Nilsson A, Danielsson A, Löfberg R, Benno P, Bergman L, Fausa O, Florholmen J, Karvonen A L, Kildebo S, Kollberg B
Department of Medicine, Umeã Hospitals, Sweden.
Am J Gastroenterol. 1995 Mar;90(3):381-7.
To compare the relapse-preventing effect and the frequency of adverse events of olsalazine and sulphasalazine in sulphasalazine-tolerant patients with ulcerative colitis.
Patients in remission, with at least two episodes of active disease during the last 5 yr, were randomized to 2 g of sulphasalazine or 1 g of olsalazine daily and were followed for 6-18 months. Relapse rates in the two groups were compared using frequency and life-table analysis. Sixty-nine patients with proctitis, 140 with left-sided colitis, and 113 with subtotal or total colitis were evaluated.
In the intention-to-treat analysis, the failure rate (relapses plus withdrawals) was 54.7% in the olsalazine and 47.2% in the sulphasalazine group. In the per-protocol analysis excluding withdrawals, 44.7% relapsed in the olsalazine and 39.3% in the sulphasalazine group. Remission curves did not differ significantly, although at all time intervals the frequency of remission was slightly higher in the sulphasalazine group (p = 0.19 in the intention-to-treat analysis and p = 0.42 in the per-protocol analysis estimated by the log-rank test). Twelve patients (of whom five had diarrhea) in the olsalazine group versus eight patients in the sulphasalazine group discontinued the study because of side effects.
The relapse-preventing effect of olsalazine and sulphasalazine in sulphasalazine-tolerant patients did not differ. Furthermore, the tolerability of olsalazine, particularly concerning diarrhea, appears to be better than previously reported.
比较奥沙拉嗪和柳氮磺胺吡啶对柳氮磺胺吡啶耐受的溃疡性结肠炎患者的预防复发效果及不良事件发生频率。
对过去5年中至少有两次活动性疾病发作且处于缓解期的患者，随机分配至每日服用2g柳氮磺胺吡啶或1g奥沙拉嗪组，并随访6 - 18个月。使用频率分析和生命表分析比较两组的复发率。对69例直肠炎患者、140例左侧结肠炎患者和113例次全结肠炎或全结肠炎患者进行了评估。
在意向性分析中，奥沙拉嗪组的失败率（复发加退出）为54.7%，柳氮磺胺吡啶组为47.2%。在排除退出病例的符合方案分析中，奥沙拉嗪组44.7%复发，柳氮磺胺吡啶组39.3%复发。缓解曲线无显著差异，尽管在所有时间间隔，柳氮磺胺吡啶组的缓解频率略高（意向性分析中p = 0.19，符合方案分析中对数秩检验估计p = 0.42）。奥沙拉嗪组有12例患者（其中5例有腹泻）因副作用停药，柳氮磺胺吡啶组有8例患者停药。
奥沙拉嗪和柳氮磺胺吡啶对柳氮磺胺吡啶耐受患者的预防复发效果无差异。此外，奥沙拉嗪的耐受性，尤其是在腹泻方面，似乎比先前报道的要好。
