Imhof E, Elsasser S, Karrer W, Grossenbacher M, Emmons R, Perruchoud A P
Department of Internal Medicine, University Hospital Basel, Switzerland.
Respiration. 1993;60(2):84-8. doi: 10.1159/000196179.
A double-blind, randomized cross-over trial was carried out in 24 patients with chronic airflow obstruction. The patients were required to demonstrate a minimum 15% absolute increase in forced expiratory volume (FEV1) after a standard dose (0.4 mg) of fenoterol (F). On a separate occasion the effect of ipratropium bromide (IB; 0.04 mg) on FEV1 was tested also; according to the increase in FEV1 the patients were grouped into IB responders (delta FEV1 > 15%) and IB nonresponders (delta FEV1 < 15%). Two puffs of F/IB (0.1 mg/0.04 mg), salbutamol (S; 0.2 mg) and placebo (P) were given by metered-dose inhaler at the same time of the day on three different occasions. FEV1 and specific airway resistance (sRaw) were assessed before and at specific intervals following inhalation. The results showed that F/IB and S produced similar maximal increases in FEV1 (delta FEV1 32% for F/IB and 31% for S) and decreases in sRaw (delta sRaw 24% for F/IB and 21% for S). These effects were significantly different both from baseline values and from P. FEV1 was still significantly different 8 h after inhalation from P in the F/IB group, but not in the group that received S. The effect of IB on FEV1 in the pretest was compared with the subsequent response to F/IB. In IB responders F/IB seemed to produce slightly more effective bronchodilation. Side effects were minimal and clinically insignificant. In conclusion, F/IB, with its ability to effect sustained bronchodilation without adverse side effects, is a viable alternative to a monotherapy in chronic obstructive pulmonary disease.
对24例慢性气流阻塞患者进行了一项双盲、随机交叉试验。要求患者在吸入标准剂量（0.4mg）非诺特罗（F）后，用力呼气量（FEV1）绝对增加至少15%。在另一个时间点，还测试了异丙托溴铵（IB；0.04mg）对FEV1的影响；根据FEV1的增加情况，将患者分为IB反应者（FEV1变化>15%）和IB无反应者（FEV1变化<15%）。在一天中的同一时间，分三次不同场合通过定量吸入器给予两喷F/IB（0.1mg/0.04mg）、沙丁胺醇（S；0.2mg）和安慰剂（P）。在吸入前和吸入后的特定时间间隔评估FEV1和比气道阻力（sRaw）。结果显示，F/IB和S使FEV1产生相似的最大增加（F/IB为32%，S为31%），sRaw降低（F/IB为24%，S为21%）。这些效应与基线值和P组相比均有显著差异。F/IB组吸入后8小时FEV1仍与P组有显著差异，但接受S组则无。将预试验中IB对FEV1的影响与随后对F/IB的反应进行了比较。在IB反应者中，F/IB似乎产生了更有效的支气管扩张作用。副作用极小，临床意义不大。总之，F/IB能够实现持续的支气管扩张且无不良副作用，是慢性阻塞性肺疾病单一疗法的可行替代方案。
