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噻托溴铵对慢性阻塞性肺疾病(COPD)急性加重低风险或高风险患者急性加重的影响:来自4年UPLIFT®试验的事后分析

Effects of Tiotropium on Exacerbations in Patients with COPD with Low or High Risk of Exacerbations: A Post-Hoc Analysis from the 4-Year UPLIFT® Trial.

作者信息

Celli Bartolome R, Decramer Marc, Asijee Guus M, Kupas Katrin, Tashkin Donald P

机构信息

Pulmonary Division, Brigham and Women's Hospital, Boston, Massachusetts.

Respiratory Division, University of Leuven, Leuven, Belgium.

出版信息

Chronic Obstr Pulm Dis. 2015 Mar 27;2(2):122-130. doi: 10.15326/jcopdf.2.2.2014.0155.

DOI:10.15326/jcopdf.2.2.2014.0155
PMID:28848836
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5556966/
Abstract

A history of past exacerbations is a predictor of future events for patients with chronic obstructive pulmonary disease (COPD). Very little is known about the effect of pharmacologic therapies on patients with frequent or infrequent exacerbations. We conducted a post-hoc analysis of the Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT)trial database. Patients were classified as having a low risk of exacerbations if they experienced ≤1 exacerbation and no COPD-related hospitalization(s) in the year preceding trial entry or as high risk of exacerbations if they had ≥2 exacerbations (courses of oral steroids/antibiotics) or ≥1 COPD-related hospitalization(s) in the year preceding the trial. In patients at low risk or high risk for exacerbations, compared to placebo, tiotropium significantly reduced: 1) the time to first COPD exacerbation (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.74, 0.88; <0.0001; HR: 0.89; 95% CI: 0.81, 0.97; =0.0066, respectively); 2) the number of COPD exacerbations (rate ratio [RR]: 0.79; 95% CI: 0.72, 0.86; <0.0001; RR: 0.88; 95% CI: 0.81; 0.95; =0.0009). Furthermore, upon treatment with tiotropium, the proportion of patients transitioning from the low- to the high-risk exacerbations group was statistically lower compared to placebo (RR: 0.78; 95% CI: 0.67, 0.92; =0.0030) : This analysis shows that tiotropium reduces the risk of subsequent exacerbation and also prolongs time to first exacerbation, in both the high- and low-risk exacerbator subgroups. It also decreases the proportion of patients who shift from the low- to the high-risk exacerbations group compared to placebo.

摘要

既往病情加重史是慢性阻塞性肺疾病(COPD)患者未来发病的一个预测指标。关于药物治疗对频繁或不频繁病情加重患者的影响,目前所知甚少。我们对噻托溴铵对肺功能潜在长期影响的理解(UPLIFT)试验数据库进行了事后分析。如果患者在进入试验前一年病情加重≤1次且无COPD相关住院,则被归类为病情加重低风险;如果在试验前一年病情加重≥2次(口服类固醇/抗生素疗程)或有≥1次COPD相关住院,则被归类为病情加重高风险。在病情加重低风险或高风险的患者中,与安慰剂相比,噻托溴铵显著降低了:1)首次COPD病情加重的时间(风险比[HR]:0.81;95%置信区间[CI]:0.74,0.88;P<0.0001;HR:0.89;95%CI:0.81,0.97;P = 0.0066);2)COPD病情加重的次数(率比[RR]:0.79;95%CI:0.72,0.86;P<0.0001;RR:0.88;95%CI:0.81,0.95;P = 0.0009)。此外,与安慰剂相比,接受噻托溴铵治疗后,从低风险病情加重组转变为高风险病情加重组的患者比例在统计学上更低(RR:0.78;95%CI:0.67,0.92;P = 0.0030):该分析表明,噻托溴铵在高风险和低风险病情加重亚组中均降低了后续病情加重的风险,并延长了首次病情加重的时间。与安慰剂相比,它还降低了从低风险病情加重组转变为高风险病情加重组的患者比例。

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