Department of General Pathology. University Rovira i Virgili, Primary Care Centre Jaume I, c Felip Pedrell, 45-47 43005 Tarragona, Spain.
BMJ. 2013 Oct 4;347:f5762. doi: 10.1136/bmj.f5762.
To evaluate the efficacy of oral anti-inflammatory or antibiotic treatment compared with placebo in the resolution of cough in patients with uncomplicated acute bronchitis and discoloured sputum.
Multicentre, parallel, single blinded placebo controlled, randomised clinical trial.
Nine primary care centres in Spain.
Adults aged 18 to 70 presenting symptoms associated with respiratory tract infection of less than one week's duration, with cough as the predominant symptom, the presence of discoloured sputum, and at least one other symptom of lower respiratory tract infection (dyspnoea, wheezing, chest discomfort, or chest pain).
Patients were randomised to receive either ibuprofen 600 mg three times daily, amoxicillin-clavulanic acid 500 mg/125 mg three times daily, or placebo three times daily for 10 days. The duration of symptoms was measured with a diary card.
Number of days with frequent cough after the randomisation visit.
416 participants were randomised (136 to ibuprofen, 137 to antibiotic, and 143 to placebo) and 390 returned their symptom diaries fully completed. The median number of days with frequent cough was slightly lower among patients assigned to ibuprofen (9 days, 95% confidence interval 8 to 10 days) compared with those receiving amoxicillin-clavulanic acid (11 days, 10 to 12 days) or placebo (11 days, 8 to 14 days), albeit without statistically significant differences. Neither amoxicillin-clavulanic acid nor ibuprofen increased the probability of cough resolution (hazard ratio 1.03, 95% confidence interval 0.78 to 1.35 and 1.23, 0.93 to 1.61, respectively) compared with placebo. Adverse events were observed in 27 patients, and were more common in the antibiotic arm (12%) than ibuprofen or placebo arms (5% and 3%, respectively; P<0.01).
No significant differences were observed in the number of days with cough between patients with uncomplicated acute bronchitis and discoloured sputum treated with ibuprofen, amoxicillin-clavulanic acid, or placebo.
Current Controlled Trials ISRCTN07852892.
评估口服抗炎或抗生素治疗与安慰剂相比在解决单纯性急性支气管炎和咳痰患者咳嗽方面的疗效。
多中心、平行、单盲安慰剂对照、随机临床试验。
西班牙 9 个初级保健中心。
年龄在 18 至 70 岁之间的成年人，有呼吸道感染症状不到一周，以咳嗽为主要症状，痰液呈有色，并有至少一个下呼吸道感染的其他症状（呼吸困难、喘息、胸部不适或胸痛）。
患者被随机分为三组，分别接受布洛芬 600mg，每日三次；阿莫西林克拉维酸 500mg/125mg，每日三次；或安慰剂，每日三次，共 10 天。症状持续时间通过日记卡进行测量。
随机就诊后频繁咳嗽的天数。
416 名参与者被随机分配（136 名接受布洛芬，137 名接受抗生素，143 名接受安慰剂），390 名参与者完整地返回了他们的症状日记。接受布洛芬治疗的患者频繁咳嗽的中位数天数略低于接受阿莫西林克拉维酸（11 天，95%置信区间 10 至 12 天）或安慰剂（11 天，8 至 14 天）治疗的患者，但差异无统计学意义。与安慰剂相比，阿莫西林克拉维酸和布洛芬均未增加咳嗽缓解的可能性（风险比分别为 1.03，95%置信区间 0.78 至 1.35 和 1.23，0.93 至 1.61）。在 27 名患者中观察到不良事件，且在抗生素组（12%）比布洛芬或安慰剂组（分别为 5%和 3%）更常见（P<0.01）。
在治疗单纯性急性支气管炎和咳痰患者方面，布洛芬、阿莫西林克拉维酸或安慰剂在咳嗽天数方面没有显著差异。
当前对照试验 ISRCTN07852892。
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