Worth Heinrich, Schacher Christian, Dethlefsen Uwe
Hospital Fürth, University Erlangen-Nürnberg, D-90766 Fürth, Germany.
Respir Res. 2009 Jul 22;10(1):69. doi: 10.1186/1465-9921-10-69.
The clinical effects of mucolytics in patients with chronic obstructive pulmonary disease (COPD) are discussed controversially. Cineole is the main constituent of eucalyptus oil and mainly used in inflammatory airway diseases as a mucolytic agent. We hypothesised that its known mucolytic, bronchodilating and anti-inflammatory effects as concomitant therapy would reduce the exacerbation rate and show benefits on pulmonary function tests as well as quality of life in patients with COPD.
In this double-blind, placebo-controlled multi-center-study we randomly assigned 242 patients with stable COPD to receive 200 mg of cineole or placebo 3 times daily as concomitant therapy for 6 months during winter-time. The frequency, duration and severity of exacerbations were combined as primary outcome measures for testing as multiple criteria. Secondary outcome measures included changes of lung function, respiratory symptoms and quality of life as well as the single parameters of the exacerbations.
Baseline demographics, lung function and standard medication of both groups were comparable. During the treatment period of 6 months the multiple criteria frequency, severity and duration of exacerbations were significantly lower in the group treated with cineole in comparison to placebo. Secondary outcome measures validated these findings. Improvement of lung function, dyspnea and quality of life as multiple criteria were statistically significant relative to placebo. Adverse events were comparable in both groups.
Concomitant therapy with cineole reduces exacerbations as well as dyspnea and improves lung function and health status. This study further suggests cineole as an active controller of airway inflammation in COPD by intervening in the pathophysiology of airway inflammation of the mucus membrane.
ISRCTN07600011.
黏液溶解剂对慢性阻塞性肺疾病（COPD）患者的临床疗效存在争议。桉叶油素是桉叶油的主要成分，主要作为黏液溶解剂用于炎症性气道疾病。我们假设，其作为辅助治疗已知的黏液溶解、支气管扩张和抗炎作用将降低急性加重率，并在肺功能测试以及COPD患者的生活质量方面显示出益处。
在这项双盲、安慰剂对照的多中心研究中，我们将242例稳定期COPD患者随机分配，在冬季作为辅助治疗，每天3次接受200mg桉叶油素或安慰剂治疗，为期6个月。将急性加重的频率、持续时间和严重程度合并作为多项标准的主要结局指标进行检测。次要结局指标包括肺功能、呼吸道症状和生活质量的变化以及急性加重的单项参数。
两组的基线人口统计学、肺功能和标准用药情况具有可比性。在6个月的治疗期内，与安慰剂组相比，接受桉叶油素治疗的组多项标准的急性加重频率、严重程度和持续时间显著更低。次要结局指标证实了这些发现。相对于安慰剂，肺功能、呼吸困难和生活质量作为多项标准的改善具有统计学意义。两组的不良事件相当。
桉叶油素辅助治疗可减少急性加重和呼吸困难，并改善肺功能和健康状况。本研究进一步表明，桉叶油素通过干预黏膜气道炎症的病理生理学，可作为COPD气道炎症的有效控制剂。
ISRCTN07600011。
