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人用或马用狂犬病免疫球蛋白对2-1-1程序暴露后狂犬病疫苗免疫原性的抑制作用:印度尼西亚的一项现场试验。MAS054临床研究小组

Suppressant effect of human or equine rabies immunoglobulins on the immunogenicity of post-exposure rabies vaccination under the 2-1-1 regimen: a field trial in Indonesia. MAS054 Clinical Investigator Group.

作者信息

Lang J, Simanjuntak G H, Soerjosembodo S, Koesharyono C

机构信息

Vector-borne Diseases, R & D Medical Department, Pasteur Mérieux Connaught, Lyon, France.

出版信息

Bull World Health Organ. 1998;76(5):491-5.

Abstract

WHO's reference protocol for post-exposure rabies vaccination advises five intramuscular injections on days 0, 3, 7, 14, and 30; in addition, rabies immunoglobulins (RIG) must be given to serious cases of exposure (grade III severity). Some studies indicate that these immunoglobulins suppress the immunogenicity of rabies vaccine when administered according to an alternative protocol of four injections (2-1-1) on days 0, 7, and 21, which was therefore not recommended for grade III exposures. To test this effect, we conducted a multicentre study in Indonesia using three groups of subjects. One group received only the Vero-cell rabies vaccine (PVRV, Verorab, usual commercial lot) according to the 2-1-1 schedule. The second and third groups received the same schedule of PVRV, plus either equine rabies immunoglobulins (ERIG, 40 IU/kg body weight) or human rabies immunoglobulins (HRIG, 20 IU/kg body weight). Our results confirmed the immunoglobulin suppressant effect, which was more pronounced with human than equine immunoglobulins. In both groups receiving immunoglobulins, the seroconversion rates did not reach 100% on day 28 and the geometric mean antibody titre was lower. Thus, WHO's recommendation in 1992 of the reference protocol plus immunoglobulins for severe cases is substantiated by these results in Indonesian subjects. If the 2-1-1 regimen is chosen by the treating physician and immunoglobulins are indicated, preference should be given to purified equine RIG, which also costs less than human RIG.

摘要

世界卫生组织(WHO)的暴露后狂犬病疫苗接种参考方案建议在第0、3、7、14和30天进行五次肌肉注射;此外,对于严重暴露病例(III级严重程度)必须给予狂犬病免疫球蛋白(RIG)。一些研究表明,按照第0、7和21天进行四次注射(2-1-1)的替代方案给予这些免疫球蛋白时,会抑制狂犬病疫苗的免疫原性,因此不建议用于III级暴露。为了测试这种效果,我们在印度尼西亚进行了一项多中心研究,使用了三组受试者。一组仅按照2-1-1方案接种Vero细胞狂犬病疫苗(PVRV,Verorab,普通商业批次)。第二组和第三组接受相同的PVRV接种方案,再加上马狂犬病免疫球蛋白(ERIG,40国际单位/千克体重)或人狂犬病免疫球蛋白(HRIG,20国际单位/千克体重)。我们的结果证实了免疫球蛋白的抑制作用,人免疫球蛋白比马免疫球蛋白的这种作用更明显。在接受免疫球蛋白的两组中,第28天时血清转化率均未达到100%,几何平均抗体滴度较低。因此,WHO 1992年关于严重病例采用参考方案加免疫球蛋白的建议在印度尼西亚受试者的这些结果中得到了证实。如果治疗医生选择2-1-1方案且需要使用免疫球蛋白,应优先选择纯化马源RIG,其成本也低于人源RIG。

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