国产乙脑灭活疫苗安全性主动监测结果分析

来源 :浙江预防医学 | 被引量 : 0次 | 上传用户:oursoftware
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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(P<0.01),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(P<0.01);接种后72 h发热率与48 h相比显著减少(P<0.01)。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(P<0.01);但与其接种后24 h的结果相比,发热率显著下降(P<0.01);接种后72 h发热率与48 h相比也显著减少(P<0.01)。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。 Objective To evaluate the safety of JE inactivated vaccine after routine application. Methods The active monitoring method was used to divide the vaccinated children into observation group I and group II of inactivated vaccine of JE, measles and rubella combined live attenuated vaccine (leprosy vaccine) group, hepatitis B vaccine third dose group and B Brain inactivated vaccine and leprosy vaccine were given to five groups. Each group of children were followed up actively at 24, 48 and 72 hours after inoculation, and relevant information on vaccine safety such as suspected immunization adverse reaction (AEFI) was collected. Results A total of 3 289 subjects with AEFI were vaccinated at the doses of 24, 48 and 72 h, respectively. There were 101 (3.07%), 47 (1.43%) and 31 (0.94%) AEFI patients, respectively, without any serious abnormal reaction. The number of fever in 24 hours after inoculation of the first dose of JE inactivated vaccine was higher than that of other groups (P <0.01), and the average body temperature of the fever was higher than that of the second dose of JE inactivated vaccine (P = 0.04) . The fever rate of JE inactivated vaccine 48 h after the first dose and the second dose 48 h after inoculation were significantly decreased (P <0.01). The fever rate 72 h after inoculation was significantly decreased compared with that of 48 h (P <0.01). At the same time, the incidence of fever at 48 hours after inoculation of JE inactivated vaccine and leprosy vaccine was higher than other groups (P <0.01), but the fever rate was significantly lower than that at 24 hours after inoculation (P <0.01) The fever rate at 72 h was also significantly lower than that at 48 h (P <0.01). Conclusions No serious abnormal reaction occurred after inoculation of JE inactivated vaccine, and all the vaccination reactions were transient. Whether the incidence of AEFI was higher than that of single vaccination needs further study.
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