Objectives

To determine the benefits and harms of discontinuing unnecessary antibiotic therapy for uncomplicated respiratory tract infections (RTI) when antibiotics are considered no longer necessary.

Methods

Multicentre, open-label, randomized controlled clinical trial in primary care centres from 2017 to 2020 (ClinicalTrials.gov, NCT02900820). Adults with RTIs—acute rhinosinusitis, sore throat, influenza or acute bronchitis—who had previously taken any dose of antibiotic for less than 3 days, which physicians no longer deemed necessary were recruited. The patients were randomly assigned in a 1:1 ratio to discontinuing antibiotic therapy or the usual strategy of continuing antibiotic treatment. The primary outcome was the duration of severe symptoms (number of days scoring 5 or 6 on a six-item Likert scale). Secondary outcomes included days with symptoms, moderate symptoms (scores of 3 or 4), antibiotics taken, adverse events, patient satisfaction and complications within the first 3 months.

Results

A total of 467 patients were randomized, out of which 409 were considered valid for the analysis. The mean (SD) duration of severe symptoms was 3.0 (1.5) days for the patients assigned to discontinuation and 2.8 (1.3) days for those allocated to the control group (mean difference 0.2 days; 95% CI –0.1 to 0.4 days). Patients randomized to the discontinuation group used fewer antibiotics after the baseline visit (52/207 (25.1%) versus 182/202 (90.1%); p 0.001). Patients assigned to antibiotic continuation presented a relative risk of adverse events of 1.47 (95% CI 0.80–2.71), but the need for further health-care contact in the following 3 months was slightly lower (RR 0.61; 95% CI 0.28–1.37).

Conclusions

Discontinuing antibiotic treatment for uncomplicated RTIs when clinicians consider it unnecessary is safe and notably reduces antibiotic consumption.

中文翻译：

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在认为不必要时停止对单纯性呼吸道感染进行抗生素治疗的有效性和安全性。初级保健中的多中心、随机临床试验

目标

当认为不再需要抗生素时，确定对单纯性呼吸道感染 (RTI) 停止不必要的抗生素治疗的益处和危害。

方法

2017 年至 2020 年在初级保健中心开展的多中心、开放标签、随机对照临床试验 (ClinicalTrials.gov, NCT02900820)。招募了患有 RTIs（急性鼻窦炎、喉咙痛、流感或急性支气管炎）的成年人，他们之前服用过任何剂量的抗生素不到 3 天，医生认为不再需要这些。患者按 1:1 的比例随机分配至停止抗生素治疗或继续抗生素治疗的常规策略组。主要结果是严重症状的持续时间（在六项李克特量表上得分为 5 或 6 的天数）。次要结果包括出现症状的天数、中度症状（评分为 3 或 4）、服用的抗生素、不良事件、患者满意度和前 3 个月内的并发症。

结果

共有 467 名患者被随机分组​​，其中 409 名被认为对分析有效。分配到停药组的患者严重症状的平均 (SD) 持续时间为 3.0 (1.5) 天，分配到对照组的患者为 2.8 (1.3) 天（平均差 0.2 天；95% CI –0.1 至 0.4 天）。随机分配到停药组的患者在基线访视后使用较少的抗生素（52/207（25.1%）对 182/202（90.1%）；p = 0.001）。被分配到继续使用抗生素的患者出现不良事件的相对风险为 1.47（95% CI 0.80–2.71），但在接下来的 3 个月内进一步就医的需求略低（RR 0.61；95% CI 0.28–1.37） ）。

结论

当临床医生认为没有必要时停止对非复杂性 RTIs 的抗生素治疗是安全的，并且显着减少了抗生素的消耗。