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[一种具有淋巴引流作用的外用复方制剂治疗下肢静脉性溃疡的多中心研究]

[Multicentric study on a topical compound with lymph-draining action in the treatment of the phlebostatic ulcer of the inferior limbs].

作者信息

Chiummariello S, De Gado F, Monarca C, Ruggiero M, Carlesimo B, Scuderi N, Alfano C

机构信息

Università degli Studi di Perugia, Cattedra di Chirurgia Plastica e Ricostruttiva.

出版信息

G Chir. 2009 Nov-Dec;30(11-12):497-501.

PMID:20109380
Abstract

Phlebostatic sore of the lower limbs is a typical chronic venous insufficiency complication and is still a widely controversial issue in its treatment. The common therapies, in fact, are not yet standardized and they not show complete efficacy. Since 2005 to 2007 a multicentric clinical trial was conducted at the Plastic and Reconstructive Surgery of "Sapienza" University of Rome and at the Plastic and Reconstructive Surgery Department, University of Perugia, in order to evaluate the efficacy of the Idrastin lymph-draining cream in patients with phlebostatic sores of the lower limbs. This study enrolled on 80 patients, split into 2 homogeneous groups of 40 patients: group A was treated by only elastocompressive therapy, group B by elastocompressive therapy and Idrastin. Multicentric analysis has considered the following parameters: local pain, perilesional flogosis , granulation tissue, perilesional tissue tropism healing time. In the group B results highlighted: reduction of the local pain, stopped in 72 hours; flogosis decrease disappeared in one week; tissue granulation growth in one week; lesion healing in 4 weeks. These results pointed out statistically significance of the variables considered. In our opinion Idrastin compounds such as phytoessence of hops and Hedera helix, had contributed to analgesia; Aesculus hippocastanum, and Vitis vinifera and Ruscus aculeatus phytoessence showed anti-flogistic action; allantoin and Centella asiatica and jaluronic acid aided to sore healing. Idrastin gives an effective support to the treatment of the phlebostatic sores warrants a faster and more effective healing process, than to the wounds treated by only the elastocompressive therapy.

摘要

下肢静脉淤积性溃疡是典型的慢性静脉功能不全并发症,其治疗仍存在广泛争议。事实上,常用治疗方法尚未标准化,且未显示出完全疗效。2005年至2007年,罗马“萨皮恩扎”大学整形与重建外科以及佩鲁贾大学整形与重建外科开展了一项多中心临床试验,以评估伊德拉斯汀淋巴引流乳膏对下肢静脉淤积性溃疡患者的疗效。该研究招募了80名患者,分为两组,每组40名:A组仅采用弹性压迫疗法治疗,B组采用弹性压迫疗法和伊德拉斯汀治疗。多中心分析考虑了以下参数:局部疼痛、病灶周围炎症、肉芽组织、病灶周围组织趋向性愈合时间。B组结果显示:局部疼痛减轻,72小时内停止;炎症在一周内减轻消失;一周内肉芽组织生长;四周内病灶愈合。这些结果表明所考虑变量具有统计学意义。我们认为,伊德拉斯汀中的啤酒花植物精华和常春藤等成分有助于镇痛;七叶树、葡萄和刺叶番荔枝植物精华具有抗炎作用;尿囊素、积雪草和透明质酸有助于溃疡愈合。与仅采用弹性压迫疗法治疗的伤口相比,伊德拉斯汀为下肢静脉淤积性溃疡的治疗提供了有效支持,保证了更快、更有效的愈合过程。

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