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: 7233235
• 负责人: Jane M Garbutt
• 金额: $ 33.96万
• 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/7233235
• 关键词: Acute; Adult; Amoxicillin; Analgesics; Antibiotic Therapy; Antibiotics; Bacterial Infections; Caring; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Trials; Communities; Decision Making; Decongestants; Diagnosis; Diagnostic; Direct Costs; Disease; Effectiveness; Enrollment; Facial Pain; Future; Guidelines; Knowledge; Maxilla; Measures; Morbidity - disease rate; Multivariate Analysis; Nose; Oral; Outcome; Outcome Measure; Patient Care; Patients; Pharmaceutical Preparations; Placebos; Primary Health Care; Productivity; Public Health; Quality of life; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recommendation; Recurrence; Research; Research Design; Series; Sinus; Sinusitis; Site; Symptoms; Telephone Interviews; Testing; Treatment Effectiveness; Treatment Protocols; United States National Institutes of Health; acute rhinosinusitis; cost; day; functional status; improved; inclusion criteria; instrument; prognostic; randomized placebo controlled trial; rhinosinusitis; satisfaction; treatment effect

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(由申请者提供)：鼻窦炎是一种常见的问题，与严重的患者发病率、生产力损失和成本有关。在门诊环境中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他们的研究结果为初级保健管理提供信息的概括性。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症状至少持续七天的中或重度患者，包括上颌或面部疼痛和化脓性鼻分泌物；2)最初的抗生素治疗应为窄谱药物。这些治疗建议的有效性尚未得到评估。这项研究的目的是根据临床标准确定阿莫西林加用症状治疗方案对诊断为急性细菌性鼻-鼻窦炎患者的增量益处。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名符合疾控中心推荐的急性细菌性鼻-鼻窦炎诊断标准的成年患者将被随机接受为期10天的阿莫西林或安慰剂疗程。此外，所有患者都将接受对症治疗，包括止痛剂、口服减充血剂和止咳药。患者的预后将在第3、7、10和28天通过电话采访进行评估。主要的结果衡量标准将是治疗对特定疾病生活质量的影响，通过经验证的评估工具-鼻鼻结果测试-16(SNOT-16)进行衡量。次要结果将包括治疗对功能状态和症状变化的影响、疾病复发、对护理的满意度以及治疗的直接成本。我们建议这项研究是一系列研究中的第一项，旨在确定对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，它将提供关于如何最好地护理急性鼻窦炎患者的知识，这是社区护理的一个常见问题。此外，从这项研究中获得的知识可以用来减少抗生素的不当使用。