Azathioprine Is Superior to Budesonide in Achieving and Maintaining Mucosal Healing and Histologic Remission in Steroid-dependent Crohn's Disease
Azathioprine Is Superior to Budesonide in Achieving and Maintaining Mucosal Healing and Histologic Remission in Steroid-dependent Crohn's Disease
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DOI：
10.1002/ibd.20777
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发表时间：
2009-03-01
影响因子：
4.9
通讯作者：
Polyzou, Paraskevi
中科院分区：
文献类型：
--
作者：
Mantzaris, Gerassimos J.;Christidou, Angeliki;Polyzou, Paraskevi
背景资料：硫唑嘌呤（AZA）和布地奈德（BUD）对克罗恩病（CD）粘膜愈合和组织学缓解的影响研究不足。在这项前瞻性研究中，我们评估了AZA和BUD油内镜和组织学活性在类固醇依赖性克罗恩氏回肠结肠炎或近端结肠炎患者中的比较效果，这些患者已经达到了临床缓解油conventional steroids.Methods：患者被随机分配到AZA（2.0-2.5 mg/kg粘土）或BUD（6-9 mg每天）1年。研究方案包括临床检查、实验室检查。计算克罗恩病活动指数（CDAI），完成炎症性肠病问卷（IBDQ），tit基线，然后每2个月一次，持续1年。回结肠镜检查与区域活检进行了基线，然后在研究结束时，以评估粘膜愈合和CD的组织学活性。结果：38例患者被随机分配到AZA和39 BUD。研究结束时，AZA组和BUD组分别有32例和25例患者临床缓解（P = 0.07）。克罗恩病内镜严重指数（CDEIS）评分仅在AZA组中显著下降（P < 0.0001）。AZA治疗组83%的患者达到完全或接近完全愈合，而BUD治疗组仅为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组中显著下降（与基线相比P < 0.001），并且在研究结束时显著低于BUD组（P < 0.001）。AZA组中有8名患者因不良事件（n = 6）或疾病复发而退出，而BUD组中有14名患者因疾病复发而退出。结论：在类固醇依赖性炎症性克罗恩病回肠炎或近端结肠炎患者中，通过常规类固醇达到临床缓解。1-AZA治疗3年在达到和维持粘膜愈合和组织学缓解方面上级BUD。
Background: 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 oil endoscopic and histologic activity in patients with steroid-dependent Crohn's ileocolitis or proximal colitis who had achieved clinical remission oil conventional steroids.Methods: patients were randomized to AZA (2.0-2.5 mg/kg a clay) 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), tit baseline and then every 2 months for I 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.Results: 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.Conclusions: In patients with steroid-dependent inflammatory Crohn's ileocolitis or proximal colitis who achieve clinical remission with conventional steroids. 1-year treatment with AZA was Superior to BUD in achieving and maintaining mucosal healing and histologic remission.