Sheng Weili, Huang Lixue, Gu Xiaoying, Wang Yeming, Jiang Mingyan, Hu Chao, Li Jingya, Ran Chunxue, Zhang Hongxu, Wang Na, Wang Yuling, Qi Xiaowei, Suo Lijun, Liu Bo, Pei Guangsheng, He Zhiyi, Wang Jinxiang, Cao Bin
Department of Pulmonary and Critical Care Medicine, Capital Medical University, Beijing, China; 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; Department of Pulmonary and Critical Care Medicine, Daxing Teaching Hospital of Capital Medical University, Beijing, China.
Department of Pulmonary and Critical Care Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Science, Beijing, China.
Clin Microbiol Infect. 2025 May;31(5):785-792. doi: 10.1016/j.cmi.2024.12.004. Epub 2024 Dec 9.
The objectives of this study are to analyse the effect and safety of procalcitonin (PCT)-guided antibiotic therapy in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
We conducted a multicentre, open-label, randomized controlled trial amongst patients hospitalized for AECOPD in six hospitals in China. Enrolled patients were randomly assigned to either the PCT-guided group or the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy-guided group. The co-primary endpoints were antibiotic prescription rate for AECOPD within 30 days after randomization (to demonstrate superiority) and treatment success rate at day 30 after randomization (to demonstrate non-inferiority). For primary outcomes, χ test, corrected χ test, or Fisher's exact test was used to evaluate the differences between the intervention and control groups. 95% CIs were calculated for all the outcomes. Secondary outcomes, including days of antibiotic use during hospitalization, length of hospital stay, and change in modified Medical Research Council dyspnoea scale and COPD Assessment Test score, were compared using the Student's t-test, with corresponding differences and 95% CIs calculated. Intention-to-treat (ITT) population were those who were randomly assigned, and per-protocol population were those who strictly adhered to the treatment plan.
A total of 455 patients were randomly assigned, with 229 in the PCT-guided group and 226 in the GOLD-guided group. The rate of antibiotic prescription for AECOPD by day 30 was significantly lower in the PCT-guided group than that in the GOLD-guided group (38% [88/229] vs. 59% [134/226]; difference -21%; 95% CI: -30% to -12%; p < 0.0001) in the ITT analysis. There was no significant difference in the clinical treatment success rate by day 30 between the 2 groups (97% [223/229] vs. 94% [212/229]; difference 4%, 95% CI: 0-7%; p 0.06). Compared with the GOLD strategy, PCT-guided antibiotic therapy was significantly associated with lower antibiotic prescription rate during hospitalization (37% vs. 59%, difference -22%, 95% CI: -31 to -13; p < 0.0001), and fewer days of antibiotic use during hospitalization (2.63 ± 4.66 vs. 4.86 ± 4.83, difference -2.23 days, 95% CI: -1.35 to -3.11; p < 0.0001). There were no significant differences between the two groups in length of hospital stay, subsequent exacerbation rate, hospital readmission rate, intensive care unit admission, and 30-day mortality in the ITT analysis. The results in the per-protocol analysis were consistent with that in the ITT analysis.
Compared with the GOLD strategy, PCT-guided antibiotic therapy significantly reduced the rate of antibiotic prescription for patients with AECOPD, without negatively affecting the treatment success rate.
本研究旨在分析降钙素原（PCT）指导下的抗生素治疗对慢性阻塞性肺疾病急性加重期（AECOPD）患者的疗效和安全性。
我们在中国六家医院对因AECOPD住院的患者进行了一项多中心、开放标签、随机对照试验。入选患者被随机分配到PCT指导组或慢性阻塞性肺疾病全球倡议（GOLD）策略指导组。共同主要终点为随机分组后30天内AECOPD的抗生素处方率（以证明优越性）和随机分组后30天的治疗成功率（以证明非劣效性）。对于主要结局，采用χ检验、校正χ检验或Fisher精确检验来评估干预组和对照组之间的差异。所有结局均计算95%置信区间（CI）。次要结局包括住院期间抗生素使用天数、住院时间、改良医学研究委员会呼吸困难量表和慢性阻塞性肺疾病评估测试评分的变化，采用Student's t检验进行比较，并计算相应的差异和95%CI。意向性分析（ITT）人群为随机分配的患者，符合方案分析（PP）人群为严格遵守治疗方案的患者。
共455例患者被随机分配，PCT指导组229例，GOLD指导组226例。ITT分析中，PCT指导组随机分组后30天AECOPD的抗生素处方率显著低于GOLD指导组（38%[88/229]对59%[134/226]；差异-21%；95%CI：-30%至-12%；p<0.0001）。两组在随机分组后30天的临床治疗成功率无显著差异（97%[223/229]对94%[212/229]；差异4%，95%CI：0-7%；p=0.06）。与GOLD策略相比，PCT指导下的抗生素治疗与住院期间较低的抗生素处方率显著相关（37%对59%；差异-22%，95%CI：-31至-13；p<0.0001），且住院期间抗生素使用天数更少（2.63±4.66对4.86±4.83；差异-2.23天，95%CI：-1.35至-3.11；p<0.0001）。ITT分析中，两组在住院时间、后续加重率、再入院率、重症监护病房入住率和30天死亡率方面无显著差异。符合方案分析的结果与ITT分析一致。
与GOLD策略相比，PCT指导下的抗生素治疗显著降低了AECOPD患者的抗生素处方率，且对治疗成功率无负面影响。
