两种部位接种13价肺炎球菌多糖结合疫苗的安全性评价

Safety of 13 valent pneumococcal polysaccharide conjugate vaccine inoculated in different sites

目的评价两种不同部位接种13价肺炎球菌多糖结合疫苗(13-valent pneumococcal polysaccharide conjugate vaccine,PCV13)的安全性。方法选取2017年5月~2018年12月北京市朝阳区4家预防接种单位自愿接种PCV13的4 014名婴幼儿为研究对象,按疫苗说明书免疫程序和剂量,经上臂三角肌或股外侧肌接种PCV13,共接种4剂次,并于每次接种后30 min、0 min^7 d、8~28 d观察不良反应发生情况,统计分析不良反应发生率。结果4 014名婴幼儿共接种13 641剂次PCV13,累计不良反应1 590人次,不良反应发生率为11. 656%(1 590/13 641),无严重不良事件。股外侧肌组的不良反应发生率[9. 660%(659/6822)]明显低于上臂三角肌组[13. 653%(931/6819)],且差异有统计学意义(P <0. 05),其中股外侧肌组接种的局部不良反应发生率[2. 917%(199/6 822)]明显低于上臂三角肌组[6. 937%(473/6819)],且差异有统计学意义(P <0. 05),两种部位接种PCV13的全身不良反应发生率差异无统计学意义(P> 0. 05)。两组人群局部不良反应以触痛为主,全身不良反应以皮疹(全身)为主,上臂三角肌组接种PCV13后局部1级、2级、3级不良反应发生率均明显高于股外侧肌组(P <0. 05)。两组人群接种PCV13后30 min^7 d的不良反应发生率明显高于30 min内和8~28 d(P <0. 05)。结论婴幼儿经股外侧肌及上臂三角肌两种不同部位疫苗接种PCV13均具有较好的安全性,其中股外侧肌接种的局部反应发生率更低,安全性更好,应为PCV13首选接种部位。

Objective To evaluate the safety of inoculation with 13 valent pneumococcal polysaccharide conjugate vaccine(PCV13)in different sites.Methods From May 2017 to December 2018,4 014 infants who were voluntarily vaccinated by four vaccination units in Chaoyang District,Beijing,were divided into two groups,and inoculated with PCV13,in anterolateral thigh muscle and upper arm deltoid according to the schedule in the instruction respectively.Adverse reactions were observed 30 min,30 min^7 d and 8~28 d after each vaccination,and the reaction rates in two groups were analyzed statistically.Results A total of 4 014 infants were vaccinated with 13 641 doses of PCV 13,in which 1 590 cases of adverse reactions were observed,indicating an adverse reactoin rate of 11.656%(1 590/13 641).However,no severe adverse reactions appeared.The adverse reaction rate in the infants vaccinated in anterolateral thigh muscle[9.660%(659/6 822)]was significantly lower than that in upper arm deltoid[13.653%(931/6 819)](P<0.05).The local adverse reaction rate in the infants vaccinated in anterolateral thigh muscle[2.917%(199/6 822)]was significantly lower than that in upper arm deltoid[6.937%(473/6 819)](P<0.05).However,no significant difference was observed between the systemic adverse reaction rates in the two groups(P>0.05).The local adverse reactions in the two groups were mainly tenderness,while the systemic reactions were mainly systemic rash.The incidence rates of local adverse reactions of levels 1,2 and 3 in the infants vaccinated in anterolateral thigh muscle were signifiantly higher than those in upper arm deltoid(P<0.05).However,the incidence rates of adverse reactions 30 min^7 d in two groups were significantly higher than those 30 min and 8~28 d after vaccination(P<0.05).Conclusion Both the vaccination with PCV13 in in anterolateral thigh muscle and in upper arm deltoid showed high safety,while the adverse reaction rate after vaccintion in anterolateral thigh muscle was lower than that in upper arm deltoid,suggesting that anterolateral thigh muscle may be used as the preferred site for PCV13 vaccination.