联合雾化吸入治疗AECOPD的临床观察

目的观察布地奈德、沙丁胺醇、氨溴索联合雾化吸入对慢性阻塞性肺疾病急性加重期（AECOPD）的临床疗效。方法将80例AECOPD患者随机分为两组,治疗组和对照组各40例。治疗组在常规治疗的基础上加布地奈德2ml、沙丁胺醇3mg、氨溴索15mg氧气驱动雾化吸入,每天2次;对照组在常规治疗的基础上加氨溴索15mg氧气驱动雾化吸入,每天2次。记录两组患者用药7d前后咳嗽、咳痰、气短或喘息、痰液等方面的变化。结果两组疗效相比有显著性差异（P〈0．05）。结论布地奈德、沙丁胺醇、氨溴索联合雾化吸入治疗AECOPD疗效肯定,且无明显副作用。     

雾化吸入布地奈德混悬液对慢性阻塞性肺疾病急性加重期患者的治疗作用及安全性评估

目的　探讨短期雾化吸入布地奈德混悬液对慢性阻塞性肺疾病急性加重期（AECOPD）患者的治疗效果及安全性评估。方法　87例AECOPD患者被随机分为吸入激素组（31例）、全身激素组（27例）和对照组（29例）。三组均给予吸氧、抗感染、氨茶碱及止咳化痰等常规治疗。吸入激素组加用布地奈德混悬液氧气雾化吸入。全身激素组在常规治疗的基础上加用泼尼松龙40mg，静脉给药。三组均于治疗前及治疗7d后测定肺功能、动脉血气及空腹血糖、电解质。结果　治疗前，三组间各指标比较无明显差异。治疗后，三组肺功能及动脉血气较治疗前均有明显改善（P〈0．01或P〈0．05）；吸入激素组与全身激素组比较，除血糖外（P=0．044），各指标差异无显著性（P均〉0．05）；吸入激素组与对照组比较，除pH值外，肺功能、血气指标差异均显著，血糖、电解质比较差异无显著性（P均〉0．05）。结论布地奈德混悬液雾化吸入治疗AECOPD安全有效。     

布地奈德混悬液吸入治疗AECOPD 180例临床观察

目的观察雾化吸入布地奈德混悬液对慢性阻塞性肺疾病急性加重期（AECOPD）的治疗效果,评价其临床应用价值。方法将180例AECOPD患者随机分为两组（治疗组和对照组）,治疗组在常规治疗的基础上加用布地奈德混悬液吸入14天,观察治疗前后及两组的肺功能指标及呼吸困难分级变化。结果两组患者在治疗前观察指标差异无显著性（P〉0．05）,治疗后治疗组肺功能指标及呼吸困难分级明显改善（P〈0．05）。结论布地奈德混悬液吸入治疗AECOPD能有效地改善患者的肺功能指标及呼吸困难分级。     

雾化吸入不同剂量布地奈德混悬液对AECOPD患者的治疗作用及安全性评估8076

目的探讨雾化吸人不同剂量的布地奈德混悬液对慢性阻塞性肺疾病急性加重期（AECOPD）患者的治疗效果及安全性评估。方法84例AECOPD患者被随机分为大剂量组（30例）、一般剂量组（28例）、和对照组（26例）。三组均给予吸氧、抗菌素、氨茶碱及止咳化痰等常规治疗。大剂量组加用布地奈德混悬液4mg氧气吸入3次／天。一般剂量组加用布地奈德混悬液2mg氧气吸入3次／天。三组均治疗前及治疗后4小时、72小时、10天测定肺功能、动脉血气。治疗前后测空腹血糖、骨代谢指标。结果治疗前三组间各指标比较无明显差异（P〉0．05）。治疗后4小时大剂量组与治疗前比较有显著差异性（P〈0．05）而其余两组均无显著差异性（P〉0．05）。治疗后72小时大剂量组和一般剂量组与治疗前比较均有显著性差异（P〈0．01或P〈O．05）。两组间比较也有显著性差异（P〈0．05）,而对照组无显著性差异。10天后三组均与治疗前比较有显著性差异（P〈0．01或P〈0．05）。而大剂量组与一般剂量组比较无显著性差异（P〉0．05）。与对照组比较仍有显著性差异。治疗后三组间血糖、骨代谢各指标与治疗前无显著性差异（P〉0．05）。结论大剂量布地奈德混悬液雾化吸入治疗AECOPD起效快而安全。     

吸入与系统应用糖皮质激素治疗慢性阻塞性肺疾病急性加重的疗效对比

目的比较吸入与系统应用糖皮质激素治疗慢性阻塞性肺疾病急性加重（AECOPD）的疗效及安全性。方法选择我院符合标准的AECOPD中度和重度患者99例,随机分为治疗组48例,晨起系统应用糖皮质激素;对照组51例,雾化吸入布地奈德混悬液2mg,2次／d。观察两组患者第一秒用力肺活量（FEV1）、挠动脉血氧分压（PaO2）、二氧化碳分压（PaCO2）及呼吸困难评分的改善情况。结果两组患者治疗前FEV1、PaO2、PaCO2和呼吸困难评分间差异均无无统计学意义（P〉0．05）。两组患者治疗后FEV1、PaO2、PaCO2和呼吸困难评分间差异均有统计学意义（P〈0．05）。结论AECOPD患者首选系统应用糖皮质激素治疗。     

雾化吸入与全身应用糖皮质激素在AECOPD中的临床研究

目的观察糖皮质激素雾化吸入对比全身治疗慢性阻塞性肺病急性加重期（AECOPD）的疗效、不良反应和经济成本。方法 70例中AECOPD患者随机分为雾化吸入组（34例）和全身应用组（38例）,分别给予布地奈德混悬液雾化吸入3mg/d（1mg/次,次/8h）,后改为2mg/d（1mg/次,次/12h）共15d;和甲泼尼龙静滴第1～3d,40mg/d,第4d开始口服泼尼松30mg/d,然后每3d减10mg,减至10mg后每3d减5mg至停药,共15d。记录治疗前和治疗15d后动脉血气PaO2和PaCO2;FEV1、FEV1/FVC,及药物的不良反应和经济成本。结果治疗后15d FEV1、FEV1/FVC雾化吸入组和静脉应用组分别上升了6.72%和8.30%（P〈0.05）,PaO2分别上升7.0mmHg和8.0mmHg,PaCO2分别下降7.3mmHg和8.1mmHg两组比较均有统计学意义（P〈0.05）。短期不良反应雾化吸入组主要为声嘶,全身应用组为血糖升高及消化道出血。两组患者住院时间,成本费用差异均无统计学意义。结论布地奈德雾化吸入治疗AECOPD与全身应用甲泼尼龙疗效一致,全身不良反应轻,短期治疗费用无明显增加。     

雾化吸入普米克令舒在AECOPD进入稳定期治疗的疗效观察

目的观察雾化吸入普米克令舒治疗慢性阻塞性肺疾病急性加重期（AECOPD）进入稳定期的临床疗效和安全性。方法将40例AECOPD患者经住院治疗，病情缓解后，随机分为观察组和对照组，观察组停止全身应用糖皮质激素，改用普米克令舒1mg吸入，2次／d；对照组全身糖皮质激素减量为口服强的松10mg，2次／d，观察两组患者治疗后第7、14天动脉血气分析、肺功能、临床症状变化及副作用情况。结果两组患者治疗后，动脉血气及肺功能均有明显改善，与治疗前比较差异有显著性（P〈0．01），两组之间比较差异无显著性（P〉0．05），观察组的副作用明显少于对照组。结论AECOPD病人静脉应用糖皮质激素治疗，病情缓解后，在全身糖皮质激素减量过渡治疗时可用雾化吸人普米克令舒代替，从而减少因全身长时间应用糖皮质激素出现的不良反应。     

布地奈德联合沙丁胺醇雾化吸入对慢性阻塞性肺疾病急性加重的治疗作用

目的探讨布地奈德联合沙丁胺醇雾化吸入对慢性阻塞性肺疾病急性加重（AECOPD）的疗效及安全性。方法将54例AECOPD患者随机分为2组，治疗组27例，对照组27例，在常规治疗的基础上治疗组给予布地奈德联合沙丁胺醇雾化吸入，对照组单用布地奈德雾化吸入，观察治疗前、治疗3天、治疗7天后患者咳、喘、气短、胸闷等临床症状的评分、FEV，占预计值的比值、血生化、生命体征等指标的变化及有无不良反应出现。结果治疗组及对照组在治疗3天后FEV。占预计值的比值，各临床症状的评分均明显改善（P〈0．01，P〈0．05），但两组间比较治疗组优势更明显（P〈0．05）。治疗7天后两组各项指标进一步改善，但两组间差异无统计学意义（P〉0．05）。观察期内无不良反应，各项生化及生命指标均正常。结论布地奈德联合沙丁胺醇雾化吸入在AECOPD治疗早期较单一吸入布地奈德临床症状缓解更加迅速，肺功能改善明显，观察期内无不良反应，值得临床推广。     

普米克令舒和万托林联合雾化吸入治疗AECOPD的效果分析

目的观察普米克令舒和万托林联合雾化吸入对慢性阻塞性肺疾病急性加重期（AECOPD）的临床疗效。方法60例AECOPD患者随机分为两组：观察组32例、给予普米克令舒1mg和万托林雾化液1ml联合雾化吸入治疗,2次／d;对照组28例、给予万托林雾化液1ml雾化吸入治疗,2次／d,地塞米松10mg静脉滴注,FEV1观察疗效及不良反应。结果两组患者治疗后临床症状评分均明显降低,FEV1和PEF及pH值、PaO2、PaCO2均有改善,治疗前后相比差异有统计学意义（P〈0．05）,但两组间相互比较差异无统计学意义（P〉0．05）;观察组不良反应明显少于对照组。结论普米克令舒和万托林联合雾化吸入能够改善AECOPD患者肺功能及临床症状,与全身使用糖皮质激素疗效相近,但不良反应明显减少。     

普米克令舒雾化吸入治疗慢性阻塞性肺疾病急性加重期的疗效观察及安全性评估

目的观察普米克令舒（布地奈德混悬液）雾化吸入治疗慢性阻塞性肺疾病急性加重期（AECOPD）的临床疗效与安全性。方法将100例AECOPD的患者随机分为三组,吸入激素组、全身激素组及对照组,三组基础药物相同,对三组的呼吸困难评分、动脉血气分析及肺功能检查进行评价。结果普米克令舒雾化吸入治疗组于治疗后7 d动脉血气分析指标及肺功能改善明显优于对照组P〈0.05,且不良反应少于全身激素组。结论普米克令舒雾化吸入治疗AECOPD的疗效明显,且副作用小。     

Comparison of nebulized budesonide and oral prednisolone with placebo in the treatment of acute exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial

Nebulized budesonide has been used successfully to treat acute asthma exacerbation, and we hypothesized that it could also be effective for exacerbations of chronic obstructive pulmonary disease (COPD). In this multicenter, double-blind, randomized, placebo-controlled trial, the efficacy of nebulized budesonide (Pulmicort Respules/Nebuamp), oral prednisolone, and placebo was compared in 199 patients with acute exacerbations of COPD requiring hospitalization. Patients received from randomization (H(0)) to 72 h (H(72)), 2 mg of budesonide every 6 h (n = 71), 30 mg of oral prednisolone every 12 h (n = 62), or placebo (n = 66). All received standard treatment, including nebulized beta(2)-agonists, ipratropium bromide, oral antibiotics, and supplemental oxygen. The mean change (95% confidence interval) in postbronchodilator FEV(1) from H(0) to H(72) was greater with active treatments than with placebo: budesonide versus placebo, 0.10 L (0.02 to 0.18 L); prednisolone versus placebo, 0.16 L (0.08 to 0.24 L). The difference in FEV(1) between budesonide and prednisolone was not significant, -0.06 L (-0.14 to 0.02 L). The occurrence of serious adverse events was similar for all groups. Budesonide had less systemic activity than prednisolone as indicated by a higher incidence of hyperglycemia observed with prednisolone. Both budesonide and prednisolone improved airflow in COPD patients with acute exacerbations when compared with placebo. Nebulized budesonide may be an alternative to oral prednisolone in the treatment of nonacidotic exacerbations of COPD but further studies should be done to evaluate its long-term impact on clinical outcomes after an initial episode of COPD exacerbation.     

Anti-inflammatory effects of combined budesonide/formoterol in COPD exacerbations

Systemic corticosteroids and additional short-acting beta2-agonists are commonly used in exacerbations of chronic obstructive pulmonary disease (COPD). In this double-blind study, the combination of a high-dose inhaled corticosteroid with a rapid-onset long-acting beta2-agonist was evaluated in the treatment of out-patient COPD exacerbations. The primary aim was to compare 14-day treatment effects of budesonide/formoterol to placebo on sputum eosinophils and, secondarily, on other indices of inflammation, forced expiratory flow in one second (FEV(1)), symptoms, health status, and adverse events. Forty-five patients not using steroids (37 male, 21/24 current/ex smoker, median packyears 38, age 65 years, FEV(1) 61% predicted), experiencing a COPD exacerbation, were treated at home with budesonide/formoterol (320/9 microg 4 times daily), prednisolone (30 mg daily), or placebo for 14 days. Sputum eosinophils were significantly reduced by budesonide/formoterol (-57%) compared to placebo (+24%) (p = 0.01). Budesonide/formoterol reduced total symptom scores significantly (p = 0.01) compared to placebo. The increase in FEV(1) by 2 weeks of treatment with budesonide/formoterol (125 ml) was not significantly different from that of placebo (43 ml) (p = 0.07). Budesonide/ formoterol treatment did not suppress morning serum cortisol compared to placebo (-16%; p = 0.50). In conclusion, budesonide/formoterol reduces sputum eosinophils and improves symptoms in the treatment of out-patient COPD exacerbations.     

不同剂量布地奈德雾化吸入和泼尼松龙静脉用药治疗AECOPD的对比研究

目的探讨不同剂量布地奈德雾化吸入对比静脉用泼尼松龙治疗慢性阻塞性肺病急性加重期(AECOPD)的临床疗效和安全性。方法92例AECOPD患者随机分为布地奈德1组(24)、布地奈德2组(25)、泼尼松龙组(22)和对照组(21),分别给予布地奈德1 mg/次(1次/8 h)、2 mg/次(1次/8 h)和泼尼松龙静点40 mg/次(1次/q12 h),其他治疗相同。记录治疗后第3、5、7、10天临床症状评分和FEV1/预计值、PaO2、PaCO2、副反应和血糖情况。结果①治疗后5、10天布地奈德组1组、2组、泼尼松龙组临床症状评分明显下降,和对照组比较有统计学意义(P0.05),布地奈德2组、泼尼松龙组和布地奈德1组间差异有统计学意义(P0.05)。②治疗后第5天布地奈德1组、2组和泼尼松龙组的FEV1和动脉血气(PaO2、PaCO2)改善程度均明显优于对照组(P0.05),布地奈德2组较1组FEV1增加(P0.05)。直至观察终点布地奈德Ⅱ组的PaO2增加较Ⅰ组和对照组更显著。③短期副反应布地奈德1、2组主要为声嘶,泼尼松龙组为血糖升高。④前三组患者的住院时间之间没有统计学差异(P0.05),但较对照组明显缩短(P0.05)。结论布地奈德雾化吸入能明显改善AECOPD患者肺功能,提高患者生活质量,其疗效与泼尼松龙一致,但全身副作用较轻;布地奈德6 mg组较布地奈德3 mg组症状及肺功能改善更快更好。     

Steroid reversibility test followed by inhaled budesonide or placebo in outpatients with stable chronic obstructive pulmonary disease. The Danish Society of Respiratory Medicine

The aim of this study was evaluate the predictive value of a 2 week course of prednisolone on the effect of 6 months treatment with inhaled budesonide in patients with stable chronic obstructive pulmonary disease (COPD). Forty patients with stable COPD entered the study, and received prednisolone (37.5 mg o.d.) for 2 weeks. They were subsequently divided into steroid-irreversible and steroid-irreversible, using 15% of baseline as a dividing point. In each group patients were randomized to receive budesonide 400 micrograms b.i.d. or placebo for 6 months. During treatment with prednisolone, three patients dropped out because of side effects. Of the remaining 37, only two patients (5%) were reversible with prednisolone forced expiratory volume in 1s [(FEV1) > 15% of baseline], and among the steroid-irreversible, 26 patients were evaluated after 6 months treatment with either placebo or budesonide. No significant differences in spirometry values, symptoms, or number of exacerbations were found between these two groups. Reversibility with prednisolone is rarely seen in COPD. In outpatients with stable COPD and no signs of asthma or atopy, 2 weeks treatment with prednisolone seems to be of no value in choosing subsequent long-term therapy.     

Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease.

Lung function in chronic obstructive pulmonary disease (COPD) can be improved acutely by oral corticosteroids and bronchodilators. Whether clinical improvement can be maintained by subsequent inhaled therapy is unknown. COPD patients (n=1,022, mean prebronchodilator forced expiratory volume in one second (FEV1) 36% predicted) initially received formoterol (9 microg b.i.d.) and oral prednisolone (30 mg o.d.) for 2 weeks. After this time, patients were randomised to b.i.d. inhaled budesonide/formoterol 320/9 microg, budesonide 400 microg, formoterol 9 microg or placebo for 12 months. Postmedication FEV1 improved by 0.21 L and health-related quality of life using the St George's Respiratory Questionnaire (SGRQ) by 4.5 units after run-in. Fewer patients receiving budesonide/formoterol withdrew from the study than those receiving budesonide, formoterol or placebo. Budesonide/formoterol patients had a prolonged time to first exacerbation (254 versus 96 days) and maintained higher FEV1 (99% versus 87% of baseline), both primary variables versus placebo. They had fewer exacerbations (1.38 versus 1.80 exacerbations per patient per year), had higher prebronchodilator peak expiratory flow, and showed clinically relevant improvements in SGRQ versus placebo (-7.5 units). Budesonide/formoterol was more effective than either monocomponent in both primary variables. Budesonide/formoterol in a single inhaler (Symbicort) maintains the benefit of treatment optimisation, stabilising lung function and delaying exacerbations more effectively than either component drug alone or placebo.     

Evaluation of the efficacy and safety of levalbuterol in subjects with COPD

The efficacy and safety of nebulized levalbuterol in adults with chronic obstructive pulmonary disease (COPD) was evaluated in this multicenter, randomized, double-blind, parallel design study. Randomized subjects (n = 209) received levalbuterol (LEV) 0.63 mg or 1.25 mg, racemic albuterol (RAC) 2.5 mg, or placebo (PBO) TID for 6 weeks. Serial spirometry was completed in-clinic after study drug alone (weeks 0, 2, and 6) or in combination with ipratropium bromide 0.5 mg (week 4). The primary endpoint was the averaged FEV1 AUC(0-8 hrs) over weeks 0, 2 and 6 compared with placebo. Other endpoints included rescue medication use, safety parameters, COPD exacerbations, and global evaluations. All active treatments demonstrated improvements in the percent change in FEV1 AUC(0-8 hrs) over the double-blind period and at each visit vs PBO (p < 0.05). Rescue medication use vs. baseline (doses/day) changed over time: PBO +0.38 +/- 3.3; LEV 0.63 mg +0.07 +/- 3.3; LEV 1.25 mg -0.84 +/- 3.8 (p = 0.02 vs. RAC); RAC +0.97 +/- 2.5. The overall rate of adverse events was PBO 56.4%, LEV 0.63 mg 56.6%, LEV 1.25 mg 67.3%, and RAC 65.4%. Protocol-defined COPD exacerbations occurred in all groups (PBO 12.7%, LEV 0.63 mg 11.3%; LEV 1.25 mg 18.4%; RAC 21.2%). Withdrawals due to COPD exacerbations were significantly higher in the RAC group compared with PBO (PBO 0%; LEV 0.63 mg 1.9%; LEV 1.25 mg 4.1%; RAC 9.6% p = 0.01 vs. PBO). In this study, levalbuterol treatment in subjects with COPD was generally well tolerated, produced significant bronchodilation compared with PBO, and improved clinical control of COPD as evidenced by reductions in rescue medication use compared with PBO and/or RAC.     

Single inhaler budesonide/formoterol in exacerbations of chronic obstructive pulmonary disease

Inhaled bronchodilators, particularly short-acting inhaled beta(2)-agonists, and systemic glucocorticosteroids are effective treatments for acute exacerbations of chronic obstructive pulmonary disease (COPD). However, in the treatment of these episodes there may be some advantages to the longer-acting agents in that there will be prolonged bronchodilation. Moreover, high doses of systemic glucocorticosteroids are associated with a significant risk of side effects. In the last few years, evidence is mounting that nebulized budesonide and inhaled formoterol might be an alternative to oral prednisolone and short-acting beta(2)-agonists, respectively, in the treatment of acute exacerbations of COPD. Interestingly, some new data suggest that a combination therapy with single inhaler containing budesonide and formoterol may be an alternative to traditional therapy in the treatment of acute exacerbations of this disorder. However, since individual studies are typically statistically underpowered and are remarkably heterogeneous with regard to their conclusions, larger studies are needed to confirm these preliminary findings and determine conclusively any impact of budesonide/formoterol combination in acutely ill COPD patients.     

Long-term effects of budesonide on inflammatory status in COPD

A beneficial effect of long-term corticosteroid treatment in patients with COPD may be linked to suppressing inflammation, in particular neutrophilic inflammation. Effects on neutrophilic and eosinophilic inflammation and on lung function of long-term inhaled budesonide treatment (800 microg daily, 6 months, double-blind, randomised, cross-over versus placebo) were studied and compared to the effects of 3 weeks oral prednisolone (30 mg daily) in 19 patients with COPD (mean age 63 y, FEV(1) 65% of predicted). Neither treatment influenced neutrophilic inflammation. Inhaled budesonide compared to placebo significantly reduced sputum % eosinophils at 3 months (-42%, p = 0.036), but not significantly at 6 months (-31%, p = 0.78). Eosinophil count per g sputum was decreased with 30% at 3 months (p = 0.09) and with 9% at 6 months (p = 0.78). FEV(1) was slightly higher after 6 months budesonide (+2.5% predicted, p = 0.09). Prednisolone significantly reduced sputum % eosinophils (-87%, p = 0.007), but did not affect eosinophil count per g sputum and did not improve FEV(1) (-0.6% predicted, p = 0.40). A higher baseline FEV(1) (%) correlated with effects of budesonide on FEV(1) (p < 0.001), effects on sputum interleukin-8 and eosinophil cationic protein (both p < 0.05) and tended to correlate with effects on sputum % eosinophils (p = 0.056). Baseline inflammatory data and effects of prednisolone did not correlate with effects of budesonide. Effects of inhaled budesonide in COPD are not restricted to patients with severe disease and may be linked to a suppression of eosinophilic inflammation. Investigating effects of prednisolone has no predictive value for long-term treatment.     

Systemic glucocorticoids in severe exacerbations of COPD

OBJECTIVE: This study aimed to compare the efficacies of 3-day and 10-day courses of methylprednisolone (MP) treatment in severe COPD exacerbations necessitating hospitalization for respiratory failure. DESIGN: Prospective, randomized, single-blind study. SETTING: Tertiary-care center. PATIENTS AND METHODS: Thirty-six patients were included in the study and randomized into two groups: group 1 received MP, 0.5 mg/kg q6h for 3 days, and group 2 was administered the same dosage of MP for the first 3 days, after which it was tapered and terminated on the tenth day. There was no difference between the groups for age, baseline FEV(1), PaO(2), PaCO(2), and pH levels. One patient in group 1 who developed pneumothorax and one patient in group 2 who had steroid-related psychosis could not complete the study. RESULTS: Both groups showed significant improvements in PaO(2) and FEV(1) levels, but these were more marked in group 2 (p = 0.012 and p = 0.019, respectively). There was a significant increase in FVC levels in group 2 only (p = 0.003). Group 2 also had a more marked improvement in dyspnea on exertion. There was no difference between the two groups with regards to other parameters, including pH, PaCO(2) levels, and other symptom scores. Six patients in group 1 and five patients in group 2 developed new exacerbations within the following 6 months. Hyperglycemia occurred in two patients in each group. CONCLUSION: In severe COPD exacerbations, a 10-day course of steroid treatment is more effective than a 3-day course in improving the outcome, but has no benefit in reducing exacerbation rates.