| 黄卓英,孙晓冬,刘捷宸,李智,任佳,吴琳琳,胡家瑜,张军楠.不同毒株脊髓灰质炎灭活疫苗开展序贯免疫程序接种的安全性观察[J].Chinese journal of Epidemiology,2019,40(5):565-570 |
| 不同毒株脊髓灰质炎灭活疫苗开展序贯免疫程序接种的安全性观察 |
| Observation on safety of sequential vaccination schedule of different strain inactivated poliovirus vaccines |
| Received:November 06, 2018 |
| DOI：10.3760/cma.j.issn.0254-6450.2019.05.014 |
| KeyWord: 脊髓灰质炎灭活疫苗 安全性 序贯程序 |
| English Key Word: Inactivated poliovirus vaccine Safety Sequential schedule |
| FundProject:上海市第四轮公共卫生三年行动计划（15GWZK0101，GWIV-1）；中华预防医学会疫苗与免疫青年人才托举项目（Q2017A3124） |
| Author Name | Affiliation | E-mail | | Huang Zhuoying | Department of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336, China | | | Sun Xiaodong | Department of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336, China | sunxiaodong@scdc.sh.cn | | Liu Jiechen | Department of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336, China | | | Li Zhi | Department of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336, China | | | Ren Jia | Department of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336, China | | | Wu Linlin | Department of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336, China | | | Hu Jiayu | Department of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336, China | | | Zhang Junnan | Department of Biological Product, Chaoyang District Center for Disease Control and Prevention, Beijing 100021, China | |
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| Abstract: |
| 目的 评价使用不同毒株脊髓灰质炎灭活疫苗（IPV）开展序贯免疫程序在大规模人群中使用的安全性。方法 于2017年3月至2018年5月，采用随机、平行对照设计，以Sabin株脊髓灰质炎灭活疫苗（sIPV）、野毒株脊髓灰质炎灭活疫苗（wIPV）和Ⅰ+Ⅲ型脊髓灰质炎减毒活疫苗（bOPV）作为研究疫苗，在上海市选择1 917例2月龄婴儿为研究对象，分为4组：①sIPV+sIPV+bOPV；②sIPV+wIPV+bOPV；③wIPV+sIPV+bOPV；④wIPV+wIPV+bOPV，采用主动观察的方法观察其在2、3、4月龄接种后的不良反应。结果 4组完成3剂基础免疫接种后总的不良事件发生率为16.79%（946/5 633），各组均未报告严重不良事件，全身和局部反应均以轻度反应为主。常见局部反应为注射部位疼痛、红和硬结等；全身反应为异常哭闹、嗜睡、腹泻和食欲下降等。接种后30 d内，局部反应率为1.65%（93/5 633），其中轻度、中度和重度反应率分别为1.26%（71/5 633）、0.21%（12/5 633）和0.20%（11/5 633）；全身反应率为15.14%（853/5 633），其中轻度、中度和重度反应率分别为11.33%（638/5 633）、3.18%（179/5 633）和0.64%（36/5 633）。各组间重度反应率差异无统计学意义（χ2=4.17，P=0.24）。结论 本研究中未观察到使用不同毒株脊髓灰质炎灭活疫苗开展序贯免疫程序接种相关的严重不良事件，多数为轻度的不良反应，所有反应均痊愈。同时或交替使用sIPV和wIPV开展序贯免疫程序对于适龄儿童均具有良好的预防接种安全性。 |
| English Abstract: |
| Objective To evaluate the safety of population based sequential vaccination schedule of inactivated poliovirus vaccines prepared with different strains. Methods This randomized, parallel-group controlled trial was conducted from March, 2017 to May, 2018, in Shanghai. Adverse reaction data of Sabin strain inactivated polio vaccine (sIPV), wild strains inactivated polio vaccines (wIPV) and bivalent types Ⅰ and Ⅲ oral poliomyelitis vaccine (bOPV) were systematically collected through active observation in 1 917 infants in Shanghai after the vaccination at 2, 3, 4 months old. The eligible infants aged 2 months were divided into 4 groups:①sIPV+sIPV+bOPV group; ②sIPV+wIPV+bOPV group; ③wIPV+sIPV+bOPV group; ④wIPV+wIPV+bOPV group. Results The incidence of adverse reaction 30 days later after 3 basic dose vaccinations was 16.79% (946/5 633). No serious adverse reaction was reported. Local and systemic reactions were mainly mild. Common local reactions were pain, erythema, cutaneous nodule, etc.; and common systemic reactions were abnormal crying, drowsiness, diarrhea and appetite lost, etc.. The incidence of local reactions 30 days later after 3 basic dose vaccinations was 1.65% (93/5 633), and the incidence rates of grade 1-3 reactions were 1.26% (71/5 633), 0.21% (12/5 633) and 0.20% (11/5 633) respectively. The incidence rate of systemic reactions 30 days later after 3 basic vaccinations was 15.14% (853/5 633), and the incidence rates of grade 1-3 reactions were 11.33% (638/5 633), 3.18% (179/5 633) and 0.64% (36/5 633) respectively. There were no significant differences in the rate of grade 3 reaction among different groups (χ2=4.17, P=0.24). Conclusions No severe adverse reactions related to sequential vaccination of different strain inactivated polio vaccines were observed, most of reactions were mild and all of them were cured. It is safe to use sIPV and wIPV simultaneously or alternately for childhood sequential vaccination. |
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