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新西兰人群带状疱疹疫苗安全性:一项自身对照病例系列研究。

Herpes zoster vaccine safety in the Aotearoa New Zealand population: a self-controlled case series study.

机构信息

School of Health, Wellington Faculty of Health, Victoria University of Wellington, Wellington, New Zealand.

School of Mathematics and Statistics, Wellington Faculty of Engineering, Victoria University of Wellington, Wellington, New Zealand.

出版信息

Nat Commun. 2023 Jul 19;14(1):4330. doi: 10.1038/s41467-023-39595-y.

DOI:10.1038/s41467-023-39595-y
PMID:37468475
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10356758/
Abstract

In Aotearoa New Zealand, zoster vaccine live is used for the prevention of zoster and associated complications in adults. This study assessed the risk of pre-specified serious adverse events following zoster vaccine live immunisation among adults in routine clinical practice. We conducted a self-controlled case series study using routinely collected national data. We compared the incidence of serious adverse events during the at-risk period with the control period. Rate ratios were estimated using Conditional Poisson regression models. Falsification outcomes analyses were used to evaluate biases in our study population. From April 2018 to July 2021, 278,375 received the vaccine. The rate ratio of serious adverse events following immunisation was 0·43 (95% confidence interval [CI]: 0·37-0·50). There was no significant increase in the risk of cerebrovascular accidents, acute myocardial infarction, acute pericarditis, acute myocarditis, and Ramsay-Hunt Syndrome. The herpes zoster vaccine is safe in adults in Aotearoa New Zealand.

摘要

在新西兰,带状疱疹活疫苗被用于预防成人带状疱疹及相关并发症。本研究评估了在常规临床实践中,带状疱疹活疫苗免疫接种后预先指定的严重不良事件的风险。我们使用常规收集的全国数据开展了一项自身对照病例系列研究。我们比较了风险期和对照期内严重不良事件的发生率。使用条件泊松回归模型估计了率比。我们使用虚假结局分析来评估研究人群中的偏倚。2018 年 4 月至 2021 年 7 月,有 278375 人接种了疫苗。接种后严重不良事件的发生率比为 0.43(95%置信区间[CI]:0.37-0.50)。接种疫苗后,脑血管意外、急性心肌梗死、急性心包炎、急性心肌炎和 Ramsay-Hunt 综合征的风险没有显著增加。带状疱疹疫苗在新西兰成年人中是安全的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de20/10356758/6974ff036325/41467_2023_39595_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de20/10356758/39c13c79d198/41467_2023_39595_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de20/10356758/6974ff036325/41467_2023_39595_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de20/10356758/39c13c79d198/41467_2023_39595_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de20/10356758/6974ff036325/41467_2023_39595_Fig2_HTML.jpg

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本文引用的文献

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Lancet Reg Health West Pac. 2022 Sep 26;31:100601. doi: 10.1016/j.lanwpc.2022.100601. eCollection 2023 Feb.
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Post-licensure zoster vaccine effectiveness against herpes zoster and postherpetic neuralgia in older adults: a systematic review and meta-analysis.带状疱疹疫苗上市后预防老年人带状疱疹和疱疹后神经痛的有效性:系统评价和荟萃分析。
Lancet Healthy Longev. 2022 Apr;3(4):e263-e275. doi: 10.1016/S2666-7568(22)00039-3. Epub 2022 Apr 4.
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Second-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland.
苏格兰第二剂 ChAdOx1 和 BNT162b2 COVID-19 疫苗接种与血小板减少性、血栓栓塞性和出血性事件。
Nat Commun. 2022 Aug 15;13(1):4800. doi: 10.1038/s41467-022-32264-6.
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Vaccine Safety Surveillance Using Routinely Collected Healthcare Data-An Empirical Evaluation of Epidemiological Designs.利用常规收集的医疗保健数据进行疫苗安全性监测——流行病学设计的实证评估
Front Pharmacol. 2022 Jul 6;13:893484. doi: 10.3389/fphar.2022.893484. eCollection 2022.
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First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland.苏格兰首剂 ChAdOx1 和 BNT162b2 COVID-19 疫苗与血小板减少性、血栓栓塞性和出血性事件。
Nat Med. 2021 Jul;27(7):1290-1297. doi: 10.1038/s41591-021-01408-4. Epub 2021 Jun 9.
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BMJ Open. 2021 Mar 25;11(3):e043880. doi: 10.1136/bmjopen-2020-043880.
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