The results of severe acute pancreatitis treatment with continuous regional arterial infusion of protease inhibitor and antibiotic: a randomized controlled study.

摘要

OBJECTIVES: A randomized controlled trial was conducted to clarify whether continuous regional arterial infusion (CRAI) of protease inhibitor and antibiotic could reduce mortality rate of severe acute pancreatitis (SAP). METHODS: Seventy-eight patients with SAP were included in the study. Thirty-nine patients were treated with CRAI, 31 patients completed the study; and another group of 39 patients was treated without CRAI therapy. Groups were well matched in clinical characteristics. The CRAI patients were treated continuously with nafamostat mesylate 240 mg/d and imipenem 1 g/d for 5 days via one of the arteries perfusing the pancreas. Later, imipenem was given intravenously (0.5 g every 8 hours) for 9 days. The non-CRAI patients received imipenem (0.5 g every 8 hours) intravenously for 14 days. Statistical analysis of the intention-to-treat (ITT) group was performed. RESULTS: Lack of septic complications was observed in 23 patients with CRAI therapy and 20 non-CRAI patients (not significant). The additional antibiotics were applied in 8 of CRAI patients and in 18 non-CRAI (ITT, P = 0.02). Mortality rate was 5.1% in CRAI and 23.1% in non-CRAI group (ITT, P = 0.02). Urgent surgical intervention was necessary in 10.3% CRAI patients and in 33.3% non-CRAI (ITT, P = 0.01). CONCLUSIONS: The results show that CRAI of protease inhibitor and antibiotic is effective in preventing complications and in reducing mortality rate in SAP.