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1 年深度缓解可预防早期克罗恩病进展。

Deep Remission at 1 Year Prevents Progression of Early Crohn's Disease.

机构信息

Icahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, New York.

Amiens University Hospital, Department of Gastroenterology, Amiens, France.

出版信息

Gastroenterology. 2020 Jul;159(1):139-147. doi: 10.1053/j.gastro.2020.03.039. Epub 2020 Mar 26.

Abstract

BACKGROUND & AIMS: We investigated the effects of inducing deep remission in patients with early Crohn's disease (CD).

METHODS

We collected follow-up data from 122 patients (mean age, 31.2 ± 11.3 y) with early, moderate to severe CD (median duration, 0.2 years; interquartile range, 0.1-0.5) who participated in the Effect of Tight Control Management on CD (CALM) study, at 31 sites, representing 50% of the original CALM patient population. Fifty percent of patients (n = 61) were randomly assigned to a tight control strategy (increased therapy based on fecal level of calprotectin, serum level of C-reactive protein, and symptoms), and 50% were assigned to conventional management. We categorized patients as those who were vs were not in deep remission (CD endoscopic index of severity scores below 4, with no deep ulcerations or steroid treatment, for 8 or more weeks) at the end of the follow-up period (median, 3.02 years; range, 0.05-6.26 years). The primary outcome was a composite of major adverse outcomes that indicate CD progression during the follow-up period: new internal fistulas or abscesses, strictures, perianal fistulas or abscesses, or hospitalization or surgery for CD. Kaplan-Meier and penalized Cox regression with bootstrapping were used to compare composite rates between patients who achieved or did not achieve remission at the end of the follow-up period.

RESULTS

Major adverse outcomes were reported for 34 patients (27.9%) during the follow-up period. Significantly fewer patients in deep remission at the end of the CALM study had major adverse outcomes during the follow-up period (P = .01). When we adjusted for potential confounders, deep remission (adjusted hazard ratio, 0.19; 95% confidence interval, 0.07-0.31) was significantly associated with a lower risk of major adverse outcome.

CONCLUSIONS

In an analysis of follow-up data from the CALM study, we associated induction of deep remission in early, moderate to severe CD with decreased risk of disease progression over a median time of 3 years, regardless of tight control or conventional management strategy.

摘要

背景与目的

我们研究了诱导早期克罗恩病(CD)患者深度缓解的效果。

方法

我们收集了 122 名(平均年龄 31.2±11.3 岁)早期、中重度 CD(中位病程 0.2 年;四分位间距 0.1-0.5)患者的随访数据,这些患者参加了 Effect of Tight Control Management on CD(CALM)研究,该研究在 31 个地点进行,代表了原始 CALM 患者人群的 50%。将 50%的患者(n=61)随机分配到强化治疗策略组(根据粪便钙卫蛋白水平、血清 C 反应蛋白水平和症状增加治疗),50%的患者分配到常规治疗组。我们将患者分为深度缓解组(CD 内镜严重程度评分<4 分,无深度溃疡或类固醇治疗,持续 8 周或以上)和未深度缓解组,在随访期末(中位数 3.02 年;范围 0.05-6.26 年)比较两组患者。主要结局是随访期间提示 CD 进展的不良结局的复合结局:新发内部瘘管或脓肿、狭窄、肛周瘘管或脓肿、或因 CD 住院或手术。采用 Kaplan-Meier 法和 bootstrap 惩罚 Cox 回归分析比较深度缓解组和未深度缓解组患者的复合结局发生率。

结果

在随访期间,34 名患者(27.9%)报告了不良结局。在 CALM 研究结束时达到深度缓解的患者在随访期间发生不良结局的比例显著较低(P=0.01)。当我们调整潜在混杂因素后,深度缓解(调整后的危险比,0.19;95%置信区间,0.07-0.31)与不良结局风险降低显著相关。

结论

在对 CALM 研究的随访数据分析中,我们发现诱导早期中重度 CD 深度缓解与疾病进展风险降低相关,中位随访时间为 3 年,与强化或常规治疗策略无关。

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