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维多珠单抗与非肠道手术术后早期并发症:一项病例匹配分析

Vedolizumab and early postoperative complications in nonintestinal surgery: a case-matched analysis.

作者信息

Kotze Paulo Gustavo, Ma Christopher, Mckenna Nicholas, Almutairdi Abdulelah, Kaplan Gilaad G, Raffals Laura E, Loftus Edward V, Panaccione Remo, Lightner Amy L

机构信息

IBD Outpatient Clinic, Cajuru University Hospital, Catholic University of Paraná (PUCPR), Rua Mauá, 682, Curitiba PR 80030-200, Brazil.

IBD Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Canada.

出版信息

Therap Adv Gastroenterol. 2018 Jun 21;11:1756284818783614. doi: 10.1177/1756284818783614. eCollection 2018.

Abstract

BACKGROUND

Vedolizumab (VDZ) is a gut-specific α4-β7 integrin antagonist that has demonstrated efficacy in Crohn's disease (CD) and ulcerative colitis (UC). The safety of VDZ in the perioperative period remains unclear. The aim of this study was to evaluate postoperative complications and perioperative safety in VDZ-treated patients undergoing nonintestinal operations.

METHODS

A case-matched study was performed at two inflammatory bowel disease (IBD) referral centers. Adult patients with CD and UC who underwent a nonintestinal surgical procedure during treatment with VDZ were included. Patients who had their last VDZ infusion up to 12 weeks before the procedure were considered exposed and were matched in a 1:1 ratio to patients without VDZ therapy, according to type of surgical procedure, age, and sex. The primary outcome was overall risk of early postoperative infectious complications (up to 30 days after surgery), readmissions, reoperations, surgical site infections, and other infections. The VDZ and control groups were subsequently compared using the Pearson χ test and Wilcoxon rank sum.

RESULTS

We identified 34 patients treated with VDZ who underwent 36 nonintestinal surgical procedures. These patients were matched with 36 control procedures. Postoperative complications were not different between the VDZ-treated and control cohorts for all outcomes analyzed: infectious complications occurred in 14% 8% ( = 0.45), superficial surgical site infections 6% 0% ( = 0.15), reoperations 6% 3% ( = 0.56) and readmissions 11% 6% ( = 0.37).

CONCLUSIONS

VDZ-treated patients with IBD undergoing nonintestinal procedures did not have an increased risk of overall postoperative infections or other complications compared with matched controls.

摘要

背景

维多珠单抗(VDZ)是一种肠道特异性α4-β7整合素拮抗剂,已在克罗恩病(CD)和溃疡性结肠炎(UC)中显示出疗效。VDZ在围手术期的安全性尚不清楚。本研究的目的是评估接受非肠道手术的VDZ治疗患者的术后并发症和围手术期安全性。

方法

在两个炎症性肠病(IBD)转诊中心进行了一项病例对照研究。纳入在VDZ治疗期间接受非肠道手术的成年CD和UC患者。在手术前12周内最后一次输注VDZ的患者被视为暴露组,并根据手术类型、年龄和性别以1:1的比例与未接受VDZ治疗的患者进行匹配。主要结局是术后早期感染并发症(术后30天内)、再次入院、再次手术、手术部位感染和其他感染的总体风险。随后使用Pearson χ检验和Wilcoxon秩和检验对VDZ组和对照组进行比较。

结果

我们确定了34例接受VDZ治疗并进行了36例非肠道手术的患者。这些患者与36例对照手术进行了匹配。在分析的所有结局中,VDZ治疗组和对照组的术后并发症无差异:感染并发症发生率为14% 对8%(P = 0.45),浅表手术部位感染发生率为6% 对0%(P = 0.15),再次手术发生率为6% 对3%(P = 0.56),再次入院发生率为11% 对6%(P = 0.37)。

结论

与匹配的对照组相比,接受非肠道手术的IBD患者在接受VDZ治疗后,总体术后感染或其他并发症的风险没有增加。

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