Huang Wei-Chang, Lin Sheng-Hao, Hang Liang-Wen, Lin Ching-Hsiung, Hsu Jeng-Yuan
Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung 407, Taiwan.
Department of Post-Baccalaureate Medicine, College of Medicine, National Chung Hsing University, Taichung 402, Taiwan.
J Clin Med. 2022 Oct 21;11(20):6210. doi: 10.3390/jcm11206210.
Glycopyrronium (GLY) is a pharmacological maintenance treatment for chronic obstructive pulmonary disease (COPD). However, its effectiveness and tolerability for COPD patients in routine clinical practice have not been well-investigated. This study aimed to assess the effectiveness of GLY on health-related quality of life and its safety in patients with COPD in a routine clinical care setting. This multi-center, prospective, six-month observational study recruited patients diagnosed with COPD and treated with GLY at three medical centers in central Taiwan. The full analysis set (n = 102) had a significant improvement in the Clinical COPD Questionnaire total (mean ± SD = −0.39 ± 0.90, p = 0.002), symptoms (mean ± SD = −0.61 ± 0.90, p < 0.001) and mental state scores (mean ± SD = −0.54 ± 1.72, p = 0.021) but not the functional state score (mean ± SD = −0.10 ± 1.15, p = 0.529). During the observational period, 58 patients (52.73%) experienced adverse events; only one adverse event (dizziness) was suspected to be related to the study drug. Three patients (2.73%) discontinued the study and GLY treatment because of an adverse event. One patient (0.91%) died during the study period because of a cerebral infarction, which was judged to be not associated with GLY treatment. In conclusion, GLY could be effective in improving the health status and is safe for patients with COPD in a real-life setting.
格隆溴铵（GLY）是慢性阻塞性肺疾病（COPD）的一种药物维持治疗药物。然而，在常规临床实践中，其对COPD患者的有效性和耐受性尚未得到充分研究。本研究旨在评估在常规临床护理环境中，GLY对COPD患者健康相关生活质量的有效性及其安全性。这项多中心、前瞻性、为期六个月的观察性研究招募了在台湾中部三个医疗中心被诊断为COPD并接受GLY治疗的患者。全分析集（n = 102）在慢性阻塞性肺疾病临床问卷总分（均值±标准差=-0.39±0.90，p = 0.002）、症状（均值±标准差=-0.61±0.90，p<0.001）和精神状态评分（均值±标准差=-0.54±1.72，p = 0.021）方面有显著改善，但功能状态评分（均值±标准差=-0.10±1.15，p = 0.529）无显著改善。在观察期内，58名患者（52.73%）发生了不良事件；只有1例不良事件（头晕）被怀疑与研究药物有关。3名患者（2.73%）因不良事件停止了研究和GLY治疗。1名患者（0.91%）在研究期间因脑梗死死亡，判定与GLY治疗无关。总之，在现实生活环境中，GLY对改善COPD患者的健康状况可能有效且安全。
