Adams Sandra G, Anzueto Antonio, Briggs Dick D, Menjoge Shailendra S, Kesten Steven
The University of Texas Health Science Center at San Antonio and the South Texas Veterans Health Care System, Audie L. Murphy Division, San Antonio, TX 78229, USA.
Respir Med. 2006 Sep;100(9):1495-503. doi: 10.1016/j.rmed.2006.03.034. Epub 2006 May 15.
Use of maintenance bronchodilator therapy is currently recommended in symptomatic patients with Chronic obstructive pulmonary disease (COPD) and in those with Stage II or greater COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD). Because no prospective data describe when rescue therapy alone is insufficient or the optimal time to start maintenance therapy, it is unclear whether maintenance therapy has benefits in milder disease. To explore potential benefits we asked: Does once-daily tiotropium improve lung function, health status, and/or symptoms in "undertreated" COPD patients (i.e., those who are not receiving maintenance bronchodilator therapy) or patients considered by their health care providers as having milder disease?
A post-hoc analysis of data from COPD patients participating in two, 1-year, placebo-controlled trials with tiotropium was performed. Patients were defined as "undertreated" if they received no respiratory medication or only as-needed short-acting beta-agonists prior to enrollment. Measures included serial spirometry, Transition Dyspnea Index (TDI), and St. George's Respiratory Questionnaire (SGRQ).
Of 921 patients enrolled, 218 (23.7%) were "undertreated": 130 received tiotropium; 88 received placebo. Demographics for the two treatment groups were comparable. Tiotropium-treated patients had significantly improved forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) compared with patients using placebo on all study days. Additionally, TDI and SGRQ scores significantly improved with tiotropium compared with placebo.
Once-daily tiotropium provides significant improvement in lung function, health status, and dyspnea when used as maintenance therapy in undertreated COPD patients who were not previously receiving maintenance bronchodilator therapy.
目前，慢性阻塞性肺疾病全球倡议组织（GOLD）建议，有症状的慢性阻塞性肺疾病（COPD）患者以及GOLD定义的II期或更严重COPD患者应使用维持性支气管扩张剂治疗。由于尚无前瞻性数据描述仅使用急救治疗何时不足或开始维持治疗的最佳时机，因此尚不清楚维持治疗对较轻疾病是否有益。为了探索潜在益处，我们提出以下问题：每日一次的噻托溴铵能否改善“治疗不足”的COPD患者（即未接受维持性支气管扩张剂治疗的患者）或其医护人员认为病情较轻的患者的肺功能、健康状况和/或症状？
对参与两项为期1年的噻托溴铵安慰剂对照试验的COPD患者的数据进行事后分析。如果患者在入组前未接受任何呼吸药物治疗或仅按需使用短效β受体激动剂，则定义为“治疗不足”。测量指标包括系列肺量计、过渡性呼吸困难指数（TDI）和圣乔治呼吸问卷（SGRQ）。
在921名入组患者中，218名（23.7%）为“治疗不足”：130名接受噻托溴铵治疗；88名接受安慰剂治疗。两个治疗组的人口统计学特征具有可比性。在所有研究日，与使用安慰剂的患者相比，接受噻托溴铵治疗的患者1秒用力呼气容积（FEV1）和用力肺活量（FVC）显著改善。此外，与安慰剂相比，噻托溴铵治疗使TDI和SGRQ评分显著改善。
对于之前未接受维持性支气管扩张剂治疗的治疗不足的COPD患者，每日一次的噻托溴铵作为维持治疗可显著改善肺功能、健康状况和呼吸困难。
