噻托溴铵治疗慢性阻塞性肺疾病的疗效及安全性评价

Evaluation of Effectiveness and Safety in Tiotropium Treatment of COPD

目的:研究临床使用噻托溴铵治疗慢性阻塞性肺疾病(COPD)的疗效及安全性。方法:使用随机、双盲、多中心、安慰剂平行对照的研究方法。2008年10月～2010年10月期间入院治疗的同意参与实验的患者191例,随机分为实验组和对照组。实验组给予噻托溴铵18μg,每日1次;对照组给予相同剂量剂型安慰剂。实验时间为16周。实验前及6周、16周时分别检测肺功能,16周时观察呼吸困难、胸闷气短、咳嗽咳痰、肺部干湿罗音等症状体征及实验室检查。结果:用药6周后实验组肺功能指标,第1秒用力呼气容积(FEV1)(1.59±0.33)L和第1秒用力呼气容积/用力肺活量(%)(FEV1/FVC(%))(61.17±7.81)%均高于对照组,肺功能有明显改善(P<0.01)。用药16周后,实验组肺功能指标FEV1(1.62±0.28)L和FEV1/FVC(%)(63.35±9.22)%与对照组比较亦有明显改善,差异有显著性(P<0.01)。且用药16周后,实验组呼吸困难、胸闷气短、咳嗽咳痰、肺部干湿啰音等症状体征的治愈率高于对照组,且差异有显著性(P<0.01)。不良反应的发生率实验组和对照组分别为7.8%、6.6%,两组差别没有统计学意义(P>0.05)。结论:临床一线使用噻托溴铵治疗慢性阻塞性肺疾病(COPD),可以有效改善患者的临床症状体征及肺功能,减少并发症,并且使用安全性较高。

Objective： To study the efficacy and safty between tiotropium and placebo in a 16-week treatment with chronic obstructive pulmonary disease（COPD）.Methods： The trial was conducted in 191 patients with COPD.They were divided into two groups at randomized,tiotropium group and placebo group.They were given tiotropium 18μg once daily in the tiotropium group,and the others were given the placebo 18μg once daily.They would have spiromentry conducted before the trial and 6 weeks and 16 weeks after treatment.Results： The forced expiratory volume in one second（FEV1）（1.59±0.33）L and forced expiratory volume in one second / forced vital capacity（%）（FEV1/FVC（%））（61.17±7.81）% in the tiotropium group was higher than the placebo group after 6 weeks and 16 weeks.Significant improvement in lung function,（P0.01）.The improvement rate of clinical,like difficulty breathing and sputum,in the tiotropium group was higher than the placebo group.The difference was statistically significant,（P0.01）.The rate of adverse reactions in the tiotropium group was 7.8%,but in the placebo group was 6.6%.The difference was not significan.Conclusion： Tiotropium was a safe and effective anticholinergic bronchodilator as first-line maintenance therapy in COPD.