Crisafulli Ernesto, Coletti Orietta, Costi Stefania, Zanasi Emanuela, Lorenzi Cristina, Lucic Sasa, Fabbri Leonardo M, Bertini Marco, Clini Enrico M
Department of Pulmonary Rehabilitation, Ospedale Villa Pineta, Pavullo-Modena, Italy.
Clin Ther. 2007 Sep;29(9):2001-9. doi: 10.1016/j.clinthera.2007.09.003.
Mucus plugging and hypersecretion have been associated with an increased relative risk of death in patients with bronchiectasis who may or may not have chronic obstructive pulmonary disease (COPD), which is of prognostic relevance in the elderly. However, chest physiotherapy and/or the use of mucoactive agents is considered to be an effective therapeutic model in treating patients with COPD and bronchiectasis.
The objective of this study was to test the effectiveness of oral erdosteine in treating elderly patients with bronchiectasis and chronic mucus hypersecretion who have been referred to a pulmonary rehabilitation program.
In this 15-day, prospective, parallel, open label, pilot study, elderly patients with bronchiectasis, hypersecretion, a noncurrent smoking status, who had been consecutively enrolled at Ospedale Villa Pineta's Pulmonary Rehabilitation Center, Pavullo-Modena, Italy, were randomized into 2 treatment groups. Group 1 consisted of those patients receiving PO erdosteine 225 mg BID and chest physiotherapy; group 2 comprised those patients receiving chest physiotherapy alone. Forced lung volumes, arterial blood gases, respiratory muscle strength, walking capacity (as measured by 6-minute walking test [6MWT]), and visual analog scale (VAS) symptoms (cough and dyspnea) were recorded at enrollment and at the conclusion of the study. Mucus density (MD), mucus purulence (MP), and mucus volume produced (MVP) were assessed using a 3-point scale (0 = best or low; 1 = moderate; and 2 = worst or high) at baseline and at 5-day time points during the study period. All measurements were assessed by personnel blinded and not directly associated with the study administration.
Thirty patients (21 [70%] male and 9 [30%] female; mean [SD] age, 71 [11] years; and mean [SD] weight, 66 [3] kg) were enrolled. Characteristics were similar in the 2 groups at baseline. At day 15, significant improvements were observed in 6MWT, VAS cough, and VAS dyspnea (P < 0.01) in both groups. However, a significant improvement in forced expiratory volume in 1 second and forced vital capacity (in milliliters) was observed only in group i (0.2 [0.3]; P < 0.05). At day 15, improvement was observed in mean (SD) in MD, MP, and MVP scores for both groups. Significant changes, however, were observed in all 3 measurements in group 1 (-0.80 [0.22], -0.71 [0.51], and 1.01 [0.39], respectively), whereas a significant improvement was observed only in MD (-0.55 [0.44]) and MVP (0.45 [0.62]) in group 2. The improvement in MVP observed in group 1 was significantly better than that observed in group 2 (P < 0.05).
This pilot study found that a regimen of PO erdosteine 225 mg BID in addition to routine chest physiotherapy provided some physiologic and clinical benefits in the treatment of these elderly patients with bronchiectasis and chronic mucus hyper-secretion.
黏液阻塞和分泌过多与支气管扩张患者的相对死亡风险增加有关，这些患者可能患有或未患有慢性阻塞性肺疾病（COPD），这在老年人中具有预后相关性。然而，胸部物理治疗和/或使用黏液促排剂被认为是治疗COPD和支气管扩张患者的有效治疗模式。
本研究的目的是测试口服厄多司坦治疗转诊至肺康复项目的老年支气管扩张和慢性黏液分泌过多患者的有效性。
在这项为期15天的前瞻性、平行、开放标签的试点研究中，连续入选意大利帕武洛 - 摩德纳市皮内塔别墅医院肺康复中心的患有支气管扩张、分泌过多且目前不吸烟的老年患者被随机分为2个治疗组。第1组由接受口服厄多司坦225 mg，每日2次及胸部物理治疗的患者组成；第2组由仅接受胸部物理治疗的患者组成。在入组时和研究结束时记录用力肺容积、动脉血气、呼吸肌力量、步行能力（通过6分钟步行试验[6MWT]测量）和视觉模拟量表（VAS）症状（咳嗽和呼吸困难）。在基线和研究期间的第5天时间点，使用3分制（0 = 最佳或低；1 = 中度；2 = 最差或高）评估黏液密度（MD）、黏液脓性（MP）和产生的黏液量（MVP）。所有测量均由不知情且与研究管理无直接关联的人员进行评估。
共纳入30例患者（21例[70%]男性和9例[30%]女性；平均[标准差]年龄为71[11]岁；平均[标准差]体重为66[3]kg）。两组在基线时特征相似。在第15天，两组的6MWT、VAS咳嗽和VAS呼吸困难均有显著改善（P < 0.01）。然而，仅在第1组观察到第1秒用力呼气量和用力肺活量（以毫升计）有显著改善（0.2[0.3]；P < 0.05）。在第15天，两组的MD、MP和MVP评分均值（标准差）均有改善。然而，第1组在所有3项测量中均有显著变化（分别为 - 0.80[0.22]、 - 0.71[0.51]和1.01[0.39]），而第2组仅在MD（ - 0.55[0.44]）和MVP（0.45[0.62]）方面有显著改善。第1组观察到的MVP改善明显优于第2组（P < 0.05）。
这项试点研究发现，除常规胸部物理治疗外，口服厄多司坦225 mg，每日2次的方案在治疗这些老年支气管扩张和慢性黏液分泌过多患者方面提供了一些生理和临床益处。
