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根据停药原因的不同,将银屑病患者甲氨蝶呤药物生存的决定因素进行拆分:前瞻性 MTX-CAPTURE 研究结果。

Determinants for drug survival of methotrexate in patients with psoriasis, split according to different reasons for discontinuation: results of the prospective MTX-CAPTURE.

机构信息

Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.

Department of Epidemiology, Biostatistics and Health Technology Assessment, Radboud University Medical Center, Nijmegen, the Netherlands.

出版信息

Br J Dermatol. 2017 Aug;177(2):497-504. doi: 10.1111/bjd.15305. Epub 2017 May 11.

Abstract

BACKGROUND

As methotrexate (MTX) is a widely used treatment for psoriasis, it is important to gain insight into the reasons for the discontinuation of MTX and to understand the determinants for drug survival.

OBJECTIVES

To describe 5-year drug survival for MTX in patients with psoriasis, split according to different reasons for discontinuation, and to identify the determinants for drug survival.

METHODS

Data were extracted from a prospective psoriasis registry of patients treated with MTX (MTX-CAPTURE). Drug survival was analysed using Kaplan-Meier estimates and the determinants for discontinuation were analysed using Cox regression analysis. Analyses were split according to the reason for discontinuation: side-effects or ineffectiveness.

RESULTS

We included 85 patients treated with MTX, with a maximum treatment duration of 5·2 years. The overall drug survival rates were 63%, 30% and 15% after 1, 3 and 5 years, respectively. The median survival was 1·8 years. Overall, 55 patients (65%) discontinued MTX for the following reasons: side-effects (35%), ineffectiveness (26%), combination of side-effects and ineffectiveness (13%), other reasons (16%) and 11% were lost to follow-up. The most reported side-effects were gastrointestinal symptoms, despite the use of folic acid in 99% of patients. Based on univariate analysis, a high Psoriasis Area and Severity Index score and a high score on the visual analogue scale for disease severity at baseline were possible determinants for a short drug survival.

CONCLUSIONS

Drug survival of MTX was low with 15% of patients 'on drug' after 5 years. Side-effects alone or in combination with inadequate disease control were more important in the context of treatment discontinuation than inadequate disease control alone.

摘要

背景

甲氨蝶呤(MTX)是一种广泛用于治疗银屑病的药物,因此了解 MTX 停药的原因并确定药物生存的决定因素非常重要。

目的

描述银屑病患者使用 MTX 的 5 年药物生存情况,根据不同的停药原因进行细分,并确定药物生存的决定因素。

方法

从接受 MTX(MTX-CAPTURE)治疗的前瞻性银屑病登记处提取数据。使用 Kaplan-Meier 估计法分析药物生存情况,使用 Cox 回归分析确定停药的决定因素。分析根据停药原因进行细分:副作用或无效。

结果

我们纳入了 85 名接受 MTX 治疗的患者,最大治疗持续时间为 5.2 年。1、3 和 5 年后的总体药物生存率分别为 63%、30%和 15%。中位生存时间为 1.8 年。总体而言,55 名患者(65%)因以下原因停用 MTX:副作用(35%)、无效(26%)、副作用和无效的组合(13%)、其他原因(16%)和 11%失访。尽管 99%的患者使用了叶酸,但最常报告的副作用是胃肠道症状。基于单变量分析,基线时较高的银屑病面积和严重程度指数评分和疾病严重程度的视觉模拟评分可能是药物生存时间短的决定因素。

结论

MTX 的药物生存时间较短,5 年后仍有 15%的患者在用药。与单纯疾病控制不佳相比,副作用单独或与治疗效果不佳一起是停药的更重要原因。

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