Brynskov J, Freund L, Rasmussen S N, Lauritsen K, de Muckadell O S, Williams N, MacDonald A S, Tanton R, Molina F, Campanini M C
Department of Internal Medicine and Gastroenterology C, Herlev University Hospital, Copenhagen, Denmark.
N Engl J Med. 1989 Sep 28;321(13):845-50. doi: 10.1056/NEJM198909283211301.
We randomly assigned 71 patients with active chronic Crohn's disease who were resistant to or intolerant of corticosteroids to treatment with oral cyclosporine (5 to 7.5 mg per kilogram of body weight per day) or placebo for three months. Disease activity was assessed on a clinical grading scale without knowledge of the treatment given. At the end of the treatment period, 22 of the 37 cyclosporine-treated patients (59 percent) had improvement, as compared with 11 of the 34 placebo-treated patients (32 percent) (P = 0.032). During cyclosporine treatment, there was significant improvement in plasma orosomucoid levels (P = 0.0025) and the Crohn's Disease Activity Index (P = 0.00012). The effect of treatment became evident after two weeks. In the subsequent three months, during which the patients were gradually withdrawn from treatment, the improvement continued in 14 of the 37 patients (38 percent) in the cyclosporine group and in 5 of the 34 (15 percent) in the placebo group (P = 0.034). No serious adverse events were observed. We conclude that cyclosporine has a beneficial therapeutic effect in patients with active chronic Crohn's disease and resistance to or intolerance of corticosteroids.
我们将71例对皮质类固醇耐药或不耐受的活动性慢性克罗恩病患者随机分为两组，分别接受口服环孢素（每天每千克体重5至7.5毫克）或安慰剂治疗，为期三个月。在不知道所给予治疗的情况下，根据临床分级量表评估疾病活动度。治疗期结束时，37例接受环孢素治疗的患者中有22例（59%）病情改善，而34例接受安慰剂治疗的患者中有11例（32%）病情改善（P = 0.032）。在环孢素治疗期间，血浆类黏蛋白水平（P = 0.0025）和克罗恩病活动指数（P = 0.00012）有显著改善。治疗效果在两周后显现。在随后的三个月里，患者逐渐停止治疗，环孢素组37例患者中有14例（38%）病情持续改善，安慰剂组34例患者中有5例（15%）病情持续改善（P = 0.034）。未观察到严重不良事件。我们得出结论，环孢素对活动性慢性克罗恩病且对皮质类固醇耐药或不耐受的患者有有益的治疗效果。
