Doctor Carles Ribas Primary Care Center, Barcelona, Spain.
Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau, Barcelona, Spain.
JAMA Intern Med. 2016 Jan;176(1):21-9. doi: 10.1001/jamainternmed.2015.7088.
Delayed antibiotic prescription helps to reduce antibiotic use with reasonable symptom control. There are different strategies of delayed prescription, but it is not yet clear which one is the most effective.
To determine the efficacy and safety of 2 delayed strategies in acute, uncomplicated respiratory infections.
DESIGN, SETTING, AND PARTICIPANTS: We recruited 405 adults with acute, uncomplicated respiratory infections from 23 primary care centers in Spain to participate in a pragmatic, open-label, randomized clinical trial.
Patients were randomized to 1 of 4 potential prescription strategies: (1) a delayed patient-led prescription strategy; (2) a delayed prescription collection strategy requiring patients to collect their prescription from the primary care center; (3) an immediate prescription strategy; or (4) a no antibiotic strategy. Delayed prescription strategies consist of prescribing an antibiotic to take only if the symptoms worsen or if there is no improvement several days after the medical visit.
The primary outcomes were the duration of symptoms and severity of symptoms. Each symptom was scored using a 6-point Likert scale (scores of 3 or 4 were considered moderate; 5 or 6, severe). Secondary outcomes included antibiotic use, patient satisfaction, and patients' beliefs in the effectiveness of antibiotics.
A total of 405 patients were recruited, 398 of whom were included in the analysis; 136 patients (34.2%) were men; mean (SD) age, 45 (17) years. The mean severity of symptoms ranged from 1.8 to 3.5 points on the Likert scale, and mean (SD) duration of symptoms described on first visit was 6 (6) days. The mean (SD) general health status on first visit was 54 (20) based on a scale with 0 indicating worst health status; 100, best status. Overall, 314 patients (80.1%) were nonsmokers, and 372 patients (93.5%) did not have a respiratory comorbidity. The presence of symptoms on first visit was similar among the 4 groups. The mean (SD) duration of severe symptoms was 3.6 (3.3) days for the immediate prescription group and 4.7 (3.6) days for the no prescription group. The median (interquartile range [IQR]) of severe symptoms was 3 (1-4) days for the prescription collection group and 3 (2-6) days for the patient-led prescription group. The median (IQR) of the maximum severity for any symptom was 5 (3-5) for the immediate prescription group and the prescription collection group; 5 (4-5) for the patient-led prescription group; and 5 (4-6) for the no prescription group. Patients randomized to the no prescription strategy or to either of the delayed strategies used fewer antibiotics and less frequently believed in antibiotic effectiveness. Satisfaction was similar across groups.
Delayed strategies were associated with slightly greater but clinically similar symptom burden and duration and also with substantially reduced antibiotic use when compared with an immediate strategy.
clinicaltrials.gov Identifier: NCT01363531.
延迟开抗生素处方有助于在合理控制症状的同时减少抗生素的使用。有不同的延迟处方策略，但目前尚不清楚哪种策略最有效。
确定 2 种延迟策略在急性、非复杂性呼吸道感染中的疗效和安全性。
设计、地点和参与者：我们从西班牙 23 个初级保健中心招募了 405 名患有急性、非复杂性呼吸道感染的成年人，参与一项实用、开放性、随机临床试验。
患者被随机分配到 4 种潜在处方策略中的 1 种：（1）患者主导的延迟处方策略；（2）需要患者从初级保健中心领取处方的延迟处方收集策略；（3）立即处方策略；或（4）无抗生素策略。延迟处方策略包括开抗生素，仅在症状恶化或医疗就诊后数天无改善时服用。
主要结局是症状持续时间和严重程度。每个症状均采用 6 分李克特量表进行评分（3 或 4 分为中度；5 或 6 分为重度）。次要结局包括抗生素使用、患者满意度以及患者对抗生素有效性的信念。
共招募了 405 名患者，其中 398 名患者纳入分析；136 名患者（34.2%）为男性；平均（SD）年龄为 45（17）岁。症状严重程度的平均评分范围为 1.8 至 3.5 分，首次就诊时症状持续时间的平均（SD）为 6（6）天。首次就诊时的平均（SD）一般健康状况为 54（20）分，0 分表示最差的健康状况；100 分为最佳状态。总体而言，314 名患者（80.1%）为不吸烟者，372 名患者（93.5%）无呼吸系统合并症。4 组患者首次就诊时的症状均相似。立即处方组严重症状的平均（SD）持续时间为 3.6（3.3）天，无处方组为 4.7（3.6）天。处方收集组和患者主导的处方组中严重症状的中位数（四分位距[IQR]）分别为 3（1-4）天和 3（2-6）天。任何症状的最大严重程度中位数（IQR）为 5（3-5）分，即立即处方组和处方收集组；5（4-5）分，即患者主导的处方组；5（4-6）分，即无处方组。随机分配至无处方策略或任何延迟策略组的患者使用的抗生素较少，且不太相信抗生素的有效性。各组的满意度相似。
与立即策略相比，延迟策略与症状负担和持续时间略有增加但临床相似，也与抗生素使用量大幅减少相关。
clinicaltrials.gov 标识符：NCT01363531。
