【摘要】 目的评估噻托溴铵在COPD患者急性加重及其气流受限方面的作用。方法以到广州市第一人民医院门诊就诊的COPD患者为对象,符合标准的患者随机分成两组,分别吸入18μg噻托溴铵或安慰剂,每天一次,持续48周。在随机分组时(第1天)、治疗第6、12、24、36、48周,采集患者COPD急性加重、因急性加重入院情况以及伴随用药等详细信息。结果共入选COPD患者173名,噻托溴铵治疗组87名,安慰剂组86名,在研究前一年内,患者的急性加重次数为(2.32±1.36)次,晨间呼气峰流速(PEF)的周均值为(225.7±94.3)L/min,平均第一秒钟用力呼气量(FEV1)为(1.36±0.76)L。噻托溴铵将首次出现急性加重的时间显著延迟了约91天,将急性加重超过一次以上的患者比例减少了17%;与安慰剂组相比,急性加重次数减少了34%,天数减少了36%。从研究的第一周起直至结束,噻托溴铵组晨间PEF周均值也较安慰剂组明显提高。研究结束时可见,噻托溴铵相对于安慰剂组明显提高了患者的FEV1谷值(用药前)、最大肺活量(FVC)和深吸气量(IC)。结论噻托溴铵在研究一年期间减少了COPD患者急性加重次数,改善了气流受限状况。更多还原

【Abstract】 Objective To evaluate the effect of tiotropium on exacerbations and airflow in patients with COPD.Method Patients with COPD were recruited from outpatient of Guangzhou First Municipal People’s Hospital.Eligible patients were randomised 1:1 to receive either tiotropium 18 mg(n=87) once daily or placebo(n=86) for 48 weeks.Detailed information on exacerbations of COPD,hospital admissions due to a COPD exacerbation and concomitant medications were collected at randomisation(day 1) as well as after 6,12,24,36 and 48 weeks of treatment.Result 173 patients with COPD were recruited.The mean ± SD number of exacerbations during the past year was 2.32 ± 1.36,the mean weekly morning peak expiratory flow(PEF) was(225.7 ± 94.3) L/min and the mean forced expiratory volume in one second(FEV1) was(1.36 ± 0.76) L.Tiotropium significantly delayed the time to first exacerbation by 91 days,reduced the proportion of patients experiencing more than one exacerbation by 17%,and decreased the number of exacerbations by 34% and exacerbation days by 36% versus placebo.Mean weekly morning PEF improved significantly with tiotropium versus placebo from week 1 until the end of the study.At the end of the study,tiotropium significantly improved trough(pre-dose) FEV1,forced vital capacity,slow vital capacity and inspiratory capacity versus placebo.Conclusion Tiotropium reduced exacerbations and improved airflow over one year in patients with chronic obstructive pulmonary disease.更多还原