Impact of Oseltamivir on Outcomes and Costs of Pediatric Influenza

描述(由申请人提供)：最近对人类感染禽流感病毒株的关注导致了加强我们应对流感大流行的能力的广泛努力。公共卫生机构和医疗保健机构认为，针对流感的抗病毒治疗将是对新出现的大流行做出初步反应的重要组成部分。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。目前有有限的数据支持针对流感的治疗方法能够改变因感染季节性或大流行流感病毒株而住院的儿童的结局。奥司他韦在儿童中的疗效仅在门诊环境中进行过研究。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好处、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、成本和不良药物事件。我们的具体目标是确定奥司他韦治疗是否能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)评估与使用奥司他韦治疗流感住院儿童有关的药物相关不良事件，特别是神经系统不良事件的发生情况；(2)确定奥司他韦治疗是否减少了与流感住院相关的直接医疗费用。我们将使用从PHIS数据库中提取的数据进行一项多点的回溯性队列研究。PHIS数据库是一个全面的、可比较的儿科数据库，由美国儿童健康公司(CHCA)为成员医院创建。它包含了600多万例患者的临床和财务细节。具体地说，该数据库包含全国40家PHIS所有者儿童医院的住院和门诊医院遇到的诊断和程序代码以及账单交易/利用数据。我们预计这一分析将推广到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，美国几乎所有的卫生保健机构目前都在制定计划，为大量感染患者提供护理。由于在针对流感大流行毒株的疫苗问世之前，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。拟议的项目将加强我们对流感特异性抗病毒治疗及其改变流感病毒住院儿童结局的能力的了解。

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.