Kaushik M L, Kashyap S, Bansal S K, Sharma A
Department of Medicine, Indira Gandhi Medical College, Shimla, H.P.
Indian J Chest Dis Allied Sci. 1999 Oct-Dec;41(4):207-12.
Thirty patients of stable chronic obstructive pulmonary disease (COPD) were studied for evaluation of effectiveness of inhaled salmeterol in a double blind, randomised, placebo controlled trial for seven days. Baseline spirometery and breathlessness score after 6 minutes walk test were assessed in all patients. Bronchial asthma was excluded in each patient by reversibility test with 200 ug of salbutamol inhalation. After inhalation of two puffs from a given inhaler through spacer device in the morning, spirometery was carried out 1, 3, 6 and 12 hrs after inhalation on day 1, 3 and 7 of trial. Six minutes walk test and breathlessness score were assessed after 3 hrs of inhalation on days 1, 3 and 7. The maximum bronchodilator response to salmeterol was observed on 7th day at three hours after inhalation. The mean increase in FEV1 was 29.2% of baseline value, which was significant as compared to placebo where the mean increase in FEV1 was 3.3% of the baseline value. The peak rise in FEV1 was observed at three hours after inhalation on all the three days. The bronchodilator effect of salmeterol persisted for upto 12 hours. The mean maximum increase in walking distance in 6 minutes walk test was observed on 7th day in salmeterol group, which was 50.7 metres whereas in placebo group it was 12.2 meters. The patients in salmeterol group perceived less breathlessness after the six minutes walk test. The study concluded that salmeterol 50 micrograms twice a day is effective in improving lung functions in patients with stable COPD and can be recommended as maintenance therapy for stable COPD patients.
在一项为期七天的双盲、随机、安慰剂对照试验中,对30例稳定期慢性阻塞性肺疾病(COPD)患者进行了吸入沙美特罗有效性的评估。对所有患者进行了基线肺量测定以及6分钟步行试验后的呼吸困难评分。通过吸入200微克沙丁胺醇进行可逆性试验,排除了每位患者的支气管哮喘。在试验的第1、3和7天,早晨通过间隔装置从给定吸入器吸入两喷后,于吸入后1、3、6和12小时进行肺量测定。在第1、3和7天吸入3小时后评估6分钟步行试验和呼吸困难评分。在第7天吸入后3小时观察到沙美特罗的最大支气管扩张反应。第一秒用力呼气容积(FEV1)的平均增加量为基线值的29.2%,与安慰剂组相比具有显著性差异,安慰剂组FEV1的平均增加量为基线值的3.3%。在所有三天中,吸入后3小时观察到FEV1的峰值上升。沙美特罗的支气管扩张作用持续长达12小时。在沙美特罗组,6分钟步行试验中步行距离的平均最大增加量在第7天观察到,为50.7米,而在安慰剂组为12.2米。沙美特罗组的患者在6分钟步行试验后感觉呼吸困难减轻。该研究得出结论,每天两次50微克的沙美特罗对改善稳定期COPD患者的肺功能有效,可推荐作为稳定期COPD患者的维持治疗。