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Article(id=1321169559172797347, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1321169495406785472, articleNumber=null, orderNo=null, doi=10.11847/zgggws1146786, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1735142400000, receivedDateStr=2024-12-26, revisedDate=1740758400000, revisedDateStr=2025-03-01, acceptedDate=1746806400000, acceptedDateStr=2025-05-10, onlineDate=1792920969049, onlineDateStr=2026-10-25, pubDate=1762704000000, pubDateStr=2025-11-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792920969049, onlineIssueDateStr=2026-10-25, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792920969049, creator=13701087609, updateTime=1792920969049, updator=13701087609, issue=Issue{id=1321169495406785472, tenantId=1146029695717560320, journalId=1319373219989389464, year='2025', volume='41', issue='11', pageStart='1281', pageEnd='1408', issueExtLink='null', onlineDate='null', pubDate='1762704000000', pubDateStr='2025-11-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792920953847, creator='13701087609', updateTime=1793011176900, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321547918390178721, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1321169495406785472, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321547918390178722, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1321169495406785472, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1352, endPage=1356, ext={EN=ArticleExt(id=1321169559420261284, articleId=1321169559172797347, tenantId=1146029695717560320, journalId=1319373219989389464, language=EN, title=The protective effect of acellular pertussis vaccine in children ≤10 years of age in Nanshan district, Shenzhen city: a case-control study, columnId=1321169511030571850, journalTitle=Chinese Journal of Public Health, columnName=Special Report—Vaccine Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To evaluate the protective effectiveness (VE) of acellular pertussis vaccine (aPV) in children ≤10 years of age in Nanshan district, Shenzhen city, Guangdong province, and to provide a reference for optimizing pertussis immunization strategies.

Methods

A 1:1 matched case-control study was conducted. A total of 442 clinically diagnosed or confirmed pertussis cases aged 4 months to 10 years reported in Nanshan district, Shenzhen city, from January 1, 2023, to March 25, 2024, were selected as the case group from the Chinese Center for Disease Control and Prevention Information System. A total of 442 healthy children with no history of pertussis infection, matched by residential community, sex, and birth date (±1 month), were selected as the control group from the Shenzhen Immunization Program Information Management System. Data on aPV immunization history were collected for both groups. A binary conditional logistic regression model was used to analyze the VE of aPV.

Results

The aPV vaccination rates in the case and control groups of children ≤10 years of age in Nanshan district, Shenzhen city were 94.3% (417/442) and 99.1% (438/442), respectively. The overall VE of aPV against pertussis was 84.8% (95%CI: 55.9%–94.7%). The VE of 1–2, 3, and 4 doses of aPV against pertussis was 82.5% (95%CI: 33.6%–95.4%), 88.6% (95%CI: 64.6%–96.3%), and 84.3% (95%CI: 54.3%–94.6%), respectively. The VE of 4 doses of whole-cell aPV, 1–3 doses of component pertussis vaccine plus 1–3 doses of whole-cell aPV, and 4 doses of component pertussis vaccine against pertussis was 80.5% (95%CI: 43.1%–93.3%), 91.3% (95%CI: 71.0%–97.4%), and 89.6% (95%CI: 68.8%–96.5%), respectively. The VE of aPV 0–2, 3–6, and 7–9 years after completion of the full vaccination schedule was 87.0% (95%CI: 60.6%–95.7%), 83.8% (95%CI: 52.8%–94.4%), and 82.5% (95%CI: 46.7%–94.3%), respectively. The VE of component pertussis vaccine 0–2, 3–6, and 7–9 years after completion of the full vaccination schedule was 87.7% (95%CI: 61.3%–96.1%), 89.9% (95%CI: 68.5%–96.8%), and 92.9% (95%CI: 72.7%–98.1%), respectively. The VE of whole-cell aPV 0–2, 3–6, and 7–9 years after completion of the full vaccination schedule was 85.3% (95%CI: 51.2%–95.6%), 80.1% (95%CI: 41.7%–93.2%), and 78.8% (95%CI: 33.8%–93.2%), respectively.

Conclusions

Timely and full aPV immunization can effectively prevent pertussis in children ≤10 years of age. It is recommended to develop component pertussis-containing combination vaccines for basic immunization.

, authors=Jinyan LUO, Keyi WU, Shiqiang JIANG, Yuwei CAI, Lifang XU, Jianhui YUAN, authorsList=Jinyan LUO, Keyi WU, Shiqiang JIANG, Yuwei CAI, Lifang XU, Jianhui YUAN, authorCompany=null, correspAuthors=Jianhui YUAN, authorNote=null, correspAuthorsNote=
YUAN Jianhui, E-mail:
, copyrightStatement=Copyright © 2025 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=1321169560011658151, articleId=1321169559172797347, tenantId=1146029695717560320, journalId=1319373219989389464, language=CN, title=无细胞百日咳疫苗对深圳市南山区≤10岁儿童保护效果病例对照研究, columnId=1321169511231898444, journalTitle=中国公共卫生, columnName=专题报道——疫苗研究, runingTitle=null, highlight=null, articleAbstract=
目的

评价无细胞百日咳疫苗（aPV）对广东省深圳市南山区≤10岁儿童保护效果（VE），为优化百日咳免疫策略提供参考依据。

方法

采用1:1匹配病例对照研究方法，抽取中国疾病预防控制信息系统中2023年1月1日—2024年3月25日深圳市南山区报告的442例4月龄～10岁临床诊断或确诊百日咳病例作为病例组。通过深圳市免疫规划信息管理系统选取与病例居住社区、性别相同且出生日期相差±1个月无百日咳感染史的442名健康儿童作为对照组。收集病例组和对照组研究对象aPV免疫史相关数据，采用二分类条件logistic回归模型分析aPV的VE。

结果

深圳市南山区病例组和对照组≤10岁儿童中aPV接种率分别为94.3%（417/442）和99.1%（438/442）。aPV预防百日咳的总VE为84.8%（95%CI=55.9%～94.7%）；接种1～2、3和4剂次者预防百日咳的VE分别为82.5%（95%CI=33.6%～95.4%）、88.6%（95%CI=64.6%～96.3%）和84.3%（95%CI=54.3%～94.6%）；接种4剂次共纯化aPV、4剂次中含1～3剂次组分纯化aPV和接种4剂次组分纯化aPV者预防百日咳的VE分别为80.5%（95%CI=43.1%～93.3%）、91.3%（95%CI=71.0%～97.4%）和89.6%（95%CI=68.8%～96.5%）；全程接种aPV后0～2、3～6和7～9年者预防百日咳的VE分别为87.0%（95%CI=60.6%～95.7%）、83.8%（95%CI=52.8%～94.4%）和82.5%（95%CI=46.7%～94.3%）；全程接种组分纯化aPV后0～2、3～6和7～9年者预防百日咳的VE分别为87.7%（95%CI=61.3%～96.1%）、89.9%（95%CI=68.5%～96.8%）和92.9%（95%CI=72.7%～98.1%）；全程接种共纯化aPV后0～2、3～6和7～9年者预防百日咳的VE分别为85.3%（95%CI=51.2%～95.6%）、80.1%（95%CI=41.7%～93.2%）和78.8%（95%CI=33.8%～93.2%）。

结论

及时全程aPV免疫能有效预防≤10岁儿童百日咳。建议开展基础免疫用组分百日咳联合疫苗的研发。

, authors=罗锦雁, 吴可怡, 姜世强, 蔡羽薇, 许丽芳, 袁建辉*, *, authorsList=罗锦雁, 吴可怡, 姜世强, 蔡羽薇, 许丽芳, 袁建辉, authorCompany=null, correspAuthors=袁建辉, authorNote=

罗锦雁（1987—），副主任医师，硕士，研究方向：免疫规划和传染病防控

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袁建辉，E-mail：
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罗锦雁（1987—），副主任医师，硕士，研究方向：免疫规划和传染病防控

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Seroepidemiology of pertussis in China: a population-based, cross-sectional study[J]. Vaccine, 2021, 39(12): 1687-1692., articleTitle=null, refAbstract=null), Reference(id=1321169570740686857, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=27, rfOrder=26, authorNames=null, journalName=null, refType=null, unstructuredReference=国家疾控局, 教育部, 工业和信息化部, 等. 关于国家免疫规划百白破疫苗和白破疫苗免疫程序调整相关工作的通知[EB/OL]. (2024-12-25)[2024-12-25]. https://www.gov.cn/zhengce/zhengceku/202412/content_6994724.htm., articleTitle=null, refAbstract=null), Reference(id=1321169570820378635, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=28, rfOrder=27, authorNames=null, journalName=null, refType=null, unstructuredReference=张倩, 吴丹, 郑徽, 等. 中国2022年百日咳流行病学特征[J]. 中国疫苗和免疫, 2024, 30(1): 34-38., articleTitle=null, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1321169560246539175, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, xref=null, ext=[AuthorCompanyExt(id=1321169560259122088, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, companyId=1321169560246539175, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Nanshan District Center for Disease Control and Prevention of Shenzhen (Nanshan District Health Inspection Institute of Shenzhen), Shenzhen 518054, China), AuthorCompanyExt(id=1321169560267510697, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, companyId=1321169560246539175, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=深圳市南山区疾病预防控制中心（深圳市南山区卫生监督所），深圳 518054)])], figs=[ArticleFig(id=1321169565942404065, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, language=EN, label=Tab.1, caption=

Vaccine effectiveness (VE) of different doses of acellular pertussis vaccine (aPV) against pertussis in children ≤10 years old in Nanshan district, Shenzhen city

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接种剂次病例组对照组OR值95%CIVE/%95%CI
例数构成比/%人数构成比/%
未接种255.740.91.000
1～2122.7112.50.1750.046～0.66482.533.6～95.4
3409.05612.70.1140.037～0.35488.664.6～96.3
436582.637183.90.1570.054～0.45784.354.3～94.6
), ArticleFig(id=1321169566068233187, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, language=CN, label=表1, caption=

aPV不同接种剂次对深圳市南山区≤10岁儿童预防百日咳保护效果

, figureFileSmall=null, figureFileBig=null, tableContent=
接种剂次病例组对照组OR值95%CIVE/%95%CI
例数构成比/%人数构成比/%
未接种255.740.91.000
1～2122.7112.50.1750.046～0.66482.533.6～95.4
3409.05612.70.1140.037～0.35488.664.6～96.3
436582.637183.90.1570.054～0.45784.354.3～94.6
), ArticleFig(id=1321169566152119268, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, language=EN, label=Tab.2, caption=

Vaccine effectiveness (VE) of acellular pertussis vaccines (aPV) produced with different purification processes against pertussis in children ≤10 years of age in Nanshan district, Shenzhen city

, figureFileSmall=null, figureFileBig=null, tableContent=
aPV纯化工艺病例组对照组OR值95%CIVE/%95%CI
例数构成比/%例数构成比/%
未接种256.441.11.000
4剂次共纯化aPV27269.722359.50.1950.067～0.56980.543.1～93.3
4剂次中含1～3剂次组分纯化aPV184.6338.80.0870.026～0.29091.371.0～97.4
4剂次组分纯化aPV7519.211530.70.1040.035～0.31289.668.8～96.5
), ArticleFig(id=1321169566303114213, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, language=CN, label=表2, caption=

aPV不同纯化工艺对深圳市南山区≤10岁儿童预防百日咳保护效果

, figureFileSmall=null, figureFileBig=null, tableContent=
aPV纯化工艺病例组对照组OR值95%CIVE/%95%CI
例数构成比/%例数构成比/%
未接种256.441.11.000
4剂次共纯化aPV27269.722359.50.1950.067～0.56980.543.1～93.3
4剂次中含1～3剂次组分纯化aPV184.6338.80.0870.026～0.29091.371.0～97.4
4剂次组分纯化aPV7519.211530.70.1040.035～0.31289.668.8～96.5
), ArticleFig(id=1321169566449914855, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, language=EN, label=Tab.3, caption=

Vaccine effectiveness (VE) of acellular pertussis vaccine (aPV) against pertussis in children ≤10 years of age in Nanshan district, Shenzhen city, by different intervals from the last vaccination

, figureFileSmall=null, figureFileBig=null, tableContent=
项目末次接种时间间隔病例组对照组OR值95%CIVE/%95%CI
例数构成比/%例数构成比/%
全程接种aPV未接种256.441.11.000
<2年6115.67520.00.1300.043～0.39487.060.6～95.7
3～6年24462.624164.30.1620.056～0.47283.852.8～94.4
7～9年6015.45514.70.1750.057～0.53382.546.7～94.3
全程接种组分纯化aPV未接种2525.043.41.000
<2年3333.04336.10.1230.039～0.38787.761.3～96.1
3～6年3434.05445.40.1010.032～0.31589.968.5～96.8
7～9年88.01815.10.0710.019～0.27392.972.7～98.1
全程接种共纯化aPV未接种258.431.81.000
<2年237.72511.00.1470.044～0.48885.351.2～95.6
3～6年20067.316170.90.1990.068～0.58380.141.7～93.2
7～9年4916.53716.30.2120.068～0.66278.833.8～93.2
), ArticleFig(id=1321169566584132584, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321169559172797347, language=CN, label=表3, caption=

aPV不同末次接种时间间隔对深圳市南山区≤10岁儿童预防百日咳保护效果

, figureFileSmall=null, figureFileBig=null, tableContent=
项目末次接种时间间隔病例组对照组OR值95%CIVE/%95%CI
例数构成比/%例数构成比/%
全程接种aPV未接种256.441.11.000
<2年6115.67520.00.1300.043～0.39487.060.6～95.7
3～6年24462.624164.30.1620.056～0.47283.852.8～94.4
7～9年6015.45514.70.1750.057～0.53382.546.7～94.3
全程接种组分纯化aPV未接种2525.043.41.000
<2年3333.04336.10.1230.039～0.38787.761.3～96.1
3～6年3434.05445.40.1010.032～0.31589.968.5～96.8
7～9年88.01815.10.0710.019～0.27392.972.7～98.1
全程接种共纯化aPV未接种258.431.81.000
<2年237.72511.00.1470.044～0.48885.351.2～95.6
3～6年20067.316170.90.1990.068～0.58380.141.7～93.2
7～9年4916.53716.30.2120.068～0.66278.833.8～93.2
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罗锦雁 , 吴可怡 , 姜世强 , 蔡羽薇 , 许丽芳 , 袁建辉 *, *
中国公共卫生 | 专题报道——疫苗研究 2025,41(11): 1352-1356
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中国公共卫生 |专题报道——疫苗研究 2025 , 41 (11) : 1352 -1356
无细胞百日咳疫苗对深圳市南山区≤10岁儿童保护效果病例对照研究
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罗锦雁（1987—），副主任医师，硕士，研究方向：免疫规划和传染病防控

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罗锦雁, 吴可怡, 姜世强, 蔡羽薇, 许丽芳, 袁建辉*, *
作者信息
  • 深圳市南山区疾病预防控制中心（深圳市南山区卫生监督所），深圳 518054
通讯作者:
袁建辉，E-mail：
作者简介:

罗锦雁（1987—），副主任医师，硕士，研究方向：免疫规划和传染病防控

The protective effect of acellular pertussis vaccine in children ≤10 years of age in Nanshan district, Shenzhen city: a case-control study
Jinyan LUO, Keyi WU, Shiqiang JIANG, Yuwei CAI, Lifang XU, Jianhui YUAN
Affiliations
  • Nanshan District Center for Disease Control and Prevention of Shenzhen (Nanshan District Health Inspection Institute of Shenzhen), Shenzhen 518054, China
    • Corresponding Author:
    YUAN Jianhui, E-mail:
出版时间: 2025-11-10 doi: 10.11847/zgggws1146786
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摘要
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目的

评价无细胞百日咳疫苗（aPV）对广东省深圳市南山区≤10岁儿童保护效果（VE），为优化百日咳免疫策略提供参考依据。

方法

采用1:1匹配病例对照研究方法，抽取中国疾病预防控制信息系统中2023年1月1日—2024年3月25日深圳市南山区报告的442例4月龄～10岁临床诊断或确诊百日咳病例作为病例组。通过深圳市免疫规划信息管理系统选取与病例居住社区、性别相同且出生日期相差±1个月无百日咳感染史的442名健康儿童作为对照组。收集病例组和对照组研究对象aPV免疫史相关数据，采用二分类条件logistic回归模型分析aPV的VE。

结果

深圳市南山区病例组和对照组≤10岁儿童中aPV接种率分别为94.3%（417/442）和99.1%（438/442）。aPV预防百日咳的总VE为84.8%（95%CI=55.9%～94.7%）；接种1～2、3和4剂次者预防百日咳的VE分别为82.5%（95%CI=33.6%～95.4%）、88.6%（95%CI=64.6%～96.3%）和84.3%（95%CI=54.3%～94.6%）；接种4剂次共纯化aPV、4剂次中含1～3剂次组分纯化aPV和接种4剂次组分纯化aPV者预防百日咳的VE分别为80.5%（95%CI=43.1%～93.3%）、91.3%（95%CI=71.0%～97.4%）和89.6%（95%CI=68.8%～96.5%）；全程接种aPV后0～2、3～6和7～9年者预防百日咳的VE分别为87.0%（95%CI=60.6%～95.7%）、83.8%（95%CI=52.8%～94.4%）和82.5%（95%CI=46.7%～94.3%）；全程接种组分纯化aPV后0～2、3～6和7～9年者预防百日咳的VE分别为87.7%（95%CI=61.3%～96.1%）、89.9%（95%CI=68.5%～96.8%）和92.9%（95%CI=72.7%～98.1%）；全程接种共纯化aPV后0～2、3～6和7～9年者预防百日咳的VE分别为85.3%（95%CI=51.2%～95.6%）、80.1%（95%CI=41.7%～93.2%）和78.8%（95%CI=33.8%～93.2%）。

结论

及时全程aPV免疫能有效预防≤10岁儿童百日咳。建议开展基础免疫用组分百日咳联合疫苗的研发。

百日咳  /  无细胞百日咳疫苗（aPV）  /  保护效果（VE）  /  病例对照研究  /  ≤10岁儿童  /  深圳市
Objective

To evaluate the protective effectiveness (VE) of acellular pertussis vaccine (aPV) in children ≤10 years of age in Nanshan district, Shenzhen city, Guangdong province, and to provide a reference for optimizing pertussis immunization strategies.

Methods

A 1:1 matched case-control study was conducted. A total of 442 clinically diagnosed or confirmed pertussis cases aged 4 months to 10 years reported in Nanshan district, Shenzhen city, from January 1, 2023, to March 25, 2024, were selected as the case group from the Chinese Center for Disease Control and Prevention Information System. A total of 442 healthy children with no history of pertussis infection, matched by residential community, sex, and birth date (±1 month), were selected as the control group from the Shenzhen Immunization Program Information Management System. Data on aPV immunization history were collected for both groups. A binary conditional logistic regression model was used to analyze the VE of aPV.

Results

The aPV vaccination rates in the case and control groups of children ≤10 years of age in Nanshan district, Shenzhen city were 94.3% (417/442) and 99.1% (438/442), respectively. The overall VE of aPV against pertussis was 84.8% (95%CI: 55.9%–94.7%). The VE of 1–2, 3, and 4 doses of aPV against pertussis was 82.5% (95%CI: 33.6%–95.4%), 88.6% (95%CI: 64.6%–96.3%), and 84.3% (95%CI: 54.3%–94.6%), respectively. The VE of 4 doses of whole-cell aPV, 1–3 doses of component pertussis vaccine plus 1–3 doses of whole-cell aPV, and 4 doses of component pertussis vaccine against pertussis was 80.5% (95%CI: 43.1%–93.3%), 91.3% (95%CI: 71.0%–97.4%), and 89.6% (95%CI: 68.8%–96.5%), respectively. The VE of aPV 0–2, 3–6, and 7–9 years after completion of the full vaccination schedule was 87.0% (95%CI: 60.6%–95.7%), 83.8% (95%CI: 52.8%–94.4%), and 82.5% (95%CI: 46.7%–94.3%), respectively. The VE of component pertussis vaccine 0–2, 3–6, and 7–9 years after completion of the full vaccination schedule was 87.7% (95%CI: 61.3%–96.1%), 89.9% (95%CI: 68.5%–96.8%), and 92.9% (95%CI: 72.7%–98.1%), respectively. The VE of whole-cell aPV 0–2, 3–6, and 7–9 years after completion of the full vaccination schedule was 85.3% (95%CI: 51.2%–95.6%), 80.1% (95%CI: 41.7%–93.2%), and 78.8% (95%CI: 33.8%–93.2%), respectively.

Conclusions

Timely and full aPV immunization can effectively prevent pertussis in children ≤10 years of age. It is recommended to develop component pertussis-containing combination vaccines for basic immunization.

pertussis  /  acellular pertussis vaccine (aPV)  /  protective effect (VE)  /  case-control study  /  children ≤10 years old  /  Shenzhen city
罗锦雁, 吴可怡, 姜世强, 蔡羽薇, 许丽芳, 袁建辉. 无细胞百日咳疫苗对深圳市南山区≤10岁儿童保护效果病例对照研究. 中国公共卫生, 2025 , 41 (11) : 1352 -1356 . DOI: 10.11847/zgggws1146786
Jinyan LUO, Keyi WU, Shiqiang JIANG, Yuwei CAI, Lifang XU, Jianhui YUAN. The protective effect of acellular pertussis vaccine in children ≤10 years of age in Nanshan district, Shenzhen city: a case-control study[J]. Chinese Journal of Public Health, 2025 , 41 (11) : 1352 -1356 . DOI: 10.11847/zgggws1146786
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百日咳作为一种呼吸道急性传染病，其致病原是百日咳鲍特菌（bordetella pertussis, Bp），这种疾病对婴幼儿群体有极大的危害，是全球致儿童发病与死亡的一种关键疾病[1]。随着百日咳联合疫苗的广泛使用，百日咳得到有效控制，发病率和死亡率均大幅下降[2]。近年来，全细胞百日咳疫苗（whole-cell pertussis vaccine, wPV）在全球范围内已逐步被无细胞百日咳疫苗（acellular pertussis vaccine, aPV）所更替，后者是采用纯度更高、成分更安全的百日咳抗原制备而成。但一种称为 “百日咳再现”的现象引发关注，即百日咳病例数在众多疫苗高覆盖率国家，多年维持低水平发病率的情况下再次呈上升趋势，同时发病群体逐渐向青少年及成年人等大年龄组人群转移[3–5]。研究发现，wPV向aPV转换是百日咳发病率增高的原因之一，疫苗的质量与效果可能因疫苗抗原的种类及数量不同、佐剂及生产工艺的差别而受到影响[6]。目前，中国使用的aPV有3种，其中国家免疫规划中使用的无细胞百白破联合疫苗（diphtheria, tetanus and acellular pertussis combined vaccine, DTaP，简称“三联疫苗”）和国产无细胞百白破b型流感嗜血杆菌联合疫苗（diphtheria, tetanus, acellular pertussis and haemophilus influenza type b combined vaccine, DTaP-Hib，简称“四联疫苗”）均采用共纯化工艺生产其百日咳抗原成分，吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌（结合）联合疫苗（diphtheria，tetanus, acellular pertussis, inactivated poliovirus and haemophilus influenza type b combined vaccine, DTaP-IPV/Hib，简称“五联疫苗”）在2010年批准进口，其百日咳抗原由纯化后的百日咳毒素（pertussis toxin, PT）、丝状血凝素（filamentous haemagglutinin, FHA）两组分构成，属于组分纯化生产工艺[7]，其中四联疫苗和五联疫苗均作为非免疫规划疫苗自费使用。南山区作为广东省深圳市主要经济区之一，居民对于非免疫规划疫苗的接种意愿较高，不同纯化工艺aPV的接种数据具有一定代表性。为评价aPV对南山区≤10岁儿童保护效果（vaccine effectiveness, VE），为优化百日咳免疫策略提供参考依据，本研究采用1:1匹配病例对照研究方法，抽取中国疾病预防控制信息系统中2023年1月1日—2024年3月25日深圳市南山区报告的442例4月龄～10岁临床诊断或确诊百日咳病例作为病例组，通过深圳市免疫规划信息管理系统选取与病例居住社区、性别相同且出生日期相差±1个月无百日咳感染史的442名健康儿童作为对照组。收集病例组和对照组研究对象aPV免疫史相关数据。采用二分类条件logistic回归模型分析aPV的VE。结果报告如下。
1　资料与方法
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1.1　资料来源
采用1:1匹配病例对照研究方法，抽取中国疾病预防控制信息系统中2023年1月1日—2024年3月25日深圳市南山区报告的442例4月龄～10岁临床诊断或确诊病例作为百日咳病例组，通过深圳市免疫规划信息管理系统选取与病例居住社区、性别相同且出生日期相差±1个月无百日咳感染史的442名健康儿童作为对照组，收集病例组和对照组研究对象aPV免疫史相关数据。内容包括是否接种、接种时间、接种剂次、每剂次疫苗种类等。本研究收集的aPV接种信息包括三联疫苗、四联疫苗和五联疫苗，aPV的国家免疫规划接种程序为3、4、5月龄各接种1剂，18月龄时加强1剂；五联疫苗可以在2月龄开始接种[8]。百日咳最长潜伏期21 d内或发病后接种aPV不纳入分析。
1.2　统计分析
采用Excel 2019建立数据库。应用SPSS 25.0软件进行统计分析。为确定病例组和对照组中aPV疫苗接种的效果差异，采用二分类条件logistic回归模型评估OR值。根据公式VE =（1−RR）×100%[9]计算aPV的保护效果。因百日咳发病率较低，本研究用OR值替代RR值。检验水准为双侧检验α=0.05。
2　结　果
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2.1　基本特征
本研究病例组和对照组最终纳入442对≤10岁儿童作为研究对象。对照组与病例组儿童的年龄、性别和居住地分布均衡。其中，男童216对（48.9%），女童226对（51.1%）；男女童性别比为1:1.05；4～11月龄52对（11.8%），1～3岁61对（13.8%），4～6岁186对（42.1%），7～10岁143对（32.4%）。
2.2　aPV对深圳市南山区≤10岁儿童预防百日咳总VE
深圳市南山区病例组和对照组≤10岁儿童中aPV接种率分别为94.3%（417/442）和99.1%（438/442）。aPV接种者百日咳的患病风险为未接种者的0.152倍（OR=0.152，95%CI=0.053～0.441）倍。aPV预防≤10岁儿童百日咳的总VE为84.8%（95%CI=55.9%～94.7%）。
2.3　aPV不同接种剂次对深圳市南山区≤10岁儿童预防百日咳VE（表1）
深圳市南山区≤10岁儿童中接种1～2、3和4剂次aPV者百日咳的患病风险分别为未接种者的0.175、0.114和0.157倍，预防百日咳的VE分别为82.5%、88.6%和84.3%。
2.4　aPV不同纯化工艺对深圳市南山区≤10岁儿童预防百日咳VE（表2）
深圳市南山区完成全程接种≤10岁儿童中接种4剂次共纯化aPV、4剂次中含1～3剂次组分纯化aPV和4剂次组分纯化aPV者百日咳的患病风险分别为未接种者的0.195、0.087和0.104倍，预防百日咳的VE分别为80.5%、91.3%和89.6%。
2.5　aPV不同末次接种时间间隔对深圳市南山区≤10岁儿童预防百日咳VE（表3）
深圳市南山区完成全程接种aPV≤10岁儿童中，末次接种时间间隔<2、3～6和7～9年者百日咳的患病风险分别为未接种者的0.130、0.162和0.175倍，预防百日咳的VE分别为87.0%、83.8%和82.5%；深圳市南山区完成全程接种组分纯化aPV≤10岁儿童中，末次接种时间间隔<2、3～6和7～9年者百日咳的患病风险分别为未接种者的0.123、0.101和0.071倍，预防百日咳的VE分别为87.7%、89.9%和92.9%；深圳市南山区完成全程接种共纯化aPV≤10岁儿童中，末次接种时间间隔<2、3～6和7～9年者百日咳的患病风险分别为未接种者的0.147、0.199和0.212倍，预防百日咳的VE分别为85.3%、80.1%和78.8%。
3　讨　论
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近年来，深圳市百日咳疫情呈总体上升趋势，特别是2023年以来上升趋势更加明显，与全国报道的百日咳疫情变化趋势一致[10]。尽管采取了积极的防控措施，但全球范围内百日咳仍是造成<10岁儿童疾病负担和伤害因素的前10位之一[11]。与DTaP使用多年且疫苗全程接种覆盖率高的国家和地区所观察到的情况相似，中国百日咳病例呈现由低龄儿童向学龄儿童、青少年和成年人变化的趋势[1,12–13]。中国疾病预防控制中心对我国2018—2021年报告的百日咳病例进行的分析显示，5～9岁儿童报告发病水平上升，在各年龄组中仅次于0～4岁儿童，需引起关注[14]。本研究纳入大年龄组儿童病例进行分析。发现aPV预防≤10岁儿童百日咳的总VE为84.8%，略低于湖北省武汉市<10岁儿童aPV预防百日咳总体VE的86.2%[15]。一项在加拿大开展的病例对照研究结果显示，针对2～3岁儿童，百日咳疫苗的VE可达92%；而在学龄前接种1剂后，直至8～9岁时VE仍能够维持在90%[16]。因此，含百日咳成分疫苗的及时接种，始终是预防百日咳最为有效的特异性手段，也是预防并减少婴幼儿百日咳重症与死亡病例的关键免疫策略[1]。
本次研究对象大部分已全程接种，其中接种4剂次aPV≤10岁儿童的VE为84.3%，低于接种3剂次aPV≤10岁儿童的88.6%，但仍高于接种1～2剂次aPV≤10岁儿童的82.5%，与国内部分病例对照研究结果中接种4剂次aPV的VE高于接种1～3剂次aPV的结果不同[17]。美国的一项研究通过生态疫苗模型估计，接种4剂次DTaP疫苗的有效性为83%[18]，与本研究结果相近。贵州省一项针对0～7岁儿童百日咳抗体水平的研究结果显示，4剂次的抗体浓度高于1～2剂次，但较3剂次略有下降[19]，与本研究结果一致。这可能与我国儿童在3、4和5月龄集中完成3剂次百日咳基础免疫，通过短期免疫刺激实现了较好的免疫保护效果有关。4剂次完全免疫后较长的时间间隔可能对本次免疫效果的评估产生影响，但这仍能表明，完成加强免疫能更好唤醒免疫记忆细胞。因此，为减少百日咳的发生，应及时全程接种含百日咳成分的疫苗。
aPV的制备主要借助提取纯化工艺去除部分无显著保护功效且容易导致不良反应的毒性物质而制成[20]。其按照提纯工艺的差异可以划分为共纯化与组分纯化2种类型。目前，我国免疫规划使用的DTaP三联疫苗和非免疫规划的四联疫苗中百日咳抗原成分均为共纯化工艺生产，采用混合提纯方法制备；五联疫苗是采用组分纯化工艺制备，虽然是作为非免疫规划疫苗，但是因其能减少接种剂次数，在深圳市等经济发达地区的接种率亦较高，其百日咳抗原为经过纯化的PT、FHA两组分按特定比例配制而成[7]。本研究中，接种4剂次组分纯化疫苗和4剂次中含1～3剂组分纯化疫苗对于预防百日咳的VE分别为89.6%和91.3%，均高于接种4剂次共纯化疫苗预防百日咳VE的80.5%。有研究提示，百日咳抗原纯化工艺可能对疫苗免疫效果产生较大影响[21]。深圳市的一项调查结果亦显示，接种五联疫苗的儿童较接种三联疫苗和四联疫苗具有更高的百日咳IgG抗体阳性率和几何平均浓度，提示接种组分纯化aPV对儿童感染百日咳具有较好的保护效果[22]。本研究结果显示，2种纯化工艺aPV混合接种同样能产生较好的保护效果。因此，在权衡经济支出和疫苗效果时可考虑采用国家免疫规划的三联疫苗和非免疫规划的五联疫苗混合接种。国外研究表明，含aPV的联合疫苗可以互换接种，且不会对安全性和免疫原性产生不利影响[20]。山东省济南市的一项免疫策略评价结果显示，wPV与DTaP组合免疫的效果可能优于单独接种DTwP[23]。但目前对于不同厂家不同工艺的无细胞百日咳联合疫苗的互换使用效果研究仍十分有限，需要进行更多的研究加以验证。有研究表明，组分纯化百日咳疫苗易于控制各组分比例的一致性，从而保证稳定的质量，具有更好的安全性。同时便于与b型流感嗜血杆菌疫苗（haemophilus influenzae type b vaccine, Hib）和灭活脊髓灰质炎疫苗（inactivated poliovirus vaccine, IPV）等制备成多种联合疫苗使用，减少接种剂次[7]，是未来我国aPV联合疫苗的重点研发方向。
本研究结果显示，全程接种aPV的VE随接种时间推移而下降。按接种疫苗纯化工艺进行分析，发现接种共纯化aPV者VE末次接种时间间隔<2年为85.3%，3～6年为80.1%，7～9年下降到78.8%。加拿大一项针对3个省份百日咳疫苗VE的荟萃分析发现，距末次接种<1年时VE为83%，1～3年时为84%，4～7年时为65%，≥8年时为60%，VE的衰减在检测阴性设计（test-negative design, TND）研究中最为显著，末次接种≥8年时合并VE为33%，而病例对照研究中为72%[24]。湖北省武汉市的一项研究亦显示，末次接种aPV后5～9年VE将下降至76.3%[12]。重庆市对1～4岁儿童的抗体水平监测显示，随着年龄的增长，百日咳抗体的阳性率和几何平均浓度均呈明显下降趋势，表明接种aPV所提供的免疫保护并非持久[25]。Zhang Z J Z等[26]通过一项百日咳抗体血清流行病学研究估计，百日咳感染率在学龄期增加，约在9岁可达到高峰。根据目前的百日咳监测数据，国家免疫规划疫苗接种方案在2025年1月1日进行了调整，在6岁时接种百白破疫苗替代白破疫苗，以提高学龄儿童的免疫水平，控制百日咳鲍特菌的传播，同时将首剂次接种时间提前到2月龄，为新生儿提供更及时有效的保护[27]。后续应扩大百日咳疫苗效果监测对象的年龄范围，结合疫苗抗体水平监测数据进一步评估免疫策略调整后大龄儿童、青少年和成年人aPV保护效果的持久性。本研究中，全程接种4剂次组分纯化aPV者VE随末次接种间隔时间的增加而有所上升，可能与接种组分纯化aPV的大年龄组百日咳病例症状不典型，就诊意愿和临床诊断意识不强，从而未能及时被发现或未就医有关[28]。因此对于此结果应该谨慎看待。今后可进一步开展前瞻性研究，分析其影响因素。
综上所述，及时接种aPV仍是防控百日咳的重要手段，其中组分纯化工艺aPV的VE较好，但仍需进一步进行流行病学和实验室研究加以验证，为全面评估和探索研发更安全有效的百日咳疫苗提供科学依据。在国家层面上，还应继续加强百日咳的监测，评估百日咳的疫情趋势和疫苗效力，适时推进青少年和成年人百日咳疫苗免疫策略的优化。由于本研究仅进行了442对儿童的病例对照研究，且深圳市≤10岁儿童的百日咳疫苗接种率较高。因此，本研究尚存在一定的局限性，今后可增加样本量进行队列研究，并组织开展疫苗抗体水平监测同步评估，以探讨不同纯化工艺百日咳疫苗的保护效果以及随时间推移的衰减规律。

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doi: 10.11847/zgggws1146786
  • 接收时间：2024-12-26
  • 首发时间：2026-10-25
  • 出版时间：2025-11-10
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  • 收稿日期：2024-12-26
  • 修回日期：2025-03-01
  • 录用日期：2025-05-10
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    深圳市南山区疾病预防控制中心（深圳市南山区卫生监督所），深圳 518054

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袁建辉，E-mail：
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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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