RCT to evaluate guidelines for acute rhinosinusitis

评估急性鼻窦炎指南的随机对照试验

• 批准号: 7033988
• 负责人: Jane M Garbutt
• 金额: $ 39.85万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7033988
• 关键词: antibiotics; clinical research; penicillins

DESCRIPTION (provided by applicant): Sinusitis is a common problem associated with significant patient morbidity, lost productivity and cost. Accurate diagnosis of bacterial disease is not possible in the ambulatory setting, and antibiotics are overused. There are few studies that assess the effectiveness of antibiotic therapy, and study inclusion criteria severely limit the generalizability of their findings to inform primary care management. To reduce the excessive use of antibiotics, the Centers for Disease Control and Prevention (CDC) and an expert panel recommended that 1) antibiotic treatment be reserved for patients with moderate or severe symptoms that persist for at least seven days and include maxillary or facial pain and purulent nasal secretions, and 2) initial antibiotic treatment be a narrow-spectrum drug. The effectiveness of these treatment recommendations has not been evaluated. The objective of this study is to determine the incremental benefit of amoxicillin added to a regimen of symptomatic treatments in patients diagnosed with acute bacterial rhinosinusitis using clinical criteria. We will conduct a.double-blinded, randomized, placebo-controlled trial in the primary care setting. Two hundred adult patients who meet the CDC recommended diagnostic criteria for acute bacterial rhinosinusitis will be randomized to receive a 10-day course of either amoxicillin or placebo. In addition, all patients will receive symptomatic treatments including an analgesic, an oral decongestant and an anti-tussive agent. Patient outcomes will be assessed by telephone interview at 3, 7, 10 and 28 days. The primary outcome measures will be the effect of treatment on the disease-specific quality of life, measured with a validated evaluative instrument, the Sino-Nasal Outcome Test-16 (SNOT-16). Secondary outcomes will include the effect of treatment on change in functional status and symptoms, disease recurrence, satisfaction with care and the direct costs of treatment. We propose the current study as the first in a series of studies designed to determine the most effective primary care management of patients with acute rhinosinusitis. We will evaluate symptomatic treatments in future studies. The relevance of this research to public health is that it will provide knowledge about how to best care for patients with acute sinusitis, a common problem that is cared for in the community. In addition, knowledge gained from this research could be used to decrease the inappropriate use of antibiotics.

描述（由申请人提供）：鼻窦炎是一种常见的问题，与显著的患者发病率、生产力损失和成本相关。在门诊不可能准确诊断细菌性疾病，而且抗生素被过度使用。很少有研究评估抗生素治疗的有效性，研究纳入标准严重限制了其结果的普遍性，以告知初级保健管理。为了减少抗生素的过度使用，疾病控制和预防中心（CDC）和一个专家小组建议：1）抗生素治疗应保留给中度或重度症状持续至少7天的患者，包括上颌或面部疼痛和脓性鼻分泌物，2）初始抗生素治疗是窄谱药物。这些治疗建议的有效性尚未得到评估。本研究的目的是确定阿莫西林添加到对症治疗方案中对使用临床标准诊断为急性细菌性鼻窦炎的患者的增量获益。我们将在初级保健环境中进行一项双盲、随机、安慰剂对照试验。200名符合CDC推荐的急性细菌性鼻窦炎诊断标准的成年患者将随机接受10天疗程的阿莫西林或安慰剂治疗。此外，所有患者将接受对症治疗，包括止痛药、口服减充血剂和止咳药。将在第3、7、10和28天通过电话访谈评估患者结局。主要结局指标将是治疗对疾病特异性生活质量的影响，采用经验证的评估工具，鼻-鼻窦结局测试-16（SNOT-16）进行测量。次要结局将包括治疗对功能状态和症状变化的影响、疾病复发、对护理的满意度和治疗的直接费用。我们建议目前的研究作为一系列研究中的第一个，旨在确定急性鼻窦炎患者最有效的初级保健管理。我们将在未来的研究中评估对症治疗。这项研究与公共卫生的相关性在于，它将提供有关如何最好地护理急性鼻窦炎患者的知识，急性鼻窦炎是社区护理的常见问题。此外，从这项研究中获得的知识可以用来减少抗生素的不适当使用。