Dougados M, Boumier P, Amor B
Rev Rhum Mal Osteoartic. 1987 Mar;54(3):255-60.
The efficacy of salazosulfapyridine (SI) has been recently reported in the course of peripheral arthritis in ankylosing spondylarthritis (SPA), but is action on the axial forms of the disease was not known. We have therefore conducted a therapeutic trial in 60 patients suffering from SPA, without peripheral involvement clinical sign evoking an enterocolopathy. This double-blind study compared the activity of SI at a dose of 2 g/day with a placebo, for 6 months. Thirteen patients had to discontinue the treatment: 6 in the placebo group (inefficacy: 3 cases, anemia: 1 case, epigastric pain: 1 case, rash: 1 case) and 7 cases in the SI group (inefficacy: 2 cases, nauseous: 3 cases, abdominal pain: 1 case, moderate elevation of transaminases: 1 case). These 13 patients were kept for the global analysis and considered as therapeutic failures. The treatment was considered effective in 15 out of 30 patients of group SI and in 30 patients on placebo (p less than 0.02). In addition, in group SI, a statistically significant decrease of the daily dose of non-steroid anti-inflammatory drugs was observed (-6.5 +/- 7.2 versus -2.4 +/- 6.4 in the placebo group, p less than 0.05); also was observed a decrease of the functional index (-5.9 +/- 6.6 versus -1.9 +/- 5.7 in the group placebo, p less than 0.05) and of the serum level of immunoglobulin G (-1.8 +/- 3.6 g/l versus +0.8 +/- 2.9 in the placebo group, p less than 0.025).(ABSTRACT TRUNCATED AT 250 WORDS)
近来有报道称柳氮磺胺吡啶（SI）对强直性脊柱炎（SPA）外周关节炎有效，但对该病轴向型的作用尚不清楚。因此，我们对60例无外周受累临床体征且无提示小肠结肠炎迹象的SPA患者进行了一项治疗试验。这项双盲研究比较了每日2克剂量的SI与安慰剂的活性，为期6个月。13例患者不得不中断治疗：安慰剂组6例（无效：3例，贫血：1例，上腹部疼痛：1例，皮疹：1例），SI组7例（无效：2例，恶心：3例，腹痛：1例，转氨酶中度升高：1例）。这13例患者纳入整体分析并视为治疗失败。SI组30例患者中有15例治疗有效，安慰剂组30例患者中有3例有效（p<0.02）。此外，在SI组中，观察到非甾体抗炎药每日剂量有统计学显著下降（-6.5±7.2，而安慰剂组为-2.4±6.4，p<0.05）；还观察到功能指数下降（-5.9±6.6，而安慰剂组为-1.9±5.7，p<0.05）以及血清免疫球蛋白G水平下降（-1.8±3.6克/升，而安慰剂组为+0.8±2.9，p<0.025）。（摘要截选至250字）
