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 三分之一的美国人将在其一生中发展带状疱疹（Hz或带状疱疹），其中10％至20％ 涉及第五颅神经的眼科划分的病例。1-3这种疾病，称为疱疹变原 眼科（HZO）与明显的发病率有关。 HZO患者可能会经历或 需要长期治疗的慢性炎症和后遗症，例如永久视力丧失，白内障， 青光眼和骨后神经痛。1,4-7预防Hz和HzO的关键公共卫生干预措施是 疫苗接种。 2017年，FDA批准了重组带轮疫苗（RZV），Shingrix©（GlaxoSmithKline），A 成人的两剂亚基疫苗≥50岁。8疫苗已显示出预防Hz和Hz的效率 然而，HZO关于其在预防HZO中的使用仍然存在一些临床问题。缺乏 有关HZO先前病史的患者RZV的益处和风险的信息，以及RZV是否具有 对HZO严重程度的影响。我们旨在确定RZV对具有HZO史的患者的影响，并且 RZV对HZO严重程度，疾病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HZO病史的患者的好处和风险，我们将使用非参数 Wilcoxon等级总测试以比较药物使用情况，在接种疫苗和 使用optumlabs健康保险数据库（AIM 1）的非疫苗接种队列。确定 RZV关于HZO的严重程度和慢性，我们将分析包括HZO在内的多个结果 夏威夷凯撒（Kaiser Permanente）电子病历系统的持续时间，青光眼和视力丧失（AIM） 2）。为了比较在接种和非接种疫苗的队列中与HZO相关的眼部发病率，我们将是 在optumlabs健康保险数据库中诊断后的诊所访问和眼镜程序评估 （目标3）。通过使用大型潜水员数据源，我们旨在获得可概括的结果。 我们拟议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的发展和过程的影响。这些结果可能具有重要的公共卫生 含义并用于制定有关疫苗使用疫苗的建议 看法。