Malchow H, Ewe K, Brandes J W, Goebell H, Ehms H, Sommer H, Jesdinsky H
Gastroenterology. 1984 Feb;86(2):249-66.
A multicenter double-blind study of the effectiveness of sulfasalazine and 6-methylprednisolone, alone and in combination, was conducted on 452 patients with Crohn's disease. One hundred sixty patients were previously untreated; 292 patients were previously treated. The Crohn's disease activity index (CDAI) was used to determine whether a patient had active (CDAI greater than or equal to 150, n = 215) or quiescent disease (CDAI less than 150, n = 237). Treatment of active disease consisted of high-dose 6-methylprednisolone, 6-methylprednisolone combined with 3 g of sulfasalazine, 3 g of sulfasalazine alone, or placebo, and lasted 6 wk. Patients in remission received maintenance doses of one of these drug regimens for periods of up to 2 yr. One hundred ninety-two patients completed the 2-yr study period. Results were evaluated using life-table analysis and outcome ranking. These methods showed 6-methylprednisolone to be the most effective drug in overall comparison of all patients (p less than 0.001); in previously treated patients (p less than 0.001); and in subgroups: active disease (p less than 0.001), only small bowel disease (p less than 0.05), and both small bowel and colon disease (p less than 0.05). Combination of 6-methylprednisolone and sulfasalazine was the most effective regimen in previously untreated patients (p less than 0.05) and when disease was localized in the colon (p less than 0.001). Sulfasalazine alone was least effective in overall comparison of all patients (p less than 0.05) and in all strata. Drug treatment was of no significant benefit to patients with quiescent disease. Continuous administration of low doses of 6-methylprednisolone, or the combination regimen, was beneficial in patients who responded initially to treatment of active disease. The addition of sulfasalazine, however, offered no advantage.
对452例克罗恩病患者进行了一项多中心双盲研究，以评估柳氮磺胺吡啶和6-甲基泼尼松龙单独及联合使用的疗效。160例患者此前未接受过治疗；292例患者此前接受过治疗。采用克罗恩病活动指数（CDAI）来确定患者患有活动性疾病（CDAI大于或等于150，n = 215）还是静止期疾病（CDAI小于150，n = 237）。活动性疾病的治疗包括大剂量6-甲基泼尼松龙、6-甲基泼尼松龙联合3g柳氮磺胺吡啶、单独使用3g柳氮磺胺吡啶或安慰剂，疗程持续6周。缓解期患者接受这些药物方案之一的维持剂量治疗，最长可达2年。192例患者完成了为期2年的研究期。使用生命表分析和结果排名对结果进行评估。这些方法显示，在所有患者的总体比较中（p < 0.001）；在既往接受过治疗的患者中（p < 0.001）；以及在亚组中：活动性疾病（p < 0.001）、仅累及小肠疾病（p < 0.05）和同时累及小肠和结肠疾病（p < 0.05），6-甲基泼尼松龙是最有效的药物。在既往未接受过治疗的患者中（p < 0.05）以及疾病局限于结肠时（p < 0.001），6-甲基泼尼松龙与柳氮磺胺吡啶联合使用是最有效的治疗方案。在所有患者的总体比较中（p < 0.05）以及在所有分层中，单独使用柳氮磺胺吡啶效果最差。药物治疗对静止期疾病患者无显著益处。持续给予低剂量的6-甲基泼尼松龙或联合治疗方案对最初对活动性疾病治疗有反应的患者有益。然而，添加柳氮磺胺吡啶并无优势。
