背景:在现实临床环境中使用吸入器治疗的慢性阻塞性肺疾病(COPD)患者的症状状态和治疗变化尚不清楚,特别是根据治疗类别。我们调查了使用吸入器治疗的COPD患者中症状患者的比例,基于临床实践中的COPD评估测试(CAT)评分,以及1年随访时吸入器治疗和症状的变化。
方法:这是对多中心数据的回顾性分析,在日本有呼吸专家的医疗机构进行的前瞻性队列研究。主要终点是登记时每个吸入器治疗组中CAT评分≥10或<10的患者比例。
结果:在整个分析集中的414名患者中,76(18.4%),261(63.0%),和77(18.6%)使用长效毒蕈碱拮抗剂(LAMA),LAMA+长效β2-激动剂(LABA),吸入性皮质类固醇(ICS)+LABA,分别,在注册。登记时每个吸入器治疗组CAT评分≥10或<10的患者比例,分别,LAMA组中分别为32.9%和67.1%,LAMA+LABA组分别为55.0%和45.0%,ICS+LABA组为50.0%和50.0%。每个吸入器治疗组的大多数患者(>75%)在1年时吸入器治疗没有变化,无论他们在注册时的CAT分数如何。大约70-80%的患者在注册时CAT评分≥10在1年时仍有CAT评分≥10;10-30%的患者在注册时CAT评分<10在1年时CAT评分≥10。
结论:在现实世界的日本临床实践中,尽管使用了单吸入器或双吸入器治疗,仍有相当比例的患者出现持续性症状(CAT评分≥10);>75%的使用吸入器治疗的COPD有症状患者在1年随访时没有经历治疗升级,并且仍有症状.
背景:ClinicalTrials.gov标识符,NCT05903989。
BACKGROUND: Symptom status and treatment changes among patients with chronic obstructive pulmonary disease (COPD) using inhaler treatment in real-world clinical settings are not well understood, particularly according to class of treatment. We investigated the proportion of symptomatic patients among those with COPD using inhaler treatment, based on COPD Assessment Test (
CAT) scores in clinical practice, and changes in inhaler treatments and symptoms at 1-year follow-up.
METHODS: This was a retrospective analysis of data from a multicenter, prospective cohort
study conducted at medical institutions with respiratory specialists in Japan. The primary endpoint was the proportion of patients with CAT scores ≥ 10 or < 10 in each inhaler treatment group at registration.
RESULTS: Of 414 patients in the full analysis set, 76 (18.4%), 261 (63.0%), and 77 (18.6%) were using long-acting muscarinic antagonist (LAMA), LAMA + long-acting β2-agonist (LABA), and inhaled corticosteroids (ICS) + LABA, respectively, at registration. The proportions of patients with
CAT scores ≥ 10 or < 10 per inhaler treatment group at registration, respectively, were 32.9% and 67.1% in the LAMA group, 55.0% and 45.0% in the LAMA + LABA group, and 50.0% and 50.0% in the ICS + LABA group. Most patients (> 75%) in each inhaler treatment group showed no change in inhaler treatment at 1 year, regardless of their CAT score at registration. Approximately 70-80% of patients with
CAT scores ≥ 10 at registration still had
CAT scores ≥ 10 at 1 year; 10-30% of patients with
CAT scores < 10 at registration had
CAT scores ≥ 10 at 1 year.
CONCLUSIONS: In real-world Japanese clinical practice, a considerable proportion of patients have persistent symptoms (CAT score ≥ 10) despite using mono or dual inhaler treatment; > 75% of symptomatic patients with COPD using inhaler treatment did not undergo treatment escalation at 1-year follow-up and remained symptomatic.
BACKGROUND: ClinicalTrials.gov identifier, NCT05903989.