Diversity Supplement: The Impact of the Herpes Zoster Vaccine on Herpes Zoster Ophthalmicus

多样性补充：带状疱疹疫苗对眼部带状疱疹的影响

• 批准号: 10416931
• 负责人: NISHA ACHARYA
• 金额: $ 4.75万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10416931
• 关键词: Address; Adrenal Cortex Hormones; Adult; Age-Years; American; Anatomy; Antiviral Agents; Benefits and Risks; Big Data; Blindness; Cataract; Chronic; Clinic Visits; Clinical; Computerized Medical Record; Data; Data Sources; Databases; Development; Diagnosis; Disease; Dose; Effectiveness; FDA approved; Glaucoma; Hawaii; Health Insurance; Health Resources; Herpes Zoster Ophthalmicus; Herpes zoster disease; Incidence; Individual; Inflammation; Monitor; Morbidity - disease rate; Ocular Hypertension; Operative Surgical Procedures; Outcome; Outcome Measure; Patients; Pharmaceutical Preparations; Physicians; Population; Postherpetic neuralgia; Prevention; Procedures; Proxy; Public Health; Rank-Sum Tests; Recombinants; Recommendation; Recording of previous events; Recurrence; Retrospective cohort study; Risk; Severities; Stroke; Subunit Vaccines; System; Trigeminal nerve structure; Vaccinated; Vaccination; Vaccines; Visit; Zoster Vaccine; clinically relevant; cohort; corneal scar; diverse data; evidence base; experience; health care service utilization; interest; prevent; public health intervention

PROJECT SUMMARY One in three Americans will develop herpes zoster (HZ, or shingles) in their lifetime, with 10-20% of these cases involving the ophthalmic division of the fifth cranial nerve.1–3 This disease, known as herpes zoster ophthalmicus (HZO), is associated with significant morbidity. Patients with HZO may experience recurrent or chronic inflammation requiring long-term therapy, and sequelae such as permanent vision loss, cataract, glaucoma, and postherpetic neuralgia.1,4–7 A key public health intervention in the prevention of HZ and HZO is vaccination. In 2017, the FDA approved the recombinant zoster vaccine (RZV), Shingrix © (GlaxoSmithKline), a two-dose subunit vaccine for adults ≥ 50 years of age.8 The vaccine has shown efficacy in preventing HZ and HZO, however, several clinical questions remain regarding its use in the prevention of HZO. There is a lack of information on the benefits and risks of RZV in patients with a prior history of HZO, and whether RZV has an impact on severity of HZO. We aim to determine the impact of RZV in patients with a prior history of HZO, and the effect of RZV on HZO severity, disease course, and related health-care utilization. We propose to use big data sources to address clinically relevant questions about HZO and the impact of RZV. To determine the benefits and risks of RZV in patients with a history of HZO, we will use a nonparametric Wilcoxon rank sum test to compare medication usage, a proxy for ocular inflammation, in a vaccinated and non-vaccinated cohort using the OptumLabs health insurance database (Aim 1). To determine the effect of RZV on the severity and chronicity of HZO, we will analyze multiple outcomes of interest, including HZO duration, glaucoma, and vision loss, in the Kaiser Permanente Hawaii electronic medical record system (Aim 2). To compare the ocular morbidity related to HZO in a vaccinated and non-vaccinated cohort, we will be assessing clinic visits and ocular procedures following diagnosis in the OptumLabs health insurance database (Aim 3). By using large, diverse data sources, we aim to obtain generalizable results. Our proposed study will provide clinically relevant information from real-world populations to characterize the impact of RZV on the development and course of HZO. These results can have significant public health implications and be used to formulate recommendations on the use of the vaccine from an ophthalmic perspective.

项目摘要 三分之一的美国人在一生中会患上带状疱疹（HZ，或带状疱疹），其中10-20%的人会患上带状疱疹。 第五脑神经眼支受累的病例。1 -3这种疾病称为带状疱疹 眼内肌萎缩症（HZO）与显著的发病率相关。HZO患者可能会出现复发或 需要长期治疗的慢性炎症和后遗症如永久性视力丧失，白内障， 青光眼和带状疱疹后神经痛。1，4 -7预防HZ和HZO的关键公共卫生干预措施是 预防针2017年，FDA批准了重组带状疱疹疫苗（RZV），Shingrix ©（葛兰素史克）， 该疫苗已显示出预防HZ的有效性， 然而，关于其在预防HZO中的用途，仍存在一些临床问题。都缺乏 关于RZV在有HZO既往史的患者中的获益和风险的信息，以及RZV是否具有 对HZO严重程度的影响。我们的目的是确定RZV对既往有HZO病史的患者的影响， RZV对HZO严重程度、病程和相关卫生保健利用的影响。 我们建议使用大数据源来解决有关HZO和RZV影响的临床相关问题。 为了确定RZV在有HZO病史的患者中的获益和风险，我们将使用非参数 Wilcoxon秩和检验，以比较接种疫苗和 使用OptumLabs健康保险数据库（Aim 1）的未接种疫苗的队列。以确定影响 RZV对HZO的严重程度和慢性程度的影响，我们将分析多种关注的结局，包括HZO 持续时间，青光眼，视力丧失，在凯撒永久夏威夷电子医疗记录系统（Aim 2）。为了比较接种和未接种队列中与HZO相关的眼部发病率，我们将 在OptumLabs健康保险数据库中评估诊断后的诊所就诊和眼科手术 (Aim 3）。通过使用大量不同的数据源，我们的目标是获得可推广的结果。 我们提出的研究将提供来自真实世界人群的临床相关信息，以表征 RZV对HZO的发展和进程的影响。这些结果可能会对公共健康产生重大影响。 的影响，并用于制定建议使用的疫苗，从眼科 perspective.