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

doi:10.19803/j.1672-8629.20240076

摘要/Abstract

摘要： 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。

关键词: 疑似预防接种异常反应, 疫苗安全, 信号检测, 对照, 灵敏度, 特异, 技术路线

Abstract: 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.

Key words: adverse events following immunization (AEFI), vaccine safety, signal detection, control, sensitivity, specificity, technical platform

中图分类号:

R979.5

夏兰芳, 李克莉, 王磊, 李燕, 王华庆. 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[J]. 中国药物警戒, 2024, 21(7): 798-804.

XIA Lanfang, LI Keli, WANG Lei, LI Yan, WANG Huaqing. Impact of comparator selection on signal detection in adverse events following immunization in China[J]. Chinese Journal of Pharmacovigilance, 2024, 21(7): 798-804.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.20240076

https://zgywjj.magtechjournal.com/CN/Y2024/V21/I7/798

参考文献

[1] ISKANDER JK, MILLER ER, CHEN RT.The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety[J]. Pediatr Ann, 2004, 33(9): 599-606.
[2] WHO. Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII[EB/OL].[2023-03-18]. https://cioms.ch/wp-content/uploads/2018/03/WG8-Signal-Detection.pdf.
[3] BRAZETE C, AGUIAR A, FURTADO I, et al.Thrombotic events and COVID-19 vaccines[J]. Int J Tuberc Lung Dis, 2021, 25(9): 701-707.
[4] CIOMS. Definition and Application of Terms for Vaccine Pharmacovigilance[EB/OL]. (2012-01-24)[2023-03-18]. https://www.who.int/publications/m/item/9789290360834.
[5] KIM M, KIM S, SHIN JY.Post-approval safety monitoring of quadrivalent and bivalent human papillomavirus vaccines based on real-world data from the Korea Adverse Events Reporting System (KAERS)[J]. Clin Drug Investig, 2020, 40(8): 727-735.
[6] YE XF, CHENG G, GUO XJ, et al.Masking effect in the process of signal detection of adverse drug reaction[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2013, 10(1): 33-35.
[7] MAIGNEN F, HAUBEN M, HUNG E, et al.Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases[J]. Pharmacoepidemiol Drug Saf, 2014, 23(2): 195-207.
[8] PARIENTE A, DIDAILLER M, AVILLACH P, et al.A potential competition bias in the detection of safety signals from spontaneous reporting databases[J]. Pharmacoepidemiol Drug Saf, 2010, 19(11): 1166-1171.
[9] HARPAZ R, DUMOUCHEL W, VAN MANEN R, et al.Signaling COVID-19 vaccine adverse events[J]. Drug Saf, 2022, 45(7): 765-780.
[10] LEE H, KIM JH, CHOE YJ, et al.Safety surveillance of pneumococcal vaccine using three algorithms: disproportionality methods, empirical bayes geometric mean, and tree-based scan statistic[J]. Vaccines (Basel), 2020, 8(2): 242.
[11] KAMATH A, MAITY N, NAYAK MA.Facial paralysis following influenza vaccination: a disproportionality analysis using the vaccine adverse event reporting system database[J]. Clin Drug Investig, 2020, 40(9): 883-889.
[12] LEROY Z, BRODER K, MENSCHIK D, et al.Febrile seizures after 2010-2011 influenza vaccine in young children, United States: a vaccine safety signal from the vaccine adverse event reporting system[J]. Vaccine, 2012, 30(11): 2020-2023.
[13] LIU YT, ZHANG LT, LIN YZ, et al.Mining and research of adverse reaction signals of pneumonia vaccines based on US Vaccine Adverse Event Reporting System[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2023, 20(1): 96-100, 116.
[14] YANG QY, SU J, ZHANG X, et al.Adverse events associated with the three US licensed COVID-19 vaccines based on VAERS database[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2023, 20(10): 1141-1147.
[15] RAMDANI Y, LARGEAU B, JONVILLE-BERA AP, et al.COVID-19 vaccination as a trigger of IgA vasculitis: a global pharmacovigilance study[J]. J Rheumatol, 2023, 50(4): 564-567.
[16] ELAS M, VILLATORO N, PEZZOLI L.Disproportionality analysis of reported drug adverse events to assess a potential safety signal for pentavalent vaccine in 2019 in El Salvador[J]. Vaccine, 2021, 39(34): 4849-4855.
[17] KIM JE, PARK J, MIN YG, et al.Associations of neuralgic amyotrophy with COVID-19 vaccination: disproportionality analysis using the World Health Organization pharmacovigilance database[J]. Muscle Nerve, 2022, 66(6): 766-770.
[18] KIM JE, PARK J, SONG TJ.A disproportionality analysis for the association of central nervous system demyelinating diseases with COVID-19 vaccination using the World Health Organization pharmacovigilance database[J]. Mult Scler, 2022, 28(13): 2112-2123.
[19] JEONG HS, CHUN BC.Signal detection of COVID-19 vaccines adverse events using spontaneous reports from South Korea[J]. Pharmacoepidemiol Drug Saf, 2023, 32(9): 961-968.
[20] PRONTSKUS V, FRESSE A, YELEHE-OKOUMA M, et al.COVID-19 vaccination and the incidence of de novo or recurrent rheumatoid arthritis: a French and international (VigiBase) signal detection study[J]. Clin Pharmacol Ther, 2023, 113(5): 1107-1116.
[21] XIA L, LI K, LI Y, et al.Comparison of statistical signal detection methods in adverse events following immunization - China, 2011-2015[J]. China CDC Wkly, 2024, 6(16): 350-356.
[22] BATE A, LINDQUIST M, EDWARDS IR, et al.A Bayesian neural network method for adverse drug reaction signal generation[J]. Eur J Clin Pharmacol, 1998, 54(4): 315-321.
[23] VAN PUIJENBROEK EP, BATE A, LEUFKENS HG, et al.A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions[J]. Pharmacoepidemiol Drug Saf, 2002, 11(1): 3-10.
[24] WHO. Global manual on surveillance of adverse events following immunization[EB/OL]. (2016-05-31)[2023-10-07]. https://www.who.int/publications/i/item /9789241507769.
[25] WU WD, LIU DW, LI KL, et al.Analysis on surveillance data of adverse events following immunization in China, 2012[J]. Chinese Journal of Vaccines and Immunization(中国疫苗和免疫), 2014, 20(1): 1-12, 66.
[26] YE JK, LI KL, XU DS, et al.Evaluation of the adverse events following immunization information management system in China, 2013[J]. Chinese Journal of Vaccines and Immunization(中国疫苗和免疫), 2015, 21(2): 121-131, 200.
[27] CHEN RT, RASTOGI SC, MULLEN JR, et al.The vaccine adverse event reporting system (VAERS)[J]. Vaccine, 1994, 12(6): 542-550.