【摘要】 目的 对比分析儿童接种冻干人用狂犬病疫苗(Vero细胞)“2-1-1”4针法与5针法的免疫应答及安全性。方法 选取2023年1月至2025年1月于平顶山市第一人民医院狂犬病疫苗门诊接种狂犬病疫苗的132例儿童纳入研究，所有儿童均接种冻干人用狂犬病疫苗(Vero细胞)，根据接种意愿分为A组(n=67)和B组(n=65),A组采用“2-1-1”4针法，B组采用5针法。比较两组儿童首针接种后不同时间点的抗体阳转率和几何平均浓度水平(GMC)，以及安全性及接种依从性。结果 A组儿童首针接种后第7天、第14天的抗体阳转率分别为70.15%、100.00%，明显高于B组的50.77%、87.69%，差异均有统计学意义(P<0.05)，而首针接种后第21/28天两组儿童的抗体阳转率为100.00%，组间比较差异无统计学意义(P>0.05)；首针接种后第14天，A组儿童的GMC为(18.56±3.52) IU/mL，明显高于B组的(15.49±3.15) IU/mL，而首针接种后第21/28天、第3个月，B组儿童的GMC分别为(47.35±12.74) IU/mL、(31.63±10.19) IU/mL，明显高于A组的(27.89±5.03) IU/mL、(16.72±2.27) IU/mL，差异均有统计学意义(P<0.05)；两组儿童的局部和全身不良反应发生率比较差异均无统计学意义(P>0.05);A组儿童的接种依从率为100.00%，明显高于B组的90.77%，差异有统计学意义(P<0.05)。结论 冻干人用狂犬病疫苗(Vero细胞)“2-1-1”4针法与5针法在儿童群体中均具有良好的免疫效果与安全性，但“2-1-1”4针法早期抗体阳转率及接种依从性更高，5针法全程接种后抗体维持能力更优。更多还原

【Abstract】 Objective To compare and analyze the immunogenicity and safety of the "2-1-1" 4-dose regimen versus the 5-dose regimen of freeze-dried human rabies vaccine(Vero cell) in children. Methods A total of 132 children who received rabies vaccination at the Rabies Vaccine Clinic of Pingdingshan First People’s Hospital from January2023 to January 2025 were enrolled in the study. All children were vaccinated with freeze-dried human rabies vaccine(Vero cell) and were divided into group A(n=67) and group B(n=65) according to their vaccination preference. Group A received the "2-1-1" 4-dose regimen, while group B received the 5-dose regimen. The antibody seroconversion rates and geometric mean concentrations(GMC) at different time points after the first vaccination, as well as safety and vaccination compliance, were compared between the two groups. Results The antibody seroconversion rates on days 7 and14 after the first vaccination in group A were 70.15% and 100.00%, respectively, which were significantly higher than50.77% and 87.69% in group B(P<0.05). On days 21/28 after the first vaccination, the antibody seroconversion rates in both groups were 100.00%, with no statistically significant difference between the groups(P>0.05). On day 14 after the first vaccination, the GMC in group A was(18.56±3.52) IU/m L, which was significantly higher than(15.49±3.15) IU/m L in group B; on days 21/28 and at month 3 after the first vaccination, the GMC in group B were(47.35±12.74) IU/m L and(31.63±10.19) IU/mL, respectively, which were significantly higher than(27.89±5.03) IU/m L and(16.72±2.27) IU/mL in group A; the differences were statistically significant(P<0.05). There were no statistically significant differences in the incidence of local and systemic adverse reactions between the two groups(P>0.05). The vaccination compliance rate in group A was 100.00%, which was significantly higher than 90.77% in group B(P<0.05). Conclusion Both the "2-1-1" 4-dose regimen and the 5-dose regimen of freeze-dried human rabies vaccine(Vero cell) have good immunogenicity and safety in children. However, the "2-1-1" 4-dose regimen achieves higher early antibody seroconversion rates and better vaccination compliance, while the 5-dose regimen demonstrates superior antibody persistence after full vaccination.更多还原