Rijk M C, van Lier H J, van Tongeren J H
Department of Gastrointestinal and Liver Diseases, University Hospital Nijmegen St. Radboud, The Netherlands.
Am J Gastroenterol. 1992 Apr;87(4):438-42.
Forty-nine patients with ulcerative colitis in remission were entered into a prospective, double-blind, multicenter trial comparing the relapse-preventing effect and safety of 4 g sulfasalazine and 2 g olsalazine daily during 48 wk. Of the 46 evaluable patients, 23 were assigned to sulfasalazine and 23 to olsalazine. Seven of 23 patients (30.4%) relapsed on sulfasalazine and six of 23 patients (26.1%) on olsalazine (95% confidence interval of the difference -22.0% to 30.3%). The relapse-free survival curves did not differ significantly at any time during the trial period. In both treatment groups, three patients dropped out because of adverse effects. Four patients on sulfasalazine and six patients on olsalazine experienced minor adverse effects. One patient on sulfasalazine had mild leukopenia, and four patients on sulfasalazine and one patient on olsalazine had decreased levels of haptoglobin. Thus, sulfasalazine and olsalazine are equally effective in maintaining remission of ulcerative colitis and are accompanied by a similar incidence of adverse effects.
49例处于缓解期的溃疡性结肠炎患者进入一项前瞻性、双盲、多中心试验，比较48周内每日服用4g柳氮磺胺吡啶和2g奥沙拉嗪预防复发的效果及安全性。在46例可评估患者中，23例被分配至柳氮磺胺吡啶组，23例被分配至奥沙拉嗪组。柳氮磺胺吡啶组23例患者中有7例（30.4%）复发，奥沙拉嗪组23例患者中有6例（26.1%）复发（差异的95%置信区间为-22.0%至30.3%）。在试验期间的任何时间，无复发存活曲线均无显著差异。在两个治疗组中，均有3例患者因不良反应退出。柳氮磺胺吡啶组有4例患者、奥沙拉嗪组有6例患者出现轻微不良反应。柳氮磺胺吡啶组有1例患者出现轻度白细胞减少，柳氮磺胺吡啶组有4例患者及奥沙拉嗪组有1例患者触珠蛋白水平降低。因此，柳氮磺胺吡啶和奥沙拉嗪在维持溃疡性结肠炎缓解方面同样有效，且不良反应发生率相似。
