Fadda G
Department of Respiratory Diseases, Alivesi Hospital, Ospedali Riuniti di Sassari, Ittiri (Sassari), Italy.
Minerva Med. 2001 Aug;92(4):269-75.
The synthetic mucolytic neltene-xine is an amide derivative of ambroxol and thiophencarboxylic acid. The aim of this open, randomised, controlled study versus sobrerol was to evaluate the efficacy and tolerability of neltenexine (oral granules in sachets) as compared with sobrerol (oral granules in sachets), administered to patients with obstructive airways disease.
Thirty male and female patients were recruited. The exclusion criteria were allergy to neltenexine or sobrerol, an assessed diagnosis of severe bronchospasm requiring beta2-agonists, corticosteroids or aminophylline, pregnant or nursing women, cystic fibrosis, active tuberculosis or an assessed diagnosis of bronchiectasis. No infections of other organs (such as urinary tract infections) were present at baseline. Concomitant treatment with antitussives or other mucolytic agents was not allowed during the course of the study. Fifteen patients were randomised to treatment with neltenexine, 1 sachet thrice daily for 20 days orally (neltenexine group) and 15 patients to treatment with sobrerol, 1 sachet thrice daily for 20 days orally (sobrerol group). The efficacy parameters were: sputum characteristics and volume, difficulty in expectorating, cough, dyspnoea, pulmonary auscultation. Tolerability was monitored and adverse events were reported.
The study highlighted that neltenexine has a good efficacy in the treatment of patients with obstructive airways disease entailing significant impairment of clinical parameters.
Neltenexine can be an effective therapeutic alternative to sobrerol.
合成黏液溶解剂奈替奈新是氨溴索与噻吩羧酸的酰胺衍生物。本项开放、随机、对照研究旨在对比索布瑞醇，评估奈替奈新（口服颗粒剂，袋装）用于阻塞性气道疾病患者时的疗效和耐受性。
招募30名男性和女性患者。排除标准包括对奈替奈新或索布瑞醇过敏、评估诊断为需要使用β2激动剂、皮质类固醇或氨茶碱的严重支气管痉挛、孕妇或哺乳期妇女、囊性纤维化、活动性肺结核或评估诊断为支气管扩张。基线时不存在其他器官感染（如尿路感染）。研究过程中不允许同时使用镇咳药或其他黏液溶解剂。15名患者随机接受奈替奈新治疗，口服，每日三次，每次1袋，共20天（奈替奈新组），15名患者接受索布瑞醇治疗，口服，每日三次，每次1袋，共20天（索布瑞醇组）。疗效参数包括：痰液特征和量、咳痰困难、咳嗽、呼吸困难、肺部听诊。监测耐受性并报告不良事件。
研究表明，奈替奈新在治疗导致临床参数显著受损的阻塞性气道疾病患者方面具有良好疗效。
奈替奈新可以成为索布瑞醇的有效治疗替代药物。
