Disease-specific adverse events following nonlive vaccines: A paradoxical placebo effect or a nocebo phenomenon?
Disease-specific adverse events following nonlive vaccines: A paradoxical placebo effect or a nocebo phenomenon?
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DOI：
10.1016/j.vaccine.2011.05.045
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发表时间：
2011-08-26
期刊：
影响因子：
5.5
通讯作者：
Soubeyrand, Benoit
中科院分区：
文献类型：
--
作者：
Okais, Claire;Gay, Constance;Soubeyrand, Benoit
疫苗可引起不良反应（AR），即疫苗引起的免疫后不良事件（AEFI），如局部反应或发热。此外，在接种者中复制的减毒活疫苗可引起疾病特异性AR，例如麻疹疫苗接种后的麻疹样皮疹。然而，非活疫苗因为它们是灭活的并且它们不会在接种者中复制，所以不太可能引起疾病特异性AR。本研究的目的是评估非活疫苗疾病特异性AEFI自发报告的未描述偏倚是否会产生安全性信号，分析了2000年1月至2010年6月法国自发报告的所有赛诺菲巴斯德默沙东疫苗AEFI，根据MedDRA术语编码，并收集在公司药物警戒数据库中。先验地选择感兴趣的疫苗-事件对。使用了预防性报告率方法，比较了接种特定疫苗后报告的特定事件比例与接种所有其他研究疫苗后报告的特定事件比例。使用报告比值比（ROR）检测每个疫苗-事件对的信号，共分析了33，275例AEFI。计算的ROR显示出统计学上不成比例的报告率，并对几乎所有检测的对产生了错误的安全性信号。三种非活疫苗对引人注目：妇科症状和四价人乳头瘤病毒（qHPV）疫苗;牙关紧闭和破伤风疫苗;肝胆疾病和B肝炎疫苗。总之，我们发现了一种新的疫苗AE自发报告偏倚：“接种非活疫苗后的疾病特异性不良事件”，表明接种者和医疗保健专业人员倾向于优先报告接种非活疫苗所针对疾病的症状。我们认为，偏见是从属于一个矛盾的安慰剂效应和/或反安慰剂现象。(C)2011爱思唯尔有限公司保留所有权利。
Vaccines can cause adverse reactions (AR), i.e. adverse events following immunization (AEFIs) due to the vaccine, such as local reactions or fever. In addition, live attenuated vaccines which replicate in vaccinees can cause disease-specific AR, e.g. measles-like rash following measles vaccination. However, nonlive vaccines because they are inactivated and they do not replicate in vaccinees, are not likely to cause disease-specific AR. The aim of the study was to assess whether safety signals could be generated by an undescribed bias in spontaneous reporting of disease-specific AEFIs with nonlive vaccines.All AEFIs of Sanofi Pasteur MSD vaccines spontaneously reported in France from January 2000 to June 2010, coded according to MedDRA terms and collected in the company's pharmacovigilance database were analyzed. Vaccine-event pairs of interest were selected a priori. The disproportionality reporting rate methodology was used, comparing the proportion of a given event reported following a given vaccine to its proportion reported following all other studied vaccines. The Reporting Odds Ratio (ROR) was used for signals detection for each vaccine-event pair selected.A total of 33,275 AEFIs were analyzed. The calculated ROR showed a statistically disproportionate reporting rate and generated false safety signals for almost all the pairs tested. Three nonlive vaccine pairs were striking: gynaecological symptoms and the quadrivalent human papillomavirus (qHPV) vaccine; trismus and tetanus vaccines; hepatobiliary disorders and hepatitis B vaccines. In conclusion we have identified a new vaccine AE spontaneous reporting bias: "disease-specific adverse events following nonlive vaccines", showing that vaccinees and healthcare professionals tend to report preferentially the symptoms of the disease against which the nonlive vaccine was administered. We suggest that bias is subordinate to a paradoxical placebo effect and/or a nocebo phenomenon. (C) 2011 Elsevier Ltd. All rights reserved.