期刊论文

Tong, Zhihui;Li, Weiqin

英文

Intensive Care Medicine

0342-4642

2022

48

7

899-909

10.1007/s00134-022-06745-7

This is a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial to assess the efficacy of Tα1 in addition to standard care on the development of IPN in patients with predicted severe ANP. The trial was approved by the local hospital ethics committees of all the participating sites and registered on the ClinicalTrials.gov Registry (NCT02473406) before enrolment commenced. The trial protocol was published in 2020 [], and the full protocol and statistical analysis plan are available in the Supplementary Protocol. This study was funded by the Science and Technology Project of Jiangsu Province of China (no. SBE2016750187) and partly supported by SciClone Pharmaceuticals Holding Limited, which provided trial drugs and support for meetings during the study period. The funders were not involved in the trial's design, data collection, interpretation, or manuscript preparation.

本校为其他机构

Purpose: Infected pancreatic necrosis (IPN) is a highly morbid complication of acute necrotising pancreatitis (ANP). Since there is evidence of early-onset immunosuppression in acute pancreatitis, immune enhancement may be a therapeutic option. This trial aimed to evaluate whether early immune-enhancing Thymosin alpha 1 (Tα1) treatment reduces the incidence of IPN in patients with predicted severe ANP. Methods: We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chr...