慢性胰腺炎中外分泌性胰腺功能不全的诊断：C-混合甘油三酯呼气试验与粪便弹性蛋白酶的比较

Diagnosis of exocrine pancreatic insufficiency in chronic pancreatitis: C-Mixed Triglyceride Breath Test versus Fecal Elastase.

作者信息

González-Sánchez Víctor, Amrani Rahma, González Victoria, Trigo Celia, Picó Antonio, de-Madaria Enrique

机构信息

Sección de Endocrinología y Nutrición, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-Fundación FISABIO), Alicante, Spain.

Servicio de Análisis Clínicos, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-Fundación FISABIO), Alicante, Spain.

出版信息

Pancreatology. 2017 Jul-Aug;17(4):580-585. doi: 10.1016/j.pan.2017.03.002. Epub 2017 Mar 6.

DOI:10.1016/j.pan.2017.03.002

PMID:28291656

Abstract

BACKGROUND

Pancreatic enzyme replacement therapy (PERT) is indicated in case of clinically relevant exocrine pancreatic insufficiency (EPI). Clinical trials addressing PERT have used the coefficient of fat absorption (CFA) to define EPI but this test is cumbersome to perform. Our aim was to compare two easier-to-perform tests to detect clinically relevant EPI: Fecal Elastase-1 (FE-1) and C-Mixed Triglyceride Breath Test (TGBT).

METHODS

We prospectively included 54 patients with chronic pancreatitis (CP), 24.1% operated, 29.6% had EPI. EPI was defined as a CFA <93%. The sensitivity (Se), specificity (Sp), positive (PPV) and negative (NPV) predictive values for different cut-offs of FE-1 and TGBT were calculated.

RESULTS

The area under the ROC curve for FE-1/TGBT was 0.861/0.876 for the global sample, 0.842/0.794 for non-operated patients and 0.917/1 for operated patients respectively. Se, Sp, PPV and NPV for a cut-off of FE-1 <200 μg/g were 93.8%, 63.2%, 51.7% and 96% respectively. The best cut-off point for FE-1 was 84 μg/g, which yielded an 87.5% Se, 81.6% Sp, 66.7% PPV and 93.9% NPV. The same parameters for a TGBT <29% were 81.3%, 84.2%, 68.4% and 91.4% respectively. The best cut-off point for TGBT was <23%, which yielded an 81.3% Se, 94.7% Sp, 86.7% PPV and 92.3% NPV. Diabetes was associated to decreased FE-1 levels, even in multivariate analysis.

CONCLUSIONS

FE-1 and TGBT showed similar results for the diagnosis of EPI in CP. In non-operated CP patients, TGBT does not offer any advantage to FE-1 but in operated CP patients TGBT seems a more accurate test.

摘要

背景

临床相关的外分泌性胰腺功能不全（EPI）患者需进行胰酶替代疗法（PERT）。针对PERT的临床试验采用脂肪吸收系数（CFA）来定义EPI，但该检测操作繁琐。我们的目的是比较两种更易于实施的检测方法，以检测临床相关的EPI：粪便弹性蛋白酶-1（FE-1）和C-混合甘油三酯呼气试验（TGBT）。

方法

我们前瞻性纳入了54例慢性胰腺炎（CP）患者；其中24.1%接受过手术，29.6%存在EPI。EPI定义为CFA<93%。计算了FE-1和TGBT不同临界值的敏感性（Se）、特异性（Sp）、阳性预测值（PPV）和阴性预测值（NPV）。

结果

FE-1/TGBT的受试者工作特征曲线下面积在总体样本中分别为0.861/0.876，未接受手术患者中为0.842/0.794，接受手术患者中为0.917/1。FE-1临界值<200μg/g时的Se、Sp、PPV和NPV分别为93.8%、63.2%、51.7%和96%。FE-1的最佳临界值为84μg/g，其Se为87.5%，Sp为81.6%，PPV为66.7%，NPV为93.9%。TGBT<29%时的相同参数分别为81.3%、84.2%、68.4%和91.4%。TGBT的最佳临界值<23%，其Se为81.3%，Sp为94.7%，PPV为86.7%，NPV为92.3%。糖尿病与FE-1水平降低相关，即使在多因素分析中也是如此。