欢迎来到《四川大学学报(医学版)》
罗柱, 刘春涛, 吴昌归等. 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[J]. 四川大学学报(医学版), 2015, 46(3): 485-487.
引用本文: 罗柱, 刘春涛, 吴昌归等. 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[J]. 四川大学学报(医学版), 2015, 46(3): 485-487.
LUO Zhu, LIU Chun-tao, WU Chang-gui. et al. Efficacy and Safety of Tiotropium Bromide in the Treatment of Chronic Obstructive Pulmonary Disease——a Multi-center Randomized Clinical Trial[J]. Journal of Sichuan University (Medical Sciences), 2015, 46(3): 485-487.
Citation: LUO Zhu, LIU Chun-tao, WU Chang-gui. et al. Efficacy and Safety of Tiotropium Bromide in the Treatment of Chronic Obstructive Pulmonary Disease——a Multi-center Randomized Clinical Trial[J]. Journal of Sichuan University (Medical Sciences), 2015, 46(3): 485-487.

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 Multi-center Randomized Clinical Trial

  • 摘要: 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18 μg吸入QD,对照组(n=111)为异丙托溴铵定量气雾剂40 μg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30 min及3 h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。

     

    Abstract: 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 18 μg Qd or control group (n=111) with ipratropium 40 μg 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 1 s (FEV 1) of both groups increased obviously 30 min and 3 h after first dosing. After four weeks treatments, FEV 1 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.

     

© 2015 《四川大学学报(医学版)》编辑部 版权所有 cc

开放获取 本文遵循知识共享署名—非商业性使用4.0国际许可协议(CC BY-NC 4.0),允许第三方对本刊发表的论文自由共享(即在任何媒介以任何形式复制、发行原文)、演绎(即修改、转换或以原文为基础进行创作),必须给出适当的署名,提供指向本文许可协议的链接,同时标明是否对原文作了修改;不得将本文用于商业目的。CC BY-NC 4.0许可协议详情请访问 https://creativecommons.org/licenses/by-nc/4.0

/

返回文章
返回