国产噻托溴铵干粉剂治疗慢性阻塞性肺疾病的多中心随机对照临床试验

Efficacy and Safety of Tiotropium Bromide in the Treatment of Chronic Obstructive Pulmonary Disease——a Multicenter Randomized Clinical Trial

目的验证国产噻托溴铵干粉剂在中国慢性阻塞性肺疾病(COPD)患者中应用的有效性和安全性。方法采用多中心、随机、阳性对照方法,试验组(n=109)给予噻托溴铵干粉剂18μg吸入QD,对照组(n=111)为异丙托溴铵定量气雾剂40μg吸入QID,疗程4周,考察指标为肺功能、临床症状及安全性。结果试验组与对照组首剂给药后30min及3h一秒用力呼气容积(FEV1)较基线均增加(P<0.05);试验组与对照组疗程结束后FEV1及用力肺活量(FVC)谷值较基线均增加(P<0.05),增加程度试验组优于对照组(P<0.05);试验组与对照组疗程结束后COPD症状评分较基线降低且试验组优于对照组(P<0.05);治疗期间两组按需使用沙丁胺醇定量气雾剂的喷数差异无统计学意义。试验组用药后不良反应发生率(22.02%)与对照组(15.32%)相当(P=0.23)。结论国产噻托溴铵干粉剂用于改善COPD患者肺功能和临床症状,安全有效,其长期疗效有待进一步验证。

Objective To investigate the efficacy and safety of domestic tiotropium inhalation capsule in patients with chronic obstructive pulmonary disease（COPD）with multi-center randomized clinical trial.Methods Patients with stable slight to moderate COPD were randomized into trial group（n=109）with tiotropium 18μg Qd or control group（n=111）with ipratropium 40μg Qid for a treatment of four weeks.The spirometry and scoring questionaire were recorded at different visits during the treatment.Rescue medication consumption and adverse events were recorded.Results Forced expiratory volume in 1s（FEV1）of both groups increased obviously 30 min and 3hafter first dosing.After four weeks treatments,FEV1 and forced vital capacity（FVC）in both groups were improved obviously,and the improvement in tiotropium group was significantly higher than that ipratropium group.COPD symptom scores were significantly reduced in both groups,and the improvement in tiotropium group was significantly better than that in ipratropium group.There was no significant difference in rescue medication consumption between the two groups.The ratios of adverse events were 22.02% and 15.32% in tiotropium and ipratropium group,respectively（P=0.23）.Conclusion Domestic tiotropium inhalation capsule is efficient and safe in the treatment of COPD.