CAJ | 학술논문

目的观察国产冻干无佐剂Vero细胞狂犬病疫苗小剂量皮内注射的接种反应及其免疫原性.方法对256名Ⅱ级狂犬病暴露受试者进行暴露后免疫,按照随机、单盲的原则分成皮内注射组:皮内注射法组128人,按照0,3,7,28,90d作2点、2点、2点、1点、1点皮内注射,每个部位0.1ml;肌肉注射组:肌肉注射法组128人,按照0,3,7,14和28d接受全量(0.5ml)三角肌注射.使用国产冻干无佐剂Vero细胞狂犬病疫苗(PVRV).观察皮内及肌肉注射疫苗后的局部和全身反应情况.采用夹心间接ELISA法检测抗体水平.结果暴露后皮内注射组局部红肿、硬结、疼痛、瘙痒,发生率分别为1.27%、0.29%、0.49%、11.43%,肌肉注射组分别为1.09%、0.16%、2.81%、1.41%.暴露后皮内注射组发热、皮疹、头痛、疲劳乏力等全身反应,发生率分别为0.31%、0.16%、0.31%、1.09%,肌肉注射组分别为0.31%、0.31%、0.63%、1.09%.所有副反应常发生在第1、第2次注射之后.暴露后免疫皮内注射、肌肉注射狂犬病疫苗后14d抗体阳转率分别是94.53%、95.31%,免疫后42d抗体阳转率分别是96.83%、97.64%.暴露后皮内、肌肉注射法,狂犬病疫苗抗体阳转率差异无统计学意义.结论国产冻干Vero细胞狂犬病疫苗,接种反应轻微,免疫原性良好.
목적 관찰국산동간무좌제Vero세포광견병역묘소제량피내주사적접충반응급기면역원성.방법 대256명Ⅱ급광견병폭로수시자진행폭로후면역,안조수궤、단맹적원칙분성피내주사조:피내주사법조128인,안조0,3,7,28,90d작2점、2점、2점、1점、1점피내주사,매개부위0.1ml;기육주사조:기육주사법조128인,안조0,3,7,14화28d접수전량(0.5ml)삼각기주사.사용국산동간무좌제Vero세포광견병역묘(PVRV).관찰피내급기육주사역묘후적국부화전신반응정황.채용협심간접ELISA법검측항체수평.결과 폭로후피내주사조국부홍종、경결、동통、소양,발생솔분별위1.27%、0.29%、0.49%、11.43%,기육주사조분별위1.09%、0.16%、2.81%、1.41%.폭로후피내주사조발열、피진、두통、피로핍력등전신반응,발생솔분별위0.31%、0.16%、0.31%、1.09%,기육주사조분별위0.31%、0.31%、0.63%、1.09%.소유부반응상발생재제1、제2차주사지후.폭로후면역피내주사、기육주사광견병역묘후14d항체양전솔분별시94.53%、95.31%,면역후42d항체양전솔분별시96.83%、97.64%.폭로후피내、기육주사법,광견병역묘항체양전솔차이무통계학의의.결론 국산동간Vero세포광견병역묘,접충반응경미,면역원성량호.
Objective To observe the vaccination reactions and immunogenicity of the application of lyophilized Vero cell rabies vaccine without adjuvant in a way of low-dose intradermal injection for post-exposure group. Methods Conducting post-exposure immunization for 256 persons with the class Ⅱ level exposure to rabies. Based on a randomized, single-blind principle, all subjects were divided into intradermal injection (ID) group (n= 128),injected 0.1 ml for each site in accordance with 0,3,7,28,90 d,2 sites,2 sites,2sites,1 site,1 site respectively, and intramuscular injection(IM) group(n= 128) in accordance with 0,3,7,14,28 d in full-volume (0.5ml) PVRV Deltoid injection. The local and systemic vaccination reactions were observed for the different injection ways. The indirect sandwich ELISA assay was used to analyze the antibody levels. Results For the intradermal injection group, the incidence rates for local redness and swelling, induration, pain, itch were 1.27%, 0.29% ,0.49% ,11.43% respectively,for the intramuscular group, the incidence rates were 1.09% ,0. 16% ,2. 81% ,1.41% respectively. From the point of systemic reactions,the incidence rates of fever,rash,headache,fatigue and weakness were 0.31 % ,0. 16% ,0. 31 % , 1.09% respectively in the intradermal injection group,and the rates were 0.31% ,0.31% ,0.63% , 1.09% respectively in intramuscular group. All the adverse effects often occurred following the 1st,2nd injection. The seroconversion rates for intradermal injection and intramuscular were 94.53% ,95.31% following 14 d immunization respectively,the rates were 96. 83% ,97.64% following 42 d immunization respectively. For the post-exposure group,no statistical difference in significance was found between the two seroconversion rates. Conclusion For the application of domestic lyophilized Vero cell rabies vaccine,its adverse reactions are mild,and immunogenicity is good.