Department of Rheumatology, Clínica Mediterráneo, Almería, Spain.
Clin Exp Rheumatol. 2012 Mar-Apr;30(2):282-9. Epub 2012 Apr 13.
Disease-modifying antirheumatic drugs (DMARDs) are frequently prescribed as a first step therapy in active psoriatic arthritis (PsA). However, evidence is sparse and scattered. The objective of this study is to evaluate the efficacy and safety of DMARDs in PsA.
We performed a systematic review based on electronic searches through Medline, Cochrane Central and Embase (from July 1980-2010) for randomised control trials (RCTs) in PsA. Outcome measures were those included in the core-set from Outcome Measures in Rheumatology Clinical Trials (OMERACT) and adverse effects.
A preliminary search identified 3781 potentially relevant RCTs, while only 11 fulfilled inclusion criteria. Ten studies had a parallel design and, one was a cross-over trial. Quality reached a Jadad score over 3 in 6/11 (54.6%). We observed evidence of a moderate improvement of pain and reduction of ESR with DMARDs. The global risk of withdrawals due to adverse events was 2.41 [95% confidence interval (CI) 1.53, 3.82]. The risk of GI adverse effects (nausea, vomiting, abdominal pain, diarrhoea and/or oral ulcers) was 2.02 [95% CI 1.34, 3.03] and of headache was 2.34[95% CI 1.05, 5.19]. There were no significant differences in the rate of increase of flu-like symptoms, rash, or liver enzymes.
The evidence of DMARD efficacy in PsA is certainly limited, basically due to the small number of studies, dissimilar outcomes being evaluated, high withdrawal rates, and absence of new published studies. With regard to adverse effects, only GI events and headaches were significant compared to placebo.
疾病修饰抗风湿药物（DMARDs）常被作为治疗活动期银屑病关节炎（PsA）的一线治疗药物。然而，目前相关证据十分有限且分散。本研究旨在评估 DMARDs 在 PsA 中的疗效和安全性。
我们通过 Medline、Cochrane 中心和 Embase（1980 年 7 月至 2010 年）电子检索进行了一项系统评价，纳入了 PsA 的随机对照试验（RCT）。主要疗效终点为 OMERACT 核心指标中的疗效指标，次要疗效终点为不良反应。
初步检索共识别出 3781 项潜在相关 RCT，但仅有 11 项符合纳入标准。10 项研究为平行设计，1 项为交叉设计。11 项研究中 6 项（54.6%）的质量评分超过 3 分。我们观察到 DMARDs 治疗可改善疼痛和血沉。由于不良反应导致停药的总体风险为 2.41（95%可信区间 1.53-3.82）。胃肠道不良反应（恶心、呕吐、腹痛、腹泻和/或口腔溃疡）的风险为 2.02（95%可信区间 1.34-3.03），头痛的风险为 2.34（95%可信区间 1.05-5.19）。流感样症状、皮疹或肝酶升高的发生率无显著差异。
目前 DMARD 治疗 PsA 的证据十分有限，主要原因是研究数量较少、评估的结局不同、较高的停药率和缺乏新的研究。在不良反应方面，与安慰剂相比，只有胃肠道事件和头痛有显著差异。
