Kadaj-Lipka Roland, Monica Magdalena, Stożek-Tutro Anita, Ryś Przemysław, Rydzewska Grażyna
Department of Gastroenterology and Internal Medicine, National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland.
HTA Consulting, Kraków, Poland.
Dig Dis Sci. 2025 Apr 1. doi: 10.1007/s10620-025-09011-0.
Pancreatic exocrine insufficiency (PEI) results from impaired exocrine function of the pancreas, causing distressing symptoms like steatorrhea, diarrhea, abdominal distention, bloating, and pain. Treatment involves pancreatic enzyme replacement therapy (PERT), yet compliance with clinical guidelines and its real-world effectiveness are unclear. This systematic review aimed to assess the concordance between real-world PERT doses and clinical guidelines and to evaluate the effectiveness of PERT doses, considering their average administration.
A systematic search of MEDLINE and EMBASE up to June 2023 identified observational studies reporting PERT doses and their effects on diarrhea and nutrition in PEI patients. Studies were classified based on adherence to current clinical guidelines for PERT dosing.
Twenty-five observational studies involving 3818 patients met the inclusion criteria. In 40% of the studies, average PERT doses were lower than the recommended 40,000-50,000 lipase units (LU) per meal. Significant alleviation of diarrhea was observed in nearly all studies with lower-than-recommended doses, but none showed benefits in nutritional status. PERT doses compliant with guidelines helped reduce diarrhea in most studies and improved or maintained nutritional status.
This review revealed that real-world PERT doses were lower than European guidelines in 40% of studies. While lower doses alleviated gastrointestinal symptoms, they were insufficient for maintaining normal nutritional status. Therefore, PERT dosing should aim for nutritional improvement by adhering to guideline-recommended doses. Individualized dosing, considering both symptom management and nutritional status, is essential due to varying responses to treatment.
胰腺外分泌功能不全（PEI）是由胰腺外分泌功能受损引起的，会导致诸如脂肪泻、腹泻、腹胀、肠胃气胀和疼痛等令人痛苦的症状。治疗方法包括胰腺酶替代疗法（PERT），但临床指南的依从性及其在现实世界中的有效性尚不清楚。本系统评价旨在评估现实世界中PERT剂量与临床指南之间的一致性，并考虑其平均给药情况来评估PERT剂量的有效性。
对截至2023年6月的MEDLINE和EMBASE进行系统检索，以确定报告PERT剂量及其对PEI患者腹泻和营养影响的观察性研究。根据对当前PERT给药临床指南的依从性对研究进行分类。
25项涉及3818名患者的观察性研究符合纳入标准。在40%的研究中，平均PERT剂量低于每餐推荐的40000-50000脂肪酶单位（LU）。在几乎所有剂量低于推荐剂量的研究中都观察到腹泻有显著缓解，但没有一项研究显示对营养状况有改善。符合指南的PERT剂量在大多数研究中有助于减少腹泻，并改善或维持营养状况。
本综述显示，在40%的研究中，现实世界中的PERT剂量低于欧洲指南。虽然较低剂量缓解了胃肠道症状，但不足以维持正常营养状况。因此，PERT给药应遵循指南推荐剂量，以实现营养改善。由于对治疗的反应各不相同，考虑症状管理和营养状况的个体化给药至关重要。
