Ravindran V, Scott D L, Choy E H
Sir Alfred Baring Garrod Clinical Trials Unit, Academic Department of Rheumatology, King's College London, London, UK.
Ann Rheum Dis. 2008 Jun;67(6):855-9. doi: 10.1136/ard.2007.072652. Epub 2007 Sep 7.
Treatments for psoriatic arthritis (PsA) range from high-cost agents such as tumour necrosis factor (TNF) inhibitors evaluated in large randomised control trials (RCTs) and low-cost disease-modifying anti-rheumatic drugs (DMARDs) studied in less detail. We compared their efficacy and toxicity in a systematic review.
We searched Medline, PubMed and EmBase (1966-2006) for RCTs in PsA. We included RCTs that were randomised, placebo-controlled, in English, involved current treatments and only enrolled PsA patients. Efficacy was assessed by the numbers of patients withdrawn for lack of effect; toxicity by withdrawals for adverse events. RCTs were compared using risk ratios (RR) with 95% confidence intervals (CI).
We identified 32 potentially relevant RCTs; 14 were excluded because they involved unused agents, were unblinded, were not placebo-controlled and enrolled patients with other diseases. 18 studies were included in the meta-analysis assessing DMARD monotherapy (11), DMARD combinations (one), TNF inhibitors (five) and alefacept (one). Treatment was more effective than placebo (RR = 0.35; 95% CI 0.25, 0.49) but caused more toxicity (RR = 2.33; 95% CI 1.61, 3.37). There was evidence that gold, sulfasalazine, leflunomide and TNF inhibitors were effective; gold and TNF inhibitors showed the largest effect sizes; TNF inhibitors had the best efficacy/toxicity ratio (number needed to harm/number needed to treat = 0.25); tolerability was least with gold and leflunomide.
Efficacy/toxicity ratios were highest with TNF inhibitors followed by leflunomide, gold and sulfasalazine. Gold, though effective, has excessive toxicity and sulfasalazine, though of low toxicity, was also relatively ineffective.
银屑病关节炎（PsA）的治疗方法多样，从在大型随机对照试验（RCT）中评估的高成本药物如肿瘤坏死因子（TNF）抑制剂，到研究较少的低成本改善病情抗风湿药（DMARDs）。我们在一项系统评价中比较了它们的疗效和毒性。
我们检索了Medline、PubMed和EmBase（1966 - 2006年）中关于PsA的RCT。纳入的RCT需为随机、安慰剂对照、英文发表、涉及当前治疗且仅纳入PsA患者。疗效通过因缺乏疗效而退出的患者数量评估；毒性通过因不良事件而退出的患者数量评估。使用风险比（RR）及95%置信区间（CI）对RCT进行比较。
我们识别出32项可能相关的RCT；14项被排除，因为它们涉及未使用的药物、未设盲、未用安慰剂对照或纳入了患有其他疾病的患者。18项研究纳入荟萃分析，评估DMARD单药治疗（11项）、DMARD联合治疗（1项）、TNF抑制剂（5项）和阿法赛特（1项）。治疗比安慰剂更有效（RR = 0.35；95% CI 0.25，0.49），但毒性更大（RR = 2.33；95% CI 1.61，3.37）。有证据表明金制剂、柳氮磺胺吡啶、来氟米特和TNF抑制剂有效；金制剂和TNF抑制剂显示出最大的效应量；TNF抑制剂的疗效/毒性比最佳（伤害所需人数/治疗所需人数 = 0.25）；金制剂和来氟米特的耐受性最差。
TNF抑制剂的疗效/毒性比最高，其次是来氟米特、金制剂和柳氮磺胺吡啶。金制剂虽有效，但毒性过大；柳氮磺胺吡啶虽毒性低，但效果也相对较差。
