Jahnz-Rózyk K, Kucharczyk A, Chciałowski A, Płusa T
Klinika Chorób Wewnetrznych, Pneumonologii i Alergologii IMW CSK WAM w Warszawie.
Pol Merkur Lekarski. 2001 Sep;11(63):239-43.
It was a randomised, double-blind, placebo controlled comparative study of the clinical symptoms and chosen parameters of ventilation of inhaled ambroxol in patients hospitalized with exacerbation of chronic obstructive pulmonary disease (COPD). Eligible patients--30 patients (13 men and 17 women) aged of mean value 70.5 +/- 6.9 years who fulfilled the clinical traits of exacerbation of chronic bronchitis entered the study. 15 patients were treated with inhaled ambroxol and 15 were treated with placebo. Moreover all patients were treated with concomitant medications typical for exacerbation of COPD (systemic steroids, intravenous infusions with euphillin, antibiotics, Berodual nebulizations and oxygen therapy). Spirometry and data related to clinical symptoms were taken at the beginning of the study and after 1 and 3 days and after the end of the treatment. At the end of the treatment period in both groups (inhaled ambroxol therapy vs. placebo) there wasn't found statistically significant difference in the number of cough and dyspnoe attacks. There was found the difference in FEV1 and FEF 50 in both groups, but improvement in patients treated with ambroxol was statistically significantly faster, that can influence the cost of treatment. Moreover there were not found important adverse events in ambroxol group.
这是一项随机、双盲、安慰剂对照的比较研究,旨在观察吸入氨溴索对慢性阻塞性肺疾病(COPD)急性加重期住院患者临床症状及选定通气参数的影响。符合条件的患者——30例(13例男性和17例女性),平均年龄70.5±6.9岁,符合慢性支气管炎急性加重的临床特征,进入研究。15例患者接受吸入氨溴索治疗,15例接受安慰剂治疗。此外,所有患者均接受COPD急性加重期的常规伴随药物治疗(全身用类固醇、静脉输注氨茶碱、抗生素、倍氯米松雾化吸入和氧疗)。在研究开始时、1天和3天后以及治疗结束后进行肺活量测定并记录临床症状相关数据。在治疗期结束时,两组(吸入氨溴索治疗组与安慰剂组)咳嗽和呼吸困难发作次数均无统计学显著差异。两组的第1秒用力呼气容积(FEV1)和50%用力呼气流量(FEF 50)均有差异,但接受氨溴索治疗的患者改善速度在统计学上显著更快,这可能会影响治疗成本。此外,氨溴索组未发现重大不良事件。