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冷杉树皮多酚提取物对银屑病的疗效:一项随机、双盲、安慰剂对照试验。

Efficacy of a polyphenolic extract from silver fir () bark on psoriasis: a randomised, double-blind, placebo-controlled trial.

作者信息

Zorko M Starbek, Štrukelj B, Švajger U, Kreft S, Lunder T

出版信息

Pharmazie. 2018 Jan 2;73(1):56-60. doi: 10.1691/ph.2018.7741.

Abstract

Silver fir (Abies alba) bark extract contains a mixture of bioactive polyphenols. We tested their effectiveness in the treatment of psoriasis in order to further investigate the potential topical anti-inflammatory activity of polyphenols by means of a randomized, double-blind, placebo-controlled add-on clinical trial, after having examined their ability to downregulate the expression of IL-1β cytokine in monocyte/macrophage primary cell culture. 61 patients with mild psoriasis met the inclusion criteria and were willing to comply with protocol requirements, were enrolled in the study. The severity of the disease was measured by psoriasis area severity index (PASI). Treatment efficacy was evaluated by assessing erythema (E, 0 to 4-point scale), desquamation (D, 0 to 4-point scale) and induration (I, 0 to 4-point scale) of lesions before and after the treatment. All patients enrolled in the study had symmetrical psoriasis plaques on the skin. All patients received O/V ointment with 2% of silver fir bark extract and/or placebo, respectively. We compared medications by right/left intra-patient comparison, so that the control group was always contralateral of the tested one. Location of the tested or control site was randomised, using a computer-generated randomisation schedule. Silver fir extract was well-tolerated. A superiority of active treatment above placebo, based on the clinical investigational PASI score system was observed by 15 % in all volunteers and in 40% regarding the improvement of psoriasis on elbows. However, statistical analysis showed no significant differences between placebo and active treatment with the extract from silver fir bark (p < 0.05).

摘要

欧洲冷杉(Abies alba)树皮提取物含有多种生物活性多酚。在检测了它们下调单核细胞/巨噬细胞原代细胞培养中IL-1β细胞因子表达的能力后,我们通过一项随机、双盲、安慰剂对照的附加临床试验,测试了它们在治疗银屑病方面的有效性,以进一步研究多酚潜在的局部抗炎活性。61例轻度银屑病患者符合纳入标准并愿意遵守方案要求,被纳入该研究。疾病严重程度通过银屑病面积严重指数(PASI)来衡量。通过评估治疗前后皮损的红斑(E,0至4分制)、脱屑(D,0至4分制)和硬结(I,0至4分制)来评估治疗效果。所有纳入研究的患者皮肤均有对称的银屑病斑块。所有患者分别接受含2%欧洲冷杉树皮提取物的O/V软膏和/或安慰剂。我们通过患者自身左右对照比较药物,使得对照组总是与测试组对侧。使用计算机生成的随机分组表对测试或对照部位进行随机化。欧洲冷杉提取物耐受性良好。在所有志愿者中,基于临床研究的PASI评分系统,活性治疗优于安慰剂15%,在肘部银屑病改善方面优于安慰剂40%。然而,统计分析显示安慰剂与欧洲冷杉树皮提取物活性治疗之间无显著差异(p<0.05)。

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