Dougados M, vam der Linden S, Leirisalo-Repo M, Huitfeldt B, Juhlin R, Veys E, Zeidler H, Kvien T K, Olivieri I, Dijkmans B
Université René Descartes, Hôpital Cochin, Paris, France.
Arthritis Rheum. 1995 May;38(5):618-27. doi: 10.1002/art.1780380507.
To assess the efficacy and tolerability of sulfasalazine (SSZ) in the treatment of spondylarthropathy.
We conducted a 6-month randomized, placebo-controlled, double-blind, multicenter study of patients with spondylarthropathy whose disease had remained active despite treatment with nonsteroidal antiinflammatory drugs. Patients were treated with SSZ (3 gm/day) or placebo. The primary efficacy variables were the physician's and patient's overall assessments, pain, and morning stiffness. End points were analyzed in the intent-to-treat and completer patient populations; the time course of effect was analyzed in the completer patient population.
Of the 351 patients enrolled, 263 (75%) completed the 6-month treatment period. The withdrawal rates were 35 (20%) and 53 (30%) in the placebo and SSZ groups, respectively. In the intent-to-treat analysis of end point efficacy, the between-treatment difference reached statistical significance only for 1 of the 4 primary outcome variables, the patient's overall assessment of disease activity, for which 60% of the patients taking SSZ improved by at least 1 point on a 5-point scale, in contrast to 44% of the patients taking placebo. Laboratory markers of inflammation also showed statistically significant change in favor of SSZ. In subgroup analysis, the most impressive effects were seen in patients with psoriatic arthritis, both for the 4 primary efficacy variables and for secondary efficacy variables such as the number of inflamed joints. Adverse events were more frequent in the SSZ group than the placebo group, but all were transient or reversible after cessation of treatment.
The results of this study show that SSZ had greater efficacy than placebo in the treatment of active spondylarthropathy, notably in patients with psoriatic arthritis.
评估柳氮磺胺吡啶（SSZ）治疗脊柱关节病的疗效和耐受性。
我们对脊柱关节病患者进行了一项为期6个月的随机、安慰剂对照、双盲、多中心研究，这些患者尽管使用了非甾体抗炎药治疗，疾病仍处于活动期。患者接受SSZ（3克/天）或安慰剂治疗。主要疗效变量为医生和患者的总体评估、疼痛和晨僵。在意向性治疗和完成治疗的患者群体中分析终点；在完成治疗的患者群体中分析疗效的时间进程。
351名入选患者中，263名（75%）完成了6个月的治疗期。安慰剂组和SSZ组的退出率分别为35名（20%）和53名（30%）。在意向性治疗终点疗效分析中，4个主要结局变量中只有1个在治疗组间差异达到统计学显著性，即患者对疾病活动的总体评估，服用SSZ的患者中有60%在5分制量表上至少提高了1分，而服用安慰剂的患者为44%。炎症的实验室指标也显示出有利于SSZ的统计学显著变化。在亚组分析中，银屑病关节炎患者在4个主要疗效变量和次要疗效变量如炎症关节数量方面均观察到最显著的效果。SSZ组的不良事件比安慰剂组更频繁，但所有不良事件在停止治疗后都是短暂的或可逆的。
本研究结果表明，SSZ在治疗活动性脊柱关节病方面比安慰剂更有效，尤其是在银屑病关节炎患者中。
