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为了研究tiotropium的支气管扩张效果和安全性,用安慰剂对照,对470例稳定期的慢性阻塞性肺疾病患者进行了研究。他们平均预计值FEV_1=38.6％。其中279例用tiotropium 18μg;191例用安慰剂。均为每日1次,用乳糖干粉吸入器吸入。 结果用药后第1、8、50和92天用肺量计检查,于用药后3小时和23～24小时作为检查时问。结果用tiotropium可显著改善用药后23～24小时的FEV_1和FVC,8天时测量比基线平均增加12％,并能维持至50～92天。用药后平均FEV_1于第1天比基线增加16％,第92天增加20％;FVC于第1天增加17％,第92天增加19％,tiotropium比安慰剂效果显著较大(P<0.0001)。早晨和傍晚的呼气峰值流速显
To investigate the bronchodilator effect and safety of tiotropium, 470 stable patients with chronic obstructive pulmonary disease were studied in a placebo-controlled manner. Their average projected FEV_1 = 38.6%. Of these, 279 received tiotropium 18 μg; 191 received placebo. Once daily, inhaled with lactose powder inhaler. RESULTS: Spirometry was performed on days 1, 8, 50, and 92 after administration, and 3 hours and 23-24 hours after treatment were taken as examinations. Results With tiotropium, FEV_1 and FVC 23 to 24 hours after treatment were significantly improved, with an average increase of 12% over the baseline measured at 8 days and maintained to 50 to 92 days. The mean FEV 1 after treatment increased 16% from baseline on Day 1, 20% on Day 92; FVC increased 17% on Day 1, 19% on Day 92, and tiotropium was significantly more effective than placebo (P 0.0001) . Morning and evening peak expiratory flow rate was significant