Andreoli A, Spinella S, Levenstein S, Prantera C
Divisione di Gastroenterologia, Ospedale Nuovo Regina Margherita, Roma, Italy.
Ital J Gastroenterol. 1994 Apr;26(3):121-5.
This prospective trial in patients with left-sided ulcerative colitis evaluated the efficacy and acceptability of biweekly high-dose 5-aminosalicylic acid (5-ASA) enemas (4g/100ml) in maintaining a remission recently induced using daily 5-ASA enemas. Thirty-one patients were randomly assigned, 16 to 5-ASA and 15 to oral sulphasalazine (2g/day), and examined monthly. Sigmoidoscopy was performed "blind" at six months or at clinical relapse. Twelve patients on 5-ASA (75%) and nine on sulphasalazine (60%) remained in clinical and endoscopic remission throughout the study (NS), and the survival curve for 5-ASA was better at all points (NS). No patient stopped therapy due to side effects, and all those on 5-ASA chose to continue rectal maintenance therapy after the study. It was concluded that biweekly 5-ASA enemas is at least as effective as oral sulphasalazine in maintaining remission in unselected patients whose remission has been achieve using local therapy.
这项针对左侧溃疡性结肠炎患者的前瞻性试验，评估了每两周一次的高剂量5-氨基水杨酸（5-ASA）灌肠剂（4g/100ml）在维持近期通过每日5-ASA灌肠诱导的缓解方面的疗效和可接受性。31名患者被随机分组，16名接受5-ASA治疗，15名接受口服柳氮磺胺吡啶（2g/天）治疗，并每月进行检查。在6个月时或临床复发时进行“盲法”乙状结肠镜检查。在整个研究过程中，12名接受5-ASA治疗的患者（75%）和9名接受柳氮磺胺吡啶治疗的患者（60%）保持临床和内镜缓解（无显著性差异），5-ASA组的生存曲线在各时间点均更好（无显著性差异）。没有患者因副作用而停止治疗，所有接受5-ASA治疗的患者在研究结束后都选择继续直肠维持治疗。得出的结论是，对于那些通过局部治疗已实现缓解的未选择患者，每两周一次的5-ASA灌肠剂在维持缓解方面至少与口服柳氮磺胺吡啶一样有效。
