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Article(id=1241675635190460593, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241675628051755031, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202401500, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1706630400000, receivedDateStr=2024-01-31, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773968140647, onlineDateStr=2026-03-20, pubDate=1732464000000, pubDateStr=2024-11-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773968140647, onlineIssueDateStr=2026-03-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773968140647, creator=13701087609, updateTime=1773968140647, updator=13701087609, issue=Issue{id=1241675628051755031, tenantId=1146029695717560320, journalId=1227665162245664772, year='2024', volume='51', issue='22', pageStart='4033', pageEnd='4224', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773968138945, creator=13701087609, updateTime=1773968595676, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241677543783322543, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241675628051755031, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241677543783322544, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241675628051755031, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=4206, endPage=4211, ext={EN=ArticleExt(id=1241675635576336599, articleId=1241675635190460593, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Safety analysis of oral live attenuated rotavirus vaccine, Shaanxi, 2018-2022, columnId=1228016573156360233, journalTitle=Modern Preventive Medicine, columnName=Disease Control and Prevention, runingTitle=null, highlight=null, articleAbstract=
Objective

To analyze the characteristics of Adverse Events Following Immunization (AEFI) of domestic rotavirus (live) vaccine (RVVO) in Shaanxi province from 2018 to 2022, and to evaluate the safety of RVVO vaccination.

Methods

The AEFI case data on RVVO vaccination in Shaanxi Province between 2018 and 2022 was gathered from the China AEFI Information Management System., and the vaccination situation of RVVO in Shaanxi province was collected through the immunization planning information management system of Shaanxi province. The analysis was conducted using the descriptive epidemiological technique.

Results

A total of 461 102 doses of RVVO were inoculated in Shaanxi province from 2018 to 2022, and 48 cases of AEFI were recorded, with an incidence of 10.41 cases per 100 000 doses, including 43 cases of normal reactions (9.33 cases per 100 000 doses) and 3 cases of abnormal reactions (0.65 cases per 100 000 doses). 2 cases of coupling disease and No serious AEFI cases recorded. The three abnormal reactions were allergic rash (0.22/100 000 doses), acute diarrhea (0.22/100 000 doses) and rotavirus diarrhea (0.22/100 000 doses). 97.92% of the reported AEFI cases were cured or improved after follow-up, and no sequelae and death cases were reported. The age of onset of AEFI was less than 1 year old and occurred on the day of inoculation. The incidence of AEFI at the first, second and third doses was 12.65 cases per 100 000 doses, 10.64 cases per 100,000 doses and 361 cases per 100 000 doses, respectively. RVVO combined with other vaccines reported a general reaction rate of 10.16 per 100 000 doses and an abnormal reaction rate of 0.97 per 100 000 doses in AEFI.

Conclusion

The domestic oral live attenuated rotavirus vaccine has good safety, and the timely vaccination rate of children should be further strengthened.

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目的

分析陕西省2018—2022年国产口服轮状病毒减毒活疫苗(Rotavirus(Live)Vaccine ,Oral, RVVO)疑似预防接种异常反应（Adverse Events Following Immunization, AEFI）的特征，评价RVVO 预防接种的安全性。

方法

通过国家AEFI 信息管理系统，收集陕西省2018—2022年接种RVVO发生的AEFI个案信息，通过陕西省免疫规划信息管理系统收集全省RVVO接种情况，采用描述性流行病学方法进行分析。

结果

陕西省2018—2022年接种RVVO共计461 102剂次，首剂接种有63.69%年龄在12月龄后。共报告发生AEFI 48例，发生率10.41/10万剂，其中一般反应43例（9.33/10万剂）、异常反应3例（0.65/10万剂），偶合症2例，未见报告严重 AEFI 病例。3例异常反应分别为过敏性皮疹（0.22/10万剂），急性腹泻（0.22/10万剂）和轮状病毒腹泻（0.22/10万剂）各1例。报告的AEFI经随访97.92%病例治愈或好转，无后遗症和死亡病例报告。报告AEFI发病年龄均小于1岁，发生时间均为接种当天；接种首剂、二剂次和三剂次AEFI发生率分别为12.65/10万剂、10.64/10万剂和3.61/10万剂；RVVO与其他疫苗联合接种报告AEFI中一般反应发生率10.16/10万剂次，异常反应发生率0.97/10万剂次。

结论

国产口服轮状病毒减毒活疫苗具有良好的安全性，应进一步加强儿童疫苗及时接种率。

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胡伟军，E-mail:
, copyrightStatement=本刊刊出的所有文章不代表中华预防医学会和本刊编委会的观点，除非特别声明。, copyrightOwner=中华预防医学会和四川大学华西公共卫生学院, extLink=null, articleAbsUrl=null, sourceXml=yMn+OpTiu9tS2+a5p8z7fA==, magXml=eMDX3MN26PrU4g9H7RtoZw==, pdfUrl=null, pdf=UDaFkuPe4mALzuRIhAxWXQ==, pdfFileSize=631850, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=Lcy1o55++R6UABVjPM2Grg==, mapNumber=null, authorCompany=null, fund=null, authors=

吕亚可(1995—)，男，硕士，主管医师，研究方向：传染病控制

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吕亚可(1995—)，男，硕士，主管医师，研究方向：传染病控制

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吕亚可(1995—)，男，硕士，主管医师，研究方向：传染病控制

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tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=CN, orderNo=2, keyword=疑似预防接种异常反应)], refs=[Reference(id=1241826540657382010, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, doi=null, pmid=null, pmcid=null, year=2023, volume=29, issue=5, pageStart=569, pageEnd=577, url=null, language=null, rfNumber=［1］, rfOrder=0, authorNames=杨帆, 孙芯蕊, 王四全, journalName=中国疫苗和免疫, refType=null, unstructuredReference=杨帆，孙芯蕊，王四全，等．湖北省2~35月龄儿童国产口服轮状病毒减毒活疫苗与部分免疫规划疫苗联合接种不良反应的真实世界研究［J］．中国疫苗和免疫, 2023, 29(5): 569-577., articleTitle=湖北省2~35月龄儿童国产口服轮状病毒减毒活疫苗与部分免疫规划疫苗联合接种不良反应的真实世界研究, refAbstract=null), Reference(id=1241826540766433924, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, doi=null, pmid=null, pmcid=null, year=2023, volume=29, issue=5, pageStart=569, pageEnd=577, url=null, language=null, rfNumber=［1］, rfOrder=1, authorNames=Yang F, Sun XR, Wang SQ, journalName=Chinese 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Monitoring of suspected abnormal reactions to vaccination in China in 2020［J］. Chinese Journal of Vaccines and Immunization, 2022, 28(2): 208-218. 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Disease burden and vaccine application for rotavirus infection in children［J］. Chinese Journal of Pediatrics, 2021, 59(5): 426-430. 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Safety surveillance and analysis of two rotavirus vaccines made and imported from Guangdong Province［J］. South China Journal of Preventive Medicine, 2022, 48(1): 119-121. (In Chinese), articleTitle=Safety surveillance and analysis of two rotavirus vaccines made and imported from Guangdong Province, refAbstract=null), Reference(id=1241826549150847904, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, doi=null, pmid=null, pmcid=null, year=2022, volume=28, issue=3, pageStart=456, pageEnd=459, url=null, language=null, rfNumber=［24］, rfOrder=45, authorNames=Pertwee E, Simas C, Larson HJ, journalName=Nature Medicine, refType=null, unstructuredReference=Pertwee E, Simas C, Larson HJ. An epidemic of uncertainty: rumors, conspiracy theories and vaccine hesitancy［J］. 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Epidemiological evaluation of oral rotavirus live vaccine among age eligible children［J］. Jiangsu Journal of Preventive Medicine, 2022, 33(3): 269-271, 355. 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Advances in the effectiveness of rotavirus vaccines and its influencing factors［J］. Chinese Journal of Microbiology and Immunology, 2019, 39(6): 472-484. (In Chinese), articleTitle=Advances in the effectiveness of rotavirus vaccines and its influencing factors, refAbstract=null)], funds=[Fund(id=1241826540296671838, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, awardId=2022PT-26, language=CN, fundingSource=陕西省创新能力支撑计划项目(2022PT-26), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1241826534894407962, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, xref=null, ext=[AuthorCompanyExt(id=1241826534902796571, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, companyId=1241826534894407962, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Shaanxi Provincial Center for Disease Control and Prevention, Xi’an, Shaanxi 710054, China), AuthorCompanyExt(id=1241826534911185180, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, companyId=1241826534894407962, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=陕西省疾病预防控制中心，陕西　西安　710054)])], figs=[ArticleFig(id=1241826538761556473, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=EN, label=Table 1, caption=

Reported incidence in Shaanxi Province, 2018-2022［n(1/100 000)］

, figureFileSmall=null, figureFileBig=null, tableContent=
AEFI分类20182019202020212022合计
n发生率(95% CI)
不良反应
一般反应5(9.36)4(4.57)13(11.48)10(8.96)11(11.54)439.33(6.75-12.56)
异常反应0(0.00)1(1.14)2(1.77)0(0.00)0(0.00)30.65(0.13-1.90)
偶合症1(1.87)0(0.00)0(0.00)1(0.90)0(0.00)20.43(0.05-1.56)
合计6(11.23)5(5.72)15(13.24)11(9.85)11(11.54)4810.41(7.67-13.80)
), ArticleFig(id=1241826538878996992, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=CN, label=表1, caption=

陕西省2018—2022年RVVO AEFI报告情况［n(1/10万)］

, figureFileSmall=null, figureFileBig=null, tableContent=
AEFI分类20182019202020212022合计
n发生率(95% CI)
不良反应
一般反应5(9.36)4(4.57)13(11.48)10(8.96)11(11.54)439.33(6.75-12.56)
异常反应0(0.00)1(1.14)2(1.77)0(0.00)0(0.00)30.65(0.13-1.90)
偶合症1(1.87)0(0.00)0(0.00)1(0.90)0(0.00)20.43(0.05-1.56)
合计6(11.23)5(5.72)15(13.24)11(9.85)11(11.54)4810.41(7.67-13.80)
), ArticleFig(id=1241826538983854600, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=EN, label=Table 2, caption=

Gender and age distribution of adverseevents following immunization of RVVO in Shaanxi Province, 2018-2022 ［n(%)］

, figureFileSmall=null, figureFileBig=null, tableContent=
AEFI特征20182019202020212022合计
性别
男3(50.00)2(40.00)9(60.00)5(45.45)8(72.73)27(56.25)
女3(50.00)3(60.00)6(40.00)6(54.55)3(27.27)21(43.75)
年龄(岁)
0~12(33.33)2(40.00)3(20.00)4(36.36)3(27.27)14(29.17)
>1~23(50.00)3(60.00)6(40.00)5(45.45)6(54.55)23(47.92)
>2~31(16.67)0(0.00)4(26.67)2(18.18)1(9.09)8(16.67)
>30(0.00)0(0.00)2(13.33)0(0.00)1(9.09)3(6.25)
合计6(12.50)5(10.42)15(31.25)11(22.92)11(22.92)48(100.00)
), ArticleFig(id=1241826539080323599, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=CN, label=表2, caption=

陕西省2018—2022年RVVO AEFI性别和年龄分布［n(%)］

, figureFileSmall=null, figureFileBig=null, tableContent=
AEFI特征20182019202020212022合计
性别
男3(50.00)2(40.00)9(60.00)5(45.45)8(72.73)27(56.25)
女3(50.00)3(60.00)6(40.00)6(54.55)3(27.27)21(43.75)
年龄(岁)
0~12(33.33)2(40.00)3(20.00)4(36.36)3(27.27)14(29.17)
>1~23(50.00)3(60.00)6(40.00)5(45.45)6(54.55)23(47.92)
>2~31(16.67)0(0.00)4(26.67)2(18.18)1(9.09)8(16.67)
>30(0.00)0(0.00)2(13.33)0(0.00)1(9.09)3(6.25)
合计6(12.50)5(10.42)15(31.25)11(22.92)11(22.92)48(100.00)
), ArticleFig(id=1241826539298427416, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=EN, label=Table 3, caption=

The age and numbers of the first doses of RVVO in Shaanxi Province, 2018-2022［n(%)］

, figureFileSmall=null, figureFileBig=null, tableContent=
首针接种年龄(月)20182019202020212022合计
0~3478(2.33)10 244(24.83)20 034(35.78)28 898(48.09)36 340(61.31)95 993(40.48)
>3~72 760(13.44)4 785(11.60)5 855(10.46)5 588(9.30)5 916(9.98)24 905(10.50)
>7~125 004(24.37)6 411(15.54)7 270(12.98)4 712(7.84)3 183(5.37)26 580(11.21)
>1212 290(59.86)19 822(48.04)22 830(40.78)20 892(34.77)13 836(23.34)89 669(37.81)
合计20 532(100.00)41 262(100.00)55 989(100.00)60 090(100.00)59 275(100.00)237 147(100.00)
), ArticleFig(id=1241826539424256546, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=CN, label=表3, caption=

陕西省2018—2022年RVVO首针接种年龄及剂次［n(%)］

, figureFileSmall=null, figureFileBig=null, tableContent=
首针接种年龄(月)20182019202020212022合计
0~3478(2.33)10 244(24.83)20 034(35.78)28 898(48.09)36 340(61.31)95 993(40.48)
>3~72 760(13.44)4 785(11.60)5 855(10.46)5 588(9.30)5 916(9.98)24 905(10.50)
>7~125 004(24.37)6 411(15.54)7 270(12.98)4 712(7.84)3 183(5.37)26 580(11.21)
>1212 290(59.86)19 822(48.04)22 830(40.78)20 892(34.77)13 836(23.34)89 669(37.81)
合计20 532(100.00)41 262(100.00)55 989(100.00)60 090(100.00)59 275(100.00)237 147(100.00)
), ArticleFig(id=1241826539587834410, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=EN, label=Table 4, caption=

The adverse events following immunization constituent and incidence of the difference doses of RVVO in Shaanxi Province, 2018-2022［n(1/100 000)］

, figureFileSmall=null, figureFileBig=null, tableContent=
接种剂次20182019202020212022合计
第一剂次6(29.22)5(12.11)8(14.29)5(8.32)6(10.12)30(12.65)
第二剂次0(0.00)0(0.00)4(13.38)6(14.21)5(9.90)15(10.64)
第三剂次0(0.00)0(0.00)3(19.57)0(0.00)0(0.00)3(3.61)
合计6(24.46)5(8.13)15(14.82)11(8.58)11(7.55)48(10.41)
), ArticleFig(id=1241826539768189497, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=CN, label=表4, caption=

陕西省2018—2022年RVVO 不同剂次 AEFI 报告病例构成及发生率［n(1/10万)］

, figureFileSmall=null, figureFileBig=null, tableContent=
接种剂次20182019202020212022合计
第一剂次6(29.22)5(12.11)8(14.29)5(8.32)6(10.12)30(12.65)
第二剂次0(0.00)0(0.00)4(13.38)6(14.21)5(9.90)15(10.64)
第三剂次0(0.00)0(0.00)3(19.57)0(0.00)0(0.00)3(3.61)
合计6(24.46)5(8.13)15(14.82)11(8.58)11(7.55)48(10.41)
), ArticleFig(id=1241826539910795843, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=EN, label=Table 5, caption=

The number of reported cases distributed by clinical impairment and time interval from inoculation to onset of RVVO in Shaanxi Province, 2018-2022［n(%)］

, figureFileSmall=null, figureFileBig=null, tableContent=
AEFI分类总例数<24 h24~48 h48~72 h>72 h
一般反应4343(89.58)0(0)0(0)0(0)
弱反应37.1~37.5℃22(4.17)0(0)0(0)0(0)
中反应37.6~38.5℃99(18.75)0(0)0(0)0(0)
强反应：≥38.6℃2323(47.92)0(0)0(0)0(0)
红肿11(2.08)0(0)0(0)0(0)
麻疹猩红热样皮疹11(2.08)0(0)0(0)0(0)
乏力11(2.08)0(0)0(0)0(0)
食欲不振33(6.25)0(0)0(0)0(0)
腹泻33(6.25)0(0)0(0)0(0)
异常反应33(6.25)0(0)0(0)0(0)
过敏性皮疹11(2.08)0(0)0(0)0(0)
急性腹泻11(2.08)0(0)0(0)0(0)
轮状病毒腹泻11(2.08)0(0)0(0)0(0)
偶合症22(4.17)0(0)0(0)0(0)
合计4848(100.00)0(0)0(0)0(0)
), ArticleFig(id=1241826540082762317, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241675635190460593, language=CN, label=表5, caption=

陕西省2018—2022年RVVO AEFI接种到发病时间间隔分布［n(%)］

, figureFileSmall=null, figureFileBig=null, tableContent=
AEFI分类总例数<24 h24~48 h48~72 h>72 h
一般反应4343(89.58)0(0)0(0)0(0)
弱反应37.1~37.5℃22(4.17)0(0)0(0)0(0)
中反应37.6~38.5℃99(18.75)0(0)0(0)0(0)
强反应：≥38.6℃2323(47.92)0(0)0(0)0(0)
红肿11(2.08)0(0)0(0)0(0)
麻疹猩红热样皮疹11(2.08)0(0)0(0)0(0)
乏力11(2.08)0(0)0(0)0(0)
食欲不振33(6.25)0(0)0(0)0(0)
腹泻33(6.25)0(0)0(0)0(0)
异常反应33(6.25)0(0)0(0)0(0)
过敏性皮疹11(2.08)0(0)0(0)0(0)
急性腹泻11(2.08)0(0)0(0)0(0)
轮状病毒腹泻11(2.08)0(0)0(0)0(0)
偶合症22(4.17)0(0)0(0)0(0)
合计4848(100.00)0(0)0(0)0(0)
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2018—2022年陕西省国产口服轮状病毒减毒活疫苗安全性监测分析
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吕亚可 , 马悦章 , 张少白 , 胡伟军
现代预防医学 | 疾病预防控制 2024,51(22): 4206-4211
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现代预防医学 | 疾病预防控制 2024, 51(22): 4206-4211
2018—2022年陕西省国产口服轮状病毒减毒活疫苗安全性监测分析
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吕亚可, 马悦章, 张少白, 胡伟军
作者信息
  • 陕西省疾病预防控制中心，陕西　西安　710054

    • 吕亚可(1995—)，男，硕士，主管医师，研究方向：传染病控制

通讯作者:

胡伟军，E-mail:
Safety analysis of oral live attenuated rotavirus vaccine, Shaanxi, 2018-2022
Ya-ke LV, Yue-zhang MA, Shao-bai ZHANG, Wei-jun HU
Affiliations
  • Shaanxi Provincial Center for Disease Control and Prevention, Xi’an, Shaanxi 710054, China
出版时间: 2024-11-25 doi: 10.20043/j.cnki.MPM.202401500
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摘要
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目的

分析陕西省2018—2022年国产口服轮状病毒减毒活疫苗(Rotavirus(Live)Vaccine ,Oral, RVVO)疑似预防接种异常反应（Adverse Events Following Immunization, AEFI）的特征，评价RVVO 预防接种的安全性。

方法

通过国家AEFI 信息管理系统，收集陕西省2018—2022年接种RVVO发生的AEFI个案信息，通过陕西省免疫规划信息管理系统收集全省RVVO接种情况，采用描述性流行病学方法进行分析。

结果

陕西省2018—2022年接种RVVO共计461 102剂次，首剂接种有63.69%年龄在12月龄后。共报告发生AEFI 48例，发生率10.41/10万剂，其中一般反应43例（9.33/10万剂）、异常反应3例（0.65/10万剂），偶合症2例，未见报告严重 AEFI 病例。3例异常反应分别为过敏性皮疹（0.22/10万剂），急性腹泻（0.22/10万剂）和轮状病毒腹泻（0.22/10万剂）各1例。报告的AEFI经随访97.92%病例治愈或好转，无后遗症和死亡病例报告。报告AEFI发病年龄均小于1岁，发生时间均为接种当天；接种首剂、二剂次和三剂次AEFI发生率分别为12.65/10万剂、10.64/10万剂和3.61/10万剂；RVVO与其他疫苗联合接种报告AEFI中一般反应发生率10.16/10万剂次，异常反应发生率0.97/10万剂次。

结论

国产口服轮状病毒减毒活疫苗具有良好的安全性，应进一步加强儿童疫苗及时接种率。

轮状病毒疫苗  /  疑似预防接种异常反应
Objective

To analyze the characteristics of Adverse Events Following Immunization (AEFI) of domestic rotavirus (live) vaccine (RVVO) in Shaanxi province from 2018 to 2022, and to evaluate the safety of RVVO vaccination.

Methods

The AEFI case data on RVVO vaccination in Shaanxi Province between 2018 and 2022 was gathered from the China AEFI Information Management System., and the vaccination situation of RVVO in Shaanxi province was collected through the immunization planning information management system of Shaanxi province. The analysis was conducted using the descriptive epidemiological technique.

Results

A total of 461 102 doses of RVVO were inoculated in Shaanxi province from 2018 to 2022, and 48 cases of AEFI were recorded, with an incidence of 10.41 cases per 100 000 doses, including 43 cases of normal reactions (9.33 cases per 100 000 doses) and 3 cases of abnormal reactions (0.65 cases per 100 000 doses). 2 cases of coupling disease and No serious AEFI cases recorded. The three abnormal reactions were allergic rash (0.22/100 000 doses), acute diarrhea (0.22/100 000 doses) and rotavirus diarrhea (0.22/100 000 doses). 97.92% of the reported AEFI cases were cured or improved after follow-up, and no sequelae and death cases were reported. The age of onset of AEFI was less than 1 year old and occurred on the day of inoculation. The incidence of AEFI at the first, second and third doses was 12.65 cases per 100 000 doses, 10.64 cases per 100,000 doses and 361 cases per 100 000 doses, respectively. RVVO combined with other vaccines reported a general reaction rate of 10.16 per 100 000 doses and an abnormal reaction rate of 0.97 per 100 000 doses in AEFI.

Conclusion

The domestic oral live attenuated rotavirus vaccine has good safety, and the timely vaccination rate of children should be further strengthened.

Rotavirus vaccine  /  Adverse events following immunization
吕亚可, 马悦章, 张少白, 胡伟军. 2018—2022年陕西省国产口服轮状病毒减毒活疫苗安全性监测分析. 现代预防医学, 2024 , 51 (22) : 4206 -4211 . DOI: 10.20043/j.cnki.MPM.202401500
Ya-ke LV, Yue-zhang MA, Shao-bai ZHANG, Wei-jun HU. Safety analysis of oral live attenuated rotavirus vaccine, Shaanxi, 2018-2022[J]. Modern Preventive Medicine, 2024 , 51 (22) : 4206 -4211 . DOI: 10.20043/j.cnki.MPM.202401500
正文
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免疫接种是预防控制传染病发病和死亡最有效、最经济的措施之一[1]。轮状病毒(Rotavirus，RV)主要感染4～24月龄人群，导致婴幼儿发生病毒性腹泻，报告显示全球每年死于RV 所致感染性腹泻的患儿达70万例[2]。我国婴幼儿轮状病毒腹泻主要发生在秋冬季，因此常被称为“秋季腹泻”[3]，接种轮状病毒疫苗是预防婴幼儿轮状病毒腹泻的有效手段之一。目前国内已上市进口口服五价重配轮状病毒减毒活疫苗(RotaTeq，RV5 , 商品名：乐儿德）和国产口服轮状病毒活疫苗(Rotavirus(Live)Vaccine ,Oral，RVVO，商品名：罗特威)，以上两种均属于非免疫规划疫苗，群众自费自愿接种，其中国产口服轮状病毒活疫苗为兰州所研发。该疫苗自2001年上市以来已累计接种数千万剂次，对重症腹泻具有极高的保护率[4]。尽管疫苗在获得使用许可前已在实验室、动物、人群等多个层面进行了广泛的安全性及免疫原性评价，但由于接种后随访时间及参与研究人数的限制，致使研究阶段无法收集到全面的安全性数据，如接种后较长时间报告的不良事件以及罕见不良事件等，因此疫苗在获得许可后进行疑似预防接种异常反应（Adverse Events Following Immunization, AEFI）监测显得更为重要[5]，也是及时发现不良事件、保护人群健康的重要措施[6]。本研究对陕西省2018—2022年适龄儿童接种疫苗后的AEFI进行主动监测的结果进行分析，评价RVVO预防接种的安全性。
1　资料与方法
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1.1　资料来源
从陕西省免疫规划信息管理系统收集获取陕西省2018—2022年RVVO疫苗接种个案信息，包括性别、接种时间、接种剂次等信息；从全国 AEFI 监测信息管理系统收集获取陕西省2018—2022年报告的RVVO疫苗发生AEFI个案信息，包括信息同上。
1.2　AEFI分类和报告发生率计算
根据《全国AEFI监测方案》[7]，AEFI 按照发生原因分为不良反应（包括一般反应和异常反应）、疫苗质量事故、接种事故、偶合症和心因性反应。接种AEFI报告发生率（1/10万剂）=报告AEFI数/RVVO的接种剂次数×10万剂。
1.3　统计分析
采用Excel 2019及R 4.3.3软件对监测数据进行分析。分析指标包括AEFI整体报告发生率，因疫苗接种后不良事件发生率较低，各事件相互独立，服从Possion分布，故使用R包epitools下的pois.exact函数计算一般反应与异常反应报告发生率及其95%置信区间(Confidence interval，CI)，单独接种组与联合接种组AEFI报告例数构成比并通过卡方检验以进行统计学假设检验，年龄、性别、接种剂次等构成特征。
2　结果
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2.1　AEFI分类
2018—2022 年陕西省共接种 RVVO 461 102剂次，报告AEFI 48例，总AEFI报告发生率为10.41/10万剂。48例AEFI中，不良反应46例，占AEFI的95.83%，发生率为9.98/10万剂，偶合症2例，占4.17%，发生率为0.43/10万剂；不良反应中，一般反应43例，占89.58%，发生率为9.33/10万剂，异常反应3例，占6.25%，发生率为0.65/10 万剂；未报告疫苗质量事故、接种事故和心因性反应。见表1。
2.2　性别、年龄分布
共计48例 AEFI中，男女性别比为1.29∶1。29.17%发生在1岁以下，47.92%发生在1~2岁，16.67%发生在2~3岁，6.25%发生在3岁以上。结果见表2。
2.3　接种剂次
按RVVO首针接种年龄分为3月龄前、3~7月龄、8~12月龄、12月龄后进行分析，其中>3~7月龄组占比最少（10.50%），0~3月龄前占比最大（40.48%），>7~12月龄接种占比11.21%，>12月龄后接种占比37.81%。结果见表3。
在报告的AEFI中，首剂接种后报告AEFI 30例（62.5%），报告发生率12.65/10 万剂；第2剂接种后报告15例（31.25%），报告发生率10.64/10万剂；第3剂接种后报告3例(6.25%)，报告发生率3.61/10万剂。结果见表4。
2.4　临床损害分布和发生时间间隔
在一般反应中，34例报告发热症状（7.37/10万剂）、3例报告呕吐腹泻等胃肠症状（0.65/10万剂）。在异常反应中，轮状病毒腹泻、急性腹泻、过敏性皮疹各报告1例（0.22/10万剂）。43例一般反应和3例异常反应均发生在接种当天。结果见表5。
2.5　单独接种、联合接种AEFI发生情况
单独接种RVVO疫苗后，共报告相关AEFI 25例，其中一般反应22例（占比为88.00%，发生率为8.65/10万剂次），异常反应1例（占比为4.00%，发生率为0.39/10万剂次）。与其他疫苗联合接种后，共报告RVVO相关AEFI23例，其中一般反应21例（占比为91.30%，发生率为10.16/10万剂次），异常反应2例（占比为8.70%，发生率为0.97/10万剂次，1例为轮状病毒腹泻、1例为过敏性皮疹）。单独接种组与联合接种组AEFI报告例数构成比差异无统计学意义（χ2=0.357，P= 0.550）。与单独接种组相比，联合接种组一般反应报告发生率及异常反应报告发生率差异均无统计学意义（一般反应分类OR=1.175，95% CI：0.646～2.136；异常反应分类OR=2.461，95% CI：0.223～27.145）。
2.6　转归
在所有48例AEFI中，47例转归为治愈或好转，1例不详，无后遗症或死亡病例报告。
3　讨论
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对陕西省2018—2022年口服轮状病毒减毒活疫苗报告的AEFI数据进行分析，结果显示报告发生率10.41/10万剂，以一般反应为主；报告的一般反应与异常反应均发生在疫苗接种后1日内，症状表现为一过性，且转归结果较好，无不良后遗症，目前尚未报告严重异常反应。
口服轮状病毒减毒活疫苗接种后不良反应报告发生率9.98/10万剂（95% CI: 7.30～13.31/10万剂），低于国内主动及被动监测结果（1,275.24/10万、16.30/10万）[8-9] ，与福建省2022年、重庆市2006至2021年被动监测AEFI发生率（8.14/10万、9.56/10万）相近[10-11]。其中本省不良反应报告发生率远低于国内主动监测报告发生率，可能与主动监测更能及时客观地获得完整的疫苗接种后安全性信息有关，有研究对比了主动监测与被动监测的敏感性及发生率特征，显示主动监测的报告发生率远高于被动监测，主动监测更能发现更多的轻微一般反应，但不良事件报告人群的性别、年龄、疫苗接种剂次构成无显著性差异。同时实施过主动监测的接种门诊在后续的被动监测中，与其他未进行主动监测的报告单位报告率差异无统计学意义，提示主动监测经验尚未能提高被动监测敏感性，考虑主动监测成本，被动监测仍是持续进行安全性观察评估最有成本效益的方法[12-14]。报告AEFI分年龄段分析主要集中在2岁以下儿童，时间均在24h内发生[15]，首剂接种后AEFI发生率最高，与湖北2015至2017年ORV相关研究一致，不同剂次AEFI发生水平存在差异，可能与联合接种、年龄、机体免疫耐受等因素有关[16-18]，因此要重点关注该年龄段首剂次接种后24 h内AEFI发生情况。陕西省2018至2022年RVVO多为单独接种，但本研究中联合接种组一般反应报告发生率与异常反应报告发生率与单独接种组相比差异均无统计学意义，提示联合接种安全性良好，因此为提高疫苗接种及时性和降低接种成本，建议接种单位在儿童家长知情同意基础上积极选择联合接种[19-21]。
RVVO在儿童2月龄即可开始接种，对儿童首针接种年龄进行分析，其中82.50%在8月龄后接种，12月龄之后接种占比63.69%，及时接种率相对较低，分析原因可能是儿童在1岁内需接种的免疫规划和非免疫规划疫苗种类较多，针次安排密集，同时也说明陕西省内家长对于轮状病毒疫苗接种意识还相对较弱[22-25]，后续工作中仍需加强对家长知识宣传，提高接种意识，也期望有更多的联合疫苗研发和使用，减少儿童接种针次，提高疫苗接种及时率[26]。
本研究通过统计分析陕西省 2018—2022年RVVO疫苗接种后AEFI发生情况，结果显示RVVO接种后出现的不良反应主要为发热、局部红肿等一般反应，且转归良好，有较好的安全性，可推广应用于重点人群的轮状病毒免疫预防。
基金
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  • 陕西省创新能力支撑计划项目(2022PT-26)
文献
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2024年第51卷第22期
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doi: 10.20043/j.cnki.MPM.202401500
  • 接收时间：2024-01-31
  • 首发时间：2026-03-20
  • 出版时间：2024-11-25
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  • 收稿日期：2024-01-31
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    陕西省疾病预防控制中心，陕西　西安　710054

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