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超声引导下对不同生物治疗方案的克罗恩病进行紧密控制和监测:一项多中心研究。

Ultrasonography Tight Control and Monitoring in Crohn's Disease During Different Biological Therapies: A Multicenter Study.

机构信息

Gastroenterology Unit, Department of Systems Medicine, University of Rome Tor Vergata, Rome.

Gastroenterology, Department of Clinical Medicine and Surgery, Federico II, School of Medicine, Naples.

出版信息

Clin Gastroenterol Hepatol. 2022 Apr;20(4):e711-e722. doi: 10.1016/j.cgh.2021.03.030. Epub 2021 Mar 26.

Abstract

BACKGROUND & AIMS: Bowel ultrasonography (BUS) is a noninvasive tool for evaluating bowel activity in Crohn's disease (CD) patients. Aim of our multicenter study was to assess whether BUS helps to monitor intestinal activity improvement/resolution following different biological therapies.

METHODS

Adult CD patients were prospectively enrolled at 16 sites in Italy. Changes in BUS parameters [i.e. bowel wall thickening (BWT), lesion length, echo pattern, blood flow changes and transmural healing (TH: normalization of all BUS parameters)] were analyzed at baseline and after 3, 6 and 12 months of different biological therapies.

RESULTS

One hundred eighty-eight out of 201 CD patients were enrolled and analyzed (116 males [62%]; median age 36 years). Fifty-five percent of patients were treated with adalimumab, 16% with infliximab, 13% with vedolizumab and 16% with ustekinumab. TH rates at 12 months were 27.5% with an NNT of 3.6. TH at 12 months after adalimumab was 26.8%, 37% after infliximab, 27.2% after vedolizumab and 20% after ustekinumab. Mean BWT improvement from baseline was statistically significant at 3 and 12 months (P < .0001). Median Harvey-Bradshaw index, C-reactive protein and fecal calprotectin decreased after 12 months from baseline (P < .0001). Logistic regression analysis showed colonic lesion was associated with a higher risk of TH at 3 months and a greater BWT at baseline was associated with a lower risk of TH at 3 months [P = .03 (OR 0.70, 95% CI 0.50-0.97)] and 12 months [P = .01 (OR 0.58, 95% CI 0.38-0.89)]. At 3 months therapy optimization during the study was the only independent factor associated with a higher risk of no ultrasonographic response [P = .02 (OR 3.34, 95% CI 1.18-9.47)] and at 12 months disease duration [P = .02 (OR 3.03, 95% CI 1.15-7.94)].

CONCLUSIONS

Data indicate that BUS is useful to monitor biologics-induced bowel activity improvement/resolution in CD.

摘要

背景与目的

肠道超声(BUS)是一种非侵入性工具,可用于评估克罗恩病(CD)患者的肠道活动。本多中心研究的目的是评估 BUS 是否有助于监测不同生物治疗后肠道活动的改善/缓解。

方法

在意大利的 16 个地点前瞻性纳入成年 CD 患者。在基线时和不同生物治疗后 3、6 和 12 个月,分析 BUS 参数的变化[即肠壁增厚(BWT)、病变长度、回声模式、血流变化和透壁愈合(TH:所有 BUS 参数的正常化)]。

结果

201 名 CD 患者中有 188 名(男性 116 名[62%];中位年龄 36 岁)入组并进行了分析。55%的患者接受阿达木单抗治疗,16%的患者接受英夫利昔单抗治疗,13%的患者接受维得利珠单抗治疗,16%的患者接受乌司奴单抗治疗。12 个月时的 TH 率为 27.5%,NNT 为 3.6。阿达木单抗治疗后 12 个月的 TH 率为 26.8%,英夫利昔单抗为 37%,维得利珠单抗为 27.2%,乌司奴单抗为 20%。与基线相比,3 个月和 12 个月时 BWT 的平均改善具有统计学意义(P<.0001)。基线后 12 个月,Harvey-Bradshaw 指数、C 反应蛋白和粪便钙卫蛋白中位数降低(P<.0001)。逻辑回归分析显示,结肠病变与 3 个月时 TH 的风险增加相关,而基线时更大的 BWT 与 3 个月(P=.03,OR 0.70,95%CI 0.50-0.97)和 12 个月(P=.01,OR 0.58,95%CI 0.38-0.89)时 TH 的风险降低相关。在 3 个月时,研究期间的治疗优化是与超声无反应风险增加相关的唯一独立因素(P=.02,OR 3.34,95%CI 1.18-9.47),而在 12 个月时,疾病持续时间(P=.02,OR 3.03,95%CI 1.15-7.94)。

结论

数据表明,BUS 可用于监测 CD 患者生物制剂诱导的肠道活动改善/缓解。

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