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目的评价国产Sabin株脊髓灰质炎(脊灰)灭活疫苗(Inactivated poliomyelitis vaccine,IPV)接种后的安全性,为中国脊灰疫苗免疫策略的调整提供依据。方法采用主动监测方法于2015年9月-2016年2月收集宁夏回族自治区同心县所有适龄儿童接种国产Sabin株IPV和三价脊灰减毒活疫苗(t OPV)后的不良反应,采取被动监测方法通过中国免疫规划信息管理系统收集2008-2016年宁夏全区国产Sabin株IPV、t OPV及其他免疫规划(EPI)疫苗的不良反应数据,比较分析不良反应发生率。结果主动监测显示接种国产IPV、t OPV后的一般反应发生率分别为2 464.33/10万剂、64.92/10万剂。被动监测显示,接种国产IPV的一般反应、异常反应发生率分别为51.68/10万剂、1.67/10万剂;接种t OPV后的一般反应、异常反应发生率分别为1.73/10万剂、0.22/10万剂。与其他EPI疫苗相比,国产IPV一般反应发生率最高,但其异常反应发生率低于麻疹减毒活疫苗、白喉破伤风联合疫苗、麻腮风联合减毒活疫苗、麻疹风疹联合减毒活疫苗和卡介苗,且无严重异常反应发生。结论接种国产Sabin株IPV安全性良好;主动监测的灵敏性高于被动监测。
Objective To evaluate the safety of inactivated poliomyelitis vaccine in domestic Sabin inoculation, and provide evidence for the adjustment of polio vaccine immunization strategy in China. Methods The active surveillance method was used to collect the adverse reactions of all the eligible children in Tongxin County of Ningxia Hui Autonomous Region from September 2015 to February 2016 after inoculation with domestic Sabin strain IPV and trivalent poliovirus live vaccine (t OPV). Passive surveillance Methods The adverse reaction data of IPV, t OPV and other EPI vaccines of domestic Sabin strains from 2008 to 2016 in Ningxia were collected through the China immunization program information management system. The incidence of adverse reactions was compared and analyzed. The results of active surveillance showed that the incidence of general reactions after inoculation of domestic IPV, t OPV were 2 464.33 / 10 million doses, 64.92 / 10 million doses. Passive surveillance showed that the incidences of general reaction and abnormal reaction were 51.68 / 100 000 and 1.67 / 100 000 respectively after inoculation of domestic IPV. The general reaction after t OPV inoculation was 1.73 / 10 000 and 0.22 / 100,000 doses. Compared with other EPI vaccines, the incidence of domestic IPV general response was the highest, but the incidence of abnormal reaction was lower than that of live attenuated measles vaccine, diphtheria tetanus combined vaccine, live attenuated mumps combined with live vaccine, measles and rubella combined attenuated live Vaccines and BCG, and no serious abnormal reaction. Conclusion Inoculation of domestic Sabin strain IPV was safe and safe. The sensitivity of active surveillance was higher than that of passive surveillance.