Lin Yi-Hua, Liao Xi-Ning, Fan Li-Li, Qu Yue-Jin, Cheng De-Yun, Shi Yong-Hong
Department of Respiratory Medicine, the First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.
Department of Respiratory Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
PLoS One. 2017 Aug 23;12(8):e0183300. doi: 10.1371/journal.pone.0183300. eCollection 2017.
The systemic inflammation is associated with clinical outcome and mortality in chronic obstructive pulmonary disease (COPD) patients. To investigate the effects of tiotropium (Tio) and/or budesonide/formoterol (Bud/Form) on systemic inflammation biomarkers in stable COPD patients of group D, a randomized, open-label clinical trial was conducted.
Eligible participants (n = 324) were randomized and received either Tio 18ug once daily (group I), Bud/Form 160/4.5ug twice daily (group II), Bud/Form 320/9ug twice daily (group III), or Tio 18ug once daily with Bud/Form 160/4.5ug twice daily (group IV) for 6 months. Systemic inflammation biomarkers were measured before randomization and during the treatment, including C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-8 (IL-8), serum amyloid A (SAA), tumor necrosis factor-α (TNF-α), fibrinogen (Fib), and white blood cell (WBC).
After 6-month treatment, CRP levels in group II, group III and group IV changed by a median (interquartile range) of -1.25 (-3.29, 1.18) mg/L, -1.13 (-2.55, 0.77) mg/L, and -1.56 (-4.64, 0.22) mg/L respectively, all of which with statistical differences compared with group I. In addition, there were no treatment differences in terms of IL-8, SAA, TNF-α, Fib and WBC levels.
A long-term treatment with Bud/Form alone or together with Tio can attenuate circulating CRP levels in COPD patients of group D, compared with Tio alone.
全身炎症与慢性阻塞性肺疾病（COPD）患者的临床结局及死亡率相关。为研究噻托溴铵（Tio）和/或布地奈德/福莫特罗（Bud/Form）对D组稳定期COPD患者全身炎症生物标志物的影响，开展了一项随机、开放标签的临床试验。
符合条件的参与者（n = 324）被随机分组，分别接受每日一次18μg的Tio（I组）、每日两次160/4.5μg的Bud/Form（II组）、每日两次320/9μg的Bud/Form（III组）或每日一次18μg的Tio联合每日两次160/4.5μg的Bud/Form（IV组）治疗6个月。在随机分组前及治疗期间测量全身炎症生物标志物，包括C反应蛋白（CRP）、白细胞介素-6（IL-6）、白细胞介素-8（IL-8）、血清淀粉样蛋白A（SAA）、肿瘤坏死因子-α（TNF-α）、纤维蛋白原（Fib）和白细胞（WBC）。
经过6个月治疗后，II组、III组和IV组的CRP水平变化中位数（四分位间距）分别为-1.25（-3.29，1.18）mg/L、-1.13（-2.55，0.77）mg/L和-1.56（-4.64，0.22）mg/L，与I组相比均有统计学差异。此外，在IL-8、SAA、TNF-α、Fib和WBC水平方面，各治疗组之间无差异。
与单独使用Tio相比，单独使用Bud/Form或联合Tio对D组COPD患者进行长期治疗可降低循环CRP水平。
