Shioya Takanobu, Satake Masahiro, Sato Kazuhiro, Sano Masa-aki, Sugawara Keiyu, Takahashi Hitomi, Honma Mitsunobu
Department of Physical Therapy, Akita University School of Health Sciences, Akita, Japan.
Arzneimittelforschung. 2008;58(1):24-8. doi: 10.1055/s-0031-1296462.
The present study was undertaken to evaluate the long-term effect of procaterol hydrochloride (CAS 62929-91-3, Meptin), a third generation beta2-receptor agonist on lung function, exercise capacity, health-related quality of life (HRQOL) and activities of daily living (ALDs) in patients with stable chronic obstructive pulmonary disease (COPD). Twenty patients were randomly assigned to the procaterol group or to the control group, who received oxitropium bromide (CAS 30286-75-0), an anticholinergic agent. Procaterol was inhaled three times a day at a dose of 20 pg, while oxitropium was inhaled three times a day at a dose of 200 microg. The subjects were evaluated based on spirometry, exercise capacity, the Borg Scale, HRQOL, and ADLs before and after 12, 24 and 52 weeks of therapy. The values of forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), total lung capacity (TLC), functional residual capacity (FRC), residual volume (RV), maximal inspiratory pressure (PImax), and maximal expiratory pressure (PEmax) were significantly improved at 12, 24 and 52 weeks compared with baseline values in the procaterol group (p < 0.05, p < 0.01), while these values did not differ from baseline values at any point in the oxitropium group (p > 0.05). Additionally, 6-min walking distances and Borg Scale values showed significant improvement at 12, 24 and 52 weeks compared with baseline values in the procaterol group (p < 0.05, p < 0.01), but did not significantly differ from baseline values in the oxitropium group at any point (p > 0.05). Likewise, the scores for dyspnea, fatigue, emotional function, mastery, total scores and ADLs were significantly higher at 12, 24 and 52 weeks compared with the baseline values in the procaterol group (p < 0.05, p < 0.01), but did not differ at any point in the oxitropium group (p > 0.05). These results suggest the effectiveness of long-term regular bronchodilator therapy with the beta2-receptor agonist procaterol in patients with stable COPD.
本研究旨在评估第三代β2受体激动剂盐酸丙卡特罗（化学物质登记号62929 - 91 - 3，美普清）对稳定期慢性阻塞性肺疾病（COPD）患者肺功能、运动能力、健康相关生活质量（HRQOL）及日常生活活动（ALD）的长期影响。20例患者被随机分为丙卡特罗组或对照组，对照组接受抗胆碱能药物氧托溴铵（化学物质登记号30286 - 75 - 0）。丙卡特罗以每日3次、每次20μg的剂量吸入，氧托溴铵以每日3次、每次200μg的剂量吸入。在治疗12周、24周和52周前后，根据肺量计、运动能力、博格量表、HRQOL及ALD对受试者进行评估。与丙卡特罗组的基线值相比，第12周、24周和52周时1秒用力呼气量（FEV1）、用力肺活量（FVC）、肺总量（TLC）、功能残气量（FRC）、残气量（RV）、最大吸气压力（PImax）和最大呼气压力（PEmax）的值显著改善（p < 0.05，p < 0.01），而在氧托溴铵组，这些值在任何时间点与基线值均无差异（p > 0.05）。此外，与丙卡特罗组的基线值相比，第12周、24周和52周时6分钟步行距离和博格量表值显著改善（p < 0.05，p < 0.01），但在氧托溴铵组，在任何时间点与基线值均无显著差异（p > 0.05）。同样，与丙卡特罗组的基线值相比，第12周、24周和52周时呼吸困难、疲劳、情绪功能、掌控感、总分及ALD的评分显著更高（p < 0.05，p < 0.01），但在氧托溴铵组，在任何时间点均无差异（p > 0.05）。这些结果表明，长期规律使用β2受体激动剂丙卡特罗进行支气管扩张治疗对稳定期COPD患者有效。
