纯化鸡胚细胞人用(冻干)狂犬病疫苗的安全性观察

Safety observation of man-use chick-embryo cell Rabies vaccine

目的观察纯化鸡胚细胞(PCECV)冻干人用狂犬病疫苗接种后局部和全身副反应。方法安全性观察设暴露后观察组300例,暴露后对照组300例,均按照0、3、7、14、28 d的5针免疫程序,分别接种鸡胚细胞冻干人用狂犬病疫苗和vero细胞冻干人用狂犬病疫苗。在每针疫苗接种后72 h内,对其局部和全身的副反应进行观察。结果观察组疫苗接种后,局部反应红肿、硬结、疼痛、瘙痒的发生率分别0.73%、1.33%、6.27%、3.73%,持续时间分别为12～24 h、12～24 h、12～48 h、12～72 h;全身反应发热、皮疹、头疼、乏力等发生率分别为1.00%、0.40%、1.40%、2.60%,均在72 h内自行消失。其差异无统计学意义。结论鸡胚细胞冻干人用狂犬病疫苗的接种反应轻微、持续时间短,其安全性与我国近年广泛使用的vero细胞冻干人用狂犬病疫苗无统计学差异。

Objective To observe the side effect on the whole or part of the body in individuals after inoculating freeze-drying chick-embryo cell rabies vaccine.Methods 300 samples were in the observation group for exposure,another 300 samples were for comparison.Inoculating freeze-drying chick-embryo cell rabies vaccine or Vero freeze-drying cell rabies vaccine were used according to the immunization program,i.e.5 injections on 0,3,7,14,28 d.Side effect of part or whole body within 72 hours after injection was observed.Results After inoculating,in the observation group,the incidence rate of symptom for part area（red and swollen,indurations,pains,pruritus） was 0.72%,1.34%,6.27%,3.73% respectively,the duration of the symptom was 12-24 h,12-24 h,12-48 h,12-72 h respectively;the symptom of the whole body（fever,erythra,headache,tiredness） was 1.00%,0.40%,2.60% respectively.All the above syndromes disappeared within 72 hours.The disparity has no statistic value.Conclusions The inoculation of freeze-drying chick-embryo cell rabies vaccine had mild side-effect,and the duration was rather short.Its safety has little disparity in statistic value as compared with Vero freeze-drying cell rabies vaccine.