| Systemic corticosteroids play an important role in treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). However, because most COPD patients are elderly and have many complications, repetitive administration of systemic corticosteroids may increase the risk of adverse events. Budesonide (NB) is an inhaled corticosteroids with powerful anti-inflammatory effect in airway location and hardly no systemic side effects, which has been widely used in the treatment of acute attacks of bronchial asthma both in children and in adults. But the role of nebulized budesonide treatment in AECOPD is still undetermined. The aim of this study is to evaluate the efficacy of nebulized budesonide in AECOPD.ObjectiveTo evaluate the efficacy and safety of nebulized budesonide (NB) in patients with AECOPD.MethodsThis study was a randomized, placebo-controlled, single-blind and parallel design study. Ninety hospitalised patients with AECOPD were randomized into three groups, with each group 30 patients. Group A (nebulized budesonide) received NB inhalation (2mg/8h),Group B(prednisone)received oral prednisone (30mg/d), Group C (placebo) did not received any glucocorticoids. Other corticosteroids were not permitted in 7-day treatment period. All patients received nebulized salbutamol (2.5 mg/8h), nebulized ipratropium bromide (500μg/8h) and other regular treatments, such as oxygen therapy, theophylline and antibiotics, were also permitted. Dyspnoea scales, pulmonary function testing, arterial blood gas analysis and adverse effects evaluation were carried out before treatment and at 24 hours,72 hours and 7 days after treatment. Length of stay, exacerbation and rehospitalization rates of post-discharge within 1 month were also compared in three groups. Statistical methods used ANOVA, t-tests and Chi-squared. Continuous variables data were expressed as mean±SEM. Statistical analyses were performed using single-factor ANOVA on the three groups and with a t-tests for comparisons of two groups. The Chi-squared method was used to compare the enumeration data. A p-value of<0.05 was assumed to be significant.Results1. Comparison of dyspnoea scales:Dyspnoea scales at 24 hours,72 hours and 7 days after treatment were significantly deceased than that before treatment in three groups (p<0.05). The improvement of dyspnoea scales at 24 hours,72 hours after treatment in group A and group B were significantly greater than that in group C (p<0.01). However, there was no difference between group A and group B (p>0.05). In addition, there was no statistically difference in the improvement of dyspnoea scales in three groups at 7 days after treatment (p> 0.05).2. Comparison of pulmonary function:FEV1%pred at 24 hours,72 hours and 7 days after treatment were significantly deceased than that before treatment in three groups (p<0.05) and the improvement of FEV1%pred exhibited a time-dependent manner. The improvement of FEV1%pred at 72 hours and 7days after treatment in group A and group B were significantly greater than that in group C (p<0.01). However, there was no difference between group A and group B (p>0.05).3. Comparison of arterial blood gases:3.1 PaO2:PaO2 at 24 hours,72 hours and 7 days after treatment were significantly increased than that before treatment in three groups (p<0.05) and the improvement of PaO2 exhibited a time-dependent manner. The improvement of PaO2 at every time point in group A and group B were significantly greater than that in group C (p<0.01). However, there was no difference between group A and group B (p>0.05).3.2 PaCO2:PaCO2 at 24 hours,72 hours and 7 days after treatment were significantly deceased than that before treatment in three groups (p<0.05). The decrease of PaCO2 at 24 hours after treatment in group A and group B were significantly greater than that in group C (group A:p=0.035; group B:p=0.008). However, there was no difference between group A and group B (p=0.563). Similar results were obtained at 72 hours after treatment. The decrease of PaCO2 at 7 days after treatment in group A and group B were significantly greater than that in group C (group A:p=0.036; group B:p=0.001). In addition, there was significantly difference between group A and group B (p=0.035). The extent of PaCO2 decrease in group A and group B were 4.19±1.54 mmHg and 5.22±1.58 mmHg, respectively.4. Comparison of length of hospital stay,exacerbation and rehospitalisation rates of post-discharge within 1 month:There was no statistically significant difference in discharge rates in three groups (p>0.05) between 7 to 10 days and the discharge rates in three groups were 76%(group A),84%(group B),68% (group C), respectively. Hospital stays were 9.1±1.9 (group A),8.8±1.7(group B),10.1±2.1(group C), respectively.Group A and group B in hospital stay significant reduced than group C (p<0.05), difference between group A and group B was not statistically significance (p>0.05).There was also no statistically significant difference in exacerbation rates of post-discharge within 1 month in three groups (p>0.05) and the exacerbation rates in three groups were 19%(group A),16%(group B),36%(group C), respectively. In addition, there was no statistically significant difference in rehospitalization rates of post-discharge within 1 month in three groups (p>0.05) and the rehospitalization rates in three groups were 8%(group A),8%(group B),16%(group C), respectively.5. Comparison of adverse effects:No serious adverse events occurred in three groups.9 cases of adverse effects occurred in group B:upset stomach (n=3), hyperglycemia (n=3), hypertension (n=2), sleep disorders (n=1).3 cases of adverse effects occurred in group A:pharyngeal discomfort (n=3), which can alleviate through gargling after inhalation treatment.2 cases of adverse effects occurred in group C:upset stomach (n=1), palpitation (n=1). The incidence rates of adverse effects in group A and group C were significantly lower than that in group B (group A:p=0.041; group C:p=0.019). There was no statistically difference in group A and group C.ConclusionBudesonide nebulized inhalation was an effective treatment for AECOPD, which showed comparative efficacy to oral prednisone and less adverse effects were observed. Our data indicated that nebulized budesonide may be an effective and safe alternative treatment choice other than systemic corticosteroids in patients with AECOPD. |
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