背景:慢性静脉疾病(CVD)的进展特征是腿部水肿和/或下肢静脉溃疡与皮肤体征和/或皮肤改变有关,比如色素沉着过度,电晕phlebectatica,毛细血管扩张症,湿疹性皮炎,脂皮肤硬化,Atrophieblanche,蜂窝织炎,和硬结。Xioglican乳膏是一种含有半乳糖胺聚糖多硫酸盐和透明质酸的医疗器械,具有很强的亲水性,保湿,和舒缓的属性。这项上市后观察性研究评估了在常规临床实践中接受治疗的CVD患者的局部Xioglican乳膏改善皮肤表现和临床体征和症状。
方法:根据临床诊断为C2-C3CVD的成年患者(18-75岁),病因学,解剖学,和病理生理学(CEAP)分类谁接受了Xioglican治疗12周(每天应用3次),根据研究者的决定(并与常规临床实践和既定的护理标准一致),他们来自意大利的两个研究中心。使用一系列终点来评估疗效,安全,对患者生活质量(QoL)的影响,以及患者对局部应用Xioglican乳膏在皮肤体征和症状的生理恢复方面的满意度。
结果:在CVD患者(n=30)中,Xioglican乳膏减少CVD相关的皮肤表现和相关症状,腿围显着减少[平均值±标准偏差(SD):左腿-3.21±3.39cm,右腿-2.92±2.70cm,p<0.0001]和局部水肿(-5.52±7.94cm,p=0.0034),静脉临床严重程度评分显着改善(平均从基线下降0.52±1.94,p=0.1952)12周后观察到。皮肤灼烧,疼痛,疼痛或疲倦,QoL也显著改善。CEAP分类没有变化。全球范围内,92.0%的患者对产品“非常满意”或“满意”。
结论:用Xioglican乳膏局部治疗可改善体征,症状,CVDC2-C3级患者的QoL。
The progression of chronic venous disease (CVD) is characterized by edema of the legs and/or venous ulcers of the lower limbs in association with cutaneous signs and/or skin alterations, such as hyperpigmentation, corona phlebectatica, telangiectasia, eczematous dermatitis, lipodermatosclerosis, atrophie blanche, cellulitis, and induration. Xioglican cream is a galactosaminoglycan polysulfate and hyaluronic acid-containing medical device with strong hydrophilic, moisturizing, and soothing properties. This post-marketing observational study evaluated topical Xioglican cream in the amelioration of skin manifestations and clinical signs and symptoms in patients with CVD treated in routine clinical practice.
Adult patients (18-75 years) with a clinical diagnosis of C2-C3 CVD according to Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification who received 12 weeks of treatment with Xioglican (applied up to 3 times daily), according to investigator decision (and consistent with conventional clinical practice and established standard of care), were enrolled from two study sites in Italy. A range of endpoints were used to evaluate efficacy, safety, effect on patient quality of life (QoL), and patient satisfaction with topical application of Xioglican cream in the physiological restoration of skin signs and symptoms.
In patients with CVD (n = 30), Xioglican cream reduced CVD-related skin manifestations and associated symptoms, with significant reductions in leg circumference [mean ± standard deviation (SD): - 3.21 ± 3.39 cm for left and - 2.92 ± 2.70 cm for right legs, both p < 0.0001] and local edema (- 5.52 ± 7.94 cm, p = 0.0034) and significant improvement in Venous Clinical Severity Scores (mean 0.52 ± 1.94 decrease from baseline, p = 0.1952) observed after 12 weeks. Skin burning, pain, aching or tiredness, and QoL were also significantly improved. There was no change in CEAP classification. Globally, 92.0% of patients were \"Very satisfied\" or \"Satisfied\" with the product.
Topical treatment with Xioglican cream improves the signs, symptoms, and QoL of patients with CVD class C2-C3.