Zeil S, Schwanebeck U, Vogelberg C
Department of Pediatric Pulmonology and Allergology, Technische Universität Dresden, Universitätsklinikum Carl Gustav Carus, 01307 Dresden, Germany.
Coordination Centre for Clinical Trials, Technische Universität Dresden, Universitätsklinikum Carl Gustav Carus, 01307 Dresden, Germany.
Phytomedicine. 2014 Sep 15;21(10):1216-20. doi: 10.1016/j.phymed.2014.05.006. Epub 2014 Jun 7.
Ivy leaves dry extract is registered as an expectorant in patients with respiratory diseases associated with productive cough. Next to its secretolytical properties, bronchospasmolytical effects are described. However only limited data exist about a possible therapeutical effect in asthmatic patients. In this double blind, placebo-controlled, randomized cross-over study, 30 children (median age 9.07 years (min-max: 6-11)) suffering from partial or uncontrolled mild persistent allergic asthma despite long-term treatment with 400 μg budesonide equivalent were investigated. After a four week run-in period, patients either received ivy leaves dry extract for four weeks in addition to their inhaled corticosteroid therapy or placebo, followed by a wash-out phase before switching to the other treatment arm. Lung function, FeNO, exhaled breath condensate pH and life quality was analyzed after each treatment period. There was a significant improvement of MEF(75-25), MEF25 and VC after treatment with ivy leaves dry extract (MEF(75-25) change in the mean 0.115 l/s, p=0.044; MEF25 change in the mean 0.086 l/s, p=0.041; VC change in the mean 0.052 l, p=0.044), but not after treatment with placebo. For the primary outcome parameters (relative change of FEV1 and MEF(75-25) before bronchodilation) no treatment effect could be detected in the cross-over analysis (FEV1 p=0.6763 and MEF(75-25) p=0.6953). This proof-of-concept study indicates that children with mild uncontrolled asthma despite regular inhaled corticosteroid therapy might benefit from an additional therapy with ivy leaves dry extract. However, further studies are needed.
常春藤叶干提取物被注册为用于治疗伴有咳痰的呼吸系统疾病患者的祛痰剂。除了其促分泌特性外，还描述了其支气管解痉作用。然而，关于其对哮喘患者可能的治疗效果的数据有限。在这项双盲、安慰剂对照、随机交叉研究中，对30名儿童（中位年龄9.07岁（最小-最大：6-11岁））进行了调查，这些儿童尽管长期使用400μg布地奈德等效物治疗，但仍患有部分或未得到控制的轻度持续性过敏性哮喘。在为期四周的导入期后，患者在吸入皮质类固醇治疗的基础上，要么接受常春藤叶干提取物治疗四周，要么接受安慰剂治疗，然后经过洗脱期后再切换到另一个治疗组。在每个治疗期后分析肺功能、呼出一氧化氮（FeNO）、呼出气冷凝液pH值和生活质量。使用常春藤叶干提取物治疗后，最大呼气中期流速（MEF）（75%-25%）、MEF25和肺活量（VC）有显著改善（MEF（75%-25%）平均变化0.115升/秒，p = 0.044；MEF25平均变化0.086升/秒，p = 0.041；VC平均变化0.052升，p = 0.044），而使用安慰剂治疗后则没有。对于主要结局参数（支气管扩张前第一秒用力呼气容积（FEV1）和MEF（75%-25%）的相对变化），在交叉分析中未检测到治疗效果（FEV1 p = 0.6763，MEF（75%-25%）p = 0.6953）。这项概念验证研究表明，尽管定期吸入皮质类固醇治疗，但轻度未得到控制的哮喘儿童可能从常春藤叶干提取物的额外治疗中获益。然而，还需要进一步的研究。
