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缬草和香蜂草的组合对治疗儿童烦躁不安和睡眠障碍有效。

A combination of valerian and lemon balm is effective in the treatment of restlessness and dyssomnia in children.

作者信息

Müller S F, Klement S

机构信息

Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany.

出版信息

Phytomedicine. 2006 Jun;13(6):383-7. doi: 10.1016/j.phymed.2006.01.013. Epub 2006 Feb 17.

Abstract

Efficacy and tolerability of a combined valerian/lemon balm preparation were investigated in an open, multicentre study in children less than 12 years suffering from restlessness and nervous dyskoimesis. Patients were dosed individually by the investigators. In total, 918 children were evaluated for therapeutic efficacy and tolerability. A distinct and convincing reduction in severity was found for all symptoms in the investigators' and parents' ratings. The core symptoms dyssomnia and restlessness were reduced from "moderate/severe" to "mild" or "absent" in most of the patients. In total, 80.9% of the patients who suffered from dyssomnia experienced an improvement for this symptom and 70.4% of the patients with restlessness improved clearly. For the other listed symptoms the total improvement was 37.8% on average. Both, parents and investigators assessed efficacy as to be "very good" or "good" (60.5% and 67.7%, respectively). The tolerability of Euvegal forte was considered as "good" (in 96.7% of the patients it was judged to be "very good" or "good"). No study medication-related adverse events occurred. In conclusion, Euvegal forte was effective in the treatment of younger children with restlessness and dyssomnia and it was very well tolerated.

摘要

在一项针对12岁以下患有不安和神经功能失调的儿童的开放性多中心研究中,对缬草/香蜂草联合制剂的疗效和耐受性进行了调查。研究人员对患者进行个体化给药。共有918名儿童接受了治疗效果和耐受性评估。在研究人员和家长的评分中,所有症状的严重程度都有明显且令人信服的降低。大多数患者的核心症状失眠和不安从“中度/重度”减轻到“轻度”或“消失”。总体而言,80.9%的失眠患者这一症状有所改善,70.4%的不安患者明显好转。对于其他列出的症状,总体改善率平均为37.8%。家长和研究人员均将疗效评估为“非常好”或“好”(分别为60.5%和67.7%)。Euvegal forte的耐受性被认为是“好”(96.7%的患者被判定为“非常好”或“好”)。未发生与研究药物相关的不良事件。总之,Euvegal forte在治疗患有不安和失眠的年幼儿童方面有效,且耐受性良好。

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