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  

Adverse reactions following co-administration of oral live attenuated rotavirus vaccine with selected immunization program vaccines among 2-35-month-old children in Hubei:a real-world study

作　　者：杨帆 孙芯蕊 王四全[2] 王雷[2] 王齐[1] 魏晟[1] Yang Fan;Sun Xinrui;Wang Siquan;Wang Lei;Wang Qi;Wei Sheng(Department of Epidemiology and Biostatistics,School of Public Health,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,Hubei,China;Hubei Provincial Center for Disease Control and Prevention,Wuhan 430079,Hubei,China)

机构地区：[1]华中科技大学同济医学院公共卫生学院流行病与卫生统计学系,湖北武汉430030 [2]湖北省疾病预防控制中心,湖北武汉430079

出　　处：《中国疫苗和免疫》2023年第5期569-577,共9页Chinese Journal of Vaccines and Immunization

摘　　要：目的评价国产口服轮状病毒减毒活疫苗(ORV)与部分免疫规划疫苗联合接种的不良反应。方法通过湖北省免疫规划信息管理系统和中国疾病预防控制信息系统收集2018-2021年2-35月龄儿童ORV与A群脑膜炎球菌多糖疫苗(MPV-A)、无细胞百白破联合疫苗(DTaP)和乙型脑炎减毒活疫苗(JE-L)联合接种和单独接种的接种剂次数和不良反应个案,分析报告发生率;采用泊松回归模型计算联合接种与单独接种报告发生率的调整后率比(Adjusted rates ratio,aRR)。结果ORV与MPV-A、DTaP、JE-L联合接种一般反应报告发生率(/10万剂)(95%CI)分别为75.71(48.84-117.34)、59.85(33.99-105.39)、27.58(15.28-49.81),异常反应分别为0.00、4.99(0.70-35.41)、2.51(0.35-17.80)。各联合接种与ORV单独接种相比的一般反应报告发生率aRR(95%CI)分别为5.52(3.45-8.83)、5.93(3.29-10.68)、2.06(1.11-3.80),与相应MPV-A、DTaP、JE-L单独接种相比分别为2.07(1.33-3.23)、0.92(0.52-1.63)、0.65(0.36-1.18)。各联合接种与ORV单独接种相比的异常反应报告发生率aRR(95%CI)分别为0.00、7.47(0.94-59.07)、2.91(0.37-23.00),与相应MPV-A、DTaP、JE-L单独接种相比分别为0.00、6.48(0.90-46.90)、1.36(0.19-9.80)。结论2-35月龄ORV与MPV-A、DTaP、JE-L联合接种的不良反应报告发生率在预期范围内;ORV与MPV-A联合接种的一般反应发生率可能高于单独接种。Objective To assess adverse reactions following co-administration of oral live attenuated rotavirus vaccine(ORV)with selected immunization program vaccines.Methods We obtained data on vaccination and adverse reactions for ORV;group A meningococcal polysaccharide vaccine(MPV-A);diphtheria,tetanus and acellular pertussis combined vaccine(DTaP);Japanese encephalitis attenuated live vaccine(JE-L);and ORV co-administered with MPV-A,DTaP,or JE-L among children aged 2 months to 3 years during 2018-2021 from the Hubei Immunization Program Information Management System and the China Disease Prevention and Control Information System.We analyzed incidence rates of reported adverse reactions and calculated adjusted rates ratios(aRR)of co-administration groups compared with standalone vaccine administration groups using Poisson regression models.Results Reporting incidence rates(95%CI)for common adverse reactions for ORV co-administered with MPV-A,DTaP,and JE-L were 75.71(48.84-117.34),59.85(33.99-105.39),and 27.58(15.28-49.81)per 100000 doses,respectively,and for rare adverse reactions were 0.00,4.99(0.70-35.41),and 2.51(0.35-17.80).The aRRs(95%CI)of common adverse reactions for the three co-administration groups were 5.52(3.45-8.83),5.93(3.29-10.68),and 2.06(1.11-3.80)compared with ORV-alone group;and were 2.07(1.33-3.23),0.92(0.52-1.63),and 0.65(0.36-1.18)compared with corresponding MPV-A,DTaP,and JE-L-alone groups.The aRRs(95%CI)of rare adverse reactions for the three co-administration groups were 0.00,7.47(0.94-59.07),and 2.91(0.37-23.00)compared with ORV-alone group;and were 0.00,6.48(0.90-46.90),and 1.36(0.19-9.80)compared with corresponding MPV-A,DTaP,and JE-L-alone groups.Conclusions The reporting rate of adverse reactions was acceptable among 2-35-month-old children when ORV was co-administered with any of MPV-A,DTaP,or JE-L.Incidences of common adverse reactions for co-administration of ORV with MPV-A may be higher than for standalone administration.

关 键 词：口服轮状病毒减毒活疫苗 联合接种 不良反应 真实世界研究 

分 类 号：R186[医药卫生—流行病学]