两种不同成分吸附破伤风疫苗预防接种安全性评价

Safety evaluation of two different components adsorbed tetanus vaccines for preventive Vaccination

目的 评价两种市售不同成分吸附破伤风疫苗(adsorbed tetanus vaccine)预防接种的安全性。方法 2021年4月—10月在晋江市罗山街道社区卫生服务中心动物致伤科招募接种吸附破伤风疫苗的11周岁以上就诊患者741例。患者自主选择接种两种不同成分吸附破伤风疫苗中的一种,A组293例接种吸附破伤风疫苗A(不含硫柳汞),B组448例接种吸附破伤风疫苗B(含硫柳汞)。比较两组预防接种后的不良事件(AEs)情况。结果 A组、B组中分别有29例、22例发生AEs,AEs发生率分别为9.90%(29/293)、4.91%(22/448),两组之间差异有统计学意义(χ^(2)=6.87, P=0.009)。不同年龄人群中,≥61岁人群在A组、B组的AEs发生率分别为6.67%(3/45)、0.00%(0/64),差异具有统计学意义(χ^(2)=12.43, P=0.036)。不同AEs类型中,疼痛在A组、B组的发生率分别为7.85%(23/293)、3.57%(16/448),差异具有统计学意义(χ^(2)=6.50, P=0.011)。在AEs持续时间方面,症状出现时间<24 h的患者在A组、B组AEs发生者中分别占44.83%(13/29)、72.72%(16/22),差异具有统计学意义(χ^(2)=3.98, P=0.046)。结论 不同成分的吸附破伤风疫苗均具有良好的预防接种安全性,但是AEs表现存在差异,A组人群的AEs发生率高于B组,但症状持续时间少于B组。

Objective To evaluate the safety of two commercially different components available adsorbed tetanus vaccines.Methods From April to October 2021,741 patients over 11 years old who were vaccinated with adsorbed tetanus vaccine were recruited from the Animal Traumatology Department of Luoshan Community Health Service Center in Jinjiang City.Patients choose to be vaccinated with one of the two different components adsorbed tetanus vaccines.293 patients in group A are vaccinated with adsorbed tetanus vaccine A(withour sulfur willow pump),and 448 patients in group B are vaccinated with adsorbed tetanus vaccine B(containing sulfur willow pump).The adverse effects(AEs)of the two groups after vaccination were compared.Results In group A and group B,there were 29 and 22 patients with AEs,and the incidence of AEs was 9.90%(29/293)and 4.91%(22/448),respectively.The difference between the two groups was statistically significant(χ^(2)=6.87,P=0.009).Among people of different ages,the incidence of AEs in group A and group B was 6.67%(3/45)and 0 for people≥61 years old,with statistically significant difference(χ^(2)=12.43,P=0.036).Among different types of AEs,the incidence of pain in group A and group B was 7.85%(23/293)and 3.57%(16/448)respectively,with statistically significant difference(χ^(2)=6.50,P=0.011).In terms of the duration of AEs,patients with symptoms less than 24 hours accounted for 44.83%(13/29)and 72.72%(16/22)of AEs in group A and group B,respectively,with a statistically significant difference(χ^(2)=3.98,P=0.046).Conclusion Different components of adsorbed tetanus vaccine have good vaccination safety,but there are differences in AEs performance.The incidence of AEs in group A is higher than that in group B,but the duration of symptoms is shorter than that in group B.