背景:免疫实践咨询委员会(ACIP)和世界卫生组织(WHO)建议使用4剂埃森肌内(IM)方案进行狂犬病暴露后预防(PEP)。但是大样本的临床证据仍然有限。
方法:在全国27个省的409个狂犬病预防诊所检测了11,752例患者的狂犬病病毒中和抗体。将5剂Essen方案第5剂(第28天)注射前或不迟于注射后1小时采集血清的患者纳入A组,观察4剂EssenIM方案的免疫疗效,并在注射第五剂量后14-28天收集患者血清纳入B组,观察5剂量EssenIM方案的免疫疗效。
结果:最后,2,351例符合纳入和排除标准,其中A组2,244例,B组107例,A组抗体滴度高于B组[12.21(4.15,32.10)IU/mlvs.9.41(3.87,27.38)IU/ml](P=0.002)。A组,中位抗体滴度为4.01IU/ml,接种纯化仓鼠肾细胞疫苗(PHKCV)的患者为11.63IU/ml和29.46IU/ml,纯化Vero细胞疫苗(PVRV),和人二倍体细胞狂犬病疫苗(HDCV),分别,具有统计学意义(P<0.001)。
结论:4剂EssenIM方案可提供满意的免疫效果。HDCV诱导的抗体效价高于PHKCV或PVRV。
BACKGROUND: The 4-dose Essen intramuscular (IM) regimen for rabies post-exposure prophylaxis (PEP) has been recommended by Advisory Committee on Immunization Practices (ACIP) and World Health Organization (WHO), but the large-sample clinical evidence is still limited.
METHODS: Rabies virus neutralizing antibodies of 11,752 patients were detected from 409 rabies prevention clinics in 27 provinces in
China. Patients with serum collected before or no later than 1 h after injection on the day of the fifth dose (day 28) of 5-dose Essen regimen were included in Group A to observe the immune efficacy of 4-dose Essen IM regimen, and patients with serum collected 14-28 days after injection of the fifth dose were included in Group B to observe the immune efficacy of 5-dose Essen IM regimen.
RESULTS: Finally, 2351 cases met the inclusion and exclusion criteria, including 2244 cases in Group A and 107 cases in Group B. The antibody titer of Group A was higher than that of Group B [12.21 (4.15, 32.10) IU/ml vs. 9.41 (3.87, 27.38) IU/ml] (P = 0.002). In Group A, the median antibody titers were 4.01IU/ml, 11.63IU/ml and 29.46IU/ml in patients vaccinated with purified hamster kidney cell vaccine (PHKCV), purified Vero cell vaccine (PVRV), and human diploid cell rabies vaccine (HDCV), respectively, with statistical significance (P < 0.001).
CONCLUSIONS: The 4-dose Essen IM regimen could provide satisfactory immune effect, and HDCV induced higher antibody titer than PHKCV or PVRV.