Kim Cheong-Ju, Yoon Hyoung-Kyu, Park Myung-Jae, Yoo Kwang-Ha, Jung Ki-Suck, Park Jeong-Woong, Lim Seong Yong, Shim Jae Jeong, Lee Yong Chul, Kim Young-Sam, Oh Yeon-Mok, Kim Song, Yoo Chul-Gyu
Department of Internal Medicine, National Health Insurance System Ilsan Hospital, Koyang.
Division of Pulmonology, Department of Internal Medicine, St Mary's Hospital, College of Medicine, The Catholic University of Korea.
Int J Chron Obstruct Pulmon Dis. 2017 May 29;12:1589-1596. doi: 10.2147/COPD.S128750. eCollection 2017.
Pulmonary tuberculosis (TB) is a risk factor for chronic obstructive pulmonary disease (COPD); however, few clinical studies have investigated treatment effectiveness in COPD patients with destroyed lung by TB. The Indacaterol effectiveness in COPD patients with Tuberculosis history (INFINITY) study assessed the efficacy and safety of once-daily inhaled indacaterol 150 µg for the treatment of Korean COPD patients with destroyed lung by TB and moderate-to-severe airflow limitation.
This was a multicenter, double-blind, parallel-group study, in which eligible patients were randomized (1:1) to receive either once-daily indacaterol 150 µg or placebo for 8 weeks. The primary efficacy endpoint was change from baseline in trough forced expiratory volume in 1 s at Week 8; the secondary endpoints included changes in transition dyspnea index score and St George's Respiratory Questionnaire for COPD score at Week 8. Safety was evaluated over 8 weeks.
Of the 136 patients randomized, 119 (87.5%) completed the study treatment. At Week 8, indacaterol significantly improved trough forced expiratory volume in 1 s versus placebo (treatment difference [TD] 140 mL, <0.001). Statistically significant improvement in transition dyspnea index score (TD =0.78, <0.05) and numerical improvement in St George's Respiratory Questionnaire for COPD score (TD =-2.36, =0.3563) were observed with indacaterol versus placebo at Week 8. Incidence of adverse events was comparable between the treatment groups.
Indacaterol provided significantly superior bronchodilation, significant improvement in breathlessness and improved health status with comparable safety versus placebo in Korean COPD patients with destroyed lung by TB and moderate-to-severe airflow limitation.
肺结核（TB）是慢性阻塞性肺疾病（COPD）的一个风险因素；然而，很少有临床研究调查过对肺部已被TB破坏的COPD患者的治疗效果。肺结核病史COPD患者茚达特罗疗效研究（INFINITY）评估了每日一次吸入150μg茚达特罗治疗肺部已被TB破坏且有中度至重度气流受限的韩国COPD患者的疗效和安全性。
这是一项多中心、双盲、平行组研究，符合条件的患者被随机（1:1）分配，接受每日一次150μg茚达特罗或安慰剂治疗8周。主要疗效终点是第8周时1秒用力呼气容积谷值相对于基线的变化；次要终点包括第8周时过渡性呼吸困难指数评分和慢性阻塞性肺疾病圣乔治呼吸问卷评分的变化。在8周内评估安全性。
136例随机分组的患者中，119例（87.5%）完成了研究治疗。在第8周时，与安慰剂相比，茚达特罗显著改善了1秒用力呼气容积谷值（治疗差异[TD]为140mL，P<0.001）。第8周时，与安慰剂相比，茚达特罗使过渡性呼吸困难指数评分有统计学意义的改善（TD =0.78，P<0.05），慢性阻塞性肺疾病圣乔治呼吸问卷评分有数值上的改善（TD = -2.36，P =0.3563）。治疗组之间不良事件的发生率相当。
对于肺部已被TB破坏且有中度至重度气流受限的韩国COPD患者，茚达特罗与安慰剂相比，在支气管扩张方面显著更优，在呼吸困难方面有显著改善，健康状况也有所改善，且安全性相当。
