Tandan Meera, Vellinga Akke, Bruyndonckx Robin, Little Paul, Verheij Theo, Butler Chris C, Goossens Herman, Coenen Samuel
Discipline of General Practice, School of Medicine, National University of Ireland Galway (NUIG), Galway, Ireland.
Discipline of Bacteriology, School of Medicine, National University of Ireland Galway (NUIG), Galway, Ireland.
Antibiotics (Basel). 2017 Dec 13;6(4):36. doi: 10.3390/antibiotics6040036.
A European placebo-controlled trial of antibiotic treatment for lower respiratory tract infection (LRTI) conducted in 16 primary care practices networks recruited participants between November 2007 and April 2010, and found adverse events (AEs) occurred more often in patients prescribed amoxicillin compared to placebo. This secondary analysis explores the causal relationship and estimates specific AEs (diarrhoea, nausea, rash) due to amoxicillin treatment for LRTI, and if any subgroup is at increased risk of any or a specific AE. A total of 2061 patients were randomly assigned to amoxicillin (1038) and placebo (1023); 595 (28%) were 60 and older. A significantly higher proportion of any AEs (diarrhoea or nausea or rash) (OR = 1.31, 95% CI 1.05-1.64, number needed to harm (NNH) = 24) and of diarrhoea (OR 1.43 95% CI 1.08-1.90, NNH = 29) was reported in the amoxicillin group during the first week after randomisation. Subgroup analysis showed rash was significantly more often reported in males prescribed amoxicillin (interaction term 3.72 95% CI 1.22-11.36; OR of amoxicillin in males 2.79 (95% CI 1.08-7.22). No other subgroup at higher risk was identified. Although the study was not powered for subgroup analysis, this analysis suggests that most patients are likely to be equally harmed when prescribed antibiotics.
一项在16个初级保健实践网络中开展的欧洲抗生素治疗下呼吸道感染（LRTI）的安慰剂对照试验，于2007年11月至2010年4月招募参与者，结果发现与安慰剂相比，使用阿莫西林治疗的患者不良事件（AE）发生率更高。这项二次分析探讨了因果关系，并估计了阿莫西林治疗LRTI导致的特定不良事件（腹泻、恶心、皮疹），以及是否有任何亚组发生任何不良事件或特定不良事件的风险增加。共有2061名患者被随机分配至阿莫西林组（1038名）和安慰剂组（1023名）；595名（28%）患者年龄在60岁及以上。在随机分组后的第一周，阿莫西林组报告的任何不良事件（腹泻或恶心或皮疹）（比值比[OR]=1.31，95%置信区间[CI]1.05 - 1.64，伤害所需人数[NNH]=24）和腹泻（OR 1.43，95% CI 1.08 - 1.90，NNH = 29）的比例显著更高。亚组分析显示，使用阿莫西林治疗的男性报告皮疹的情况显著更常见（交互项3.72，95% CI 1.22 - 11.36；男性使用阿莫西林的OR为2.79（95% CI 1.08 - 7.22））。未发现其他风险更高的亚组。尽管该研究没有足够的效力进行亚组分析，但该分析表明，大多数患者在使用抗生素治疗时可能受到同等程度的伤害。
