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轻症和中度急性胰腺炎患者即刻口服喂养:一项多中心随机对照试验(PADI 试验)。

Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial).

机构信息

General and Digestive Surgery Department, Consorci Sanitari Garraf, Sant Pere de Ribes, Barcelona, Spain.

General and Digestive Surgery Department, Hospital Clínic, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona, Spain.

出版信息

Ann Surg. 2021 Aug 1;274(2):255-263. doi: 10.1097/SLA.0000000000004596.

Abstract

OBJECTIVE

To establish the optimal time to start oral refeeding in mild and moderate acute pancreatitis (AP) to reduce hospital length-of-stay (LOS) and complications.

SUMMARY BACKGROUND DATA

Oral diet is essential in mild and moderate AP. The greatest benefits are obtained if refeeding starts early; however, the definition of "early" remains controversial.

METHODS

This multicenter, randomized, controlled trial (NCT03829085) included patients with a diagnosis of mild or moderate AP admitted consecutively to 4 hospitals from 2017 to 2019. Patients were randomized into 2 treatment groups: immediate oral refeeding (IORF) and conventional oral refeeding (CORF). The IORF group (low-fat-solid diet initiated immediately after hospital admission) was compared to CORF group (progressive oral diet was restarted when clinical and laboratory parameters had improved) in terms of LOS (primary endpoint), pain relapse, diet intolerance, complications, and, hospital costs.

RESULTS

One hundred and thirty one patients were included for randomization. The mean LOS for the IORF and CORF groups was 3.4 (SD ± 1.7) and 8.8 (SD ± 7.9) days, respectively (P < 0.001). In the CORF group alone, pain relapse rate was 16%. There were fewer complications (8% vs 26%) and health costs were twice as low, with a savings of 1325.7€/patient in the IORF than CORF group.

CONCLUSIONS

IORF is safe and feasible in mild and moderate AP, resulting in significantly shorter LOS and cost savings, without causing adverse effects or complications.

摘要

目的

确定轻度和中度急性胰腺炎(AP)开始口服喂养的最佳时间,以减少住院时间(LOS)和并发症。

摘要背景数据

口服饮食对于轻度和中度 AP 至关重要。如果尽早开始喂养,将获得最大的益处;然而,“早期”的定义仍存在争议。

方法

这项多中心、随机、对照试验(NCT03829085)纳入了 2017 年至 2019 年连续入住 4 家医院的轻度或中度 AP 诊断患者。患者被随机分为 2 个治疗组:即刻口服喂养(IORF)和常规口服喂养(CORF)。低脂肪固体饮食在入院后立即开始)与 CORF 组(当临床和实验室参数改善时重新开始逐步口服饮食)相比,在 LOS(主要终点)、疼痛复发、饮食不耐受、并发症和住院费用方面。

结果

131 例患者被纳入随机分组。IORF 和 CORF 组的平均 LOS 分别为 3.4(SD ± 1.7)和 8.8(SD ± 7.9)天,差异有统计学意义(P < 0.001)。仅在 CORF 组中,疼痛复发率为 16%。并发症较少(8% vs 26%),医疗费用降低一倍,与 CORF 组相比,IORF 组每位患者节省 1325.7 欧元。

结论

在轻度和中度 AP 中,IORF 安全且可行,可显著缩短 LOS 并节省成本,且不会引起不良反应或并发症。

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