本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.8771

摘要内容如下：

重要性

慢性阻塞性肺疾病（COPD）是世界范围内发病率和死亡率的主要原因。观察性研究报道，β受体阻滞剂的使用可能与COPD急性加重的风险降低有关。然而，最近的一项试验报告称，美托洛尔并不能减少COPD急性加重，反而会增加需要住院的COPD急性加重。

目的

测试比索洛尔是否能降低COPD急性加重高危人群的COPD急性加重。

设计、设置和参与者

比索洛尔治疗COPD研究（BICS）是一项在英国76个地点（45个初级保健诊所和31个二级诊所）进行的双盲安慰剂对照随机临床试验。COPD患者在肺活量测定中至少有中度气流阻塞（呼气第一秒用力呼气量[FEV1]与用力肺活量的比值<0.7；FEV1<80%预计值）和至少2次在前12个月内接受口服皮质类固醇、抗生素或两者治疗的COPD急性加重患者于2018年10月17日至2022年5月31日入组。随访于2023年4月18日结束。

干预措施

患者被随机分配至比索洛尔组（n=261）或安慰剂组（n=258）。比索洛尔从每天口服1.25 mg开始，并在4个疗程中根据耐受情况滴定至最大剂量5 mg/d，使用标准化方案。

主要成果和措施

主要临床结果是在1年治疗期内使用口服皮质类固醇、抗生素或两者治疗的患者报告的COPD急性加重的数量。安全性结果包括严重不良事件和不良反应。

结果

尽管该试验计划招募1574名患者，但由于COVID-19大流行，从2020年3月16日至2021年7月31日暂停招募。每组中有两名患者在随机化后被排除。在515名患者中（平均[SD]年龄，68[7.9]岁；274名男性[53%]；平均FEV1，50.1%），514名患者（99.8%）和371名（72.0%）继续服用研究药物的主要结果数据可用。比索洛尔组患者报告的口服皮质类固醇、抗生素或两者联合治疗的COPD急性加重的主要转归为526例，平均急性加重率为2.03/年，而安慰剂组为513例，平均急性加重率为2.01/年。调整后的发病率比值为0.97（95%CI，0.84-1.13；P=.72）。比索洛尔组255例患者中有37例（14.5%）发生严重不良事件，安慰剂组251例患者中有36例（14.3%）发生严重不良事件。相对危险度1.01；95%可信区间为0.62~1.66；P=.96）。

结论和相关性

在COPD急性加重高危人群中，比索洛尔治疗并不能减少自我报告的需要口服皮质类固醇、抗生素或两者治疗的COPD急性加重患者的数量。

试用注册

ISRCTN.org标识符：ISRCTN10497306

英文原文如下：

Abstracts

Importance  Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Observational studies report that β-blocker use may be associated with reduced risk of COPD exacerbations. However, a recent trial reported that metoprolol did not reduce COPD exacerbations and increased COPD exacerbations requiring hospital admission.

Objective  To test whether bisoprolol decreased COPD exacerbations in people with COPD at high risk of exacerbations.

Design, Setting, and Participants  The Bisoprolol in COPD Study (BICS) was a double-blind placebo-controlled randomized clinical trial conducted in 76 UK sites (45 primary care clinics and 31 secondary clinics). Patients with COPD who had at least moderate airflow obstruction on spirometry (ratio of forced expiratory volume in the first second of expiration [FEV1] to forced vital capacity <0.7; FEV1 <80% predicted) and at least 2 COPD exacerbations treated with oral corticosteroids, antibiotics, or both in the prior 12 months were enrolled from October 17, 2018, to May 31, 2022. Follow-up concluded on April 18, 2023.

Interventions  Patients were randomly assigned to bisoprolol (n = 261) or placebo (n = 258). Bisoprolol was started at 1.25 mg orally daily and was titrated as tolerated during 4 sessions to a maximum dose of 5 mg/d, using a standardized protocol.

Main Outcomes and Measures  The primary clinical outcome was the number of patient-reported COPD exacerbations treated with oral corticosteroids, antibiotics, or both during the 1-year treatment period. Safety outcomes included serious adverse events and adverse reactions.

Results  Although the trial planned to enroll 1574 patients, recruitment was suspended from March 16, 2020, to July 31, 2021, due to the COVID-19 pandemic. Two patients in each group were excluded postrandomization. Among the 515 patients (mean [SD] age, 68 [7.9] years; 274 men [53%]; mean FEV1, 50.1%), primary outcome data were available for 514 patients (99.8%) and 371 (72.0%) continued taking the study drug. The primary outcome of patient-reported COPD exacerbations treated with oral corticosteroids, antibiotics, or both was 526 in the bisoprolol group, with a mean exacerbation rate of 2.03/y, vs 513 exacerbations in the placebo group, with a mean exacerbation rate of 2.01/y. The adjusted incidence rate ratio was 0.97 (95% CI, 0.84-1.13; P = .72). Serious adverse events occurred in 37 of 255 patients in the bisoprolol group (14.5%) vs 36 of 251 in the placebo group (14.3%; relative risk, 1.01; 95% CI, 0.62-1.66; P = .96).

Conclusions and Relevance  Among people with COPD at high risk of exacerbation, treatment with bisoprolol did not reduce the number of self-reported COPD exacerbations requiring treatment with oral corticosteroids, antibiotics, or both.

Trial Registration  isrctn.org Identifier: ISRCTN10497306.

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