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西他列汀联合窄谱中波紫外线治疗中度斑块状银屑病(DINUP):一项随机对照临床试验。

Sitagliptin and Narrow-Band Ultraviolet-B for Moderate Psoriasis (DINUP): A Randomised Controlled Clinical Trial.

机构信息

Charles Department of Dermatology, St Vincent's University Hospital, Dublin, Ireland.

School of Health Sciences and Charles Institute, University College Dublin, Dublin, Ireland.

出版信息

Dermatology. 2022;238(1):140-147. doi: 10.1159/000514494. Epub 2021 Apr 16.

DOI:10.1159/000514494
PMID:33866313
Abstract

BACKGROUND

Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor licensed for the treatment of type 2 diabetes mellitus (T2DM), has been reported to improve psoriasis.

OBJECTIVE

We compared the effects of sitagliptin treatment, a DPP-4 inhibitor, in combination with narrow-band ultraviolet-B (NB-UVB) phototherapy compared to NB-UVB alone on psoriasis severity, quality of life, cardiovascular disease risk factors and immune parameters in people with moderate psoriasis without T2DM.

METHODS

In this 39-week, single-centre, randomised controlled trial, people were allocated randomly to receive sitagliptin for 24 weeks with NB-UVB or NB-UVB alone. The primary endpoint was the change in Psoriasis Area and Severity Index (PASI) from baseline to 24 weeks. We estimated that 120 participants would be needed to have 80% power to find a significant difference between the groups.

RESULTS

A total of 118 patients were randomised. The median (IQR) baseline PASI was 8.8 (7.5-11.6). At 24 weeks, the mean difference from baseline in PASI (-1.0 [95% CI -2.0 to 0.0]) was significantly larger in the sitagliptin/NB-UVB arm than in the NB-UVB-alone arm (p = 0.044). There were significant differences in the change in Hospital Anxiety and Depression Scale (-2.5 [95% CI -4.0 to -1.0]; p = 0.002) and EuroQol 5-item questionnaire (0.1 [95% CI 0.0-0.1]; p = 0.036) values from baseline to 24 weeks between the sitagliptin/NB-UVB and the NB-UVB-alone arm. There were no treatment-related serious adverse events.

CONCLUSION

Sitagliptin therapy combined with NB-UVB phototherapy significantly improved psoriasis severity, albeit modestly, compared to NB-UVB phototherapy alone in patients with moderate psoriasis without T2DM.

摘要

背景

西他列汀是一种二肽基肽酶-4(DPP-4)抑制剂,已获许可用于治疗 2 型糖尿病(T2DM),据报道其可改善银屑病。

目的

我们比较了二肽基肽酶-4(DPP-4)抑制剂西他列汀联合窄谱中波紫外线(NB-UVB)光疗与单独 NB-UVB 光疗对无 T2DM 的中度银屑病患者的银屑病严重程度、生活质量、心血管疾病危险因素和免疫参数的影响。

方法

在这项为期 39 周的单中心随机对照试验中,患者被随机分配接受西他列汀联合 NB-UVB 治疗 24 周或单独 NB-UVB 治疗。主要终点是从基线到 24 周时银屑病面积和严重程度指数(PASI)的变化。我们估计需要 120 名参与者才能有 80%的把握发现两组之间的显著差异。

结果

共 118 例患者被随机分组。中位(IQR)基线 PASI 为 8.8(7.5-11.6)。24 周时,西他列汀/NB-UVB 组与 NB-UVB 单药组相比,从基线开始的 PASI 平均差值(-1.0[95%CI-2.0 至 0.0])显著更大(p=0.044)。西他列汀/NB-UVB 组与 NB-UVB 单药组相比,从基线到 24 周时,医院焦虑和抑郁量表(HADS)的变化(-2.5[95%CI-4.0 至-1.0];p=0.002)和欧洲五维健康量表(EQ-5D)问卷(0.1[95%CI0.0-0.1];p=0.036)的变化均有显著差异。两组均无与治疗相关的严重不良事件。

结论

与单独 NB-UVB 光疗相比,西他列汀联合 NB-UVB 光疗可显著改善无 T2DM 的中度银屑病患者的银屑病严重程度,尽管改善程度较小。

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