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在接受 vedolizumab 与其他生物制剂治疗后行炎性肠病手术的患者中,术后结局的病例对照比较。

Case-matched Comparison of Postoperative Outcomes Following Surgery for Inflammatory Bowel Disease After Exposure to Vedolizumab vs Other Biologics.

机构信息

Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA.

出版信息

J Crohns Colitis. 2020 Feb 10;14(2):185-191. doi: 10.1093/ecco-jcc/jjz129.

Abstract

BACKGROUND AND AIM

The effects of vedolizumab [VEDO] exposure on perioperative outcomes following surgery for inflammatory bowel disease [IBD] remain controversial. The aim of our study was to compare postoperative morbidity of IBD surgery following treatment with VEDO vs other biologics or no biologics.

METHODS

An institutional review board-approved, prospectively collected database was queried to identify all patients undergoing abdominal surgery for IBD between August 2012 and May 2017. The impact of VEDO within 12 weeks preoperatively on postoperative morbidity was initially assessed with univariate and multivariable analyses on all patients. A case-matched analysis was then carried out comparing patients exposed to VEDO vs other biologic agents, based on gender, age ± 5 years, diagnosis, date of surgery ± 2 years, and surgical procedure.

RESULTS

Out of 980 patients, 141 received VEDO. The majority of patients [59%] underwent surgery involving end or diverting ostomy creation. The initial multivariate analysis conducted on all patients indicated that VEDO use was independently associated with increased overall morbidity [p <0.001], but not infectious morbidity [p = 0.30]. However, the case-matched comparison of 95 VEDO-treated patients vs 95 patients treated with adalimumab or infliximab did not indicate any difference in overall morbidity [p = 0.32], infectious complications [p = 0.15], or surgical site infections [p = 0.12].

CONCLUSIONS

In a study population having a high rate of surgery involving ostomy creation, the exposure to preoperative VEDO was not associated with an increased morbidity rate when compared with other biologics.

摘要

背景与目的

维得利珠单抗[VEDO]暴露对炎症性肠病[IBD]手术后围手术期结局的影响仍存在争议。本研究的目的是比较接受 VEDO 治疗与其他生物制剂或无生物制剂治疗后 IBD 手术的术后发病率。

方法

通过机构审查委员会批准的前瞻性收集数据库,检索 2012 年 8 月至 2017 年 5 月期间所有接受腹部 IBD 手术的患者。首先通过单变量和多变量分析对所有患者进行了术前 12 周内 VEDO 对术后发病率影响的评估。然后,根据性别、年龄±5 岁、诊断、手术日期±2 年和手术方式,对接受 VEDO 与其他生物制剂的患者进行病例匹配分析。

结果

在 980 例患者中,有 141 例接受了 VEDO。大多数患者[59%]接受了涉及末端或转流造口术的手术。对所有患者进行的初始多变量分析表明,VEDO 的使用与总发病率增加独立相关[P<0.001],但与感染发病率无关[P=0.30]。然而,对 95 例接受 VEDO 治疗的患者与 95 例接受阿达木单抗或英夫利昔单抗治疗的患者进行的病例匹配比较并未表明总发病率[P=0.32]、感染并发症[P=0.15]或手术部位感染[P=0.12]有差异。

结论

在一个具有高造口术手术率的研究人群中,与其他生物制剂相比,术前接受 VEDO 暴露与发病率增加无关。

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