Mandelberg A, Chen E, Noviski N, Priel I E
Department of Pulmonary Medicine, The Edith Wolfson Medical Center, Holon, Israel.
Chest. 1997 Dec;112(6):1501-5. doi: 10.1378/chest.112.6.1501.
To determine the efficacy of a metered-dose inhaler (MDI) with a large spacer device as compared to nebulized wet aerosols in the treatment of an unselected population with severe airflow limitation.
Randomized, double blind, placebo-controlled trial.
University Hospital Department of Emergency Medicine (DEM).
Fifty patients, referred to the DEM between October 1, 1994 and March 31, 1995 with a severe, acute obstructive pulmonary event. Thirteen patients were diagnosed as having COPD; 37 patients were diagnosed as having asthma.
Patients received either placebo MDI through a 750-mL cone-shaped spacer (Glaxo) [2 puffs] and nebulized salbutamol aerosol 0.5 mL in 1.5 mL saline solution (group 1, n=25) or salbutamol MDI and 0.5 mL saline solution in 1.5 mL saline solution administered in the same manner as above (group 2, n=25). The above treatment was repeated three times every 15 min, unless side effects appeared. Upon enrollment into the study, the FEV1 in group 1 was 0.78+/-0.7 L (mean+/-SD), 32% of predicted, and in group 2, 0.74+/-0.51 L, 29% of predicted (p=0.83). The FEV1 values after the first, second, and third interventions were as follows: in group 1, 1.18+/-0.99 L, 1.40+/-0.8, and 1.47+/-0.79, respectively, and in group 2, 1.17+/-0.99 L, 1.46+/-1.01, and 1.54+/-0.79 (p=0.83, 0.36, and 0.48, respectively). We observed no difference in spirometric measurements between the two groups at any time.
Even in the setting of the unselected group of patient referrals to the DEM for episodes of severe airflow limitation, the clinical and the objective bronchodilator responses to the administration of salbutamol are independent of the method of delivery: MDI with a large spacer vs aerosol nebulization.
比较定量吸入器(MDI)搭配大型储雾罐装置与雾化湿气雾剂在治疗未经过筛选的严重气流受限人群中的疗效。
随机、双盲、安慰剂对照试验。
大学医院急诊科(DEM)。
1994年10月1日至1995年3月31日期间转诊至DEM的50例患有严重急性阻塞性肺事件的患者。13例被诊断为慢性阻塞性肺疾病(COPD);37例被诊断为哮喘。
患者接受以下两种治疗之一:通过750毫升锥形储雾罐(葛兰素史克公司)吸入安慰剂MDI[2喷],并雾化吸入0.5毫升沙丁胺醇气雾剂(溶于1.5毫升盐溶液中)(第1组,n = 25);或者以与上述相同方式吸入沙丁胺醇MDI和1.5毫升盐溶液中的0.5毫升盐溶液(第2组,n = 25)。除非出现副作用,上述治疗每15分钟重复三次。入组研究时,第1组的第1秒用力呼气量(FEV1)为0.78±0.7升(平均值±标准差),为预测值的32%,第2组为0.74±0.51升,为预测值的29%(p = 0.83)。第一次、第二次和第三次干预后的FEV1值如下:第1组分别为1.18±0.99升、1.40±0.8升和1.47±0.79升,第2组分别为1.17±0.99升、1.46±1.01升和1.54±0.79升(p分别为0.83、0.36和0.48)。我们在任何时间观察到两组之间的肺功能测量值均无差异。
即使在未经过筛选的因严重气流受限发作而转诊至DEM的患者组中,给予沙丁胺醇后的临床和客观支气管扩张反应也与给药方式无关:搭配大型储雾罐的MDI与气雾剂雾化。