与大型药企资助的慢性阻塞性肺疾病（COPD）研究相比的基层医疗COPD患者：一项UNLOCK验证研究
Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.
作者信息
Kruis Annemarije L, Ställberg Björn, Jones Rupert C M, Tsiligianni Ioanna G, Lisspers Karin, van der Molen Thys, Kocks Jan Willem H, Chavannes Niels H
机构信息
Department of Public Health and Primary Care, Leiden University Medical Centre, Leiden, The Netherlands.
Department of Public Health and Caring Science, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.
出版信息
PLoS One. 2014 Mar 5;9(3):e90145. doi: 10.1371/journal.pone.0090145. eCollection 2014.
BACKGROUND
Guideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care.
OBJECTIVE
We aimed to evaluate the external validity of six LPCS (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) on which current guidelines are based, in relation to primary care COPD patients, in order to inform future clinical practice guidelines and trials.
METHODS
Baseline data of seven primary care databases (n=3508) from Europe were compared to baseline data of the LPCS. In addition, we examined the proportion of primary care patients eligible to participate in the LPCS, based on inclusion criteria.
RESULTS
Overall, patients included in the LPCS were younger (mean difference (MD)-2.4; p=0.03), predominantly male (MD 12.4; p=0.1) with worse lung function (FEV1% MD -16.4; p<0.01) and worse quality of life scores (SGRQ MD 15.8; p=0.01). There were large differences in GOLD stage distribution compared to primary care patients. Mean exacerbation rates were higher in LPCS, with an overrepresentation of patients with ≥ 1 and ≥ 2 exacerbations, although results were not statistically significant. Our findings add to the literature, as we revealed hitherto unknown GOLD I exacerbation characteristics, showing 34% of mild patients had ≥ 1 exacerbations per year and 12% had ≥ 2 exacerbations per year. The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT).
CONCLUSION
Primary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations. More research is needed to determine the effect of pharmacological treatment in mild to moderate patients. We encourage future guideline makers to involve primary care populations in their recommendations.
背景
慢性阻塞性肺疾病（COPD）的指南建议基于大型药企资助的COPD研究（LPCS）结果。在初级保健层面，关于疾病特征的数据匮乏，而大多数COPD患者在初级保健机构接受治疗。
目的
我们旨在评估当前指南所依据的六项LPCS（ISOLDE、TRISTAN、TORCH、UPLIFT、ECLIPSE、POET-COPD）相对于初级保健COPD患者的外部效度，以便为未来的临床实践指南和试验提供参考。
方法
将来自欧洲的七个初级保健数据库（n = 3508）的基线数据与LPCS的基线数据进行比较。此外，我们根据纳入标准检查了符合参与LPCS条件的初级保健患者的比例。
结果
总体而言，LPCS纳入的患者更年轻（平均差异（MD）-2.4；p = 0.03），男性居多（MD 12.4；p = 0.1），肺功能更差（第一秒用力呼气容积百分比（FEV1%）MD -16.4；p < 0.01），生活质量评分更差（圣乔治呼吸问卷（SGRQ）MD 15.8；p = 0.01）。与初级保健患者相比，慢性阻塞性肺疾病全球倡议（GOLD）分级分布存在很大差异。LPCS中的平均急性加重率更高，≥1次和≥2次急性加重的患者比例过高，尽管结果无统计学意义。我们的研究结果丰富了文献，因为我们揭示了迄今未知的GOLD 1级急性加重特征，显示34%的轻度患者每年有≥1次急性加重，12%的患者每年有≥2次急性加重。符合纳入LPCS条件的初级保健患者比例从17%（TRISTAN）到42%（ECLIPSE、UPLIFT）不等。
结论
初级保健COPD患者在性别、肺功能、生活质量和急性加重方面与LPCS纳入的患者不同。需要更多研究来确定药物治疗对轻至中度患者的效果。我们鼓励未来的指南制定者在其建议中纳入初级保健人群。
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