单位：[1]Department of Pulmonary and Critical Care Medicine, Capital Medical University, Beijing, China[2]Department of Pulmonary and Critical Care Medicine,National Center for Respiratory Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China–Japan Friendship Hospital, Beijing, China[3]Department of Pulmonary and Critical Care Medicine,Beijing Luhe Hospital, Capital Medical University, Beijing, China[4]Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China[5]Department of Pulmonary and Critical Care Medicine, Daxing teaching hospital of Capital Medical University, Beijing, China[6]Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China[7]Tsinghua University-Peking University Joint Center for Life Sciences, Beijing, China
Introduction Current antibiotic prescription for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is generally based on the Anthonisen criteria in The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline that have a potential risk of antibiotics overuse. The dilemma is to identify patients who are most likely to benefit from antibiotics while avoiding unnecessary antibiotic use. Procalcitonin (PCT), a more sensitive and specific biomarker of bacterial infection than other conventional laboratory tests, has the potential to determine those patients in whom antibiotics would be beneficial. It is unclear whether PCT-guided antibiotic therapy is safe and effective for patients hospitalised with AECOPD. The study hypothesis is that PCT-guided antibiotic therapy could reduce the antibiotic prescription rate for AECOPD, compared with the GOLD guideline recommendations, without negatively impacting the treatment success rate. Methods and analysis In this multicenter, open-label, randomised controlled trial, we aim to enrol 500 hospitalised patients with AECOPD that will be randomly assigned to either a PCT-guided group or a GOLD guideline-guided group. The coprimary endpoints are antibiotic prescription rate for AECOPD within 30 days post randomisation and treatment success rate at day 30 post randomisation. The secondary outcomes include: antibiotic prescription rate at day 1 post randomisation; hospital antibiotic exposure; length of hospital stay; rate of subsequent exacerbation and hospital readmission; overall mortality within 30 days post randomisation; changes in lung function and the score of COPD assessment test and modified Medical Research Council; and rate of intensive care unit admission. Ethics and dissemination This trial has been approved by the ethic committee of China-Japan Friendship Hospital. The findings of the study will be disseminated in peer-reviewed journals. If the results of the study are positive, PCT-guided antibiotic therapy is likely to change the guidelines for antibiotic recommendations for patients with AECOPD.
基金：
Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences [CIFMS 2018-I2M-1-003, 2020-I2M-CoV19-005]
第一作者单位：[1]Department of Pulmonary and Critical Care Medicine, Capital Medical University, Beijing, China[2]Department of Pulmonary and Critical Care Medicine,National Center for Respiratory Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China–Japan Friendship Hospital, Beijing, China
通讯作者：
通讯机构：[1]Department of Pulmonary and Critical Care Medicine, Capital Medical University, Beijing, China[2]Department of Pulmonary and Critical Care Medicine,National Center for Respiratory Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China–Japan Friendship Hospital, Beijing, China[6]Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China[7]Tsinghua University-Peking University Joint Center for Life Sciences, Beijing, China
推荐引用方式(GB/T 7714)：
Lixue Huang,Jinxiang Wang,Xiaoying Gu,et al.Procalcitonin-guided initiation of antibiotics in AECOPD inpatients: study protocol for a multicenter randomised controlled trial[J].BMJ OPEN.2021,11(8):doi:10.1136/bmjopen-2021-049515.
APA：
Lixue Huang,Jinxiang Wang,Xiaoying Gu,Weili Sheng,Yeming Wang&Bin Cao.(2021).Procalcitonin-guided initiation of antibiotics in AECOPD inpatients: study protocol for a multicenter randomised controlled trial.BMJ OPEN,11,(8)
MLA：
Lixue Huang,et al."Procalcitonin-guided initiation of antibiotics in AECOPD inpatients: study protocol for a multicenter randomised controlled trial".BMJ OPEN 11..8(2021)
