Li Chenglong, Zhou Yumin, Liu Sha, Zheng Mengning, Zheng Jinzhen, Peng Huanhuan, Deng Zhishan, Zhong Nanshan, Ran Pixin
The State Key Laboratory of Respiratory Disease, National Clinical Researcher Center for Respiratory Diseases, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
These authors contributed equally to this study.
ERJ Open Res. 2019 Feb 18;5(1). doi: 10.1183/23120541.00175-2018. eCollection 2019 Feb.
Tiotropium improves lung function and ameliorates the annual decline in forced expiratory volume in 1 s (FEV) after bronchodilator use in patients with mild to moderate chronic obstructive pulmonary disease (COPD). However, whether these benefits persist in patients with early-stage COPD after tiotropium discontinuation is unknown.
In this prospective cohort observational follow-up study, patients who had completed the Tiotropium in Early-Stage COPD (Tie-COPD) trial were followed for a maximum of 3 years, continuing or discontinuing treatment according to their willingness. The outcomes measured were spirometry parameters, COPD exacerbations, COPD Assessment Test (CAT) scores, Clinical COPD Questionnaire (CCQ) scores, modified Medical Research Council (mMRC) scores and the use of respiratory medications.
Out of 376 patients, 262 (126 in the post-placebo group and 136 in the post-tiotropium group) completed the maximum 3-year follow-up after the study medication was withdrawn. After discontinuation, the decrease in FEV and forced vital capacity (FVC) did not differ significantly between the two groups, and neither did their annual decline. In addition, the frequency of acute COPD exacerbations and the mMRC scores were similar between the two groups after medication withdrawal. Both the mean CAT and CCQ scores were significantly lower in the post-tiotropium group than in the post-placebo group (p<0.05 for all comparisons) at the 1-year follow-up after withdrawal, but they were not different at the next follow-up.
Withdrawal of tiotropium treatment in early-stage COPD resulted in difference reduction of both FEV and FVC, indicating that treatment should be continued.
噻托溴铵可改善轻度至中度慢性阻塞性肺疾病（COPD）患者使用支气管扩张剂后一秒用力呼气容积（FEV）的肺功能并减缓其年度下降。然而，噻托溴铵停药后这些益处是否在早期COPD患者中持续尚不清楚。
在这项前瞻性队列观察性随访研究中，完成早期COPD噻托溴铵（Tie-COPD）试验的患者最多随访3年，根据其意愿继续或停止治疗。测量的结果包括肺量计参数、COPD急性加重、COPD评估测试（CAT）评分、临床COPD问卷（CCQ）评分、改良医学研究委员会（mMRC）评分以及呼吸药物的使用情况。
376例患者中，262例（安慰剂后组126例，噻托溴铵后组136例）在研究药物停用后完成了最长3年的随访。停药后，两组FEV和用力肺活量（FVC）的下降无显著差异，其年度下降也无差异。此外，停药后两组COPD急性加重的频率和mMRC评分相似。停药后1年随访时，噻托溴铵后组的平均CAT和CCQ评分均显著低于安慰剂后组（所有比较p<0.05），但在下一次随访时无差异。
早期COPD患者停用噻托溴铵治疗导致FEV和FVC的差异减小，表明应继续治疗。
