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日本慢性阻塞性肺疾病(COPD)临床试验数据库及世界其他地区血液嗜酸性粒细胞水平的分布情况。

The distribution of blood eosinophil levels in a Japanese COPD clinical trial database and in the rest of the world.

作者信息

Barnes Neil, Ishii Takeo, Hizawa Nobuyuki, Midwinter Dawn, James Mark, Hilton Emma, Jones Paul W

机构信息

Respiratory Medicine Franchise, GlaxoSmithKline, Brentford, UK.

William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, London, UK.

出版信息

Int J Chron Obstruct Pulmon Dis. 2018 Feb 2;13:433-440. doi: 10.2147/COPD.S144108. eCollection 2018.

DOI:10.2147/COPD.S144108
PMID:29440882
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5799851/
Abstract

BACKGROUND

Blood eosinophil measurements may help to guide physicians on the use of inhaled corticosteroids (ICS) for patients with chronic obstructive pulmonary disease (COPD). Emerging data suggest that COPD patients with higher blood eosinophil counts may be at higher risk of exacerbations and more likely to benefit from combined ICS/long-acting beta-agonist (LABA) treatment than therapy with a LABA alone. This analysis describes the distribution of blood eosinophil count at baseline in Japanese COPD patients in comparison with non-Japanese COPD patients.

METHODS

A post hoc analysis of eosinophil distribution by percentage and absolute cell count was performed across 12 Phase II-IV COPD clinical studies (seven Japanese studies [N=848 available absolute eosinophil counts] and five global studies [N=5,397 available eosinophil counts] that included 246 Japanese patients resident in Japan with available counts). Blood eosinophil distributions were assessed at baseline, before blinded treatment assignment.

FINDINGS

Among Japanese patients, the median (interquartile range) absolute eosinophil count was 170 cells/mm (100-280 cells/mm). Overall, 612/1,094 Japanese patients (56%) had an absolute eosinophil count ≥150 cells/mm and 902/1,304 Japanese patients (69%) had a percentage eosinophil ≥2%. Among non-Japanese patients, these values were 160 (100-250) cells/mm, 2,842/5,151 patients (55%), and 2,937/5,155 patients (57%), respectively. The eosinophil distribution among Japanese patients was similar to that among non-Japanese patients. Within multi-country studies with similar inclusion criteria, the eosinophil count was numerically lower in Japanese compared with non-Japanese patients (median 120 vs 160 cells/mm).

INTERPRETATION

The eosinophil distribution in Japanese patients seems comparable to that of non-Japanese patients; although within multi-country studies, there was a slightly lower median eosinophil count for Japanese patients compared with non-Japanese patients. These findings suggest that blood eosinophil data from global studies are of relevance in Japan.

摘要

背景

血液嗜酸性粒细胞测量可能有助于指导医生对慢性阻塞性肺疾病(COPD)患者使用吸入性糖皮质激素(ICS)。新出现的数据表明,血液嗜酸性粒细胞计数较高的COPD患者急性加重风险可能更高,与单独使用长效β受体激动剂(LABA)治疗相比,联合使用ICS/LABA治疗可能更有益。本分析描述了日本COPD患者与非日本COPD患者基线时血液嗜酸性粒细胞计数的分布情况。

方法

对12项II-IV期COPD临床研究(7项日本研究[N = 848个可用的绝对嗜酸性粒细胞计数]和5项全球研究[N = 5397个可用的嗜酸性粒细胞计数])进行事后分析,这些研究纳入了246名居住在日本且有可用计数的日本患者,按百分比和绝对细胞计数分析嗜酸性粒细胞分布情况。在盲法治疗分配前,于基线时评估血液嗜酸性粒细胞分布情况。

研究结果

在日本患者中,绝对嗜酸性粒细胞计数的中位数(四分位间距)为170个细胞/mm³(100 - 280个细胞/mm³)。总体而言,612/1094名日本患者(56%)的绝对嗜酸性粒细胞计数≥150个细胞/mm³,902/1304名日本患者(69%)的嗜酸性粒细胞百分比≥2%。在非日本患者中,这些数值分别为160(100 - 250)个细胞/mm³、2842/5151名患者(55%)和2937/5155名患者(57%)。日本患者的嗜酸性粒细胞分布与非日本患者相似。在纳入标准相似的多国研究中,日本患者的嗜酸性粒细胞计数在数值上低于非日本患者(中位数为120个细胞/mm³对160个细胞/mm³)。

解读

日本患者的嗜酸性粒细胞分布似乎与非日本患者相当;尽管在多国研究中,日本患者的嗜酸性粒细胞计数中位数略低于非日本患者。这些发现表明全球研究中的血液嗜酸性粒细胞数据在日本具有相关性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d20/5799851/66d407e076ec/copd-13-433Fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d20/5799851/fb3a0011caa2/copd-13-433Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d20/5799851/66d407e076ec/copd-13-433Fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d20/5799851/fb3a0011caa2/copd-13-433Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d20/5799851/66d407e076ec/copd-13-433Fig2.jpg

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