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静脉注射乌司奴单抗维持治疗克罗恩病的疗效和安全性。

Efficacy and safety of intravenous ustekinumab maintenance therapy in Crohn's disease.

机构信息

Digestive Diseases, Hospital Universitario de Cabueñes, España.

Digestive Diseases, Hospital Universitario de Cabueñes.

出版信息

Rev Esp Enferm Dig. 2023 Jun;115(6):340-341. doi: 10.17235/reed.2023.9594/2023.

Abstract

Crohn's disease is a chronic multifactorial disease for which therapeutic options have expanded in the last decades. However there are still patients who lack or lose response to current standard treatment strategies. A unicentric, retrospective, study was performed in order to evaluate the clinical and biochemical response to intravenous ustekinumab manteinance therapy (IVUMT) in patients with refractory CD. We included 12 patients from our centre who started IVUMT between September 2018 and November 2021. 75% started IV treatment after previous subcutaneous (SC) treatment. At week 8 (n=8), 63% had clinical response, with 25% in clinical remission. At week 16 (n=10), 60% had clinical response, with 50% in clinical remission. At week 26 (n=10), 90% had clinical response, with 60% in clinical remission. At week 52 (n=11), 91% had clinical response, with 64% in clinical remission (Fig. 2). Basal faecal calprotectin (FCP) median level was 684µg/g, with a significant reduction at 52 weeks, with median FCP 97µg/g (p=0,017). Basal C-reactive protein (CRP) median level was 11,6mg/L. A significant reduction was observed at week 26, with median CRP 2,8mg/L (p=0,008); and 52 weeks, with median CRP 2,7 (p=0,013). Average follow-up was 117,1 weeks, average treatment survival was 105,9 weeks. There were no severe adverse events. Our results suggest IVUMT is a safe and effective treatment for most patients with refractory and complex CD and should be considered as an option in selected patients.

摘要

克罗恩病是一种慢性多因素疾病,在过去几十年中,治疗选择已经扩大。然而,仍有一些患者对当前的标准治疗策略缺乏或失去反应。进行了一项单中心、回顾性研究,以评估难治性 CD 患者静脉用乌司奴单抗维持治疗(IVUMT)的临床和生化反应。我们纳入了 2018 年 9 月至 2021 年 11 月期间我们中心开始 IVUMT 的 12 名患者。75%的患者在开始 IV 治疗前接受过皮下(SC)治疗。在第 8 周(n=8),63%的患者有临床反应,其中 25%的患者达到临床缓解。在第 16 周(n=10),60%的患者有临床反应,其中 50%的患者达到临床缓解。在第 26 周(n=10),90%的患者有临床反应,其中 60%的患者达到临床缓解。在第 52 周(n=11),91%的患者有临床反应,其中 64%的患者达到临床缓解(图 2)。基线粪便钙卫蛋白(FCP)中位数为 684µg/g,第 52 周时显著降低,中位数为 97µg/g(p=0.017)。基线 C 反应蛋白(CRP)中位数为 11.6mg/L。第 26 周时观察到显著降低,中位数 CRP 为 2.8mg/L(p=0.008);第 52 周时,中位数 CRP 为 2.7mg/L(p=0.013)。平均随访时间为 117.1 周,平均治疗生存期为 105.9 周。无严重不良事件。我们的结果表明,IVUMT 是治疗难治性和复杂 CD 患者的一种安全有效的治疗方法,应在选择的患者中考虑作为一种选择。

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