TREATMENT OF ACUTE BRONCHITIS IN PRIMARY CARE

初级保健中急性支气管炎的治疗

• 批准号: 3427596
• 负责人: DANA Edwin KING
• 金额: $ 5.91万
• 依托单位: EAST CAROLINA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 1994-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3427596
• 关键词: Mycoplasma pneumoniae; acute bronchitis; antibody; clinical trials; complement fixation tests; erythromycin; human subject; human therapy evaluation; patient care management; primary care physician; respiratory disorder chemotherapy; respiratory disorder diagnosis

Acute bronchitis is a clinical syndrome characterized by an acute, productive cough, accompanied by evidence of an upper respiratory tract infection in the absence of pneumoniae or underlying lung disease. Acute bronchitis is one of the most frequently encountered illnesses is primary care clinical practice, and treatment costs are substantial. Recent studies suggest that Mycoplasma pneumoniae is present in a significant number of patients with acute bronchitis. Randomized, controlled clinical trials of antibiotics have yielded conflicting results; appropriate treatment remains uncertain. Objectives: The objectives of this project are to: 1. Determine the utility of treatment with erythromycin in primary care patients with acute bronchitis who have no underlying lung disease. 2. Determine if M. pneumoniae is present in a significant number of primary care patients with acute bronchitis. 3. Determine if a newly developed rapid M. pneumoniae antibody test is helpful in predicting which patients will respond to erythromycin therapy. Methods: This will be a randomized, prospective, double-blind clinical trial of erythromycin in the treatment of patients with acute bronchitis. The study will be performed at three different primary care clinical sites in North Carolina. All patients will be tested for antibodies to M. pneumoniae using a newly developed rapid test as well as the traditional acute and convalescent titers by complement fixation. Patients will be seen initially and again after two weeks, with two phone call assessments to monitor side effects and compliance in the interim. Analysis of the results according to response to therapy and according to the presence of M. pneumoniae will provide information to meet the stated objectives. Sample size calculations indicate that enrolling 120 patients (40 at each site) will be sufficient.

急性支气管炎是一种以急性、 咳痰，伴有上呼吸道症状 在没有肺炎或潜在肺部疾病的情况下感染。 急性 支气管炎是最常见的疾病之一，是原发性的 护理临床实践和治疗费用是巨大的。 最近的 研究表明肺炎支原体存在于重要的 急性支气管炎患者的数量。 随机对照临床 抗生素试验产生了相互矛盾的结果；合适的 治疗仍不确定。 目标：该项目的目标是： 1. 确定红霉素治疗在初级保健中的效用 无基础肺部疾病的急性支气管炎患者。 2. 确定大量原发性肺炎支原体是否存在 护理急性支气管炎患者。 3. 确定新开发的快速肺炎支原体抗体测试是否有效 有助于预测哪些患者将对红霉素治疗有反应。 方法：这将是一项随机、前瞻性、双盲临床研究 红霉素治疗急性支气管炎患者的试验。 该研究将在三个不同的初级保健临床中心进行 在北卡罗来纳州。 所有患者都将接受 M 抗体检测。 使用新开发的快速检测方法以及传统的方法来检测肺炎链球菌 通过补体结合测定急性和恢复期滴度。 患者将会 最初和两周后再次见面，并进行了两次电话评估 在此期间监测副作用和依从性。 分析 根据对治疗的反应和根据是否存在的结果 肺炎支原体将提供信息以实现既定目标。 样本量计算表明，招募了 120 名患者（每个患者 40 名） 站点）就足够了。