国产乙脑灭活疫苗安全性主动监测结果分析

发布时间：2019-02-25 12:27

【摘要】：目的评价乙脑灭活疫苗常规应用后的安全性。方法采用主动监测法,将纳入观察的接种儿童分为乙脑灭活疫苗第一剂组和第二剂组,麻疹风疹联合减毒活疫苗(麻风疫苗)组,乙肝疫苗第三剂组以及乙脑灭活疫苗和麻风疫苗联合接种组5个组,分别在接种后24、48及72 h对各组儿童进行一次主动随访,并收集疑似预防接种不良反应(AEFI)等疫苗安全性相关信息。结果 3 289名观察对象接种相应疫苗24、48和72 h后出现AEFI者分别为101人(3.07%)、47人(1.43%)和31人(0.94%),均无严重异常反应发生。乙脑灭活疫苗接种第一剂组接种后24 h内出现发热人数高于其他各组(P0.01),且发热者平均体温比乙脑灭活疫苗第二剂组高(P=0.04)。乙脑灭活疫苗第一剂和第二剂接种后48 h的发热率较24 h均显著下降(P0.01);接种后72 h发热率与48 h相比显著减少(P0.01)。同时,乙脑灭活疫苗和麻风疫苗联合接种后48 h发热人数高于其他组(P0.01);但与其接种后24 h的结果相比,发热率显著下降(P0.01);接种后72 h发热率与48 h相比也显著减少(P0.01)。结论乙脑灭活疫苗接种后无严重异常反应发生,且所有接种反应均为一过性;联合接种的AEFI发生率是否高于单苗接种尚需进一步研究。
[Abstract]:Objective to evaluate the safety of inactivated Japanese encephalitis vaccine after routine application. Methods the children were divided into the first dose group and the second dose group, and the measles rubella combined live attenuated vaccine group (leprosy vaccine) group. The third dose of hepatitis B vaccine group and the combined inoculation group of Japanese encephalitis vaccine and leprosy vaccine were followed up for each group at 24: 48 and 72 hours after inoculation respectively. The information about the safety of (AEFI) vaccine was collected. Results the incidence of AEFI in 3 289 subjects was 101 (3.07%), 47 (1.43%) and 31 (0.94%), respectively. There was no serious abnormal reaction. The number of fever in the first dose group was higher than that in the other groups (P0.01), and the average body temperature of the fever group was higher than that of the second dose group (P0. 04). The fever rate of the first and second doses of inactivated Japanese encephalitis vaccine at 48 h was significantly lower than that of 24 h (P0.01), and the fever rate at 72 h after inoculation was significantly lower than that at 48 h (P0.01). At the same time, the number of fever at 48 h after inoculation of inactivated encephalitis B vaccine and leprosy vaccine was higher than that of other groups (P0.01), but the febrile rate decreased significantly compared with the results at 24 h after inoculation (P0.01). The fever rate at 72 h after inoculation was significantly lower than that at 48 h (P0.01). Conclusion there is no serious abnormal reaction after inoculation of Japanese encephalitis B inactivated vaccine and all inoculation reactions are transient. Whether the incidence of AEFI in combination inoculation is higher than that in single vaccine should be further studied.
【作者单位】：杭州市疾病预防控制中心;浙江省疾病预防控制中心;
【分类号】：R186

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