奥沙拉秦钠胶囊和柳氮磺胺吡啶片治疗溃疡性结肠炎的随机对照研究

目的评价奥沙拉秦钠胶囊治疗溃疡性结肠炎(UC)的临床疗效与安全性.方法采用随机对照试验,将符合入选标准的UC患者135例,分成治疗组105例,对照组30例.治疗组奥沙拉秦钠胶囊1 g,3次/d,餐中服用;对照组柳氮磺胺吡啶片(SASP)1.0 g,4次/d,餐后服用;疗程均为4周.结果治疗组和对照组的临床疗效分别为86.0%和76.7%.腹泻、腹痛、黏液血便总有效率,在治疗组中分别为85.6%、91.3%、92.5%;对照组中分别为84.0%、90.0%、68.0%.黏液血便改善治疗组较对照组为优(P＜0.05).结肠镜下疗效观察治疗组显著优于对照组(P＜0 01),其有效率分别为79.4%和42.9%.治疗组不良反应以腹泻最常见(20.0%),有5例在治疗初期因腹泻加重而中途退出.其次为恶心、上腹不适、皮疹等.对照组以白细胞减少多见(33.3%),其次为恶心、皮疹、上腹不适等.结论奥沙拉秦钠胶囊治疗UC是一种安全有效的药物.

Olsalazine versus sulfasalazine in the treatment of ulcerative colitis: Randomized controlled Clinical trial

Objective To evaluate the therapeutic effect and safety of olsalazine sodium and sulfasalazine in patients with ulcerative colitis. Methods Patients with ulcerative colitis were randomized to receive either olsalazine sodium, 3 g/d ( n =105), or sulfasalazine, 4 g/d ( n =30), for up to 4 weeks. Results There were 86.0% of the patients treated with olsalazine sodium and 76.7% of the ones with sulfasalazine in the therapeutic effect. Effect rate of diarrhoea, bellyache, hematochezia in the patients treated with olsalazine sodium and sulfasalazine is 85.6%, 91.3%, 92.5% and 84.0%, 90.0%, 68.0%, respectively. The therapeutic effect of olsalazine sodium treated patients was better than one of patients treated with sulfasalazine in hematochezia ( P =0.027). Of the patients treated with olsalazine sodium, 79.4% achieved endoscopic remission, compared with 42.9% of patients treated with sulfasalazine. This difference was significant ( P =0.007). Adverse events were seen in 20.0% diarrhoea of olsalazine sodium treated patients and in 33.3% leucopenia of sulfasalazine treated patients. Five patients treated with olsalazine sodium withdrew from the study because of diarrhoea. Conclusion Olsalazine sodium is effective and safe in treating patients with ulcerative colitis.