Gunn S D, Ayres J G, McConchie S M
Chest Research Institute, Birmingham Heartlands Hospital, UK.
Eur J Clin Pharmacol. 1995;48(1):23-8. doi: 10.1007/BF00202167.
The aim of the study was to compare the efficacy, tolerability and patient acceptability of bambuterol (Bambec) against controlled release (CR) salbutamol (Volmax) in the treatment of nocturnal asthma. One hundred and fifty two asthmatic patients aged 17-78 years, using > or = 800 micrograms/day of an inhaled steroid, with nocturnal asthma symptoms, openly received three weeks of bambuterol 20 mg nocte and three weeks of salbutamol CR 8 mg b.i.d. in a randomised, cross over sequence. Both bambuterol and salbutamol CR treatment produced a significant 63% decrease in the severity of baseline nocturnal asthma symptoms. This improved control of nocturnal asthma was reflected by significant improvements in baseline lung function. Both the severity and number of days of tremor during the first week of treatment was significantly lower with bambuterol than with salbutamol CR. Patients considered bambuterol to cause less shakiness and treatment preference was bambuterol 49%, salbutamol CR 36%, no preference 15%. The predominant reason for patient treatment preference was control of asthma symptoms, however a significant sub-group of patients (27%) chose bambuterol because of fewer adverse effects compared to 11% choosing salbutamol CR. Fifty six percent of patients preferred taking their medication once-daily and 7% preferred twice-daily. This study shows that both bambuterol and salbutamol CR are equally effective treatments for nocturnal asthma in patients already receiving inhaled steroid. The most important factor in terms of patient treatment acceptability appears to be control of symptoms. Sub-groups of patients may chose bambuterol due to its better adverse effect profile and once-daily regimen.
本研究旨在比较班布特罗(Bambec)与控释沙丁胺醇(Volmax)治疗夜间哮喘的疗效、耐受性及患者接受度。152例年龄在17至78岁之间、每日吸入类固醇≥800微克且有夜间哮喘症状的哮喘患者,以随机交叉顺序,分别公开接受为期三周的每晚20毫克班布特罗治疗及为期三周的每日两次每次8毫克控释沙丁胺醇治疗。班布特罗和控释沙丁胺醇治疗均使基线夜间哮喘症状严重程度显著降低63%。夜间哮喘控制的改善体现在基线肺功能的显著改善上。治疗第一周,班布特罗引起震颤的严重程度及天数均显著低于控释沙丁胺醇。患者认为班布特罗引起的颤抖较少,治疗偏好方面,选择班布特罗的占49%,选择控释沙丁胺醇的占36%,无偏好的占15%。患者选择治疗方案的主要原因是哮喘症状得到控制,然而,有相当一部分患者(27%)选择班布特罗是因为其不良反应较少,相比之下,选择控释沙丁胺醇的为11%。56%的患者更喜欢每日服用一次药物,7%的患者更喜欢每日服用两次。本研究表明,对于已接受吸入类固醇治疗的患者,班布特罗和控释沙丁胺醇治疗夜间哮喘同样有效。就患者治疗接受度而言,最重要的因素似乎是症状控制。部分患者可能因班布特罗不良反应较小且为每日一次用药方案而选择它。