日本慢性阻塞性肺疾病的真实世界治疗模式和患者报告结局：REMIND 研究。
Real-World Treatment Patterns and Patient-Reported Outcomes in Chronic Obstructive Pulmonary Disease in Japan: The REMIND Study.
机构信息
Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, 30-1 Oyaguchi Kamicho, Itabashi, Tokyo, 173-8610, Japan.
Medical Department, AstraZeneca K.K., Osaka, Japan.
出版信息
Adv Ther. 2024 Sep;41(9):3585-3597. doi: 10.1007/s12325-024-02927-5. Epub 2024 Jul 24.
INTRODUCTION
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 β-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.
CONCLUSION
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.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT05903989.
简介
在真实临床环境中，使用吸入器治疗的慢性阻塞性肺疾病（COPD）患者的症状状况和治疗变化尚不清楚，特别是根据治疗类别。我们根据 COPD 评估测试（CAT）评分调查了使用吸入器治疗的 COPD 患者中症状患者的比例，并在 1 年随访时调查了吸入器治疗和症状的变化。
方法
这是一项在日本具有呼吸专科医生的医疗机构进行的多中心、前瞻性队列研究数据的回顾性分析。主要终点是每个吸入器治疗组中 CAT 评分≥10 或 <10 的患者比例。
结果
在全分析集中的 414 名患者中，分别有 76 名（18.4%）、261 名（63.0%）和 77 名（18.6%）患者在登记时分别使用长效抗毒蕈碱药物（LAMA）、LAMA+长效β-激动剂（LABA）和吸入性皮质类固醇（ICS）+LABA。在每个吸入器治疗组中，登记时 CAT 评分≥10 或 <10 的患者比例分别为 LAMA 组 32.9%和 67.1%、LAMA+LABA 组 55.0%和 45.0%和 ICS+LABA 组 50.0%和 50.0%。在每个吸入器治疗组中，大多数患者（>75%）在 1 年内没有改变吸入器治疗，而与他们的登记时的 CAT 评分无关。大约 70-80%的登记时 CAT 评分≥10 的患者在 1 年内仍有 CAT 评分≥10；而 10-30%的登记时 CAT 评分<10 的患者在 1 年内 CAT 评分≥10。
结论
在日本真实临床实践中，尽管使用单药或双联吸入器治疗，仍有相当一部分患者存在持续性症状（CAT 评分≥10）；在使用吸入器治疗的 COPD 有症状患者中，>75%的患者在 1 年随访时未进行治疗升级，且仍有症状。
试验注册
ClinicalTrials.gov 标识符，NCT05903989。
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