFileBig=feFmnVkf3hhQft5sNDCEXg==, tableContent=null), ArticleFig(id=1323941362827141485, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=EN, label=Table 1, caption=

Gender distribution of AEFI cases before and after the adjustment of the poliomyelitis immunization schedule in Tianjin

, figureFileSmall=null, figureFileBig=null, tableContent=
性别bOPVIPV
2016—2019年2020—2024年合计2016—2019年2020—2024年合计
例数占比(%)例数占比(%)例数占比(%)例数占比(%)例数占比(%)例数占比(%)
男27757.114859.2632557.4211751.3218055.3829753.71
女20842.893340.7424142.5811148.6814544.6225646.29
合计485100.0081100.00566100.00228100.00325100.00553100.00
), ArticleFig(id=1323941362923610478, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=CN, label=表1, caption=

天津市脊灰疫苗免疫程序调整前后的AEFI病例性别分布

, figureFileSmall=null, figureFileBig=null, tableContent=
性别bOPVIPV
2016—2019年2020—2024年合计2016—2019年2020—2024年合计
例数占比(%)例数占比(%)例数占比(%)例数占比(%)例数占比(%)例数占比(%)
男27757.114859.2632557.4211751.3218055.3829753.71
女20842.893340.7424142.5811148.6814544.6225646.29
合计485100.0081100.00566100.00228100.00325100.00553100.00
), ArticleFig(id=1323941362986525039, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=EN, label=Table 2, caption=

Reported incidence of AEFI by category for bOPV before and after immunization schedule adjustment in Tianjin (per 100 000 doses)

, figureFileSmall=null, figureFileBig=null, tableContent=
最终反应分类2016—2019年2020—2024年合计χ2值P值
例数发生率例数发生率例数发生率
一般反应39430.066421.1045828.376.97<0.01
偶合症221.6830.99251.550.380.54
异常反应695.26144.62835.140.20.65
合计48537.008126.7056635.067.45<0.01
), ArticleFig(id=1323941363053633904, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=CN, label=表2, caption=

天津市bOPV免疫程序调整前后AEFI分类报告发生率(/10万剂)

, figureFileSmall=null, figureFileBig=null, tableContent=
最终反应分类2016—2019年2020—2024年合计χ2值P值
例数发生率例数发生率例数发生率
一般反应39430.066421.1045828.376.97<0.01
偶合症221.6830.99251.550.380.54
异常反应695.26144.62835.140.20.65
合计48537.008126.7056635.067.45<0.01
), ArticleFig(id=1323941363120742769, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=EN, label=Table 3, caption=

Reported incidence of AEFI by category for IPV before and after immunization schedule adjustment in Tianjin (per 100 000 doses)

, figureFileSmall=null, figureFileBig=null, tableContent=
最终反应分类2016—2019年2020—2024年合计χ2值P值
例数发生率例数发生率例数发生率
一般反应19843.8727728.2447533.1722.77<0.01
偶合症61.33131.33191.330.001.00
异常反应245.32353.57594.122.300.13
合计22850.5232533.1355338.6124.20<0.01
), ArticleFig(id=1323941363200434546, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=CN, label=表3, caption=

天津市IPV免疫程序调整前后AEFI分类报告发生率(/10万剂)

, figureFileSmall=null, figureFileBig=null, tableContent=
最终反应分类2016—2019年2020—2024年合计χ2值P值
例数发生率例数发生率例数发生率
一般反应19843.8727728.2447533.1722.77<0.01
偶合症61.33131.33191.330.001.00
异常反应245.32353.57594.122.300.13
合计22850.5232533.1355338.6124.20<0.01
), ArticleFig(id=1323941363355623795, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=EN, label=Table 4, caption=

Distribution of AEFI incidence by clinical diagnosis for poliomyelitis vaccines before and after immunization schedule adjustment in Tianjin (per 100 000 doses)

, figureFileSmall=null, figureFileBig=null, tableContent=
最终临床诊断bOPVIPV
2016—2019年2020—2024年合计2016—2019年2020—2024年合计
例数发生率例数发生率例数发生率例数发生率例数发生率例数发生率
一般反应
发热/红肿/硬结等28521.745317.4733820.9416837.2224324.7741128.70
发热24718.844615.1729318.1514732.5722623.0437326.04
局部红肿00.0000.0000.00224.87252.55473.28
局部硬结00.0000.0000.0000.0090.9290.63
皮疹493.7410.33503.10183.9970.71251.75
胃肠道反应574.3530.99603.7261.3380.82140.98
荨麻疹20.1520.6640.2500.0020.2020.14
过敏性皮疹00.0041.3240.2500.00141.43140.98
斑丘疹00.0010.3310.0600.0000.0000.00
其他30.230.0030.1961.3330.3190.63
异常反应
其他临床诊断20.1500.0020.1200.0010.1010.07
血小板减少性紫癜20.1500.0020.1220.4420.2040.28
其他过敏反应30.2300.0030.1910.2230.3140.28
斑丘疹20.1500.0020.1200.0010.1010.07
荨麻疹151.1430.99181.1230.6660.6190.63
血管性水肿40.3110.3350.3120.4410.1030.21
过敏性皮疹382.90103.30482.97153.32202.04352.44
过敏性紫癜10.0800.0010.0600.0000.0000.00
麻疹猩红热样皮疹20.1500.0020.1210.2200.0010.07
热性惊厥00.0000.0000.0000.0010.1010.07
), ArticleFig(id=1323941363426926964, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=CN, label=表4, caption=

天津市脊灰疫苗免疫程序调整前后的AEFI发生率(/10万剂)临床诊断分布

, figureFileSmall=null, figureFileBig=null, tableContent=
最终临床诊断bOPVIPV
2016—2019年2020—2024年合计2016—2019年2020—2024年合计
例数发生率例数发生率例数发生率例数发生率例数发生率例数发生率
一般反应
发热/红肿/硬结等28521.745317.4733820.9416837.2224324.7741128.70
发热24718.844615.1729318.1514732.5722623.0437326.04
局部红肿00.0000.0000.00224.87252.55473.28
局部硬结00.0000.0000.0000.0090.9290.63
皮疹493.7410.33503.10183.9970.71251.75
胃肠道反应574.3530.99603.7261.3380.82140.98
荨麻疹20.1520.6640.2500.0020.2020.14
过敏性皮疹00.0041.3240.2500.00141.43140.98
斑丘疹00.0010.3310.0600.0000.0000.00
其他30.230.0030.1961.3330.3190.63
异常反应
其他临床诊断20.1500.0020.1200.0010.1010.07
血小板减少性紫癜20.1500.0020.1220.4420.2040.28
其他过敏反应30.2300.0030.1910.2230.3140.28
斑丘疹20.1500.0020.1200.0010.1010.07
荨麻疹151.1430.99181.1230.6660.6190.63
血管性水肿40.3110.3350.3120.4410.1030.21
过敏性皮疹382.90103.30482.97153.32202.04352.44
过敏性紫癜10.0800.0010.0600.0000.0000.00
麻疹猩红热样皮疹20.1500.0020.1210.2200.0010.07
热性惊厥00.0000.0000.0000.0010.1010.07
), ArticleFig(id=1323941363565338997, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=EN, label=Table 5, caption=

Reported incidence of serious adverse reactions for poliomyelitis vaccines before and after immunization schedule adjustment in Tianjin (per 100 000 doses)

, figureFileSmall=null, figureFileBig=null, tableContent=
严重异常反应bOPVIPV
2016—2019年2020—2024年合计2016—2019年2020—2024年合计
例数发生率例数发生率例数发生率例数发生率例数发生率例数发生率
血小板减少性紫癜20.1500.0020.1220.4420.2040.28
过敏性紫癜10.0800.0010.0600.0000.0000.00
其他过敏反应20.1500.0020.1200.0000.0000.00
其他10.0800.0010.0600.0000.0000.00
血管性水肿00.0010.3310.0600.0000.0000.00
热性惊厥00.0000.0000.0000.0010.1010.07
合计60.4610.3370.4320.4430.3150.35
), ArticleFig(id=1323941363666002294, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=CN, label=表5, caption=

天津市脊灰疫苗免疫程序调整前后的严重异常反应报告发生率(/10万剂)

, figureFileSmall=null, figureFileBig=null, tableContent=
严重异常反应bOPVIPV
2016—2019年2020—2024年合计2016—2019年2020—2024年合计
例数发生率例数发生率例数发生率例数发生率例数发生率例数发生率
血小板减少性紫癜20.1500.0020.1220.4420.2040.28
过敏性紫癜10.0800.0010.0600.0000.0000.00
其他过敏反应20.1500.0020.1200.0000.0000.00
其他10.0800.0010.0600.0000.0000.00
血管性水肿00.0010.3310.0600.0000.0000.00
热性惊厥00.0000.0000.0000.0010.1010.07
合计60.4610.3370.4320.4430.3150.35
), ArticleFig(id=1323941363779248503, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=EN, label=Table 6, caption=

Distribution of the time interval to onset of AEFI for poliomyelitis vaccines before and after immunization schedule adjustment in Tianjin

, figureFileSmall=null, figureFileBig=null, tableContent=
发生时间(d)bOPVIPV
2016—2019年2020—2024年合计2016—2019年2020—2024年合计
例数占比(%)例数占比(%)例数占比(%)例数占比(%)例数占比(%)例数占比(%)
<133869.696175.3139970.4916471.9325879.3842276.31
110421.441316.0511720.674720.614513.859216.64
2255.1567.41315.4883.51123.69203.62
3~7132.6811.23142.4783.5182.46162.89
≥851.0300.0050.8810.4420.6230.54
合计485100.0081100.00566100.00228100.00325100.00553100.00
), ArticleFig(id=1323941363993158008, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1323941356095283529, language=CN, label=表6, caption=

天津市脊灰疫苗免疫程序调整前后的AEFI发生时间间隔分布

, figureFileSmall=null, figureFileBig=null, tableContent=
发生时间(d)bOPVIPV
2016—2019年2020—2024年合计2016—2019年2020—2024年合计
例数占比(%)例数占比(%)例数占比(%)例数占比(%)例数占比(%)例数占比(%)
<133869.696175.3139970.4916471.9325879.3842276.31
110421.441316.0511720.674720.614513.859216.64
2255.1567.41315.4883.51123.69203.62
3~7132.6811.23142.4783.5182.46162.89
≥851.0300.0050.8810.4420.6230.54
合计485100.0081100.00566100.00228100.00325100.00553100.00
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郭百慧 , 骆晓艳 , 李永成 , 朱迪
现代预防医学 | 疾病预防控制 2025,52(23): 4390-4395
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天津市脊髓灰质炎疫苗免疫程序调整前后疑似预防接种异常反应发生率比较分析
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郭百慧 , 骆晓艳, 李永成, 朱迪
作者信息
  • 天津市疾病预防控制中心,天津 300000
通讯作者:
郭百慧,E-mail:
作者简介:

郭百慧(1995—),女,硕士,医师,研究方向:免疫规划

Comparative analysis of the incidence of adverse events following immunization before and after the adjustment of the poliomyelitis immunization schedule in Tianjin
Bai-hui GUO , Xiao-yan LUO, Yong-cheng LI, Di ZHU
Affiliations
  • Tianjin Centers for Disease Control and Prevention, Tianjin 300000, China
出版时间: 2025-12-10 doi: 10.20043/j.cnki.MPM.202502395
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目的

比较分析天津市脊髓灰质炎疫苗免疫程序调整前后的疑似预防接种异常反应(adverse event following immunization,AEFI)报告发生率。

方法

从免疫规划信息系统收集2016年5月—2019年12月(免疫程序转换前)和2020年1月—2024年9月(免疫程序转换后)脊灰疫苗的AEFI个案数据,以及脊灰疫苗接种剂次数,计算报告发生率并进行分析和比较。

结果

脊灰疫苗免疫程序转换之前,天津市的bOPV、IPV的AEFI报告发生率分别为37.00/10万剂、50.52/10万剂,其中一般反应分别为30.06/10万剂、43.87/10万剂,异常反应分别为5.26/10万剂、5.32/10万剂;策略调整之后,bOPV、IPV AEFI报告发生率分别为26.70/10万剂、33.13/10万剂,其中一般反应分别为21.10/10万剂、28.24/10万剂,异常反应分别为4.62/10万剂、3.57/10万剂,调整前后的AEFI报告发生率均有统计学差异(χ2=7.45,P<0.01;χ2=24.20,P<0.01)。

结论

天津市脊灰疫苗的免疫程序调整后AEFI报告发生率均有所下降,严重异常反应报告发生率较低,总体安全性良好。

脊髓灰质炎疫苗  /  免疫策略  /  疑似预防接种异常反应
Objective

To compare and analyze the reported incidence of adverse events following immunization (AEFI) before and after the adjustment of the poliomyelitis immunization schedule in Tianjin.

Methods

We obtained AEFI case data and the vaccine doses for poliomyelitis vaccine from the Immunization Program Information System from May 2016 to December 2019(pre-adjustment) and from January 2020 to September 2024 (post-adjustment). Reported incidence rates were calculated and compared between the periods.

Results

Before the adjustment, the reported incidence rates of AEFI in Tianjin were 37.00 per 100 000 doses for bOPV and 50.52 per 100 000 doses for IPV, the incidence rates of common adverse reactions were 30.06 per 100 000 doses (bOPV) and 43.87 per 100 000 doses (IPV), while those of abnormal reactions were 5.26 per 100 000 doses(bOPV) and 5.32 per 100 000 doses (IPV). After the adjustment, the reported incidence rates of AEFI declined to 26.70 per 100 000 doses for bOPV and 33.13 for IPV per 100 000 doses, the incidence rates of common adverse reactions were 21.10 per 100 000 doses (bOPV) and 28.24 per 100 000 doses (IPV), and abnormal reactions were 4.62 per 100 000 doses (bOPV) and 3.57 per 100 000 doses (IPV). There were statistically significant differences in the reported incidence of AEFI before and after the adjustment (χ2=7.45, P<0.01; χ2=24.20, P<0.01).

Conclusion

After the adjustment to the immunization strategy of polio vaccine in Tianjin, AEFI reporting rates decreased, with rare serious adverse reactions and favorable overall safety.

Poliomyelitis vaccine  /  Immunization strategy  /  Adverse event following immunization
郭百慧, 骆晓艳, 李永成, 朱迪. 天津市脊髓灰质炎疫苗免疫程序调整前后疑似预防接种异常反应发生率比较分析. 现代预防医学, 2025 , 52 (23) : 4390 -4395 . DOI: 10.20043/j.cnki.MPM.202502395
Bai-hui GUO, Xiao-yan LUO, Yong-cheng LI, Di ZHU. Comparative analysis of the incidence of adverse events following immunization before and after the adjustment of the poliomyelitis immunization schedule in Tianjin[J]. Modern Preventive Medicine, 2025 , 52 (23) : 4390 -4395 . DOI: 10.20043/j.cnki.MPM.202502395
脊髓灰质炎(以下简称脊灰)是由于感染Ⅰ、Ⅱ、Ⅲ型脊灰病毒(poliovirus, PV)所引起的一种急性传染病,多发于小儿,以发热及肢体迟缓性瘫痪为主要临床表现[1]。脊灰疫苗使用之前,脊灰感染者中大概有0.5%的脊灰麻痹病例,而麻痹病例中又有5% ~ 10%由于呼吸肌麻痹而死亡的病例[2]。自1965年起,我国开始逐步推广使用三价口服脊髓灰质炎减毒活疫苗(tivalent oral poliomyelitis attenuated livevaccine,tOPV),脊灰发病和死亡病例数急剧减少。考虑tOPV所含的Ⅱ型脊灰病毒易导致疫苗相关麻痹型脊灰(vaccine associated paralytic poliomyelitis, VAPP)病例[3-6],同时接种脊髓灰质炎灭活疫苗(inactivated poliomyelitis vaccine, IPV)后再口服OPV的免疫顺序可以减少或预防VAPP[7], 2016年5月1日起中国全面停止使用tOPV,改用二价口服脊髓灰质炎减毒活疫苗(bivalent oral poliomyelitis attenuated livevaccine,bOPV)替代tOPV,并将IPV增加进免疫程序,实施“1+3”模式,即“1剂次IPV加3剂次bOPV”[8-9]。自2020年1月1日起,脊灰疫苗常规免疫程序由“1+3”模式调整为“2+2”模式,即“2剂次IPV加2剂次bOPV”,第2剂由接种bOPV调整为接种IPV。本文对2020年1月1日天津市脊灰疫苗免疫程序调整前后的疑似预防接种异常反应(adverse event following immunization,AEFI)进行比较分析,系统评价不同免疫程序下接种脊灰疫苗的安全性,为今后调整及制定脊灰的防控措施及脊灰疫苗的免疫策略提供科学依据。
AEFI是指在预防接种后发生的怀疑与预防接种有关的反应或事件[10]。按发生原因分成不良反应(一般反应和异常反应)、疫苗质量事故、接种事故、偶合症及心因性反应。其中,死亡、危及生命、需要住院治疗或延长已在住院治疗的时间、持续的或显著的人体伤残/失能、先天性异常或者出生缺陷(怀疑受种者母亲孕期接种疫苗所致),如不干预或者治疗可能出现上述所列情况的情形为严重AEFI。
接到AEFI报告后,除明确诊断的一般反应(如单纯发热、接种部位的红肿、硬结等)外均需调查,天津市及各区疾病预防控制中心均成立调查诊断专家组,专家组由流行病学、临床医学等专家组成,负责预防接种异常反应调查诊断。怀疑与预防接种有关的死亡、严重残疾、群体性疑似预防接种异常反应、对社会有重大影响的AEFI,由天津市疾病预防控制中心组织调查诊断专家组进行调查诊断。
脊灰疫苗免疫程序转换前2016年5月—2019年12月和转换后2020年1月—2024年9月的AEFI个案数据均按接种日期从中国疾病预防控制信息系统免疫规划子系统AEFI监测模块导出,同期脊灰疫苗的接种数据通过天津市免疫规划信息管理系统导出(导出日期均为2024年12月)。
使用Microsoft Excel 2021、SPSS 24.0进行数据整理、分析。采用描述性流行病学研究方法对AEFI监测数据进行分析。率的比较使用χ2检验,双侧检验,检验水准α=0.05。AEFI报告发生率(/10万剂)=AEFI报告发生数/接种剂次数×10万剂。
天津市2016年5月—2024年9月共接种3 046 359剂脊灰疫苗,报告1 119例AEFI,其中接种IPV、bOPV后报告的AEFI分别为553和566例,报告发生率分别为38.61/10万剂、35.06/10万剂。在免疫程序转换之前,天津市的bOPV、IPV的接种剂次数分别为1 310 877和451 311,报告的AEFI病例数分别为485和228例,报告发生率分别为37.00/10万剂、50.52/10万剂。在免疫程序调整之后,天津市bOPV、IPV接种剂次数分别为303 323和980 848次,报告的AEFI例数分别为81和325例,报告发生率分别为26.70/10万剂、33.13/10万剂。免疫程序调整前后,接种bOPV及IPV后的AEFI报告发生率均有统计学差异(χ2=7.45,P<0.01;χ2=24.20,P<0.01)。
在免疫程序转换之前,天津市报告的bOPV、IPV的AEFI病例中,男女性别比例为1.33∶1、1.05∶1,在免疫程序转换之后,其比例分别为1.45∶1、1.24∶1。见表1。
在免疫程序转换之前,天津市各月报告bOPV的AEFI病例数在0~23例之间,转换之后在0~5例之间;在免疫程序转换之前,天津市各月报告IPV的AEFI病例数在1~13例之间,转换之后在0~27例之间,2020年3月IPV的AEFI病例数出现了一个较为明显的高峰。见图1。
2016年5月1日—2024年9月1日,天津市接种bOPV、IPV后报告的AEFI病例中,一般反应分别为458和475例,发生率为28.37/10万剂、33.17/10万剂;偶合症分别为25和19例,发生率为1.55/10万剂、1.33/10万剂,异常反应分别为83和59例,发生率分别为5.14/10万剂、4.12/10万剂。免疫程序调整前后,接种bOPV及IPV发生的一般反应报告发生率均有统计学差异(χ2=6.97,P<0.01;χ2=22.77,P<0.01)。见表2、3。
在一般反应中,接种bOPV、IPV后发生的AEFI均以一般反应症状诊断(发热/红肿/硬结等)为主,报告发生率分别是20.94/10万剂、28.70/10万剂;在异常反应中,接种bOPV、IPV发生的AEFI均以过敏反应-过敏性皮疹为主,报告发生率分别是2.97/10万剂、2.44/10万剂。见表4。
2016年5月—2024年9月接种IPV及bOPV后发生的严重异常反应以血小板减少性紫癜为主,无VAPP和疫苗衍生脊髓灰质炎病毒(vaccine-derived poliovirus,VDPV)发生。在免疫程序转换之前,接种IPV、bOPV后报告的严重异常反应分别为2和6例,报告发生率分别为0.44/10万剂、0.46/10万剂,调整之后,接种IPV、bOPV后报告的严重异常反应分别为3和1例,报告发生率分别为0.31/10万剂、0.33/10万剂,策略调整前后,两种疫苗接种后的严重异常反应报告发生率均无统计学差异(χ2=0.17,P>0.05;χ2=0.09,P>0.05)。见表5。
接种bOPV后发生的566例AEFI中,发生在接种后<1 d、1 d、2 d、3~7 d、≥8 d的病例数分别占70.49%、20.67%、5.48%、2.47%、0.88%;接种IPV后发生的553例 AEFI中,发生在接种后<1 d、1 d、2 d、3~7 d、≥8 d的病例数分别占76.31 %、16.64 %、3.62 %、2.89 %、0.54 %。见表6。
2016年5月1日—2024年9月1日天津市接种IPV、bOPV的AEFI年均报告发生率分别为38.61/10万剂、35.06/10万剂,均高于全国平均监测水平[11-15],提示天津市AEFI监测系统运转正常,监测敏感性较高。从性别分布来看,免疫程序调整前后,接种bOPV和IPV报告的AEFI,女性占比都低于男性,这可能与天津市适龄儿童性别构成相关[16]。从时间分布来看,在免疫程序调整之后,天津市2020年3月IPV的AEFI病例数出现了一个较为明显的高峰,这可能与免疫程序调整初期,家长及接种医生对疫苗安全性关注度较高有关。并且IPV的AEFI报告发生率明显高于bOPV,与国家[11-15]及多省市[17-19]的监测结果一致,这可能与接种途径有关,IPV作为注射疫苗,若出现红肿、发热等症状容易被发现,而bOPV作为口服疫苗,若出现轻微的胃肠道反应不易被监护人察觉,但具体原因需要进一步探讨。IPV及bOPV的AEFI均以一般反应为主,其中又以发热为主要临床症状,过敏性皮疹则为常见的异常反应,这与多数疫苗的AEFI发生规律一致,与国家监测结果一致[11-15]。从AEFI发生距离接种时间来看,接种bOPV、IPV后24 h内发生的AEFI占比分别为70.49%、76.31%,这和全国AEFI发生时间间隔比例较为一致[11-15],提示预防接种后的留观及应急处置的重要性。
综上所述,天津市脊灰疫苗的AEFI监测敏感性高,免疫程序调整后,接种IPV及bOPV的AEFI报告发生率均有所下降,以一般反应为主,症状较轻,多为发热,异常反应中多为过敏性皮疹,严重异常反应报告发生率较低,免疫策略的调整,提高了疫苗接种安全性。
根据WHO发布的《全球消灭脊灰计划2022—2026》[20],计划在2026年底认证完成脊灰病毒Ⅰ型野毒株消灭及Ⅱ型疫苗衍生脊灰病毒循环的消除后,将逐步停止使用bOPV。有相关研究表明[21-22],随着IPV剂次的增加,Ⅱ型抗体阳转率提高,接种3剂次IPV后三种类型抗体阳转率均较高,综合IPV及OPV的安全性及保护效率,建议我国考虑先在低风险、高接种率地区逐步减少bOPV的剂次,最后过渡到全程IPV的免疫策略,目前上海、江苏、浙江等均已开始实施全程IPV接种。本文以期为后续免疫策略的调整,逐步推进全IPV免疫策略提供科学依据,但本文仅涉及天津市脊灰AEFI数据,并不具有全国代表性,并且系统数据为被动监测获得,可能存在漏报,后续还应持续监测,为免疫策略的制定提供更为全面的证据,推动脊灰消除的进程。
  • 国家疾病预防控制局公共卫生人才培养支持项目
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2025年第52卷第23期
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doi: 10.20043/j.cnki.MPM.202502395
  • 接收时间:2025-02-24
  • 首发时间:2026-11-02
  • 出版时间:2025-12-10
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  • 收稿日期:2025-02-24
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国家疾病预防控制局公共卫生人才培养支持项目
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    天津市疾病预防控制中心,天津 300000

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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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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