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Article(id=1240972423454052703, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1240972413354176744, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202312009, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1701360000000, receivedDateStr=2023-12-01, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773800481904, onlineDateStr=2026-03-18, pubDate=1715270400000, pubDateStr=2024-05-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773800481904, onlineIssueDateStr=2026-03-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773800481904, creator=13701087609, updateTime=1773800481904, updator=13701087609, issue=Issue{id=1240972413354176744, tenantId=1146029695717560320, journalId=1227665162245664772, year='2024', volume='51', issue='9', pageStart='1537', pageEnd='1728', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773800479495, creator=13701087609, updateTime=1773800596829, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1240972905568334240, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1240972413354176744, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1240972905568334241, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1240972413354176744, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1702, endPage=1707, ext={EN=ArticleExt(id=1240972423814762875, articleId=1240972423454052703, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Evaluation of the effect of EV71 Vaccine on reported incidence of hand, foot, and mouth disease in Quzhou city based on interruption time series, columnId=1228016573156360233, journalTitle=Modern Preventive Medicine, columnName=Disease Control and Prevention, runingTitle=null, highlight=null, articleAbstract=
Objective

To evaluate the effect of EV71 inactivated vaccine on the epidemiological characteristics and reported incidence of hand, foot, and mouth disease (HFMD) in Quzhou city.

Methods

The surveillance data of HFMD cases in Quzhou city from 2009 to 2022 were collected by China Infectious Disease Reporting Information Management system, and the epidemiological characteristics were descriptively analyzed. The change trend of reported incidence of HFMD in Quzhou before and after the application of EV71 inactivated vaccine was analyzed by interruption time series design.

Results

The average reported incidence of HFMD in Quzhou from 2009 to 2022 was 200.02/100 000. After the application of EV71 inactivated vaccine in Quzhou, the instantaneous change of HFMD reported incidence was -30.296/100 000 (t=0.30, P=0.773), the slope changes was-75.694/100 000 (t=5.43, P < 0.001), and the slope was -33.923 (β1+β3=33.923). The proportion of reported cases aged 0 to 4 years in all age groups decreased from 97.72% in 2009—2015 to 90.93% in 2016—2022.

Conclusion

The EV71 vaccine has achieved good prevention and control effect in a short time after coming into the market in Quzhou city, but the incidence rate is still high. It is necessary to strengthen the vaccination of children of school age, especially those less than 12 months old.

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目的

评价肠道病毒71型（EV71）灭活疫苗上市应用对衢州市手足口病流行病学特征和报告发病率变化的影响。

方法

通过中国传染病报告信息管理系统收集衢州市2009—2022年手足口病病例监测数据，进行描述性分析流行病学特征。利用中断时间序列设计分析EV71灭活疫苗上市应用前后衢州市手足口病报告发病率变化趋势。

结果

2009—2022年衢州市手足口病报告发病率平均为200.02/10万；衢州市EV71灭活疫苗上市应用后，手足口病报告发病率瞬时变化量为-30.296/10万（t=0.30,P=0.773），手足口病报告发病率的斜率改变量为-75.694/10万（t=-5.43，P<0.001），手足口病报告发病率的斜率为-33.923（β1+β3=33.923）；0～4岁报告病例占所有年龄段的比例从2009—2015年的97.72%，下降到2016—2022年的90.93%。

结论

EV71灭后疫苗在衢州市上市应用后短期内取得了较好的防控效果，但发病率仍较高，需要加强适龄儿童疫苗接种，特别是小于12月龄儿童。

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尹志英，E-mail:
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徐文杰（1998—），男，本科，医师，研究方向：公共卫生

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徐文杰（1998—），男，本科，医师，研究方向：公共卫生

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keyword=手足口病), Keyword(id=1240986263004705386, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, orderNo=2, keyword=流行特征), Keyword(id=1240986263155700340, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, orderNo=3, keyword=EV71灭活疫苗), Keyword(id=1240986263411552896, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, orderNo=4, keyword=中断时间序列)], refs=[Reference(id=1240986267731686210, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, doi=null, pmid=null, pmcid=null, year=2022, volume=29, issue=6, pageStart=461, pageEnd=466, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=赵好, 蒲欣岩, 董帅兵, journalName=国际病毒学杂志, refType=null, unstructuredReference=赵好，蒲欣岩，董帅兵，等.北京市2017—2019年手足口病流行病学特征及时空聚集性分析[J].国际病毒学杂志，2022，29（6）：461-466., articleTitle=北京市2017—2019年手足口病流行病学特征及时空聚集性分析, 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BMC Public Health, 2021, 21(1):1118., articleTitle=Vaccination coverage estimates and utilization patterns of inactivated enterovirus 71 vaccine post vaccine introduction in Ningbo, China, refAbstract=null), Reference(id=1240986275105272831, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, doi=null, pmid=null, pmcid=null, year=2018, volume=44, issue=4, pageStart=349, pageEnd=351, url=null, language=null, rfNumber=[19], rfOrder=31, authorNames=龙遗芳, 李胜峰, 谢莘, journalName=华南预防医学, refType=null, unstructuredReference=龙遗芳，李胜峰，谢莘，等.广东省2017年肠道病毒71型灭活疫苗接种现况分析[J].华南预防医学，2018，44（4）：349-351., articleTitle=广东省2017年肠道病毒71型灭活疫苗接种现况分析, refAbstract=null), Reference(id=1240986275277238276, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, doi=null, pmid=null, pmcid=null, year=2018, volume=44, issue=4, pageStart=349, pageEnd=351, url=null, language=null, rfNumber=[19], rfOrder=32, authorNames=Long WF, Li SF, Xie S, journalName=South China Journal of Preventive Medicine, refType=null, unstructuredReference=Long WF, Li SF, Xie S, et al. 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Chinese Journal of Vaccines and Immunization, 2023, 29(4): 412-416., articleTitle=Epidemiological characteristics and interrupted time series analysis of pertussis in Ningbo from 1970 to 2021, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1240986256679694631, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, xref=1., ext=[AuthorCompanyExt(id=1240986256696471849, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, companyId=1240986256679694631, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Quzhou Center for Disease Control and Prevention, Quzhou, Zhejiang 324000, China), AuthorCompanyExt(id=1240986256704860458, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, companyId=1240986256679694631, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.衢州市疾病预防控制中心，浙江 衢州 324000)]), AuthorCompany(id=1240986256805523767, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, xref=2., ext=[AuthorCompanyExt(id=1240986256813912376, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, companyId=1240986256805523767, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.浙江中医药大学)])], figs=[ArticleFig(id=1240986264271385238, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=EN, label=Figure 1, caption=Time series of reported incidence rates of hand, foot, and mouth disease in Quzhou city from 2009 to 2022, figureFileSmall=VkL0LNMecOevqKsKKGXv7Q==, figureFileBig=aMyQmRtjigmBsioHVs0iyA==, tableContent=null), ArticleFig(id=1240986264481100450, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, label=图1, caption=2009—2022年衢州市手足口病报告发病率的时间序列, figureFileSmall=VkL0LNMecOevqKsKKGXv7Q==, figureFileBig=aMyQmRtjigmBsioHVs0iyA==, tableContent=null), ArticleFig(id=1240986264711787184, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=EN, label=Figure 2, caption=Regional distribution of reported incidence rates of hand, foot, and mouth disease in Quzhou city from 2009 to 2022, figureFileSmall=qGpafMTk4lZlMvKMCiEItw==, figureFileBig=pjdktNEkDBWNHtxUGO+K/w==, tableContent=null), ArticleFig(id=1240986264887947961, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, label=图2, caption=2009—2022年衢州市手足口病报告发病率的地区分布, figureFileSmall=qGpafMTk4lZlMvKMCiEItw==, figureFileBig=pjdktNEkDBWNHtxUGO+K/w==, tableContent=null), ArticleFig(id=1240986265097663172, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=EN, label=Figure 3, caption=Composition ratio of reported hand, foot, and mouth disease cases by month in Quzhou city from 2009 to 2022, figureFileSmall=Z1zQQc0O23GVh+6A2Xq3hQ==, figureFileBig=VeBJ4/Dzn+05XhP7YTwrZA==, tableContent=null), ArticleFig(id=1240986265215103694, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, label=图3, caption=衢州市2009—2022年各月份手足口病报告病例构成比, figureFileSmall=Z1zQQc0O23GVh+6A2Xq3hQ==, figureFileBig=VeBJ4/Dzn+05XhP7YTwrZA==, tableContent=null), ArticleFig(id=1240986265508704988, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=EN, label=Figure 4, caption=Vaccination status of inactivated EV71 vaccine in birth cohorts in Quzhou city from 2009 to 2022, figureFileSmall=ULiEu5gaAHFx4KlNn1Sb8Q==, figureFileBig=BNb3s8t7oUsPm6fvRDRlKg==, tableContent=null), ArticleFig(id=1240986265772946148, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, label=图4, caption=衢州市2009—2022年出生队列EV71灭活疫苗接种情况, figureFileSmall=ULiEu5gaAHFx4KlNn1Sb8Q==, figureFileBig=BNb3s8t7oUsPm6fvRDRlKg==, tableContent=null), ArticleFig(id=1240986265991049969, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=EN, label=Figure 5, caption=Segmented regression line chart of reported incidence rates of hand, foot, and mouth disease and EV71 inactivated vaccine before and after its market application in Quzhou city from 2009 to 2022, figureFileSmall=HweQGVcI1tWb5S/KExa+yQ==, figureFileBig=YVe2HzwD+nX8+a98Pi5OtQ==, tableContent=null), ArticleFig(id=1240986266108490490, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, label=图5, caption=2009—2022年衢州市手足口病报告发病率及EV71灭活疫苗上市应用前后分段回归直线图

注：圆点表示年报告发病率；虚线表示干预纳入；实线表示年报告发病率的拟合直线。

, figureFileSmall=HweQGVcI1tWb5S/KExa+yQ==, figureFileBig=YVe2HzwD+nX8+a98Pi5OtQ==, tableContent=null), ArticleFig(id=1240986266204959488, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=EN, label=Table 1, caption=

Assignment of interrupted time series models for reported incidence rate of hand, foot, and mouth disease in Quzhou city, 2009—2022

, figureFileSmall=null, figureFileBig=null, tableContent=
年份
（年）		报告发病率
（/10万）		时间变量time值干预变量intervention值长期效果变量post-slope值
200915.92100
201097.08200
2011168.18300
2012163.94400
2013304.48500
2014357.93600
2015186.45700
2016373.37810
2017213.55911
2018270.121012
2019215.621113
2020206.451214
2021118.971315
2022141.031416
), ArticleFig(id=1240986266469200654, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, label=表1, caption=

2009—2022年衢州市手足口病报告发病率中断时间序列模型赋值

, figureFileSmall=null, figureFileBig=null, tableContent=
年份
（年）		报告发病率
（/10万）		时间变量time值干预变量intervention值长期效果变量post-slope值
200915.92100
201097.08200
2011168.18300
2012163.94400
2013304.48500
2014357.93600
2015186.45700
2016373.37810
2017213.55911
2018270.121012
2019215.621113
2020206.451214
2021118.971315
2022141.031416
), ArticleFig(id=1240986266687304468, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=EN, label=Table 2, caption=

Composition ratio (%) of reported hand, foot, and mouth disease cases by age group in Quzhou city from 2009 to 2022

, figureFileSmall=null, figureFileBig=null, tableContent=
年龄（岁）2009—2015年2016—2022年合计
发病数构成比（%）发病数构成比（%）发病数构成比（%）
0～427 09197.7230 68190.9357 77293.99
03 57912.912 5647.606 1439.99
110 10536.459 93929.4520 04432.61
27 14425.777 49122.2014 63523.81
34 59916.596 90420.4611 50318.71
41 6646.003 78311.215 4478.86
5～96322.282 9708.803 6025.86
≥1000.00920.27920.15
合计27 723100.0033 743100.0061 466100.00
), ArticleFig(id=1240986266934768411, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, label=表2, caption=

衢州市2009—2022年手足口病报告病例的年龄构成比

, figureFileSmall=null, figureFileBig=null, tableContent=
年龄（岁）2009—2015年2016—2022年合计
发病数构成比（%）发病数构成比（%）发病数构成比（%）
0～427 09197.7230 68190.9357 77293.99
03 57912.912 5647.606 1439.99
110 10536.459 93929.4520 04432.61
27 14425.777 49122.2014 63523.81
34 59916.596 90420.4611 50318.71
41 6646.003 78311.215 4478.86
5～96322.282 9708.803 6025.86
≥1000.00920.27920.15
合计27 723100.0033 743100.0061 466100.00
), ArticleFig(id=1240986267148677926, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=EN, label=Table 3, caption=

The t-test of regression coefficients for the multiple linear regression model

, figureFileSmall=null, figureFileBig=null, tableContent=
变量回归系数β值（95%CI）t值P值
time41.771（6.280～77.262）2.620.025
intervention-30.296（-258.196～197.604）-0.300.773
post-slop-75.694（-106.782～-44.606）-5.43<0.001
常数项17.770（-89.537～125.077）0.370.72
), ArticleFig(id=1240986267341615921, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1240972423454052703, language=CN, label=表3, caption=

多重线性回归模型回归系数的t检验

, figureFileSmall=null, figureFileBig=null, tableContent=
变量回归系数β值（95%CI）t值P值
time41.771（6.280～77.262）2.620.025
intervention-30.296（-258.196～197.604）-0.300.773
post-slop-75.694（-106.782～-44.606）-5.43<0.001
常数项17.770（-89.537～125.077）0.370.72
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基于中断时间序列评价EV71疫苗上市应用对衢州市手足口病报告发病情况影响
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徐文杰 1 , 尹志英 1 , 郑灿杰 1 , 富灿涯 2 , 龚晓英 1 , 方泉均 1
现代预防医学 | 疾病预防控制 2024,51(9): 1702-1707
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现代预防医学 | 疾病预防控制 2024, 51(9): 1702-1707
基于中断时间序列评价EV71疫苗上市应用对衢州市手足口病报告发病情况影响
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徐文杰1, 尹志英1 , 郑灿杰1, 富灿涯2, 龚晓英1, 方泉均1
作者信息
  • 1.衢州市疾病预防控制中心，浙江 衢州 324000
  • 2.浙江中医药大学

    • 徐文杰（1998—），男，本科，医师，研究方向：公共卫生

通讯作者:

尹志英，E-mail:
Evaluation of the effect of EV71 Vaccine on reported incidence of hand, foot, and mouth disease in Quzhou city based on interruption time series
Wen-jie XU1, Zhi-ying YIN1 , Can-jie ZHENG1, Can-ya FU2, Xiao-ying GONG1, Quan-jun FANG1
Affiliations
  • Quzhou Center for Disease Control and Prevention, Quzhou, Zhejiang 324000, China
出版时间: 2024-05-10 doi: 10.20043/j.cnki.MPM.202312009
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摘要
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目的

评价肠道病毒71型（EV71）灭活疫苗上市应用对衢州市手足口病流行病学特征和报告发病率变化的影响。

方法

通过中国传染病报告信息管理系统收集衢州市2009—2022年手足口病病例监测数据，进行描述性分析流行病学特征。利用中断时间序列设计分析EV71灭活疫苗上市应用前后衢州市手足口病报告发病率变化趋势。

结果

2009—2022年衢州市手足口病报告发病率平均为200.02/10万；衢州市EV71灭活疫苗上市应用后，手足口病报告发病率瞬时变化量为-30.296/10万（t=0.30,P=0.773），手足口病报告发病率的斜率改变量为-75.694/10万（t=-5.43，P<0.001），手足口病报告发病率的斜率为-33.923（β1+β3=33.923）；0～4岁报告病例占所有年龄段的比例从2009—2015年的97.72%，下降到2016—2022年的90.93%。

结论

EV71灭后疫苗在衢州市上市应用后短期内取得了较好的防控效果，但发病率仍较高，需要加强适龄儿童疫苗接种，特别是小于12月龄儿童。

手足口病  /  流行特征  /  EV71灭活疫苗  /  中断时间序列
Objective

To evaluate the effect of EV71 inactivated vaccine on the epidemiological characteristics and reported incidence of hand, foot, and mouth disease (HFMD) in Quzhou city.

Methods

The surveillance data of HFMD cases in Quzhou city from 2009 to 2022 were collected by China Infectious Disease Reporting Information Management system, and the epidemiological characteristics were descriptively analyzed. The change trend of reported incidence of HFMD in Quzhou before and after the application of EV71 inactivated vaccine was analyzed by interruption time series design.

Results

The average reported incidence of HFMD in Quzhou from 2009 to 2022 was 200.02/100 000. After the application of EV71 inactivated vaccine in Quzhou, the instantaneous change of HFMD reported incidence was -30.296/100 000 (t=0.30, P=0.773), the slope changes was-75.694/100 000 (t=5.43, P < 0.001), and the slope was -33.923 (β1+β3=33.923). The proportion of reported cases aged 0 to 4 years in all age groups decreased from 97.72% in 2009—2015 to 90.93% in 2016—2022.

Conclusion

The EV71 vaccine has achieved good prevention and control effect in a short time after coming into the market in Quzhou city, but the incidence rate is still high. It is necessary to strengthen the vaccination of children of school age, especially those less than 12 months old.

Hand, foot, and mouth disease  /  Epidemic characteristics  /  EV71 inactivated vaccine  /  Interruption time series
徐文杰, 尹志英, 郑灿杰, 富灿涯, 龚晓英, 方泉均. 基于中断时间序列评价EV71疫苗上市应用对衢州市手足口病报告发病情况影响. 现代预防医学, 2024 , 51 (9) : 1702 -1707 . DOI: 10.20043/j.cnki.MPM.202312009
Wen-jie XU, Zhi-ying YIN, Can-jie ZHENG, Can-ya FU, Xiao-ying GONG, Quan-jun FANG. Evaluation of the effect of EV71 Vaccine on reported incidence of hand, foot, and mouth disease in Quzhou city based on interruption time series[J]. Modern Preventive Medicine, 2024 , 51 (9) : 1702 -1707 . DOI: 10.20043/j.cnki.MPM.202312009
正文
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手足口病（hand, foot and mouth disease）是一种由肠道病毒引起的儿童常见传染病，具有明显的季节性，春秋季为发病高峰[1]，常见于≤5岁儿童尤其是0～3岁儿童，多数患者症状轻微并具有自限性，少数儿童可引起严重的并发症，甚至引起死亡[2]。目前已知主要有20多种(型)血清型[3]的肠道病毒可引发手足口病，其中以肠道病毒71型（enterovirus type 71, EV71）和柯萨奇病毒A16型(Cox A16)最为常见[4]。2016年我国自主研发的EV71灭活疫苗陆续获批上市应用[5-6]。目前EV71灭活疫苗作为非免疫规划疫苗已在全国范围内上市应用，对手足口病报告发病率下降显著，深圳市[7]手足口病发病率明显下降，由2016年的516.13/10万下降至2020年的84.42/10万，与福建省研究类似[8]。本研究以2016年衢州市EV71灭活疫苗上市应用为中断时间节点，对衢州市手足口病报告发病率进行中断时间序列分析，从而评价衢州市EV71疫苗上市后手足口病的防控效果，为今后衢州市手足口病防控提供参考和依据。
1　材料与方法
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1.1　材料来源
2009—2022年衢州市手足口病报告发病数据来自中国传染病报告信息管理系统，2009—2022年出生队列人群EV71灭活疫苗接种数据来自衢州市免疫规划信息系统，人口资料来自衢州市统计年鉴。
1.2　研究方法
2009—2022年衢州市手足口病报告发病率资料按年排列。衢州市于2016年上半年开始实施EV71灭活疫苗接种工作，故本研究以2016年作为干预实施的时间点，构建中断时间序列，比较干预前后衢州市手足口病报告发病率的变化趋势，并对干预前后报告发病率的变化水平进行统计学检验，从而评价EV71灭活疫苗在衢州市上市应用对手足口病报告发病率的影响。
1.3　应用条件
中断时间序列设计对数据的要求不高，可利用公共数据或者官方汇总数据对相关政策和干预措施进行效果评价，终点可为发病率、死亡率和病死率等[9]。该方法要求结果变量在干预前后随时间呈线性趋势，其次要求时间序列不存在自相关。
1.4　模型构建
采用中断时间序列分析方法比较不同手足口病疫苗免疫策略干预前后手足口病报告发病率水平和斜率的变化，time为连续时间序列取值为0、1、2……、14，依次对应相应年份；intervention表示相应干预是否发生的哑变量，干预前取值为0，干预后取值均为1；post-slope为另一个连续时间序列，干预当年取值均为0，之后至研究结束取值依次为1、2、3……；ε为误差项，表示自变量不能解释的部分。回归模型为：
其中因变量Y表示年报告发病率；β0为时间序列开始时衢州市手足口病报告发病率；β1是干预前衢州市手足口病报告发病率的斜率，若为正值表示报告发病率升高，反之则表示报告发病率降低；β2是在干预发生后（2016年EV71灭活疫苗上市）衢州市手足口病报告发病率的瞬时变化量，若假设检验后差异有统计学意义，则表示EV71灭活疫苗在衢州市上市应用对衢州市手足口病报告发病率具有短期影响；β3是在干预发生后衢州市手足口病报告发病率斜率改变量，正值表示报告发病率下降速度较干预前减慢，反之则表示报告发病率下降速度较干预前加快，若假设检验后差异有统计学意义，则表示EV71灭活疫苗在衢州市上市应用对衢州市手足口病报告发病率具有长期影响；β1+β3为干预后衢州市手足口病报告发病率的斜率。模型赋值见表1。
1.5　统计学方法
利用Excel 2019软件对数据进行整理，使用Stata 18.0统计软件进行中断事件序列分析，使用Prism 9.5.1制作时间序列图、构成比图、出生队列图，计数资料用率表示，时间序列的自相关性检验方法为Ljung-Box Q检验。回归系数的假设检验方法为t检验，双侧检验，检验水准α=0.05。
2　结果
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2.1　流行概况
2009—2022年衢州市手足口病报告病例共61 466例（其中死亡2例），手足口病年报告发病率为200.02/10万。EV71灭活疫苗上市应用前（2009—2015年），衢州市手足口病报告发病率平均为181.54/10万。EV71灭活疫苗上市应用后（2016—2022年）衢州市手足口病报告发病率平均为218.27/10万。见图1。
2.2　地区分布
2009—2022年报告病例61 466例，6个县（市、区）均有分布，其中柯城区、开化县年均报告发病率较高，分别为280.10/10万；258.56/10万，其它4个县（市、区）年均报告发病率在107.66/10万～211.93/10万之间，报告病例数在7 200～10 300例之间。见图2。
2.3　时间分布
2009—2022年衢州市手足口病报告病例月份分布呈4—6月和10—12月两个高峰，各月构成比在3.42%（8月）～14.79%（5月）之间，其中2009—2015年、2016—2022年衢州市手足口病报告发病数各月构成比分别在2.69%（8月）～14.49%（5月）、4.02%（8月）～17.52%（6月）之间，见图3。
2.4　年龄分布
2009—2022年衢州市手足口病报告病例有年龄分布信息，0～4岁、5～9岁、≥10岁年龄组手足口病报告病例构成比分别为93.99%、5.86%、0.15%，见表2。
2.5　疫苗接种情况
在衢州市免疫规划信息系统中查询2009—2022年出生队列EV71灭活疫苗接种情况，衢州市2009—2013年出生队列儿童EV71灭活疫苗基础免疫和加强免疫接种率都低于3.51%，2014—2016年出生队列儿童EV71灭活疫苗基础免疫和加强免疫接种率分别从13.62%上升到50.58%、11.59%上升到47.10%，2017—2021年出生队列儿童EV71灭活疫苗基础免疫和加强免疫接种率均维持在55.4%以上。见图4。
2.6　实验室诊断病例分布
2009—2022年衢州市报告的手足口病例中2 692例有实验室诊断信息，其中2009—2016年检出Cox A16、EV71和其他肠道病毒占比分别为18.24%、28.66%、53.10%，2017—2022年检出Cox A16、EV71和其他肠道病毒占比分别为27.23%、11.21%、61.56%，其中EV71检出占比下降50%以上。
2.7　中断时间序列分析
2.7.1　自相关性检验
2009—2022年衢州市手足口病报告发病率Ljung-Box Q检验的统计量为5.626（P=0.017 7），表示该时间序列存在自相关性，一阶自相关性检验统计量为5.68（P=0.017 2）表示该时间序列存在一阶自相关性，但不存在二阶和三阶自相关(χ2=5.69，P=0.058 1；χ2=5.78，P=0.123)。
2.7.2　中断时间序列分析
采用Newey-West法取一阶差分，构建的中断线性回归模型方程为Y=59.541+41.771×time-30.296×intervention-75.694×post-slope+ ε。该回归模型表示时间序列呈现先上升后下降趋势，开始时衢州市手足口病年报告发病率水平为59.541/10万，干预前衢州市手足口病报告发病率每年上升41.771/10万（t=2.62,P=0.025），干预后衢州市手足口病报告发病率瞬时变化量为-30.296/10万（t =0.30,P=0.773），斜率改变量为-75.694/10万（t=-5.43，P<0.001），斜率-33.923（β1+β3=-33.923），见表3、图5。
3　讨论
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衢州市EV71灭活疫苗2016年上市应用前，手足口病处于自然流行状态，年报告发病率远高于全国平均水平且在2014年前呈现“直线”上升趋势，2015年后呈波动下降，高峰出现在2014年与全国、广西变化趋势类似[10-11]，年报告发病率低于广西[10]，高于甘肃[12]，与福建年报告发病率持平[12]。2016年EV71灭活疫苗上市应用后，适龄儿童接种率持续上升且维持在较高水平，手足口病报告发病率呈下降趋势。EV71灭活疫苗上市应用对衢州市手足口病流行具有良好的短期防控效果。但2016—2022年衢州市手足口病年报告发病率仍维持在较高水平，可能与手足口病病毒优势株变化也有关，2016年EV71灭活疫苗上市应用后衢州市手足口病报告病例实验室诊断中EV71型肠道病毒占所有报告检出肠道病毒占比下降50%以上，此外可能还与衢州市气候、社会发展程度和人员流动情况有关。
我国每年春夏季是手足口病的高发季节，部分地区还会出现秋季小高峰[6，13]。衢州市手足口病报告发病率季节性呈现双峰趋势，一个主峰在4—6月，一个次峰在10—12月，与陕西省类似[14]。提示春季和秋季是防控衢州市手足口病疫情的关键时期。不同地区的手足口病报告发病季节不同可能与气候因素等对肠道病毒的影响有关。但本研究发现，衢州市手足口病报告发病季节在疫苗上市前后有所改变，衢州市手足口病自然流行时期的报告发病季节流行高峰在4—6月，而EV71灭活疫苗上市应用后衢州市手足口病报告发病季节流行高峰5—7月，EV71灭活疫苗上市应用后出现报告发病率流行季节高峰后移的情况，可能与自然气候变化或者肠道病毒特性有关。有研究表明温度和湿度是影响手足口病流行的关键，温度和湿度上升时期的变化会影响报告发病率流行季节高峰出现的季节变化。也可能EV71灭活疫苗上市应用后，衢州市手足口病的疫情和季节性高发态势得到控制。
通过分析衢州市2009—2022年手足口病报告病例资料可知，0～4岁儿童病例手足口病报告发病率高，占所有报告发病病例的93.99%，与甘肃[12]、金华[15]研究结果一致。2015年发表的我国儿童EV71血清抗体水平研究的系统综述表明[16]，0～5月龄婴儿EV71中和抗体水平随着年龄增长而降低，6～11月龄都维持在低水平，学龄前儿童随着年龄增长EV71中和抗体水平逐渐上升。5岁以后相对稳定。有研究表明在EV71灭活疫苗上市早期实际接种人群主要为1～3岁儿童，占总接种数84.33%[17]，宁波市[18]一项调查报告2012—2018年出生队列儿童EV71灭活疫苗接种率为21.97%，广东省[19]一项接种个案调查发现，2013—2020年出生队列儿童EV71灭活疫苗接种率为25.91%，提示适龄儿童接种率普遍偏低，且完成全程免疫年龄偏大。出生后婴幼儿存在一段EV71中和抗体水平低的时期，EV71灭活疫苗为非免疫规划疫苗价格较高且一岁前婴幼儿其它疫苗的接种剂次较多，以上原因会增加儿童感染肠道病毒的风险，推迟适龄儿童接种EV71灭活疫苗时间，增加感染儿童手足口病的可能，因此中国CDC建议EV71灭活疫苗接种对象为≥6月龄易感儿童，越早接种越好，鼓励在12月龄之前完成接种程序，以便发挥保护效果[6]。此外，衢州市手足口病报告发病率在各县（市、区）之间有较大差异，可能与不同地区经济条件以及城镇化水平存在联系，经济发达地区人口流动大、聚集场所多、交通便利和人群就诊意识高都会影响手足口病的发病率。
本研究报告发病数来源于被动监测数据可能存在偏倚会低估手足口病实际发病率，可能存在各年份报告发病率的偏差，如2008年5月开始手足口病纳入法定传染病，2009年报告发病率远低于其他各年份，且新型冠状病毒感染疫情可能导致2020—2022年衢州市手足口病报告发病率有所下降。除此之外，还有社会经济、人口流动、实验室检测技术应用、临床上对疾病的关注度[20]等因素会对手足口病的报告发病率产生影响，需要进一步收集相关数据开展更为深入的研究。
综上所述，EV71灭活疫苗在衢州市上市应用对手足口病报告发病率降低起到了一定的影响，但0～4岁儿童手足口病发病率仍较高，被动监测数据可能没有完全反映衢州市手足口病发病的真实情况，衢州市手足口病防控形势仍然严峻。亟需建立和完善手足口病监测体系，提高EV71疫苗接种率，加强手足口病防控工作。
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2024年第51卷第9期
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doi: 10.20043/j.cnki.MPM.202312009
  • 接收时间：2023-12-01
  • 首发时间：2026-03-18
  • 出版时间：2024-05-10
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  • 收稿日期：2023-12-01
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    1.衢州市疾病预防控制中心，浙江 衢州 324000
    2.浙江中医药大学

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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
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红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
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