Impact of Oseltamivir on Outcomes and Costs of Pediatric Influenza

奥司他韦对小儿流感的结果和费用的影响

• 批准号: 7290563
• 负责人: SUSAN MD COFFIN
• 金额: $ 8.25万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-14 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7290563
• 关键词: Adverse event; Amantadine; Americas; Antiviral Agents; Antiviral Therapy; Benefits and Risks; Birds; Caring; Case Series; Cessation of life; Child; Child health care; Childhood; Chronically Ill; Class; Clinical; Code; Cohort Studies; Complication; Data; Databases; Diagnosis; Disease; Effectiveness; Event; Future; Healthcare; Hospitalization; Hospitalized Child; Hospitals; Human; Infection; Influenza; Inpatients; Institution; Knowledge; Length of Stay; Medical; Medical Surveillance; Neuraminidase inhibitor; Neurologic; Numbers; Oseltamivir; Outcome; Outpatients; Patients; Pediatric Hospitals; Pharmaceutical Preparations; Procedures; Prophylactic treatment; Public Health; Rate; Readiness; Reporting; Resistance; Respiratory Failure; Rimantadine; Risk; Role; Site; Time; United States; United States Dept. of Health and Human Services; United States Food and Drug Administration; Vaccines; Viral; abstracting; aerosolized; comparative; cost; design; improved; influenza virus strain; influenzavirus; member; pandemic disease; pandemic influenza; response; zanamivir

DESCRIPTION (provided by applicant): Recent concerns about human infection with avian strains of influenza have led to widespread efforts to enhance our ability to respond to an influenza pandemic. Public health agencies and healthcare institutions have assumed that influenza-specific antiviral therapy will be an important component of an initial response to an emerging pandemic. Oseltamivir has emerged as the antiviral drug that is anticipated to be of greatest potential benefit for patients infected with either seasonal or pandemic influenza in the future. Limited data exist to support the ability of influenza-specific therapies to alter the outcomes of children hospitalized due to infection with either seasonal or pandemic strains of influenza virus. The efficacy of oseltamivir in children has been exclusively studied in the outpatient setting. Furthermore, during a pandemic, it is anticipated that the demand for oseltamivir will exceed supply; thus understanding the benefits, risks, and costs associated with use of this antiviral agent in patients with serious influenza infection will be helpful in times of shortage. We propose to examine the outcomes, costs, and adverse drug events associated with the use of oseltamivir for the treatment of influenza in hospitalized children. Our specific aim was designed to determine if treatment with oseltamivir improves the clinical outcomes of children hospitalized with influenza. Furthermore, we have developed two secondary aims to: (1) assess the occurrence of drug related adverse events, specifically neurologic adverse events, associated with the use of oseltamivir in children hospitalized with influenza; and (2) to determine if treatment with oseltamivir reduces direct medical costs associated with influenza hospitalization. We will conduct a multi-site, retrospective cohort study using data abstracted from the PHIS database. The PHIS database is a comprehensive, comparative pediatric database that was created by Child Health Corporation of America (CHCA) for member hospitals. It contains clinical and financial details of more than six million patient cases. Specifically, the database contains the diagnosis and procedure codes and billed transaction/utilization data of inpatient and outpatient hospital encounters among the 40 PHIS owner children's hospitals nationwide. We anticipate this analysis will be generalizable to children hospitalized anywhere in the United States. Recognizing the potential threat of pandemic influenza, virtually all health care agencies in the United States are currently developing plans to provide care to large numbers of infected patients. Because the disease is likely to be widespread before a vaccine specific for a pandemic strain of influenza is available, antiviral medications are anticipated to be a critical component of the early response to a pandemic. The proposed project will enhance our understanding of influenza-specific antiviral therapy and its ability to alter the outcomes of children hospitalized with the influenza virus.

描述（由申请人提供）：最近对人类感染禽流感病毒株的担忧导致人们广泛努力提高我们应对流感大流行的能力。公共卫生机构和医疗机构认为，流感特异性抗病毒治疗将是针对新出现的大流行的初步应对措施的重要组成部分。奥司他韦已成为一种抗病毒药物，预计对未来感染季节性或大流行性流感的患者具有最大的潜在益处。有限的数据支持流感特异性疗法能够改变因感染季节性或大流行性流感病毒株而住院的儿童的结果。奥司他韦对儿童的疗效仅在门诊进行了研究。此外，在大流行期间，预计奥司他韦将供不应求；因此，了解在严重流感感染患者中使用这种抗病毒药物的益处、风险和成本将在短缺时期有所帮助。我们建议检查与使用奥司他韦治疗住院儿童流感相关的结果、成本和药物不良事件。我们的具体目标是确定奥司他韦治疗是否可以改善因流感住院的儿童的临床结果。此外，我们还制定了两个次要目标：（1）评估与流感住院儿童使用奥司他韦相关的药物相关不良事件的发生，特别是神经系统不良事件； (2) 确定奥司他韦治疗是否可以降低与流感住院相关的直接医疗费用。我们将使用从 PHIS 数据库提取的数据进行多地点回顾性队列研究。 PHIS 数据库是一个综合性比较儿科数据库，由美国儿童健康公司 (CHCA) 为成员医院创建。它包含超过 600 万例患者的临床和财务详细信息。具体来说，该数据库包含全国 40 家 PHIS 所有者儿童医院的诊断和程序代码以及住院和门诊医院就诊的计费交易/使用数据。我们预计这一分析将适用于美国任何地方住院的儿童。认识到大流行性流感的潜在威胁，美国几乎所有医疗保健机构目前都在制定计划，为大量感染患者提供护理。由于在专门针对大流行性流感株的疫苗问世之前，这种疾病可能会广泛传播，因此抗病毒药物预计将成为早期应对大流行的关键组成部分。拟议的项目将增强我们对流感特异性抗病毒治疗及其改变因流感病毒住院儿童的结果的能力的理解。