成人 70-79 岁人群中使用活减毒带状疱疹疫苗的安全性：来自澳大利亚 MedicineInsight 计划初级保健数据的自身对照病例系列分析。
Safety of live attenuated herpes zoster vaccine in adults 70-79 years: A self-controlled case series analysis using primary care data from Australia's MedicineInsight program.
机构信息
Wesfarmers Centre of Vaccines & Infectious Diseases, Telethon Kids Institute, 15 Hospital Ave, Nedlands, Western Australia 6009, Australia.
Wesfarmers Centre of Vaccines & Infectious Diseases, Telethon Kids Institute, 15 Hospital Ave, Nedlands, Western Australia 6009, Australia; The University of Sydney, School of Public Health, Sydney, New South Wales 2006, Australia; National Centre for Immunisation Research and Surveillance, Cnr Hawkesbury Rd & Hainsworth St, Westmead, New South Wales 2145, Australia.
出版信息
Vaccine. 2020 May 13;38(23):3968-3979. doi: 10.1016/j.vaccine.2020.03.054. Epub 2020 Apr 11.
BACKGROUND
Australia introduced a funded shingles vaccination program for older adults in November 2016, administered predominantly in primary care clinics. MedicineInsight, a nationally representative primary care database, was used to investigate the risk of pre-specified outcomes following live attenuated herpes zoster vaccine (ZVL) in Australia.
METHODS
Individuals aged 70-79 years who received ZVL between 1 November 2016 and 31 July 2018 were identified from MedicineInsight. The self-controlled case series (SCCS) method was used to estimate the seasonally-adjusted relative incidence (RI) of seven pre-specified outcome events (injection site reaction (ISR) [positive control], burn [negative control], myocardial infarction (MI), stroke, rash, rash with an antiviral prescription, and clinical attendance) during a plausible post-vaccination at-risk window compared with times distant from vaccination. Sensitivity analyses examined the effect of common concomitant vaccinations and restriction to first outcome events.
RESULTS
A total of 332,988 vaccination encounters among 150,054 individuals were identified during the study period; over 2 million clinical attendances were observed. There was an increased RI of ISR in the seven days following ZVL (RI = 77.4, 95% CI 48.1-124.6); the RI of clinical attendance (RI = 0.94, 95% CI 0.94-0.95) and stroke (RI = 0.58, 95% CI 0.44-0.78) were lower in the 42 days following administration of ZVL compared to control periods. There was no evidence of a change in the RI of MI (RI = 0.74, 95% CI 0.41-1.33), rash (RI = 0.97, 95% CI 0.88-1.08), or rash with antiviral prescription (RI = 0.83, 95% CI 0.62-1.10) in the 42 days following ZVL compared to control periods.
CONCLUSION
No new safety concerns were identified for ZVL in this study based on a novel, Australian primary care data source. An expected increased risk of ISR was identified; findings in relation to cardiovascular disease were reassuring but require confirmation using additional data, including hospital records.
背景
澳大利亚于 2016 年 11 月为老年人推出了一项带状疱疹疫苗资助计划，主要在初级保健诊所实施。利用 MedicineInsight 这一全国代表性的初级保健数据库，调查了澳大利亚带状疱疹活疫苗（ZVL）接种后的七个预先规定的结果的风险。
方法
从 MedicineInsight 中确定了 2016 年 11 月 1 日至 2018 年 7 月 31 日期间接受 ZVL 治疗的 70-79 岁人群。采用自身对照病例系列（SCCS）方法，估计与接种时间相隔较远的时间相比，接种后合理的风险窗口内七个预先规定的结果事件（注射部位反应（ISR）[阳性对照]、烧伤[阴性对照]、心肌梗死（MI）、中风、皮疹、有抗病毒处方的皮疹和临床就诊）的季节性调整相对发病率（RI）。敏感性分析检查了常见同时接种疫苗的影响以及对首次结果事件的限制。
结果
在研究期间，共确定了 332988 次接种事件和 150054 名个体，观察到超过 200 万次临床就诊。ZVL 接种后 7 天内，ISR 的 RI 增加（RI=77.4，95%CI 48.1-124.6）；ZVL 给药后 42 天内，临床就诊的 RI（RI=0.94，95%CI 0.94-0.95）和中风的 RI（RI=0.58，95%CI 0.44-0.78）低于对照期。ZVL 给药后 42 天内，MI（RI=0.74，95%CI 0.41-1.33）、皮疹（RI=0.97，95%CI 0.88-1.08）或有抗病毒处方的皮疹（RI=0.83，95%CI 0.62-1.10）的 RI 没有变化。
结论
基于澳大利亚初级保健数据的新来源，本研究未发现 ZVL 的新安全性问题。已确定 ISR 的风险增加；心血管疾病方面的发现令人欣慰，但需要使用包括医院记录在内的其他数据进行确认。
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