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胰腺外分泌功能不全诊断和治疗相关用药研究进展

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目的 为胰腺外分泌功能不全(PEI)的诊断和胰酶替代治疗(PERT)提供参考。方法 检索PubMed、中国知网、万方数据库2009 年 1 月至 2022 年 6 月的PEI相关文献,分析PEI的流行病学与病因、临床特点、诊断及外分泌功能评估方法、PERT治疗时机与用药选择,总结已批准上市的胰酶制剂及其成分和使用注意事项。结果 胰腺的分泌功能受神经和激素两方面调节,PEI发生机制包括胰腺实质丧失、胰腺分泌抑制或失活和术后胰腺分泌不协调,成人常见病因为慢性胰腺炎和胰腺癌,儿童为囊性纤维化。PEI诊断的"金标准"是 72h粪便脂肪测试,但已逐渐被粪便弹性蛋白酶 1(FE-1)检测取代,且需运用多学科方法评估胰腺外分泌功能。PERT为相关诊疗规范推荐的PEI首选治疗方案,可显著提高患者的生存率和生活质量。美国、中国、英国及欧盟批准上市的常用胰酶制剂共有 18 种,其中我国有 8 种(国产 5 种,进口 3 种),以释放稳定、对酸稳定性高、可高剂量使用的肠涂层制剂为首选。涉及胰酶与其他药物相互作用的文献较少,临床用药中应予以关注。结论 开发更精准的PEI诊断方法,以及作用更稳定持久的胰酶制剂,对于PEI的治疗有重要意义。该研究加深了对PEI的认知,完善了临床诊疗方案,推进了PERT药物的利用,可为临床个体化用药提供参考。
Research Progress in the Diagnosis and Treatment Drugs of Pancreatic Exocrine Insufficiency
Objective To provide a reference for the diagnosis of pancreatic exocrine insufficiency(PEI)and pancreatic enzyme replacement therapy(PERT).Methods The PEI-related studies in the PubMed,CNKI and WanFang databases from January 2009 to June 2022 were searched to analyze the epidemiological characteristics,etiology,clinical characteristics,diagnosis of PEI,exocrine function evaluation methods,the treatment timing and medication selection of PERT.The approved pancreatic enzyme preparations,relevant ingredients and the attentions for their use were summarized.Results The secretion function of the pancreas was regulated by nerves and hormones.The mechanisms of PEI included loss of pancreatic parenchyma,inhibition or inactivation of pancreatic secretion function and imbalance of postoperative pancreatic secretion function.The common etiologies of PEI were chronic pancreatitis and pancreatic cancer in adults,and cystic fibrosis in children.The gold standard for PEI diagnosis was the 72-hour fecal fat test,but it had gradually been replaced by the fecal elastase-1(FE-1)test,and the pancreatic exocrine function was evaluated by multidisciplinary methods.PERT was the preferred option for PEI recommended by relevant diagnostic and treatment standards,which can significantly improve the survival rate and quality of life of patients.A total of 18 commonly-used pancreatic enzyme preparations were approved by the United States,China,the United Kingdom and the European Union,including eight in China(five domestic and three imported drugs),in which the intestinal coating preparations with stable release,high stability to acids and ability to be used at high doses were the preferred drugs.There were limited studies involving the interaction between pancreatic enzymes and other drugs,which should be given attention in clinical medication.Conclusion Developing more accurate diagnostic methods for PEI and more stable and long-acting pancreatic enzyme preparations is of great significance for the treatment of PEI.This study expands the knowledge of PEI,improves clinical diagnosis and treatment regimens,promotes the utilization of PERT drugs,which can provide a reference for individualized clinical medication.

pancreatic exocrine insufficiencydiagnostic methodpancreatic enzyme replacement therapypancreatic enzyme preparationintestinal coating preparation

郑云华、仇滔、黄玥、张丽娜、陈俐

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西南交通大学附属医院·四川省成都市第三人民医院,四川 成都 610014

中国人民解放军西部战区总医院,四川 成都 610083

胰腺外分泌功能不全 诊断方法 胰酶替代治疗 胰酶制剂 肠涂层制剂

四川省卫生计生委科研项目四川省医院协会医院管理科研专项四川省成都市第三人民医院院内科研项目

18PJ392YG2342CSY-YN-01-2023-052

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(12)