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目的观察不同甲型肝炎疫苗的安全性。方法采取整群随机抽样方法,将362名4～10岁儿童分成3组作为试验组,分别接种国产冻干甲肝减毒活疫苗、国产甲肝灭活疫苗、进口甲肝灭活疫苗。另抽取120名儿童接种乙肝疫苗为对照组,对被接种儿童进行接种后30 m in内及3 d内反应观察,并由接种人员对异常反应进行核实。结果接种后30 m in内试验组和对照组均未出现疑似异常反应。接种后3 d内试验组和对照组学生均未出现发热、皮疹及其他全身异常反应。试验组发生1例局部硬结(0.28%),6例红肿(1.66%),7例局部发痒(1.93%),17例局部疼痛(4.70%);而对照组无局部硬结,1例局部红肿(0.88%),2例局部发痒(1.75%),4例局部疼痛(3.51%)。3种不同甲肝疫苗间疑似异常反应比较差异无统计学意义(均P>0.05);试验组与对照组间疑似异常反应差异亦无统计学意义(P>0.05)。结论不同甲型肝炎疫苗的安全性均良好。
Objective To observe the safety of different hepatitis A vaccine. Methods A total of 362 children aged 4 to 10 years were divided into three groups as experimental groups. The patients were vaccinated with live attenuated live attenuated hepatitis A virus vaccine, domestic hepatitis A inactivated vaccine, and imported hepatitis A inactivated vaccine respectively. Another 120 children were vaccinated with hepatitis B vaccine as the control group. The vaccinated children were vaccinated within 30 min and within 3 days after vaccination, and the abnormalities were verified by vaccinates. Results No abnormal reaction occurred in the test group and the control group within 30 minutes after inoculation. Within 3 days after inoculation, there was no fever, rash and other systemic abnormalities in the test group and the control group. There were 1 case of local induration (0.28%), 6 cases of inflamed (1.66%), 7 cases of itching (1.93%) and 17 cases of local pain (4.70%) in the experimental group, while the control group had no local induration and 1 case of local inflamed (0.88%), 2 cases of itching (1.75%) and 4 cases of local pain (3.51%). There was no significant difference in the suspected abnormal response between the three kinds of hepatitis A vaccine (all P> 0.05). There was no significant difference in the suspected abnormal reaction between the experimental group and the control group (P> 0.05). Conclusion The safety of different hepatitis A vaccines is good.