Papi Claudio, Festa Virginia, Leandro Gioacchino, Moretti Alessandra, Tanga Monica, Koch Maurizio, Capurso Lucio
Gastroenterology Unit, S. Filippo Neri Hospital, Rome, Italy.
Am J Gastroenterol. 2007 Apr;102(4):814-9. doi: 10.1111/j.1572-0241.2007.01055.x. Epub 2007 Jan 11.
Corticosteroids are the gold standard in the treatment of moderate to severe Crohn's disease but are often associated with severe and potentially dangerous side effects. Despite an initial clinical response many patients become steroid dependent or require further steroid courses in the long term. The aim of the present study was to assess the probability of the need for further steroid treatment in Crohn's disease patients following steroid-induced remission and to establish if clinical variables can predict further steroid needs. PATIENTS AND All
patients at their first steroid course and with corticosteroid-induced remission, defined as a Crohn's Disease Activity Index (CDAI) <150, 4 wk after steroid weaning, were studied and observed at follow-up for 12 months. The main outcome was clinical relapse requiring further steroid treatment. Statistical analysis was performed using the Kaplan-Meier method and multivariable Cox proportional hazard regression model taking into consideration gender, age at diagnosis, disease location and behavior, smoking habits, CDAI score before steroid treatment, and C reactive protein values at steroid weaning, as covariates.
A total of 77 patients with steroid-induced remission were included. One-year follow-up was available in 75 of the 77 patients (97.4%). During follow-up 49 of 75 patients (65.3%) maintained remission or presented mild relapse not requiring steroids while 26 of 75 patients (34.6%) had moderate to severe relapse requiring further steroid treatment. The cumulative probability of a course free from steroids was 93.3%, 82.6%, 78.6%, and 66.6% at 3, 6, 9, and 12 months, respectively. At multivariate analysis, increased C reactive protein at steroid weaning and penetrating complications were independent risk factors for further steroid requirement (OR 5.57, 95% CI 1.20-25.91, P= 0.001 and OR 4.20, 95% CI 1.76-10.04, P= 0.005, respectively).
Despite an initial clinical response and successful steroid tapering, 35% of patients required further steroid treatment within 1 yr. An increased C reactive protein value, at steroid weaning, despite clinical remission, and penetrating complications may predict further steroid requirement in already steroid responsive patients.
皮质类固醇是治疗中度至重度克罗恩病的金标准,但常伴有严重且潜在危险的副作用。尽管有初始临床反应,但许多患者会出现类固醇依赖或长期需要进一步的类固醇疗程。本研究的目的是评估克罗恩病患者在类固醇诱导缓解后需要进一步类固醇治疗的可能性,并确定临床变量是否能预测进一步的类固醇需求。
研究首次接受类固醇疗程且类固醇诱导缓解(定义为类固醇撤药4周后克罗恩病活动指数[CDAI]<150)的所有患者,并对其进行12个月的随访观察。主要结局是需要进一步类固醇治疗的临床复发。采用Kaplan-Meier方法和多变量Cox比例风险回归模型进行统计分析,将性别、诊断时年龄、疾病部位和行为、吸烟习惯、类固醇治疗前的CDAI评分以及类固醇撤药时的C反应蛋白值作为协变量。
共纳入77例类固醇诱导缓解的患者。77例患者中有75例(97.4%)获得了1年的随访。随访期间,75例患者中有49例(65.3%)维持缓解或出现无需类固醇治疗的轻度复发,而75例患者中有26例(34.6%)出现中度至重度复发,需要进一步类固醇治疗。在3、6、9和12个月时,无类固醇疗程的累积概率分别为93.3%、82.6%、78.6%和66.6%。多变量分析显示,类固醇撤药时C反应蛋白升高和穿透性并发症是进一步需要类固醇治疗的独立危险因素(分别为OR 5.57,95%CI 1.20 - 25.91,P = 0.001和OR 4.20,95%CI 1.76 - 10.04,P = 0.005)。
尽管有初始临床反应且成功减停类固醇,但35%的患者在1年内需要进一步类固醇治疗。在类固醇撤药时,尽管临床缓解,但C反应蛋白值升高以及穿透性并发症可能预测已对类固醇有反应的患者进一步需要类固醇治疗。