Gelbmann Cornelia M, Rogler Gerhard, Gross Volker, Gierend Michael, Bregenzer Nicole, Andus Tilo, Schölmerich Jürgen
Department of Internal Medicine I, University of Regensburg, Germany.
Am J Gastroenterol. 2002 Jun;97(6):1438-45. doi: 10.1111/j.1572-0241.2002.05685.x.
Some patients with Crohn's disease (CD) do not respond to corticosteroid therapy. Furthermore, corticosteroids frequently cause side effects. Thus, predictive parameters for treatment refractoriness would be helpful for treatment decisions.
A total of 300 patients with active CD (i.e., with a Crohn's Disease Activity Index [CDAI] >200) entered the study. Treatment started with 60-100 mg/day prednisolone equivalent, which was then tapered to 10-15 mg/day within 6 wk and maintained at that dose for another 4 wk. After 10 wk of treatment, response to steroids was defined by a CDAI <150, steroid resistance by a CDAI always > or =150 and steroid dependency by a relapse after dose reduction. Of 239 eligible patients, 196 were responders, 26 were steroid resistant, and 17 were steroid dependent.
Prior bowel resections, a high initial CDAI, and perianal disease were associated with steroid resistance. Of the steroid resistant patients 53.9% were bowel-resected compared to 20.4% of the responders (relative risk = 3.63; 95% CI = 1.79-7.36). Perianal disease was observed in 42.3% of steroid resistant patients versus 21.9% of responders (relative risk = 2.28; 95% CI = 1.12-4.66) and initial CDAI was 347+/-91 in resistant patients versus 301+/-81 in responders (p < 0.05). Parameters for steroid dependent patients were not significantly different from those of responders.
In this study (thus far the largest study for the evaluation of predictive factors for treatment refractoriness to corticosteroids in CD), only prior bowel resection, perianal disease, and a high initial CDAI were found to be predictive of resistance to steroid treatment.
一些克罗恩病(CD)患者对皮质类固醇治疗无反应。此外,皮质类固醇经常引起副作用。因此,治疗难治性的预测参数将有助于治疗决策。
共有300例活动期CD患者(即克罗恩病活动指数[CDAI]>200)进入研究。治疗开始时使用60 - 100mg/天的泼尼松等效剂量,然后在6周内减至10 - 15mg/天,并维持该剂量4周。治疗10周后,对类固醇的反应定义为CDAI<150,类固醇抵抗定义为CDAI始终>或 =150,类固醇依赖定义为剂量减少后复发。在239例符合条件的患者中,196例有反应,26例对类固醇抵抗,17例对类固醇依赖。
既往肠道切除术、高初始CDAI和肛周疾病与类固醇抵抗相关。在类固醇抵抗患者中,53.9%接受过肠道切除术,而有反应者为20.4%(相对风险 = 3.63;95%可信区间 = 1.79 - 7.36)。42.3%的类固醇抵抗患者有肛周疾病,而有反应者为21.9%(相对风险 = 2.28;95%可信区间 = 1.12 - 4.66),抵抗患者的初始CDAI为347±91,有反应者为301±81(p<0.05)。类固醇依赖患者的参数与有反应者无显著差异。
在本研究(迄今为止评估CD患者对皮质类固醇治疗难治性预测因素的最大规模研究)中,仅发现既往肠道切除术、肛周疾病和高初始CDAI可预测对类固醇治疗的抵抗。