Safety Assessment of Influenza Vaccination for Neurological Outcomes Among Older Adults in Japan: A Self-Controlled Case Series Study.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-01-01 DOI:10.1002/pds.70082

Mitsunori Ogawa, Yoshinori Takeuchi, Yukino Iida, Masao Iwagami, Kohei Uemura, Sachiko Ono, Nobuaki Michihata, Daisuke Koide, Yutaka Matsuyama, Hideo Yasunaga

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引用次数: 0

Abstract

Purpose: To assess adverse neurological risks following influenza vaccination in older adults.

Methods: Using a linked database of healthcare administrative claims data and vaccination records from an urban city in Japan (April 1, 2014, to March 31, 2020), we conducted an observational study utilizing a self-controlled case series design. We identified individuals aged ≥ 65 years who experienced adverse neurological outcomes, defined as hospitalizations related to epilepsy, paralysis, facial paralysis, neuralgia, neuritis, optic neuritis, migraine, extrapyramidal disorders, Guillain-Barre syndrome, or narcolepsy. We used conditional Poisson regression to analyze within-subject incidence rate ratios, comparing the risk of these outcomes during risk periods following influenza vaccination (0-6 days and 7-29 days after each vaccination) with nonvaccination periods. Our analysis was adjusted for age and season groups as time-varying covariates.

Results: We enrolled 3283 eligible individuals (men: 1643; mean [standard deviation] age: 76 [7.3] years). The incidence rate ratio for the outcome during the risk periods was 0.93 (95% confidence interval, 0.66-1.30) in risk period 1 (0-6 days after vaccination) and 1.14 (0.96-1.35) in risk period 2 (7-29 days after vaccination), respectively.

Conclusions: We found no evidence that the risk of adverse neurological events was increased after influenza vaccination in older adults. These results may help reassure older adults who are hesitant to receive influenza vaccination because of concerns regarding adverse neurological outcomes.

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流感疫苗接种对日本老年人神经系统预后的安全性评估：一项自我控制病例系列研究

目的：评估老年人接种流感疫苗后的不良神经风险。方法：利用日本某城市（2014年4月1日至2020年3月31日）医疗保健行政索赔数据和疫苗接种记录的链接数据库，我们采用自控病例系列设计进行了一项观察性研究。我们确定了年龄≥65岁、经历神经系统不良结局的个体，定义为与癫痫、瘫痪、面瘫、神经痛、神经炎、视神经炎、偏头痛、锥体外系疾病、格林-巴利综合征或发作性睡病相关的住院治疗。我们使用条件泊松回归分析受试者内发病率比，比较接种流感疫苗后（每次接种后0-6天和7-29天）和未接种流感疫苗期间这些结果的风险。我们的分析调整了年龄和季节组作为随时间变化的协变量。结果：我们招募了3283名符合条件的个体(男性：1643；平均[标准差]年龄：76[7.3]岁)。危险期1（接种疫苗后0 ~ 6天）和危险期2（接种疫苗后7 ~ 29天）的结局发生率比分别为0.93（95%可信区间0.66 ~ 1.30）和1.14（0.96 ~ 1.35）。结论：我们没有发现证据表明老年人接种流感疫苗后不良神经事件的风险增加。这些结果可能有助于打消那些因担心不良神经系统后果而对接种流感疫苗犹豫不决的老年人的疑虑。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.