Barna Milos, Kucera Alexander, Hladícova Marie, Kucera Miroslav
Abteilung für Sportmedizin und Rehabilitation, 2. Medizinische Fakultät der Karls-Universität Prag, Prag, Tschechishe Republik.
Wien Med Wochenschr. 2007;157(21-22):569-74. doi: 10.1007/s10354-007-0474-y.
Wound healing effects of a topically applied preparation (Traumaplant) containing a concentrate (10 % active ingredient) from the aerial parts of medicinal comfrey (Symphytum x uplandicum NYMAN: ) were examined in a randomized clinical double-blind study including 278 patients with fresh abrasions (verum: n = 137), among them 64 patients of up to 20 years of age (verum n = 29, reference product n = 35). An otherwise identical low-dose preparation (1 % active ingredient; n = 141) was used as a reference.
After 2-3 days of application of the study medication a highly significantly and clinically relevantly faster initial reduction of wound size of 49 + or - 19 % versus 29 + or - 13 % per day in favour of verum (p < 5x10(-21)) was found. From linear regression time to complete healing was determined to be 2.97 days faster with verum than with reference (4.08 vs. 7.05 days, p = 7.4 x 10(-45) in the t-Test comparison of regression lines). The physicians rated efficacy as good to very good in 93.4 % of cases, as compared to 61.7 % in the group treated with the reference product (p = 2 x 10(-11)). On a scale of 0-100 verum was rated with 84.4 + or - 10.1 points by the patients themselves. The reference product was rated with 65.5 + or - 24.8 points (p = 6.1 x 10(-18)). In subgroup analyses no significant influence of abrasion area, gender and age on healing effects was found, albeit a tendency towards better effects with increasing age was observed. No adverse effects or problems with drug tolerability occurred. Specifically, cutaneous reactions were observed in none of the patients throughout the 10 day observation phase.
Symphytum herb extract can be attributed distinct wound healing effects, effects that can explicitly be used in paediatry.
在一项随机临床双盲研究中，对278例新鲜擦伤患者（试验组：n = 137）使用一种局部应用制剂（Traumaplant）进行伤口愈合效果研究，该制剂含有药用紫草（Symphytum x uplandicum NYMAN）地上部分的浓缩物（10%活性成分），其中64例患者年龄在20岁及以下（试验组n = 29，对照产品组n = 35）。另一种成分相同但剂量较低的制剂（1%活性成分；n = 141）用作对照。
使用研究药物2 - 3天后，发现试验组伤口大小每日初始减少幅度显著高于对照且具有临床相关性，分别为49±19%和29±13%（有利于试验组，p < 5×10⁻²¹）。通过线性回归确定试验组完全愈合时间比对照组快2.97天（分别为4.08天和7.05天，回归线的t检验比较中p = 7.4×10⁻⁴⁵）。医生对疗效的评价为93.4%的病例为良好至非常好，而对照产品治疗组为61.7%（p = 2×10⁻¹¹）。患者自身对试验组在0 - 100分的评分中为84.4±10.1分。对照产品评分为65.5±24.8分（p = 6.1×10⁻¹⁸）。亚组分析未发现擦伤面积、性别和年龄对愈合效果有显著影响，尽管观察到随着年龄增加有效果更好的趋势。未出现不良反应或药物耐受性问题。具体而言，在整个10天观察期内，未观察到任何患者出现皮肤反应。
紫草提取物具有明显的伤口愈合效果，且这种效果可明确用于儿科。
