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尿肠型脂肪酸结合蛋白诊断结直肠吻合口漏的准确性。

Diagnostic accuracy of urinary intestinal fatty acid binding protein in detecting colorectal anastomotic leakage.

机构信息

Department of Gastrointestinal Surgery, Amsterdam UMC, VU University Medical Center, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.

Department of Pediatric Surgery, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam and VU University Medical Center, Amsterdam, The Netherlands.

出版信息

Tech Coloproctol. 2020 May;24(5):449-454. doi: 10.1007/s10151-020-02163-3. Epub 2020 Feb 27.

Abstract

BACKGROUND

Anastomotic leakage (AL) remains a severe complication following colorectal surgery, having a negative impact on both short- and long-term outcomes. Since timely detection could enable early intervention, there is a need for the development of novel and accurate, preferably, non-invasive markers. The aim of this study was to investigate whether urinary intestinal fatty acid binding protein (I-FABP) could serve as such a marker.

METHODS

This prospective multicenter cross-sectional phase two diagnostic study was conducted at four centers in the Netherlands between March 2015 and November 2016. Urine samples of 15 patients with confirmed colorectal AL and 19 patients without colorectal AL on postoperative day 3 were included. Urinary I-FABP levels were determined using enzyme-linked immunosorbent assays and adjusted for urinary creatinine to compensate for renal dysfunction.

RESULTS

Urinary I-FABP levels were significantly elevated in patients with confirmed AL compared to patients without AL on postoperative day 3 (median: 2.570 ng/ml vs 0.809 ng/ml, p = 0.006). The area under the receiver operating characteristics curve (AUROC) was 0.775, yielding a sensitivity of 80% and specificity of 74% at the optimal cutoff point (> 1.589 ng/ml). This difference remained significant after calculation of I-FABP/creatinine ratios (median: 0.564 ng/µmol vs. 0.158 ng/µmol, p = 0.040), with an AUROC of 0.709, sensitivity of 60% and specificity of 90% at the optimal cutoff point (> 0.469 ng/µmol).

CONCLUSIONS

Levels of urinary I-FABP and urinary I-FABP/creatinine were significantly elevated in patients with confirmed AL following colorectal surgery, suggesting their potential as a non-invasive biomarker for colorectal anastomotic leakage.

摘要

背景

吻合口漏(AL)仍然是结直肠手术后的一种严重并发症,对短期和长期结果都有负面影响。由于及时发现可以进行早期干预,因此需要开发新型的、准确的、最好是无创的标志物。本研究旨在探讨尿肠脂肪酸结合蛋白(I-FABP)是否可以作为此类标志物。

方法

这是一项在荷兰四个中心进行的前瞻性多中心横断面二期诊断研究,于 2015 年 3 月至 2016 年 11 月进行。纳入术后第 3 天有明确结直肠 AL 的 15 例患者和无结直肠 AL 的 19 例患者的尿液样本。使用酶联免疫吸附试验测定尿 I-FABP 水平,并根据尿肌酐进行调整,以补偿肾功能障碍。

结果

术后第 3 天,与无 AL 的患者相比,确诊 AL 的患者尿 I-FABP 水平显著升高(中位数:2.570ng/ml 比 0.809ng/ml,p=0.006)。受试者工作特征曲线下面积(AUROC)为 0.775,最佳截断点(>1.589ng/ml)时的灵敏度为 80%,特异性为 74%。在计算 I-FABP/肌酐比值后,这种差异仍然显著(中位数:0.564ng/µmol 比 0.158ng/µmol,p=0.040),AUROC 为 0.709,最佳截断点(>0.469ng/µmol)时的灵敏度为 60%,特异性为 90%。

结论

结直肠手术后,确诊 AL 的患者尿 I-FABP 和尿 I-FABP/肌酐水平显著升高,提示其作为结直肠吻合口漏无创生物标志物的潜力。

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