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降钙素原和肺部超声即时检验用于指导基层医疗机构下呼吸道感染患者抗生素处方:实用型整群随机试验。

Procalcitonin and lung ultrasonography point-of-care testing to determine antibiotic prescription in patients with lower respiratory tract infection in primary care: pragmatic cluster randomised trial.

机构信息

Infectious Diseases Service, Lausanne University Hospital, Lausanne, Switzerland.

Institute for Infectious Diseases, University of Bern, Bern, Switzerland.

出版信息

BMJ. 2021 Sep 21;374:n2132. doi: 10.1136/bmj.n2132.

Abstract

OBJECTIVE

To assess whether point-of care procalcitonin and lung ultrasonography can safely reduce unnecessary antibiotic treatment in patients with lower respiratory tract infections in primary care.

DESIGN

Three group, pragmatic cluster randomised controlled trial from September 2018 to March 2020.

SETTING

60 Swiss general practices.

PARTICIPANTS

One general practitioner per practice was included. General practitioners screen all patients with acute cough; patients with clinical pneumonia were included.

INTERVENTIONS

Randomisation in a 1:1:1 of general practitioners to either antibiotics guided by sequential procalcitonin and lung ultrasonography point-of-care tests (UltraPro; n=152), procalcitonin guided antibiotics (n=195), or usual care (n=122).

MAIN OUTCOMES

Primary outcome was proportion of patients in each group prescribed an antibiotic by day 28. Secondary outcomes included duration of restricted activities due to lower respiratory tract infection within 14 days.

RESULTS

60 general practitioners included 469 patients (median age 53 years (interquartile range 38-66); 278 (59%) were female). Probability of antibiotic prescription at day 28 was lower in the procalcitonin group than in the usual care group (0.40 0.70, cluster corrected difference -0.26 (95% confidence interval -0.41 to -0.10)). No significant difference was seen between UltraPro and procalcitonin groups (0.41 0.40, -0.03 (-0.17 to 0.12)). The median number of days with restricted activities by day 14 was 4 days in the procalcitonin group and 3 days in the usual care group (difference 1 day (95% confidence interval -0.23 to 2.32); hazard ratio 0.75 (95% confidence interval 0.58 to 0.97)), which did not prove non-inferiority.

CONCLUSIONS

Compared with usual care, point-of-care procalcitonin led to a 26% absolute reduction in the probability of 28 day antibiotic prescription without affecting patients' safety. Point-of-care lung ultrasonography did not further reduce antibiotic prescription, although a potential added value cannot be excluded, owing to the wide confidence intervals.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03191071.

摘要

目的

评估在初级保健中,即时检测降钙素原和肺部超声是否能安全减少下呼吸道感染患者不必要的抗生素治疗。

设计

2018 年 9 月至 2020 年 3 月进行的三组、实用、集群随机对照试验。

地点

60 家瑞士全科诊所。

参与者

每家诊所纳入一位全科医生。全科医生对所有急性咳嗽患者进行筛查;纳入有临床肺炎的患者。

干预措施

按 1:1:1 的比例将全科医生随机分为三组,分别接受即时检测降钙素原和肺部超声的抗生素指导(UltraPro;n=152)、降钙素原指导的抗生素治疗(n=195)或常规治疗(n=122)。

主要结局

主要结局是每组患者在第 28 天开具抗生素的比例。次要结局包括在 14 天内因下呼吸道感染限制活动的持续时间。

结果

60 名全科医生纳入了 469 名患者(中位数年龄 53 岁(四分位距 38-66);278 名(59%)为女性)。与常规治疗组相比,降钙素原组第 28 天开具抗生素的可能性较低(0.40 0.70,集群校正差异-0.26(95%置信区间-0.41 至 -0.10))。UltraPro 组和降钙素原组之间未见显著差异(0.41 0.40,-0.03(-0.17 至 0.12))。降钙素原组第 14 天限制活动的中位数天数为 4 天,常规治疗组为 3 天(差异 1 天(95%置信区间-0.23 至 2.32);风险比 0.75(95%置信区间 0.58 至 0.97)),未证明非劣效性。

结论

与常规治疗相比,即时检测降钙素原可使 28 天抗生素开具的可能性绝对降低 26%,而不影响患者的安全性。即时检测肺部超声并未进一步减少抗生素的开具,尽管由于置信区间较宽,不能排除潜在的附加价值。

试验注册

ClinicalTrials.gov NCT03191071。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6a04/9083102/df4be30ac77f/lhol063784.f1.jpg

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