Interuniversity Institute for Biostatistics and Statistical Bioinformatics (iBIOSTAT), Hasselt University, Hasselt, Belgium; Laboratory of Medical Microbiology, Vaccine & Infectious Diseases Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Aldermoor Health Centre, University of Southampton, Southampton, UK; Centre for Health Economic Research and Modelling Infectious Diseases (CHERMID), Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Institute of Primary Care and Public Health, Cardiff University, Cardiff, UK; Julius Centre for Health, Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands; Department of Primary and Interdisciplinary Care (ELIZA), University of Antwerp, Antwerp, Belgium; Department of Epidemiology and Social Medicine (ESOC), University of Antwerp, Antwerp, Belgium.
Interuniversity Institute for Biostatistics and Statistical Bioinformatics (iBIOSTAT), Hasselt University, Hasselt, Belgium; Laboratory of Medical Microbiology, Vaccine & Infectious Diseases Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Aldermoor Health Centre, University of Southampton, Southampton, UK; Centre for Health Economic Research and Modelling Infectious Diseases (CHERMID), Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Institute of Primary Care and Public Health, Cardiff University, Cardiff, UK; Julius Centre for Health, Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands; Department of Primary and Interdisciplinary Care (ELIZA), University of Antwerp, Antwerp, Belgium; Department of Epidemiology and Social Medicine (ESOC), University of Antwerp, Antwerp, Belgium.
Clin Microbiol Infect. 2018 Aug;24(8):871-876. doi: 10.1016/j.cmi.2017.10.032. Epub 2017 Nov 3.
We aimed to assess the effects of amoxicillin treatment in adult patients presenting to primary care with a lower respiratory tract infection (LRTI) who were infected with a potential bacterial, viral, or mixed bacterial/viral infection.
This multicentre randomized controlled trial focused on adults with LRTI not suspected for pneumonia. Patients were randomized to receive either antibiotic (amoxicillin 1 g) or placebo three times daily for 7 consecutive days using computer-generated random numbers (follow-up 28 days). In this secondary analysis of the trial, symptom duration (primary outcome), symptom severity (scored 0-6), and illness deterioration (reconsultation with new or worsening symptoms, or hospital admission) were analysed in pre-specified subgroups using regression models. Subgroups of interest were patients with a (strictly) bacterial, (strictly) viral, or combined infection, and patients with elevated values of procalcitonin, C-reactive protein, or blood urea nitrogen.
2058 patients (amoxicillin n = 1036; placebo n = 1022) were randomized. Treatment did not affect symptom duration (n = 1793). Patients from whom a bacterial pathogen only was isolated (n = 207) benefited from amoxicillin in that symptom severity (n = 804) was reduced by 0.26 points (95% CI -0.48 to -0.03). The odds of illness deterioration (n = 2024) was 0.24 (95% CI 0.11 to 0.53) times lower from treatment with amoxicillin when both a bacterial and a viral pathogen were isolated (combined infection; n = 198).
Amoxicillin may reduce the risk of illness deterioration in patients with a combined bacterial and viral infection. We found no clinically meaningful benefit from amoxicillin treatment in other subgroups.
我们旨在评估阿莫西林治疗患有下呼吸道感染（LRTI）的成年患者的效果，这些患者在初级保健机构就诊时被感染了潜在的细菌、病毒或混合细菌/病毒感染。
这项多中心随机对照试验主要针对非疑似肺炎的 LRTI 成年患者。患者被随机分为接受抗生素（阿莫西林 1g）或安慰剂，每天三次，连续 7 天，使用计算机生成的随机数（随访 28 天）。在该试验的二次分析中，使用回归模型分析了症状持续时间（主要结局）、症状严重程度（评分 0-6）和病情恶化（新出现或恶化的症状重新就诊或住院）在预先指定的亚组中的情况。感兴趣的亚组包括具有（严格）细菌、（严格）病毒或混合感染的患者，以及降钙素原、C 反应蛋白或血尿素氮值升高的患者。
2058 名患者（阿莫西林 n=1036；安慰剂 n=1022）被随机分组。治疗并未影响症状持续时间（n=1793）。仅分离出细菌病原体的患者（n=207）从阿莫西林治疗中受益，症状严重程度（n=804）降低了 0.26 分（95%CI-0.48 至-0.03）。当同时分离出细菌和病毒病原体时（混合感染；n=198），阿莫西林治疗使病情恶化的几率（n=2024）降低了 0.24（95%CI0.11 至 0.53）倍。
阿莫西林可能降低患有细菌和病毒混合感染的患者病情恶化的风险。我们在其他亚组中未发现阿莫西林治疗有临床意义的获益。
