Status of clinical research on pancreatic enzyme markers

doi:10.3969/j.issn.1673-8640.2025.09.016

Abstract

Abstract:

The pancreas is one of the important digestive organs in the human body. The enzymes secreted by it can be classified into carbohydrate-degrading enzymes [such as amylase （AMY），maltase]，protein-degrading enzymes （trypsin，elastase，chymotrypsin，carboxypeptidase A，carboxypeptidase B） and fat-degrading enzymes [lipase （LPS），phospholipase A2 （PLA2）]. Currently，pancreatic enzymes like AMY and LPS have been widely used as biomarkers for pancreatic-related diseases in clinical practice. Serum elastase 1 not only has significant reference value for the diagnosis of acute and chronic pancreatitis，but also，when combined with tumor markers，can significantly increase the positive determination rate of early pancreatic cancer （early pancreatic head cancer）. Moreover，elastase 1 in fecal samples can be used as a biomarker for evaluating pancreatic exocrine function. Serum trypsin can be used to predict pancreatitis after endoscopic retrograde cholangiopancreatography （ERCP），and its predictive efficacy is superior to AMY. This review presents the current clinical research status of main pancreatic enzyme markers such as AMY，LPS，trypsin and elastase，and focuses on summarizing the clinical research progress of elastase 1 and trypsin，providing references for clinical diagnosis of pancreatic diseases and assessment of pancreatic exocrine function.

Key words: Pancreatic enzyme marker, Elastase 1, Trypsin, Amylase, Lipase

CLC Number:

R446.1

CHEN Fujun, CHEN Maoming. Status of clinical research on pancreatic enzyme markers[J]. Laboratory Medicine, 2025, 40(9): 918-924.

Figures/Tables 2

References 46

[1]	HALL J E, HALL M E. Guyton and hall textbook of medical physiology [M]. 14th ed. Amsterdam: Elsevier, 2020.
[2]	大塚奈央, 清水京子. 膵炎診断のための生化学検査[J]. 胆と膵, 2019,40:1121-1125.
[3]	清重篤志, 大井幸子, 芳川拓巳, 等. アミラーゼ測定試薬の基質間(G2およびG7)におけるAMY値の特徴とその測定値に大きな乖離を認めた検体について[J]. 医学検査, 2025, 74(2):304-311.
[4]	MOGEKAR S, JAYAKAR S, SRI SAI TEJA SAMPATH K, et al. A study on urinary amylase and serum amylase in diagnosing acute pancreatitis[J]. Cureus, 2024, 16(10):e70809.
[5]	中华医学会外科学分会胰腺外科学组. 中国急性胰腺炎诊治指南(2021)[J]. 中国实用外科杂志, 2021, 41(7):739-746.
[6]	AKINFEMIWA O, ZUBAIR M, MUNIRAJ T. Amylase[EB/OL]. (2023-11-12)[2025-04-22]. https://www.ncbi.nlm.nih.gov/books/NBK557738/.
[7]	ALAYAHYA B, ALASHAIKH A, ALTAWEEL A, et al. The prevalence of simultaneously ordering amylase and lipase for diagnosing pancreatitis[J]. Emerg Med Int, 2023,3988278.
[8]	朱惠云, 杜奕奇, 李兆申. 胰LPS升高的检测及临床意义[J]. 中华胰腺病杂志, 2022, 22(4):317-320.
[9]	ISMAIL O Z, BHAYANA V. Lipase or amylase for the diagnosis of acute pancreatitis?[J]. Clin Biochem, 2017, 50(18):1275-1280. DOI PMID
[10]	杨秋兰, 袁俊蓉. C反应蛋白、血清AMY、LPS在急性胰腺炎患者中的诊断研究[J]. 系统医学, 2024, 9(4):42-44.
[11]	王璐. LPS、AMY、CRP联合检验在急性胰腺炎诊断中的应用效果分析[J]. 中国现代药物应用, 2023, 17(2):34-37.
[12]	OPPENLANDER K E, CHADWICK C, CARMAN K. Acute pancreatitis:rapid evidence review[J]. Am Fam Physician, 2022, 106(1):44-50.
[13]	植田進之介, 牧亜矢子, 久保田芽里, 等. 血中膵酵素測定試薬「リブリア®エラスターゼI」基本性能評価と基準範囲の確認[J]. 医学と薬学, 2024, 81(12):657-664.
[14]	FLAMION B, DELHAYE M, HORANYI Z, et al. Comparison of elastase-1 with amylase,lipase,and trypsin-like immunoreactivity in the diagnosis of acute pancreatitis[J]. Am J Gastroenterol, 1987, 82(6):532-535.
[15]	MORIMOTO T, HIRAI K, FUKUMURA A, et al. Early diagnosis of asparaginase associated pancreatitis based on elevated serum elastase 1 levels:case reports[J]. Biomed Rep, 2013, 1(4):651-653.
[16]	北川元二, 成瀬達, 石黒洋, 等. ラテックス凝集法による血清エラスターゼI測定の臨床的意義[J]. 胆と膵, 2002, 23(6):481-485.
[17]	赵景润, 任晓燕, 连丽, 等. 健康成人粪便弹性蛋白酶-1的分布特征[J]. 中华胰腺病杂志, 2023, 23(6):452-455.
[18]	正宗淳. 慢性膵炎の診断と治療[J]. 日本内科学雑誌, 2022, 112(3):399-405.
[19]	YOKOE M, TAKADA T, MAYUMI T, et al. Japanese guidelines for the management of acute pancreatitis:Japanese Guidelines 2015[J]. J Hepatobiliary Pancreat Sci, 2015, 22(6):405-432.
[20]	日本消化器病学会. 慢性膵炎診療ガイドライン2021[M]. 3版. 东京: 株式会社南江堂, 2021.
[21]	CHI S F, LAI C Y, DONG W T, et al. Establishing the blood reference interval of pancreatic elastase-1:a prospective study[J]. J Gastroenterol Hepatol, 2022, 37(1):117-123.
[22]	SAKAMOTO S, HIRAIDE H, MINODA M, et al. Identification of activity-based biomarkers for early-stage pancreatic tumors in blood using single-molecule enzyme activity screening[J]. Cell Rep Methods, 2024, 4(1):100688.
[23]	日本膵臓学会膵癌診療ガイドライン改訂委員会. 膵癌診療ガイドライン[M]. 东京: 金原出版株式会社, 2022.
[24]	YANG C Y, LIN R T, CHEN C Y, et al. Accuracy of simultaneous measurement of serum biomarkers:carbohydrate antigen 19-9,pancreatic elastase-1,amylase,and lipase for diagnosing pancreatic ductal adenocarcinoma[J]. J Formos Med Assoc, 2022, 121(12):2601-2607.
[25]	RANA S S, DAMBALKAR A, CHHABRA P, et al. Is pancreatic exocrine insufficiency in celiac disease related to structural alterations in pancreatic parenchyma?[J] Ann Gastroenterol, 2016, 29(3):363-366.
[26]	李满平, 吴浩, 邹文斌, 等. 胰弹性蛋白酶1在胰腺外分泌功能不全诊断中的研究进展[J]. 中华胰腺病杂志, 2024, 24(3):230-234.
[27]	STEPHENSON K G, LINGLE A J, BAUMBERGER K A, et al. Changes in fecal elastase-1 following initiation of CFTR modulator therapy in pediatric patients with cystic fibrosis[J]. J Cyst Fibros, 2023, 22(6):996-1001. DOI PMID
[28]	FARRELL P M, ROSENSTEIN B J, WHITE T B, et al. Guidelines for diagnosis of cystic fibrosis in newborns through older adults:cystic fibrosis foundation consensus report[J]. J Pediatr, 2008, 153(2):S4-S14.
[29]	中国医师协会胰腺病专业委员会慢性胰腺炎专委会. 慢性胰腺炎诊治指南(2018,广州)[J]. 中华消化内镜杂志, 2018, 35(11):814-822.
[30]	ANAIZI A, HART P A, CONWELL D L. Diagnosing chronic pancreatitis[J]. Dig Dis Sci, 2017, 62(7):1713-1720.
[31]	GUMMADI V V, GONSKA T. Serum trypsin is a reliable biomarker of pancreas function[J]. Pancreas, 2025, 54(4):e360-e368.
[32]	宮谷博幸, 吉田行雄, 前川瑞穂, 等. ELISA法を用いた血清トリプシン測定の臨床応用[J]. 医学と薬学, 2006, 56(5):771-775.
[33]	植田進之介, 山梨麻由, 牧亜矢子. 血中膵酵素測定試薬「リブリア®トリプシン」の基本性能評価と基準範囲の確認[J]. 医学と薬学, 2020, 77(12):1659-1668.
[34]	楠本聖典, 中井喜貴, 糸川芳男, 等. ERCP前と2時間後の血清アミラーゼ値の比較によるERCP後膵炎の早期予測[J]. 日本消化器病学会雑誌, 2020, 117(9):788-795.
[35]	TAMURA T, ASHIDA R, EMORI T, et al. Serum trypsin as an early predictor of post-endoscopic retrograde cholangiopancreatography pancreatitis[J]. J Hepatobiliary Pancreat Sci, 2024, 31(12):917-925.
[36]	YASUDA H, KATAOKA K, TAKEYAMA Y, et al. Usefulness of urinary trypsinogen-2 and trypsinogen activation peptide in acute pancreatitis:a multicenter study in Japan[J]. World J Gastroenterol, 2019, 25(1):107-117.
[37]	CHEN M, FANG H, WU J, et al. Establishment of trypsinogen-2 amplification luminescent proximity homogeneous assay and its application in acute pancreatitis[J]. J Fluoresc, 2025, 35(7):5355-5366.
[38]	BOXHOORN L, VOERMANS R P, BOUWENSE S A, et al. Acute pancreatitis[J]. Lancet, 2020, 396(10252):726-734. DOI PMID
[39]	HACKERT T, PFEIL D, HARTWIG W, et al. Platelet function in acute experimental pancreatitis[J]. J Gastrointest Surg, 2007, 11(4):439-444. DOI PMID
[40]	MA M, ZHAI C X, SUN C X. Correlations between LP-PLA2 gene polymorphisms and susceptibility and severity of acute pancreatitis in a Chinese population[J]. Genet Test Mol Biomarkers, 2017, 21(4):206-212.
[41]	急性膵炎診療ガイドライン2021改定出版委員会. 急性膵炎診療ガイドライン2021[M]. 5版. 东京: 金原出版株式会社, 2021.
[42]	王丹晨, 侯立安, 邱玲, 等. 4种脂蛋白相关磷脂酶A2活性测定试剂的性能评价[J]. 中华检验医学杂志, 2018, 41(3):208-213.
[43]	CHEN X, ZHOU K, XIANG Z, et al. Establishment and clinical application of time-resolved immunofluorescence assay of lipoprotein-associated phospholipase A2[J]. Anal Biochem, 2022, 648:114674.
[44]	YAMAURA S, SAKASEGAWA S I, KOGUMA E, et al. Novel enzymatic method for assaying Lp-PLA2 in serum[J]. Clin Chim Acta, 2018, 481:184-188.
[45]	MARAVÍ POMA E, LAPLAZA SANTOS C, GORRAIZ LÓPEZ B, et al. Clinical pathways in acute pancreatitis:recommendations for early multidisciplinary management. Scientific Committee of the SEMICYUC. Working group on infectious diseases(GTEI-SEMICYUC)[J]. Med Intensiva, 2012, 36(5):351-357.
[46]	TENNER S, VEGE S S, SHETH S G, et al. American college of gastroenterology guidelines:management of acute pancreatitis[J]. Am J Gastroenterol, 2024, 119(3):419-437.

分类	名称	生理功能
糖类分解酶	AMY	使淀粉转化为糊精和麦芽糖
糖类分解酶	麦芽糖酶	将麦芽糖分解为葡萄糖
蛋白质分解酶	胰蛋白酶	能使蛋白质转化为蛋白胨、氨基酸
	弹性蛋白酶	将弹性纤维的弹性胶原蛋白分解为氨基酸；通过裂解肽键来破坏志贺菌的毒性，切割疏水性氨基酸的C末端
	凝乳蛋白酶	属于水解酶，功能与胰蛋白酶相同，参与蛋白质氨基酸代谢
	羧肽酶A、羧肽酶B	羧肽酶A和羧肽酶B的每个分子均含有锌原子，可特异性水解蛋白质和多肽底物，以及C末端碱性氨基酸氨基端的肽键
脂肪分解酶	LPS	分解脂肪类食物；在小肠内与辅酯酶结合，水解脂肪为脂肪酸
脂肪分解酶	PLA2^①	是催化磷脂甘油分子上二位酰基的水解酶，产生的脂质介质在炎症和组织损伤时的细胞膜通道活化、信息传递、血流动力学和病理生理过程，以及在调节细胞内外代谢中起关键性作用

分类	名称	生理功能
糖类分解酶	AMY	使淀粉转化为糊精和麦芽糖
糖类分解酶	麦芽糖酶	将麦芽糖分解为葡萄糖
蛋白质分解酶	胰蛋白酶	能使蛋白质转化为蛋白胨、氨基酸
	弹性蛋白酶	将弹性纤维的弹性胶原蛋白分解为氨基酸；通过裂解肽键来破坏志贺菌的毒性，切割疏水性氨基酸的C末端
	凝乳蛋白酶	属于水解酶，功能与胰蛋白酶相同，参与蛋白质氨基酸代谢
	羧肽酶A、羧肽酶B	羧肽酶A和羧肽酶B的每个分子均含有锌原子，可特异性水解蛋白质和多肽底物，以及C末端碱性氨基酸氨基端的肽键
脂肪分解酶	LPS	分解脂肪类食物；在小肠内与辅酯酶结合，水解脂肪为脂肪酸
脂肪分解酶	PLA2^①	是催化磷脂甘油分子上二位酰基的水解酶，产生的脂质介质在炎症和组织损伤时的细胞膜通道活化、信息传递、血流动力学和病理生理过程，以及在调节细胞内外代谢中起关键性作用

项目	样本类型	敏感性	急性胰腺炎			慢性胰腺炎（功能不全）	胰腺癌
项目	样本类型	敏感性	早期	中后期	重症预测	慢性胰腺炎（功能不全）	胰腺癌
AMY
唾液AMY	血	一般	☆	×	×	☆	×
胰AMY	血	一般	☆	☆	×	☆	☆
尿AMY	尿液	一般	×	☆	×	×	×
LPS	血	灵敏	☆☆	☆	×	×	☆
胰蛋白酶	血	灵敏	☆☆	☆☆	☆	☆☆	☆
胰蛋白酶原-2	尿液	灵敏	☆	☆	×	×	×
弹性蛋白酶1	血	灵敏	☆	☆☆	×	×	☆☆☆①
弹性蛋白酶1	粪便	灵敏	☆	☆	×	☆☆	☆
PLA2	血	灵敏	☆	☆	☆☆☆	☆	☆

项目	样本类型	敏感性	急性胰腺炎			慢性胰腺炎（功能不全）	胰腺癌
项目	样本类型	敏感性	早期	中后期	重症预测	慢性胰腺炎（功能不全）	胰腺癌
AMY
唾液AMY	血	一般	☆	×	×	☆	×
胰AMY	血	一般	☆	☆	×	☆	☆
尿AMY	尿液	一般	×	☆	×	×	×
LPS	血	灵敏	☆☆	☆	×	×	☆
胰蛋白酶	血	灵敏	☆☆	☆☆	☆	☆☆	☆
胰蛋白酶原-2	尿液	灵敏	☆	☆	×	×	×
弹性蛋白酶1	血	灵敏	☆	☆☆	×	×	☆☆☆①
弹性蛋白酶1	粪便	灵敏	☆	☆	×	☆☆	☆
PLA2	血	灵敏	☆	☆	☆☆☆	☆	☆