| Objective: Chronic obstructive pulmonary disease(COPD) is one of the leading causes of chronic morbidity and mortality on the world and is projected to rand fifth in 2020 as a worldwide burden of disease.COPD is an increasingly common problem in China. The cellular and molecular mechanisms of exacerbations are still not well understood but most evidence suggests that they are due to a further amplification of the inflammatory process triggered by bacteria, viruses and noninfective stimuli. There is a marked increase in neutrophil numbers (accounting for the change in sputum colour) and cytokines that are increased in stable COPD (tumour necrosisfactor TNF-αand IL-8) are further increased during the Exacerbation. Decreases in inflammatory cytokines, C-reactive protein, and inflammatory cells have been observed with corticosteroid use, suggesting a possible mechanism for a therapeutic benefit of steroids. systemic corticosteroids are strongly recommended in the management ofexacerbations of chronic obstructive pulmonary disease by all international guidelinesthe risk of development of severe adverse effects due to repeated courses of systemic corticosteroidis much higher in this subgroup. Nebulised corticosteroids have been available for the last decade. Since their topical anti-inflammatory activity is high, they are safely used as asubstitute for inhaled corticosteroids in patients with stable COPD and bronchial asthma, where necessary. However, there are only a few studiesin the literature related to their use in the management of exacerbations of bronchial asthma and COPD. The current authors designed a study to evaluate the safety and efficacy of nebulised budesonide suspension compared with systemic corticosteroid in the treatment of patients with respiratory failure requiring mechanical ventilation for an exacerbation.Methods: COPD patients for an exacerbation were prospectively enrolled in the study. Informed consent was obtained from all the participants. The patients during November,2009～December,2011 were randomly sorted into three groups. The treatment groups were as follows. Group A received bronchodilator treatment with nebulised salbutamol (2ml,Q6h) and nebulised ipratropium bromide (0.5 mg q.i.d.) in separate sessions. Group B received systemic corticosteroids with methylprednisolone (i.v. 40mg q.i.d.) for 5 days beside the same bronchodilator treatments as group A. Group C received nebulised corticosteroids with nebulised budesonide (2mg,Q8h) for 5 days beside the same bronchodilator treatments as group A. All patients were given mechanical ventilation and antibiotics that were used according to patient's condition. IL-8,TNF-αand CRP of induced sputum was detected at 1h,72h,5d,7d for mechanical ventilation.Complete blood counts, detailed biochemical analysis were carried out at admission .In addition, the following were recorded: adverse effects developed; absolute blood glucose level; patient's withdrawal for any reason; in-hospital deaths; deaths after discharge within 1 month; exacerbation and rehospitalisation rates within 1 month after discharge.Results: 48 patients completed the study (15 in group A, 17 in group B, 16 in group C). 1 Level of interleukin-8 in sputumAt 1h for mechanical ventilation, there is no statistical difference for sputum IL-8 in group A(1982±901ng/L),group B (1906±921ng/L) and group C (1974±899ng/L) ;At 72h for mechanical ventilation, Sputum IL-8 in group B(1428±446 ng/L) and C (1439±399 ng/L) were lower than those At 1h ( P <0.05) ; At 5d for mechanical ventilation, Sputum IL-8 in group A was lower than those At 1h(P=0.023);There is no statistical difference for sputum IL-8 levels at 72h,5d,7d between group B and group C(P>0.05). 2 Level of tumor necrosis factor-αin sputumAt 1h for mechanical ventilation, there is no statistical difference for sputum TNF-αin group A(1649±526ng/L),group B (1650±519ng/L) and group C (1638±511ng/L) ;At 72h for mechanical ventilation, Sputum TNF-αin group B(1129±343 ng/L) and C(1189±357 ng/L) were lower than those At 1h ( P <0.05) ; At 5d for mechanical ventilation, Sputum TNF-αin group A was lower than those At 1h(P=0.031);There is no statistical difference for sputum TNF-αlevels at 72h,5d,7d between group B and group C(P>0.05). 3 Level of C-reactive protein in sputumAt 1h for mechanical ventilation, there is no statistical difference for sputum C-reactive protein in group A(0.8±0.2mg/L),group B (0.8±0.2mg/L) and group C (0.8±0.2mg/L) ;At 72h for mechanical ventilation, Sputum C-reactive protein in group B(0.5±0.2 mg/L) and C(0.5±0.1 mg/L) were lower than those At 1h ( P <0.05) ; At 5d for mechanical ventilation, Sputum C-reactive protein in group A was lower than those At 1h(P=0.042);There is no statistical difference for sputum C-reactive protein levels at 72h,5d,7d between group B and group C(P>0.05). 4 OthersBlood glucose exhibited an upward trend only in group B. There is no statistical difference for in-hospital deaths,deaths after discharge and rehospitalisation rates within 1 month after discharge in the 3 groups.Conclusion: nebulised budesonide exerted less systemic activity than systemic corticosteroid administration, as indicated by serial blood glucose measurements. In conclusion, the data suggest that high-dose nebulised budesonide may be an alternative to systemic corticosteroids in the treatment of exacerbations of chronic obstructive pulmonary disease.
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