噻托溴铵粉雾剂治疗慢性阻塞性肺病的有效性及安全性

Efficacy and safety of tiotropium on chronic obstructive pulmonary disease

目的观察噻托溴铵粉雾剂治疗慢性阻塞性肺病(COPD)的临床疗效及安全性。方法选取122例COPD患者采用信封法随机分为2组,两组患者均给予沙丁胺醇气雾剂吸入、抗生素抗感染等常规对症支持治疗。对照组62例患者在上述治疗基础上,吸入异丙托溴铵,2喷/次,3次/d。同时采用与观察组噻托溴铵粉雾剂外观相同的安慰剂吸入。观察组60例吸入噻托溴铵粉雾剂,18μg/次,每天1次,同时采用与爱全乐气雾剂相同外观的安慰剂吸入。分别在两组患者治疗前、治疗6周后、治疗12周后测定FEV1(第一秒用力呼气量)、FVC(用力肺活量)、FEV1/FVC(第一秒率)。观察两组患者治疗期间不良反应发生情况。结果观察组临床症状改善率为93.33%,对照组为77.42%,观察组改善率明显高于对照组(P<0.05)。观察组治疗后6周及12周时,FEV1、FVC及FEV1/FVC均明显高于治疗前及对照组治疗后(P<0.05)。观察组不良反应发生率低于对照组,但差异无统计学意义(P>0.05)。结论噻托溴铵粉雾剂用于COPD患者的治疗,可明显改善患者临床症状,改善患者肺功能,不良反应发生率低,疗效确切,安全可靠。

Objective To observe the clinical efficacy and safety of tiotropium treatment for chronic obstruc-tive pulmonary disease （ COPD） . Methods 122 cases of COPD patients were randomly divided into two groups using the envelope method,patients were given albuterol inhalation aerosol,antibiotic-resistant infections and other conven-tional treatment. 62 patients in the control group on the basis of the above treatment with ipratropium bromide inhala-tion,two spray per time,3 times a day. While using placebo inhalation looked like tiotropium of the observation group. 60 patients in the observation group inhaled tiotropium 18 μg per time a day,while using the placebo inhalation looked like atrovent aerosol. Before treatment and after 6 weeks and 12 weeks treatment,FEV1 （ forced expiratory volume in one second）,FVC （forced vital capacity）,FEV1/FVC （first second rate） were measured of the two groups and the adverse events were recorded during treatment. Results The clinical improvement rate was 93. 33% in the control group,and it was 77. 42% in the observation group, there was significant difference between the two groups （ P ＆lt;0. 05）. After 6 weeks and 12 weeks treatment,FEV1,FVC and FEV1/FVC of the observation group were significantly higher than those before treatment and control group （ P〈0. 05 ） . The adverse reaction rate of observation group was lower than that of the control group,but the difference was not significant （P＆gt;0. 05）. Conclusion Tiotropium treat-ment for the patients with COPD can significantly improve the clinical symptoms and lung function,decrease the inci-dence of adverse reactions,and has better efficacy,it is safe and reliable.