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噻托溴铵治疗慢性阻塞性肺疾病随机双盲双模拟对照临床试验
Randomized double - blind double - dummy controlled clinical trial of tiotropium bromide in the treatment of chronic obstructive pulmonary disease
【摘要】 目的评价噻托溴铵治疗慢性阻塞性肺疾病(COPD)的疗效和安全性。 方法用双盲双模拟随机对照方法,观察了COPD病人吸入噻托溴铵(21例, 18μg,qd)与异丙托溴铵(23例,40μg q 6 h)的支气管扩张作用及安全性。 结果用药后,噻托溴铵组病人第1秒用力呼气容积(FEV1)和用力肺活量 (FVC)均显著增加(P<0.001);2,3 h时,FEV1的增加较异丙托溴铵组有显著 性差异(P<0.05);治疗2,4周时,噻托溴铵组病人FEV1谷值明显上升(P< 0.01),较异丙托溴铵组分别高0.14,0.05 L。2组药物不良反应发生率无统 计学差异。结论噻托溴铵是治疗COPD病人有效和安全的支气管扩张药物, 疗效和用法均优于异丙托溴铵。
【Abstract】 Objective To evaluate the bronchodilation efficacy and safety of tiotropium in the treatment of patients with chronic obstructive pulmonary disease (COPD). Methods A randomized, double - blind, double-dummy , ipratropium - controlled clinical trial was conducted in 44 patients with COPD. Of them, 21 patients were treated by tiotropium (18 μg, qd inhaled ) and 23 patients were treated by ipratropium (40 μg, q6h inhaled) for 4 weeks. Results Forced expiratory volum in one second ( FEV1 ) and forced vital capacity ( FVC) in two groups were significantly increased after treatment (P < 0.001). The increase of FEV1 in tiotropium group was higher than that in ipratropium group after 2 - hour and 3 - hour treatment (P <0. 05). Compared with baseline, trough FEV1 in tiotropium group was significantly increased after 2 - week and 4 - week treatment respectively (P <0. 01) and the trough FEV1 in tiotropium group was 0. 14L and 0. 05L higher than that in ipratropium group (P < 0. 05 ). The incidence of adverse effects in two groups was similar. Laboratory test did not significantly change after treatment. Conclusion Tiotropium is an effective and safe bronchodilator in the treatment of COPD patients. The bronchodilation effect and usage of tiotropium were superior to that of ipratropium.
【Key words】 tiotropium bromide capsule; ipratropium quantitive aerosol; chronic obstructive pulmonary disease;
- 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2005年05期
- 【分类号】R563.9
- 【被引频次】12
- 【下载频次】201