真实世界使用双联支气管扩张剂治疗慢性阻塞性肺疾病患者的临床特征及治疗规范性分析

Clinical characteristics and therapy norms for patients with COPD treated with LAMA/LABA fixed-dose combination in the real world

目的 观察真实世界中使用长效β受体激动剂(LABA)和长效抗胆碱能药物(LAMA)(LABA/LAMA,双支扩剂)固定剂量联合制剂(FDC)治疗的慢性阻塞性肺疾病(COPD)患者的临床特征,并分析上述患者使用LABA/LAMA FDC是否遵循指南的推荐意见。方法 选取2018年12月—2021年12月于呼吸科就诊并予以LABA/LAMA FDC治疗的COPD患者,按照入组前是否使用其他维持治疗药物分为初始组和原LAMA组、原ICS(吸入性糖皮质激素)/LABA组、原ICS/LABA+LAMA组,分析各组基线特征,包括COPD评估测试(CAT)评分、呼吸困难指数(mMRC)评分,年中度、重度急性加重次数,肺功能等。结果 本研究共纳入691名COPD患者,平均年龄为(65.67±8.28)岁,CAT<10分的患者占比23.59%,10~19分占55.43%,≥20分占20.98%,平均CAT为(14.63±6.57)分,B组(mMRC≥2分,CAT评分≥10分,且0~1次中度急性加重)患者占比42.11%,D组(mMRC≥2分,CAT评分≥ 10分,且≥2次中度急性加重或≥ 1次重度急性加重)占比37.19%,80.75%患者的肺功能为GOLD2~3级。初始组占总研究人群75.69%,CAT<10分的患者占24.67%,10~19分占55.45%,≥20分占19.88%,平均CAT为(14.28±6.34)分,43.40%的患者分在B组,31.93%为D组患者;原LAMA组、原ICS/LABA组、原ICS/LABA+LAMA组在总研究人群占比分别为7.53%、10.56%、6.22%。结论 在真实世界中,双支扩剂主要用于COPD患者的初始启动维持治疗,其中绝大部分双支扩剂治疗患者为中度和重度COPD,临床症状较重,一部分用于调整治疗,基本与GOLD推荐一致。但临床实践中,临床医师处方部分双支扩剂患者的症状较GOLD推荐轻,甚至推荐了部分症状轻的患者使用双支扩剂。

Objective To describe the clinical characteristics in the real world chronic obstructive pulmonary disease (COPD) patients treated with long-acting β-agonist and long-acting muscarinic antagonist (LABA/LAMA) fixed-dose combination (FDC).Methods Patients were included in the study cohort if they had a diagnosis of COPD and at least one prescription of LABA/LAMA FDC therapy between December 2018 and December 2021.According to whether another maintenance medication was used before the enrollment,they were divided into an initial group,a prior LAMA group,a prior ICS/LABA group,and a prior ICS/LABA plus LAMA group.The baseline clinical characteristics of each group were analyzed,including CAT,mMRC score,moderate or severe acute exacerbations over the past year,and spirometry results.Results Totally 691 COPD patients were included,with an average age of (65.67±8.28) years.The mean CAT score was (14.63±6.57),with CAT<10 accounting for 23.59%,CAT 10~19 accounting for 55.43% and CAT≥20 about 20.98%.The distribution of patients according to GOLD stage and claasification was 80.75% from 2 to 3,42.11% in group B (0~1 moderate exacerbations per year,mMRC ≥2 and or CAT ≥10) and 37.19% in group D (≥2 moderate exacerbations per year,≥1 severe exacerbation,mMRC ≥2 and or CAT ≥10) respectively,75.69% of participants initiating LABA/LAMA FDC treatment had a mean CAT (14.28±6.34),with classifications as follows:CAT<10 (24.67%),CAT 10~19 (55.45%),and CAT≥20 (19.88%).43.40% of patients in the initial group were in GOLD B group and 31.93% in GOLD D group,The proportion of patients who switched from the LAMA group,the ICS/LABA group,or the ICS/LABA+LAMA group to LABA/LAMA FDC was 7.53%,10.56%,and 6.22%,respectively.Conclusion In the real world,LABA/LAMA FDC is mainly used for initial maintenance therapy in COPD patients and the majority were moderate and severe COPD with multi-symptoms.A small part of patients change from other prescriptions to double bronchodilators.The application of LABA/LAMA FDC follows the recommendations of the GOLD.But in the real world,LABA/LAMA FDC were precribed to patients with fewer symptoms than recommendations,even some patients with mild symptoms were treated with LABA/LAMA FDC.