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.

项目概要 三分之一的美国人一生中会患上带状疱疹（HZ 或带状疱疹），其中 10-20% 第五脑神经眼科病例。1-3 这种疾病，称为带状疱疹 眼部脓肿 (HZO) 与 HZO 患者的发病率较高有关，可能会出现复发或复发。 需要长期治疗的慢性炎症，以及永久性视力丧失、白内障等后遗症， 青光眼和带状疱疹后神经痛。1,4–7 预防带状疱疹和带状疱疹后遗症的关键公共卫生干预措施是 2017 年，FDA 批准了重组带状疱疹疫苗 (RZV) Shingrix © (GlaxoSmithKline)，这是一种疫苗。 适用于 50 岁以上成人的两剂亚单位疫苗。8 该疫苗已显示出预防带状疱疹和 然而，HZO 在预防 HZO 方面的应用仍存在一些临床问题。 有关 RZV 对既往 HZO 病史患者的益处和风险的信息，以及 RZV 是否具有 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、病程和相关医疗保健利用的影响。 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 对有 HZO 病史的患者的益处和风险，我们将使用非参数 Wilcoxon 秩和检验用于比较疫苗接种和疫苗接种中药物使用情况（眼部炎症的代表） 使用 OptumLabs 健康保险数据库（目标 1）确定未接种疫苗的效果。 RZV 关于 HZO 的严重性和慢性性，我们将分析多个感兴趣的结果，包括 HZO 夏威夷凯撒医疗机构电子病历系统中的持续时间、青光眼和视力丧失（Aim 2). 为了比较接种疫苗组和未接种疫苗组中与 HZO 相关的眼部发病率，我们将 在 OptumLabs 健康保险数据库中诊断后评估诊所就诊和眼科手术 （目标 3）。通过使用大量、多样化的数据源，我们的目标是获得可概括的结果。 我们提出的研究将提供来自现实世界人群的临床相关信息，以表征 RZV 对 HZO 的发展和病程的影响这些结果可能对公共健康产生重大影响。 影响并用于制定眼科疫苗使用建议 看法。