Jones G, Crotty M, Brooks P
Department of Rheumatology, Menzies Centre for Population Health Res, GPO Box 252C, Hobart, Tasmania, Australia, 7001.
Cochrane Database Syst Rev. 2000;2000(2):CD000212. doi: 10.1002/14651858.CD000212.
To assess the effects of salazopyrin, auranofin, etretinate, fumaric acid, IMI gold, azathioprine, and methotrexate, in psoriatic arthritis.
We searched Medline up to 1995, and Excerpta Medica (June 1974-95). Search terms were psoriasis, arthritis, therapy and/or controlled trial. This was supplemented by manually searching bibliographies of previously published reviews, conference proceedings and contacting drug companies. All languages were included in the initial search.
All randomized trials comparing salazopyrin, auranofin, etretinate, fumaric acid, IMI gold, azathioprine, and methotrexate, in psoriatic arthritis. The main outcome measures included individual component variables derived from Outcome Measures in Rheumatology Clinical Trials (OMERACT). These include Acute Phase Reactants, Disability, Pain, Patient Global Assessment, Physician Global Assessment, Swollen joint count, Tender joint count and radiographic changes of joints in any trial of 1 year or longer [Tugwell 1993], and the change in pooled disease index. Only English trials were included in the review.
Data were independently extracted from the published reports by two of the reviewers. An independent blinded quality assessment was also performed.
Nineteen randomized trials were identified of which eleven were included in the quantitative analysis with data from 777 subjects. Although all agents were better than placebo, parenteral high dose methotrexate (not included), salazopyrin, azathioprine and etretinate were the agents that achieved statistical significance in a global index of disease activity (although it should be noted that only one component variable was available for azathioprine and only one trial was available for etretinate suggesting some caution is necessary in interpreting these results). Analysis of response in individual disease activity markers was more variable with considerable differences between different medications and responses. In all trials the placebo group improved over baseline (pooled improvement 0.43 DI units, 95% CI 0. 28-0.59). There was insufficient data to examine toxicity.
REVIEWER'S CONCLUSIONS: Parenteral high dose methotrexate and salazopyrin are the only two agents with well demonstrated published efficacy in psoriatic arthritis. The magnitude of the effect seen with azathioprine, etretinate, oral low dose methotrexate and perhaps colchicine suggests that they may be effective but that further multicentre clinical trials are required to establish their efficacy. Furthermore, the magnitude of the improvement observed in the placebo group strongly suggests that uncontrolled trials should not be used to guide management decisions in this condition.
评估柳氮磺胺吡啶、金诺芬、依曲替酯、富马酸、肌内注射金、硫唑嘌呤和甲氨蝶呤对银屑病关节炎的疗效。
检索截至1995年的Medline以及《医学文摘》(1974年6月至1995年)。检索词为银屑病、关节炎、治疗和/或对照试验。通过人工检索先前发表的综述的参考文献、会议论文集并联系制药公司对其进行补充。初始检索纳入所有语言的文献。
所有比较柳氮磺胺吡啶、金诺芬、依曲替酯、富马酸、肌内注射金、硫唑嘌呤和甲氨蝶呤治疗银屑病关节炎的随机试验。主要结局指标包括源自风湿病临床试验结局指标(OMERACT)的各个组成变量。这些指标包括急性期反应物、残疾情况、疼痛、患者整体评估、医生整体评估、肿胀关节计数、压痛关节计数以及任何为期1年或更长时间的试验中关节的影像学改变[Tugwell 1993],以及综合疾病指数的变化。该综述仅纳入英文试验。
两位审阅者独立从已发表的报告中提取数据。还进行了独立的盲法质量评估。
共识别出19项随机试验,其中11项纳入定量分析,涉及777名受试者的数据。尽管所有药物均优于安慰剂,但胃肠外高剂量甲氨蝶呤(未纳入)、柳氮磺胺吡啶、硫唑嘌呤和依曲替酯在疾病活动综合指数方面具有统计学意义(不过应注意,硫唑嘌呤仅有一个组成变量可用,依曲替酯仅有一项试验可用,这表明在解释这些结果时需谨慎)。对各个疾病活动标志物反应的分析变异性更大,请不同药物和反应之间存在显著差异。在所有试验中,安慰剂组较基线有所改善(综合改善0.43疾病指数单位,95%可信区间0.28 - 0.59)。数据不足以检查毒性。
胃肠外高剂量甲氨蝶呤和柳氮磺胺吡啶是仅有的两种在银屑病关节炎方面已证实具有确切疗效的药物。硫唑嘌呤、依曲替酯、口服低剂量甲氨蝶呤以及可能还有秋水仙碱所显示的疗效表明它们可能有效,但需要进一步开展多中心临床试验来确定其疗效。此外,安慰剂组观察到的改善程度强烈表明,不应使用非对照试验来指导对此病的管理决策。