选择不同对照疫苗对疑似预防接种异常反应信号检测的影响

Impact of comparator selection on signal detection in adverse events following immunization in China

目的探索不同类型疫苗做对照时的信号检出情况,为疑似预防接种异常反应(AEFI)信号检测中选择适宜对照疫苗提供参考。方法分别选择所有其他疫苗和同技术路线其他疫苗做对照,对所有疫苗和特定疫苗进行信号检测,汇总所有其他疫苗和同技术路线其他疫苗做对照时信号检出数量,相同信号、新出现信号和消失信号个数及其反应分类分布,检测灵敏度和特异度。结果与所有其他疫苗做对照时相比,同技术路线其他疫苗做对照时,各种类疫苗信号检出个数均明显减少,全部信号检出数从501个减少至254个;新出现信号35个,新出现信号比例最大的是多糖疫苗,为24.39%(10/41),反应分类为一般反应(10个)、异常反应(3个)、偶合症(2个);消失信号282个,消失信号比例最大的是重组蛋白疫苗,为94.92%(56/59),消失信号的反应分类为偶合症(53个)、异常反应(23个)、一般反应(13个)。同技术路线其他疫苗做对照时,检测一般反应和异常反应的灵敏度降低,特异度增加,但减毒活疫苗和多糖疫苗中检测一般反应的灵敏度增加。结论不同类型疫苗做对照时,检出信号数差异较大;同技术路线其他疫苗做对照时,可以增加一般反应中信号的检出数量,但可能会造成较多异常反应信号消失。建议对于较严重的异常反应进行检测时,使用所有其他疫苗做对照。

Objective To investigate the impact of comparator selection on results of signal detection in order to contribute to signal detection in adverse events following immunization(AEFI)in China.Methods All the vaccines and specified vaccines selected were subject to signal detection using two control groups separately,one of which was composed of other types of vaccines,and the other consisted of vaccines of the same type.The number of signals detected using either control group was recorded.Numbers of the same signals,those of new signals and those of missed signals compared with the two control groups were calculated.Results The number of signals detected using all other vaccines on the same technical platform as control(n=501)was reduced compared with the control that used other different vaccines(n=254).Using other different vaccines of the same type as control,the percentage of new signals related to polysaccharide vaccines was the highest[24.39%(10/41)].The AEFI category of new signals included common reactions(n=10),rare reactions(n=3)and coincidental events(n=2).Using other vaccines on the same technical platform as control,recombinant protein vaccines manifested the highest percentage of missed signals[94.92%(56/59)].The AEFI category of missed signals included coincidental events(n=53),rare reactions(n=23)and common reactions(n=13).Using other vaccines on the same technical platform as control,the overall sensitivity decreased during detection of both common reactions and rare ones,but increased when it came to common reactions in live attenuated vaccines and polysaccharide vaccines.Overall specificity increased.Conclusion Significant variations are found in signal detection using all other vaccines as control and using all other vaccines of the same type as control respectively.Compared with signal detection using all other vaccines as control,the ability to detect common reactions is increased using all other vaccines of the same type as control.However,signals of rare reactions may be missed.The use of all other vaccines as control is recommended in order to detect rare reactions.