Ewe K, Press A G, Singe C C, Stufler M, Ueberschaer B, Hommel G, Meyer zum Büschenfelde K H
Department of Medicine, Johannes-Gutenberg-University, Mainz, Germany.
Gastroenterology. 1993 Aug;105(2):367-72. doi: 10.1016/0016-5085(93)90709-l.
The role of azathioprine (AZA) in the treatment of active Crohn's disease (CD) is still controversial. This study examined whether AZA combined with standard prednisolone therapy improved the therapeutic outcome compared with monotherapy with prednisolone.
Forty-two patients with a Crohn's Disease Activity Index (CDAI) of > 150 were randomized into two groups. Both received 60 mg of prednisolone daily in a tapering regimen to a maintenance dose of 10 mg. In addition, group 1 received 2.5 mg AZA/kg body wt and group 2 received a placebo over the whole study period of 4 months.
At the end of the trial, 16 of 21 patients (76%) in group 1 were in remission (CDAI < 150), compared with 8 of 21 (38%) in group 2 (P = 0.03). The CDAI in group 1 dropped from 290 +/- 97 (SD) to 72 +/- 84 and from 285 +/- 110 to 155 +/- 105 in group 2. The differences between activity indices in groups 1 and 2 became statistically significant after 8 weeks. The average prednisolone dose per day was 20.9 mg in group 1 and 26.7 mg in group 2 (P = 0.02). No major side effects were observed in this study.
The combination of prednisolone and AZA was superior to the treatment with prednisolone alone in active CD. Patients receiving AZA showed remission more frequently, more quickly, and with lower doses of prednisolone.
硫唑嘌呤（AZA）在治疗活动性克罗恩病（CD）中的作用仍存在争议。本研究旨在探讨与泼尼松龙单药治疗相比，AZA联合标准泼尼松龙治疗是否能改善治疗效果。
42例克罗恩病活动指数（CDAI）>150的患者被随机分为两组。两组均采用泼尼松龙每日60mg的递减方案，直至维持剂量10mg。此外，在为期4个月的整个研究期间，第1组患者接受2.5mg AZA/ kg体重治疗，第2组患者接受安慰剂治疗。
试验结束时，第1组21例患者中有16例（76%）缓解（CDAI<150），而第2组21例中有8例（38%）缓解（P=0.03）。第1组的CDAI从290±97（标准差）降至72±84，第2组从285±110降至155±105。两组活动指数的差异在8周后具有统计学意义。第1组泼尼松龙的日均剂量为20.9mg，第2组为26.7mg（P=0.02）。本研究未观察到严重副作用。
在活动性CD中，泼尼松龙与AZA联合治疗优于泼尼松龙单药治疗。接受AZA治疗的患者缓解更频繁、更快，且所需泼尼松龙剂量更低。
