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一种外用软膏作为生物制剂联合用药治疗中重度银屑病的疗效:一项前瞻性、观察性真实世界研究

Benefit of a topic ointment as co-medication with biologic drugs for the management of moderate-severe psoriasis: a prospective, observational real-life study.

作者信息

Bernardini N, Skroza N, Tolino E, Marchesiello A, Mambrin A, Balduzzi V, Michelini S, Maddalena P, Volpe S, Proietti I, Potenza C

机构信息

Dermatology Unit "D. Innocenzi", Polo Pontino, Sapienza University of Rome, Rome, Italy.

出版信息

Clin Ter. 2020 Jul-Aug;171(4):e310-e315. doi: 10.7417/CT.2020.2234.

Abstract

BACKGROUND

Psoriasis is a multifactorial chronic inflammatory skin disease characterized by erythemato-squamous lesions with a chronic relapsing course. The desease clinical activity (PASI) and the patient's quality of life (DLQI) are the main elements to assess for setting up a correct therapeutic management.

OBJECTIVES

The aim of the study was to evaluate the management of the patient with moderate-severe psoriasis in therapy with biological drugs and to establish the difference in the achievement of PASI 90 and DLQI 0-1 between a group of patients treated with only biological drugs and a group of patients receiving biologic therapy in combination with a topical ointment.

METHODS

We conducted a prospective, observational real-life study enrolling 60 patients with moderate to severe psoriasis and divided in two groups: Group A patients treated with biological drugs, Group B patiens treated with biological drugs in association with an ointment composed of betamethasone, salicylic acid and ammonium sulpho-ichtyolate, applied 2 times a day. PASI and DLQI were evaluated at study beginning (T0) for both study groups, after 12 weeks (T3) for sample in therapy with biological drugs and after 24 weeks (T6) for sample in co-medication therapy.

RESULTS

The two-way ANOVA method was used to evaluate the standard deviations (SD): at T3 and T6 Group B obtained a significant PASI reduction and improvement of DLQI (* p value <0.05) compared to Group A.

CONCLUSIONS

Our study shown that the patients treated with biologics in co-medication with topical therapy reached a significantly higher PASI and DQLI compared with those treated with only biologics. Furthermore we observed that the association with topical oinment showed more efficacy in the treatment of areas such as palm-plantar region, that is often difficult-to-treat region, even for biologic drugs.

摘要

背景

银屑病是一种多因素慢性炎症性皮肤病,其特征为红斑鳞屑性皮损,病程呈慢性复发。疾病临床活动度(PASI)和患者生活质量(DLQI)是评估正确治疗管理的主要要素。

目的

本研究旨在评估中度至重度银屑病患者接受生物药物治疗的管理情况,并确定仅接受生物药物治疗的患者组与接受生物治疗联合外用软膏的患者组在实现PASI 90和DLQI 0 - 1方面的差异。

方法

我们进行了一项前瞻性、观察性的真实生活研究,纳入60例中度至重度银屑病患者,分为两组:A组患者接受生物药物治疗,B组患者接受生物药物治疗并联合一种由倍他米松、水杨酸和硫磺煤焦油组成的软膏,每天涂抹2次。在研究开始时(T0)对两个研究组评估PASI和DLQI,接受生物药物治疗的样本在12周后(T3)评估,联合用药治疗的样本在24周后(T6)评估。

结果

采用双向方差分析方法评估标准差:在T3和T6时,与A组相比,B组的PASI显著降低,DLQI得到改善(*p值<0.05)。

结论

我们的研究表明,与仅接受生物制剂治疗的患者相比,联合外用治疗的生物制剂治疗患者达到了显著更高的PASI和DQLI。此外,我们观察到联合外用软膏在治疗如掌跖区域等通常难以治疗的区域时显示出更高的疗效,即使对于生物药物也是如此。

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