根据基线 FEV 水平，GOLD 组 B COPD 患者中支气管扩张剂双联治疗与单药治疗的比较：III 期随机临床试验的患者水平汇总分析。
Dual versus monotherapy with bronchodilators in GOLD group B COPD patients according to baseline FEV level: a patient-level pooled analysis of phase-3 randomized clinical trials.
机构信息
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Republic of Korea.
Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Seoul, Republic of Korea.
出版信息
Respir Res. 2021 Feb 12;22(1):55. doi: 10.1186/s12931-021-01648-5.
BACKGROUND
Which patients should receive dual therapy as initial treatment for chronic obstructive pulmonary disease (COPD) is only loosely defined. We evaluated if a lower forced expiratory volume in 1 s (FEV) identifies a population more likely to benefit from dual therapy than monotherapy among group B COPD patients in whom Global initiative for Chronic Obstructive Pulmonary Disease (GOLD) recommends monotherapy as initial treatment.
METHODS
This was a patient-level pooled analysis of phase-3 randomized controlled trials involving dual bronchodilators. Study patients were classified into two groups based on the FEV of 50% of the predicted value (GOLD I/II versus GOLD III/IV). We evaluated the efficacy of dual versus monotherapy (long-acting beta-2 agonist [LABA] or long-acting muscarinic antagonist [LAMA]) between these two groups in the following outcomes: changes in trough FEV, the St. George's Respiratory Questionnaire (SGRQ) score, the proportion of SGRQ responders, time to first exacerbation, and risk of adverse events.
RESULTS
A total of 14,449 group B patients from 12 studies were divided into GOLD III/IV (n = 8043) or GOLD I/II group (n = 6406). In the GOLD III/IV group, dual therapy was significantly more effective in improving FEV, reducing SGRQ scores, and achieving a higher proportion of SGRQ responders compared with either LABA or LAMA. Dual therapy also showed a significantly longer time to first exacerbation compared with LABA in the GOLD III/IV group. In contrast, in the GOLD I/II group, the benefits of dual therapy over monotherapy were less consistent. Although dual therapy resulted in significantly higher FEV than either LABA or LAMA, it did not show significant differences in the SGRQ score and proportion of SGRQ responders as compared with LABA. The time to first exacerbation was also not significantly different between dual therapy and either LABA or LAMA in the GOLD I/II group.
CONCLUSIONS
Dual therapy demonstrated benefits over monotherapy more consistently in patients with lower FEV than those with higher FEV.
背景
对于慢性阻塞性肺疾病（COPD）患者，哪些患者应接受双联治疗作为初始治疗方法尚未明确界定。我们评估了在全球慢性阻塞性肺疾病倡议（GOLD）推荐作为初始治疗的 B 组 COPD 患者中，用力呼气量（FEV）较低的患者是否比单药治疗更有可能从双联治疗中获益。
方法
这是一项针对涉及双支气管扩张剂的 3 期随机对照试验的患者水平汇总分析。根据预测值的 50%（GOLD I/II 与 GOLD III/IV）FEV ，将研究患者分为两组。我们评估了这两组患者中，双药治疗（长效β2 激动剂[LABA]或长效抗胆碱能药物[LAMA]）与单药治疗相比在以下结局方面的疗效差异：FEV 谷值变化、圣乔治呼吸问卷（SGRQ）评分、SGRQ 应答者比例、首次加重时间和不良事件风险。
结果
共有 12 项研究的 14449 名 B 组患者被分为 GOLD III/IV（n=8043）或 GOLD I/II 组（n=6406）。在 GOLD III/IV 组中，与 LABA 或 LAMA 相比，双药治疗在改善 FEV、降低 SGRQ 评分和获得更高比例的 SGRQ 应答者方面更为有效。与 LABA 相比，双药治疗也显示出在 GOLD III/IV 组中首次加重时间显著延长。相比之下，在 GOLD I/II 组中，双药治疗比单药治疗的优势不太一致。虽然双药治疗与 LABA 或 LAMA 相比，FEV 显著升高，但与 LABA 相比，SGRQ 评分和 SGRQ 应答者比例差异无统计学意义。在 GOLD I/II 组中，双药治疗与 LABA 或 LAMA 相比，首次加重时间也无显著差异。
结论
在 FEV 较低的患者中，双药治疗比单药治疗更能带来获益，而在 FEV 较高的患者中，这种获益并不一致。
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