疑似人乳头瘤病毒疫苗接种后的不良反应：日本疫苗接种与症状出现之间的时间关系。

Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan.

机构信息

Department of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine, Matsumoto, Japan.

Intractable Disease Care Center, Shinshu University Hospital, Matsumoto, 390-0802, Japan.

出版信息

Drug Saf. 2017 Dec;40(12):1219-1229. doi: 10.1007/s40264-017-0574-6.

DOI:10.1007/s40264-017-0574-6

PMID:28744844

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5688202/

Abstract

INTRODUCTION

In Japan, after receiving human papillomavirus vaccination, a significant number of adolescent girls experienced various symptoms, the vast majority of which have been ascribed to chronic regional pain syndrome, orthostatic intolerance, and/or cognitive dysfunction. However, a causal link has not been established between human papillomavirus vaccination and the development of these symptoms.

OBJECTIVE

The aim of this study was to clarify the temporal relationship between human papillomavirus vaccination and the appearance of post-vaccination symptoms.

METHODS

Between June 2013 and December 2016, we examined symptoms and objective findings in 163 female patients who had received human papillomavirus vaccination. We used newly defined diagnostic criteria for accurate inclusion of patients who experienced adverse symptoms after human papillomavirus vaccination; these diagnostic criteria were created for this study, and thus their validity and reliability have not been established.

RESULTS

Overall, 43 female patients were excluded. Among the remaining 120 patients, 30 were diagnosed as having definite vaccine-related symptoms, and 42 were diagnosed as probable. Among these 72 patients, the age at initial vaccination ranged from 11 to 19 years (average 13.6 ± 1.6 years), and the age at appearance of symptoms ranged from 12 to 20 years (average 14.4 ± 1.7 years). The patients received the initial human papillomavirus vaccine injection between May 2010 and April 2013. The first affected girl developed symptoms in October 2010, and the last two affected girls developed symptoms in October 2015. The time to onset after the first vaccine dose ranged from 1 to 1532 days (average 319.7 ± 349.3 days).

CONCLUSIONS

The period of human papillomavirus vaccination considerably overlapped with that of unique post-vaccination symptom development. Based on these sequential events, it is suggested that human papillomavirus vaccination is related to the transiently high prevalence of the previously mentioned symptoms including chronic regional pain syndrome and autonomic and cognitive dysfunctions in the vaccinated patients.

摘要

简介

在日本，大量青少年女性在接种人乳头瘤病毒疫苗后出现各种症状，其中绝大多数被归因于慢性区域性疼痛综合征、直立不耐受和/或认知功能障碍。然而，人乳头瘤病毒疫苗接种与这些症状的发展之间尚未建立因果关系。

目的

本研究旨在阐明人乳头瘤病毒疫苗接种与接种后症状出现之间的时间关系。

方法

在 2013 年 6 月至 2016 年 12 月期间，我们检查了 163 名接受过人乳头瘤病毒疫苗接种的女性患者的症状和客观发现。我们使用了新定义的诊断标准来准确纳入接种人乳头瘤病毒疫苗后出现不良反应症状的患者；这些诊断标准是为本研究创建的，因此其有效性和可靠性尚未建立。

结果

总体而言，有 43 名女性患者被排除在外。在其余的 120 名患者中，有 30 名被诊断为有明确的疫苗相关症状，42 名被诊断为可能的症状。在这 72 名患者中，初次接种年龄从 11 岁到 19 岁（平均 13.6 ± 1.6 岁），症状出现年龄从 12 岁到 20 岁（平均 14.4 ± 1.7 岁）。患者于 2010 年 5 月至 2013 年 4 月期间接受了首次人乳头瘤病毒疫苗接种。第一位出现症状的女孩于 2010 年 10 月出现症状，最后两位出现症状的女孩于 2015 年 10 月出现症状。从首次接种疫苗到出现症状的时间范围为 1 天至 1532 天（平均 319.7 ± 349.3 天）。