Brynskov J, Freund L, Nørby Rasmussen S, Lauritsen K, Schaffalitzky de Muckadell O, Williams C N, MacDonald A S, Tanton R, Molina F, Campanini M C
Dept. of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen, Denmark.
Scand J Gastroenterol. 1991 Jul;26(7):689-95. doi: 10.3109/00365529108998585.
In a previous report we published the immediate results of a 3-month placebo-controlled trial (n = 34) showing that cyclosporin (n = 37) has a beneficial therapeutic effect in active chronic Crohn's disease. Here we report on the final outcome of the patients. During the 3-month tapering-off period eight initially improved patients (36%) in the cyclosporin group worsened, as did six (55%) in the placebo group. The therapeutic gain of cyclosporin treatment was consistently significant during this period. It ranged from 22% to 25% (95% confidence limits, 2-46%). An outcome ranking showed that 7 patients of the cyclosporin group (19%) were substantially improved, 7 (19%) moderately improved, and 23 (62%) not improved after the tapering off. In contrast, no significant differences were seen during the 6-month follow-up period. Four patients of the cyclosporin group (11%) were substantially improved, 3 (8%) moderately improved, and 30 (81%) not improved at final follow-up. Significant interactions between cyclosporin and prednisolone treatment were demonstrated both at the end of the initial treatment period and at the end of the tapering-off period. We conclude that a short course of cyclosporin treatment does not result in long-term improvement in active chronic Crohn's disease.
在之前的一份报告中，我们发表了一项为期3个月的安慰剂对照试验（n = 34）的即时结果，结果显示环孢素（n = 37）对活动性慢性克罗恩病具有有益的治疗效果。在此，我们报告这些患者的最终结局。在3个月的减量期内，环孢素组最初病情改善的8名患者（36%）病情恶化，安慰剂组有6名患者（55%）病情恶化。在此期间，环孢素治疗的治疗获益始终显著。获益率在22%至25%之间（95%置信区间，2 - 46%）。结局排名显示，环孢素组有7名患者（19%）病情大幅改善，7名患者（19%）病情中度改善，23名患者（62%）在减量期后病情未改善。相比之下，在6个月的随访期内未观察到显著差异。在最终随访时，环孢素组有4名患者（11%）病情大幅改善，3名患者（8%）病情中度改善，30名患者（81%）病情未改善。在初始治疗期结束时和减量期结束时均证实环孢素与泼尼松龙治疗之间存在显著交互作用。我们得出结论，短期环孢素治疗不会使活动性慢性克罗恩病获得长期改善。
