高龄慢性阻塞性肺疾病患者长期雾化吸入布地奈德的疗效及安全性评估

Efficacy and safety of long term nebulized budesonide inhalation in elderly patients with chronic obstructive pulmonary disease

目的 观察高龄慢性阻塞性肺疾病（chronic obstructive pulmonary disease,COPD）患者雾化吸入布地奈德混悬液的临床疗效及安全性评估.方法 25例高龄COPD稳定期患者随机分为两组,分别给予布地奈德1mg bid,2 mg bid雾化吸入1年.15例正常高龄老人为对照组.结果 雾化吸入布地奈德2mg bid明显改善COPD患者PaCO2（P＜0.01）、FEV1 （P＜0.05）.治疗6m后两组CAT评分均较治疗前明显改善（P＜ 0.05,P＜0.01）;较高剂量组治疗12 m后CAT评分较治疗6m后有进一步改善（P＜0.05）,治疗6m后及12 m后的CAT改善率均优于较低剂量组（P＜0.05,P＜ 0.01）.两组患者治疗期内慢性阻塞性肺疾病急性加重的发生率无明显差异.治疗组与正常对照组相比,糖代谢及血尿骨代谢均无明显影响.治疗期间两组患者肺炎的发生率无明显差异.结论 雾化吸入布地奈德1年可改善中重度COPD高龄患者肺功能和临床症状,未对糖代谢和骨代谢产生不良影响.较高剂量雾化吸入布地奈德1年未增加COPD患者的肺炎发生率.

Objective To evaluate the clinical efficacy and safety of long-term inhalation of nebulized budesonide in elderly patients with chronic obstructive pulmonary disease （COPD）. Methods 25 elderly COPD patients of stable stage were randomly allocated into 2 treatment groups （group A： budesonide 1 mg bid; group B： budesonide 2 mg bid, separately）. The duration of the follow-up was one year. Fifteen healthy old male subjects were recruited as normal age- matched control. Forced expiratory volume in 1 second （FEV1）, blood gas analysis, COPD-assessment test （CAT）, glycometabolism and bone metabolism markers were collected before and after treatment. Results Of patients in group B, PaCO2 and FEV1 were significantly improved compared with baseline （P〈 0.01, P〈 0.05） after one year treatment. CAT scores markedly improved after 6 months treatment in two groups of COPD patients （P〈 0.05, P〈0.01 ）. CAT score was further improved in group B after 12 months therapy compared with 6 month therapy （P〈 0.05）. The ratio of CAT improvement after 6 months and 12 months were higher in group B compared with group A （P〈 0.05, P〈 0.01 ）. There was no significant difference in the percentage of annual rates in acute exacerbations between two treatment groups. Compared with the normal control, no evidence showed bad effect of glycometabolism and bone metabolism in COPD pa- tients. The incidence of pneumonia was similar in two treatment groups. Conclusions One-year treatment with nebulized budesonide could improve the lung function and clinical symptoms in elderly patients with moderate to severe COPD, while no adverse effect on glycometabolism and bone metabolism was reported. No significant increase was discovered in the in- cidence of pneumonia after 1 year treatment.