伴有脓性痰的非复杂性急性支气管炎患者使用抗炎治疗与抗生素治疗和安慰剂的疗效比较。BAAP 研究方案。
Effectiveness of anti-inflammatory treatment versus antibiotic therapy and placebo for patients with non-complicated acute bronchitis with purulent sputum. The BAAP Study protocol.
机构信息
University Rovira i Virgili, Primary Healthcare Centre Jaume I, Tarragona, Spain.
出版信息
BMC Pulm Med. 2011 Jun 21;11:38. doi: 10.1186/1471-2466-11-38.
BACKGROUND
Acute bronchitis is one of the most prevalent respiratory infections in primary care, and in more than 90% of the cases antibiotics are prescribed, mainly when purulent expectoration is present. However, this process is usually viral in origin and the benefits of antibiotic treatment are marginal. On the other hand, in recent years bronchitis has been considered more as an inflammatory than an infectious process. Thus, the aim of this study is to evaluate the clinical effectiveness of a schedule of an oral anti-inflammatory compared with an antibiotic regimen and another group assigned to receive a placebo.
METHODS AND DESIGN
A total of 420 patients from 15 to 70 years of age with no associated comorbidity, presenting respiratory tract infection of at least one week of evolution, with cough as the predominant symptom, the presence of purulent expectoration and at least one other symptom of the respiratory tract (dyspnoea, wheezing, chest discomfort or pain), with no alternative explanation such as pneumonia, will be included in a prospective, randomised and controlled, clinical trial with placebo. The patients will be randomised to receive one of three treatments: ibuprofen, amoxycillin and clavulanic acid or placebo for 10 days. The main outcome measure is the number of days with frequent cough defined by the symptom diary with a score of 1 or more.
DISCUSSION
This trial is designed to evaluate the number of days with frequent cough with anti-inflammatory treatment compared with antimicrobial treatment and placebo in previously healthy patients with a clinical picture of acute bronchitis and purulent expectoration. It is hypothesized that anti-inflammatory treatment is more effective than antibiotic treatment to reduce cough, which is the most disturbing symptom for patients with this infection.
TRIAL REGISTRATION
ISRCTN07852892.
背景
急性支气管炎是初级保健中最常见的呼吸道感染之一，超过 90%的病例会开具抗生素，主要是在出现脓性痰时。然而，这种情况通常是病毒引起的，抗生素治疗的益处有限。另一方面，近年来支气管炎被认为更多的是一种炎症过程而不是感染过程。因此，本研究旨在评估口服抗炎药与抗生素方案的临床疗效，并与接受安慰剂的另一组进行比较。
方法和设计
共纳入 420 名年龄在 15 至 70 岁之间、无合并症、有至少一周呼吸道感染史、以咳嗽为主要症状、有脓性痰且至少有另一种呼吸道症状（呼吸困难、喘息、胸部不适或疼痛）、无肺炎等其他解释的患者，将他们纳入一项前瞻性、随机、对照、安慰剂临床试验。患者将随机接受三种治疗之一：布洛芬、阿莫西林克拉维酸或安慰剂治疗 10 天。主要观察指标是根据症状日记评分 1 或更高的频繁咳嗽天数。
讨论
本试验旨在评估在有脓性痰的急性支气管炎和临床症状的既往健康患者中，抗炎治疗与抗菌治疗和安慰剂相比，减少咳嗽的天数。假设抗炎治疗比抗生素治疗更有效，以减轻咳嗽，这是此类感染患者最困扰的症状。
试验注册
ISRCTN07852892。
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