Feng Jun-Fei, Ding Guo-Rong, Xie Yan-Zhong, Zhao Dejun, Wang Xuehui
Department of Respiratory Medicine Emergency Department, Hangzhou Fuyang Hospital of Traditional Chinese Medicine Department of Respiratory Medicine, The People's Hospital of Fuyang, Hangzhou Department of Respiratory Medicine, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China.
Medicine (Baltimore). 2018 Jun;97(22):e10841. doi: 10.1097/MD.0000000000010841.
This study investigated the efficacy and safety of budesonide/formoterol (B/F) and tiotropium combination in the management of chronic obstructive pulmonary disease (COPD) in Chinese patients.Between January 2015 and November 2017, 113 eligible Chinese patients with COPD were included and divided into an intervention group and a control group. Sixty-three patients in the intervention group underwent B/F combined tiotropium, while 50 patients in the control group received tiotropium alone. The primary outcome was severity of dyspnea on exertion (DOE), measured by the 6-minute walk test (6MWT) scale. The secondary outcomes included lung function, measured by the forced expiratory volume in 1 second (FEV1), quality of life, measured by the St. George's Respiratory Questionnaire (SGRQ), and adverse events. All outcomes were measured at the end of 12-week treatment.B/F and tiotropium combination showed greater efficacy in DOE (P < .01), lung function (P < .01), and quality of life (P < .01), compared with tiotropium alone at the end of 12-week treatment. In addition, adverse events in both groups were similar and tolerable.The findings suggest that B/F and tiotropium combination can be used as an effective treatment in Chinese patients with COPD.
本研究调查了布地奈德/福莫特罗（B/F）与噻托溴铵联合用药在中国慢性阻塞性肺疾病（COPD）患者管理中的疗效和安全性。2015年1月至2017年11月，纳入113例符合条件的中国COPD患者，分为干预组和对照组。干预组63例患者接受B/F联合噻托溴铵治疗，而对照组50例患者仅接受噻托溴铵治疗。主要结局是运动性呼吸困难（DOE）的严重程度，通过6分钟步行试验（6MWT）量表进行测量。次要结局包括肺功能，通过第1秒用力呼气量（FEV1）进行测量；生活质量，通过圣乔治呼吸问卷（SGRQ）进行测量；以及不良事件。所有结局均在12周治疗结束时进行测量。在12周治疗结束时，与单独使用噻托溴铵相比，B/F与噻托溴铵联合用药在DOE（P<0.01）、肺功能（P<0.01）和生活质量（P<0.01）方面显示出更大的疗效。此外，两组的不良事件相似且可耐受。研究结果表明，B/F与噻托溴铵联合用药可作为中国COPD患者的有效治疗方法。
