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基于检测阴性设计评价兰州羔羊株轮状病毒活疫苗对2~35月龄儿童轮状病毒胃肠炎的保护效果

林子安 杨伟康 邱双燕 张钰莹 陈文盛 张丽君 陈宏标 于传宁

林子安, 杨伟康, 邱双燕, 张钰莹, 陈文盛, 张丽君, 陈宏标, 于传宁. 基于检测阴性设计评价兰州羔羊株轮状病毒活疫苗对2~35月龄儿童轮状病毒胃肠炎的保护效果[J]. 中华疾病控制杂志, 2023, 27(9): 1030-1036. doi: 10.16462/j.cnki.zhjbkz.2023.09.008
引用本文: 林子安, 杨伟康, 邱双燕, 张钰莹, 陈文盛, 张丽君, 陈宏标, 于传宁. 基于检测阴性设计评价兰州羔羊株轮状病毒活疫苗对2~35月龄儿童轮状病毒胃肠炎的保护效果[J]. 中华疾病控制杂志, 2023, 27(9): 1030-1036. doi: 10.16462/j.cnki.zhjbkz.2023.09.008
LIN Zian, YANG Weikang, QIU Shuangyan, ZHANG Yuying, CHEN Wensheng, ZHANG Lijun, CHEN Hongbiao, YU Chuanning. Effectiveness of the Lanzhou lamp rotavirus vaccine against rovavirus gastroenteritis among children aged 2-35 months: a test-negative design study[J]. CHINESE JOURNAL OF DISEASE CONTROL & PREVENTION, 2023, 27(9): 1030-1036. doi: 10.16462/j.cnki.zhjbkz.2023.09.008
Citation: LIN Zian, YANG Weikang, QIU Shuangyan, ZHANG Yuying, CHEN Wensheng, ZHANG Lijun, CHEN Hongbiao, YU Chuanning. Effectiveness of the Lanzhou lamp rotavirus vaccine against rovavirus gastroenteritis among children aged 2-35 months: a test-negative design study[J]. CHINESE JOURNAL OF DISEASE CONTROL & PREVENTION, 2023, 27(9): 1030-1036. doi: 10.16462/j.cnki.zhjbkz.2023.09.008

基于检测阴性设计评价兰州羔羊株轮状病毒活疫苗对2~35月龄儿童轮状病毒胃肠炎的保护效果

doi: 10.16462/j.cnki.zhjbkz.2023.09.008
基金项目: 

深圳市龙华区科技创新资金项目 2021042

详细信息
    通讯作者:

    于传宁,E-mail: 10556992@qq.com

    陈宏标,E-mail: gesila2021@163.com

  • 中图分类号: R183.4

Effectiveness of the Lanzhou lamp rotavirus vaccine against rovavirus gastroenteritis among children aged 2-35 months: a test-negative design study

Funds: 

Shenzhen Longhua District Science and Technology Innovation Fund Program 2021042

More Information
  • 摘要:   目的  评价兰州羔羊株轮状病毒(rotavirus,RV)(Lanzhou lamp rotavirus,LLR)疫苗对实验室确诊的儿童轮状病毒胃肠炎(rotacirus gastroenteritis,RVGE)的疫苗保护效果(vaccine effectiveness,VE),为疾病防控政策提供数据支持。  方法  采用检测阴性设计,通过中国疾病预防控制系统和预防接种信息管理系统收集深圳市龙华区2019―2021年RVGE流行季期间所有实验室确诊腹泻病例和LLR疫苗接种史,使用非条件和条件logistic回归分析模型计算并评价疫苗的校正OR值(adjusted odds ratio,aOR)和VE。  结果  共1 052例实验室确诊腹泻的患儿纳入研究,其中RV阳性组(RVGE+)849例和阴性对照组(RVGE-)203例,共326例匹配成功(RVGE+组163例,RVGE-组163例)。非条件和条件logistic回归分析模型中,≥1剂次LLR疫苗的VE分别为50.7% (95% CI: 28.2%~66.2%)和50.4%(95% CI: 11.7%~71.8%)。  结论  LLR疫苗对2~35月龄儿童在RVGE流行季提供中等程度的保护效果, 并提示LLR疫苗在2~11月龄儿童的接种率过低和第1剂接种年龄过晚。建议对于错过五价重配轮状病毒减毒活(pentavalent human-reassortant rotavirus, RV5)疫苗接种时间窗的儿童应鼓励尽早接种LLR疫苗。
  • 图  1  参与者入组流程

    LLR:兰州羔羊株轮状病毒;RV5:五价重配轮状病毒。

    Figure  1.  Participant enrollment flow chart

    LLR: Lanzhou lamp rotavirus; RV5: pentavalent human-reassortant rotavirus.

    表  1  非匹配的RVGE+病例组和RVGE-对照组的基本特征描述

    Table  1.   Descriptive characteristics of unmatched RVGE+ cases group and RVGE- control group

    变量 Variable 病例组[人数(占比/%)]
    Cases [Number of people (proportion/%)]
    对照组[人数(占比/%)]
    Controls[Number of people(proportion/%)]
    χ2
    value
    P
    value
    性别Gender 0.625 0.429
      男Male 497(58.5) 125(61.6)
      女Female 352(41.5) 78(38.4)
    发病年份Onset year 37.114 < 0.001
      2019 472(51.7) 72(35.5)
      2020 158(18.6) 36(17.7)
      2021 314(29.8) 95(46.8)
    发病月份Onset month 140.504 <0.001
      10 81(9.5) 71(35.0)
      11 85(10.0) 50(24.6)
      12 209(24.6) 36(17.7)
      次年1月Next January 265(27.8) 27(13.3)
      次年2月Next February 209(24.6) 19(9.4)
    月龄Age of months 0.324 0.850
      2~ < 12 183(21.6) 44(21.7)
      12~ < 24 480(56.5) 111(54.7)
      24~ < 36 186(21.9) 48(23.6)
    居住区域(街道)Residential area (subdistrict) 6.313 0.097
      A街道 146(17.2) 40(19.7)
      B街道 192(22.6) 42(20.7)
      C街道 280(33.0) 52(25.6)
      D街道 231(27.2) 69(34.0)
    LLR疫苗接种LLR vaccination 19.025 <0.001
      无Unvaccinated 698(82.2) 139(68.5)
      有Vaccinated 151(17.8) 64(31.5)
    接种剂次Vaccination 24.213 <0.001
      0 698(82.2) 139(68.5)
      1 134(15.8) 52(25.6)
      2 17(2.0) 11(5.4)
      3 0(0) 1(0.5)
    合计Total 849(100.0) 203(100.0)
    注:LLR, 兰州羔羊株轮状病毒。
    Note: LLR, Lanzhou lamp rotavirus.
    下载: 导出CSV

    表  2  按照出生日期(±1个月)、就诊日期(±1个月)匹配的RVGE+病例组和RVGE-对照组的基本特征描述

    Table  2.   Descriptive characteristics of RVGE+ cases group and RVGE-control group by matching age (±1 month)and clinic attending/hospital admission date (±1 month)

    变量 Variable 病例组[人数(占比/%)]
    Cases [Nnumber of people (proportion/%)]
    对照组[人数(占比/%)]
    Controls[Nnumber of people(proportion/%)]
    χ2
    value
    P
    value
    性别Gender 0.456 0.499
      男Male 93(57.1) 99(60.7)
      女Female 70(42.9) 64(39.3)
    发病年份Onset year 0.096 0.953
      2019 71(43.6) 71(43.6)
      2020 31(19.0) 33(20.2)
      2021 61(37.4) 59(36.3)
    发病月份Onset month 4.703 0.319
      10 35(21.5) 44(27.0)
      11 37(22.7) 45(27.6)
      12 42(25.8) 28(17.2)
      次年1月Next January 29(17.8) 27(16.6)
      次年2月Next February 20(12.0) 19(11.7)
    月龄Age of months 0.079 0.961
      2~ < 12 37(22.7) 35(21.5)
      12~ < 24 85(52.1) 87(53.4)
      24~ < 36 41(25.2) 41(25.2)
    居住区域Residential area 3.009 0.390
      A 29(17.8) 27(16.6)
      B 35(21.5) 33(20.2)
      C 52(31.9) 42(25.8)
      D 47(28.8) 61(37.4)
    LLR疫苗接种LLR vaccination 3.985 0.046
      无Unvaccinated 127(77.9) 111(68.1)
      有Vaccinated 36(22.1) 52(31.9)
    接种剂次Vaccination 4.998 0.082
      0 127(77.9) 111(68.1)
      1 32(19.6) 42(25.8)
      2 4(2.5) 10(6.1)
      3 0(0) 0(0)
    合计Total 163(100.0) 163(100.0)
    注:LLR, 兰州羔羊株轮状病毒。
    Note: LLR, Lanzhou lamp rotavirus.
    下载: 导出CSV

    表  3  非条件logistic回归分析模型计算LLR疫苗对于2~35月龄儿童RVGE的保护效果

    Table  3.   LLR vaccine effectiveness against RVGE among children age 2~35 month calculated by unconditional logistic regression analysis

    LLR疫苗接种剂次
    Number of doses of LLR vaccine
    病例组[人数(占比/%)]
    Cases [Number of people (proportion/%)]
    对照组[人数(占比/%)]
    Controls[Number of people(proportion/%)]
    aOR值value
    (95% CI)
    VE%(95% CI) P
    value
    接种月龄Vaccination months old
      2~ < 12
        1剂dose 9(4.9) 4(9.1) 0.697 (0.186~2.612) 30.7(-161.2~81.4) 0.593
      12~ < 24
        1剂dose 91(19.0) 37(34.9) 0.422 (0.250~0.711) 57.8(28.1~75.0) 0.001
        2剂dose 1(0.3) 5(6.8) 0.019 (0.002~0.174) 81.0(72.6~99.8) <0.001
        ≥1剂dose 92(19.2) 42(37.8) 0.361 (0.218~0.598) 63.9(40.3~78.2) <0.001
      24~ < 35
        1剂dose 34(20.0) 11(26.8) 0.734 (0.312~1.727) 26.6(-72.2~68.8) 0.479
        2剂dose 16(10.5) 6(16.7) 0.795 (0.268~2.360) 20.5(-136.0~72.2) 0.680
        ≥1剂dose 50(26.9) 18(37.5) 0.746 (0.356~1.563) 23.4(-56.3~64.4) 0.438
      2~ < 35
        ≥1剂dose 151(17.8) 64(31.5) 0.493 (0.338~0.718) 50.7(28.2~66.2) <0.001
    合计Total 849(100.0) 203(100.0)
    注:1. LLR, 兰州羔羊株轮状病毒。2. 3剂次LLR的比例过低,LLR所有剂次用≥1剂来表示;非条件logistic回归分析模型调整的部分混杂因素有:就诊年份、就诊月份。
    Note: 1. LLR, Lanzhou lamp rotavirus.2. The proportion of LLR in 3 doses is too low, and all doses of LLR are represented by ≥1 dose; Some confounding factors adjusted by unconditioned logistic regression analysis model were: year of visit and month of visit.
    下载: 导出CSV

    表  4  条件logistic回归模型评价LLR疫苗对于2~35月龄儿童RVGE的保护效果

    Table  4.   LLR vaccine effectiveness against RVGE among children age 2-35 month by conditional logistic regression model

    LLR疫苗接种剂次
    Number of doses of LLR vaccine
    病例组[人数(占比/%)]
    Cases [Number of people (proportion/%)]
    对照组[人数(占比/%)]
    Controls[Number of people(proportion/%)]
    cOR值value
    (95% CI)
    VE%(95% CI) P
    value
    接种月龄Vaccination months old
      2~ < 12
        1剂dose 4(10.8) 4(11.4) 0.958 (0.157~5.854) 4.2(-485.4~84.3) 0.958
      12~ < 24
        1剂dose 16(18.8) 30(34.5) 0.304(0.131~0.709) 69.6(19.1~86.9) 0.003
        2剂dose 0(0) 5(5.7)
        ≥1剂dose 16(18.8) 35(40.2) 0.259(0.113~0.595) 74.1(40.5~88.7) 0.001
      24~ < 35
        1剂dose 13(31.0) 8(19.5) 1.333(0.463~3.843) -33.3(-284.3~53.7) 0.594
        2剂dose 4(9.5) 5(12.2) 2.000(0.181~22.056) -100.0(-2105.6~81.9) 0.571
        ≥1剂dose 16(39.0) 13(31.7) 1.429(0.544~3.753) -42.9(-265.3~45.6) 0.469
      2~ < 35
        ≥1剂dose 36(22.1) 52(31.9) 0.499(0.282~0.883) 50.1(11.7~71.8) 0.017
    合计Total 163(100.0) 163(100.0)
    注:LLR, 兰州羔羊株轮状病毒。①匹配后的条件logistic回归分析模型计算OR时,OR无需校正。Note: LLR, Lanzhou lamp rotavirus.① When the matched conditional logistic regression analysis model calculates OR, OR does not need to be corrected.
    下载: 导出CSV
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  • 收稿日期:  2022-09-01
  • 修回日期:  2022-12-28
  • 网络出版日期:  2023-10-12
  • 刊出日期:  2023-09-10

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