Mantzaris Gerassimos J, Christidou Angeliki, Sfakianakis Michael, Roussos Anastassios, Koilakou Stavroula, Petraki Kalliopi, Polyzou Paraskevi
First Department of Gastroenterology, Evangelismos Hospital, Athens, Greece.
Inflamm Bowel Dis. 2009 Mar;15(3):375-82. doi: 10.1002/ibd.20777.
The effects of azathioprine (AZA) and budesonide (BUD) on mucosal healing and histologic remission of Crohn's disease (CD) are insufficiently studied. In this prospective study we evaluated the comparative effects of AZA and BUD on endoscopic and histologic activity in patients with steroid-dependent Crohn's ileocolitis or proximal colitis who had achieved clinical remission on conventional steroids.
Patients were randomized to AZA (2.0-2.5 mg/kg a day) or BUD (6-9 mg a day) for 1 year. The study protocol included clinical examination, laboratory tests, calculation of the Crohn's Disease Activity Index (CDAI), completion of the Inflammatory Bowel Disease Questionnaire (IBDQ), at baseline and then every 2 months for 1 year. Ileocolonoscopy with regional biopsies was performed at baseline and then at the end of the study to assess mucosal healing and the histologic activity of CD.
Thirty-eight patients were randomized to AZA and 39 to BUD. At the end of the study 32 and 25 patients in the AZA and BUD groups, respectively, were in clinical remission (P = 0.07). The Crohn's Disease Endoscopic Index of Severity (CDEIS) score fell significantly only in the AZA group (P < 0.0001). Complete or near complete healing was achieved in 83% of AZA-treated patients compared with only 24% of BUD-treated patients (P < 0.0001). Histologic activity as assessed by an average histology score (AHS) fell significantly only in the AZA group (P < 0.001 versus baseline) and was significantly lower than in the BUD group at the end of the study (P < 0.001). Eight patients in the AZA group were withdrawn for adverse events (n = 6) or relapse of disease compared with 14 patients in the BUD group who were withdrawn for relapse of disease.
In patients with steroid-dependent inflammatory Crohn's ileocolitis or proximal colitis who achieve clinical remission with conventional steroids, a 1-year treatment with AZA was superior to BUD in achieving and maintaining mucosal healing and histologic remission.
硫唑嘌呤（AZA）和布地奈德（BUD）对克罗恩病（CD）黏膜愈合和组织学缓解的影响尚未得到充分研究。在这项前瞻性研究中，我们评估了AZA和BUD对依赖类固醇的克罗恩回结肠炎症或近端结肠炎症患者内镜及组织学活性的比较效果，这些患者在常规类固醇治疗下已实现临床缓解。
患者被随机分为接受AZA（每日2.0 - 2.5mg/kg）或BUD（每日6 - 9mg）治疗1年。研究方案包括临床检查、实验室检测、计算克罗恩病活动指数（CDAI）、完成炎症性肠病问卷（IBDQ），在基线时进行，然后在1年中每2个月进行一次。在基线时以及研究结束时进行回结肠镜检查并取局部活检，以评估CD的黏膜愈合情况和组织学活性。
38例患者被随机分配至AZA组，39例至BUD组。研究结束时，AZA组和BUD组分别有32例和25例患者处于临床缓解状态（P = 0.07）。仅AZA组的克罗恩病内镜严重程度指数（CDEIS）评分显著下降（P < 0.0001）。83%接受AZA治疗的患者实现了完全或近乎完全愈合，而接受BUD治疗的患者中这一比例仅为24%（P < 0.0001）。通过平均组织学评分（AHS）评估的组织学活性仅在AZA组显著下降（与基线相比，P < 0.001），且在研究结束时显著低于BUD组（P < 0.001）。AZA组有8例患者因不良事件（n = 6）或疾病复发退出研究，而BUD组有14例患者因疾病复发退出研究。
对于依赖类固醇的炎症性克罗恩回结肠炎症或近端结肠炎症患者，在通过常规类固醇实现临床缓解后，接受1年的AZA治疗在实现和维持黏膜愈合及组织学缓解方面优于BUD。
