Bai C X, Tang Y, Xin J B, Li Y L, Li Z K, Kang J, Huang J A, Xiao W, Wen Z G, Fu X H, He B, Liu C T, Chen P
Department of Respiratory and Critical Care Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital, Guangzhou Medical College, Guangzhou 510120, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2019 Nov 12;42(11):838-844. doi: 10.3760/cma.j.issn.1001-0939.2019.11.010.
To compare the efficacy and safety profiles of tiotropium/olodaterol with the mono-components in Chinese and total study population from TONADO trial. In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase Ⅲ TONADO studies (TONADO 1+2), patients received tiotropium/olodaterol, tiotropium, or olodaterol via the Respimat(®) Inhaler (Boehringer Ingelheim, Germany). Primary end points were forced expiratory volume in 1 second (FEV(1)) area under the curve from 0 to 3 hours (AUC(0-3h)) response and trough FEV(1) response, and St George's respiratory questionnaire (SGRQ) total score at 24 weeks. Adverse events were also collected. This subgroup analysis only focused on the efficacy and safety of the drug at the approved dose in China. 548 Chinese patients were randomized, aged 41 to 82 years [mean age, (63±8) years] and most were male (526, 96%), 111 received tiotropium/olodaterol 5/5 μg, and 127 received tiotropium 5 μg and 95 received olodaterol 5 μg. The baseline characteristics of these groups were similar. After 24 weeks, treatment with tiotropium/olodaterol 5/5 μg, tiotropium 5 μg and olodaterol 5 μg resulted in an adjusted mean FEV(1) AUC(0-3h) response of 0.240, 0.157 and 0.079 L, and trough FEV(1) response of 0.117, 0.068 and-0.001 L, respectively. Tiotropium/olodaterol 5/5 μg significantly improved SGRQ scores in Chinese patients compared with olodaterol 5 μg (32.729 and 37.202, respectively). Generally, the safety profile of tiotropium/olodaterol was comparable with mono-components in 52 weeks. Compared with tiotropium or olodaterol, tiotropium/olodaterol in Chinese patients provided significant improvement in lung function and quality of life, and the safety profiles were similar.
比较噻托溴铵/奥达特罗与单一组分在中国人群以及TONADO试验的全部研究人群中的疗效和安全性。在重复、双盲、平行组、活性药物对照、随机、为期52周的Ⅲ期TONADO研究（TONADO 1+2）中，患者通过Respimat®吸入器（德国勃林格殷格翰公司）吸入噻托溴铵/奥达特罗、噻托溴铵或奥达特罗。主要终点为0至3小时的1秒用力呼气容积（FEV₁）曲线下面积（AUC₀₋₃h）反应、FEV₁谷值反应以及24周时圣乔治呼吸问卷（SGRQ）总分。同时收集不良事件。该亚组分析仅关注在中国批准剂量下药物的疗效和安全性。548名中国患者被随机分组，年龄41至82岁[平均年龄，（63±8）岁]，大多数为男性（526名，96%），111名接受5/5μg噻托溴铵/奥达特罗，127名接受5μg噻托溴铵，95名接受5μg奥达特罗。这些组的基线特征相似。24周后，接受5/5μg噻托溴铵/奥达特罗、5μg噻托溴铵和5μg奥达特罗治疗的患者，调整后的平均FEV₁ AUC₀₋₃h反应分别为0.240、0.157和0.079L，FEV₁谷值反应分别为0.117、0.068和 -0.001L。与5μg奥达特罗相比，5/5μg噻托溴铵/奥达特罗显著改善了中国患者的SGRQ评分（分别为32.729和37.202）。总体而言，噻托溴铵/奥达特罗在52周内的安全性与单一组分相当。与噻托溴铵或奥达特罗相比，中国患者使用噻托溴铵/奥达特罗可显著改善肺功能和生活质量，且安全性相似。
