Immune enhancement in patients with predicted severe acute necrotising pancreatitis: a multicentre double-blind randomised controlled trial

• DOI: 10.1007/s00134-022-06745-7
• Publication Date: 2022-06-17T15:03:40Z
• Authors: Lu Ke; Jing Zhou; Wenjian Mao; Tao Chen; Yin Zhu; Xinting Pan; Hong Mei; Vikesh Singh; James Buxbaum; Gordon Doig; Chengjian He; Weili Gu; Weihua Lu; Shumin Tu; Haibin Ni; Guoxiu Zhang; Xiangyang Zhao; Junli Sun; Weiwei Chen; Jingchun Song; Min Shao; Jianfeng Tu; Liang Xia; Wenhua He; Qingyun Zhu; Kang Li; Hongyi Yao; Jingyi Wu; Long Fu; Wendi Jiang; He Zhang; Jiajia Lin; Baiqiang Li; Zhihui Tong; John Windsor; Yuxiu Liu; Weiqin Li; ; Lu Ke; Jing Zhou; Wenjian Mao; Wendi Jiang; He Zhang; Jiajia Lin; Mingfeng Huang; Longxiang Cao; Mengjie Lu; Yan Chen; Gang Li; Bo Ye; Baiqiang Li; Zhihui Tong; Yuxiu Liu; Weiqin Li; Tao Chen; Fang Shao; Nonghua Lv; Yin Zhu; Liang Xia; Wenhua He; Zhenping Chen; Xinting Pan; Qingyun Zhu; Youdong Wan; Hong Mei; Kang Li; Miao Chen; Chengjian He; Hongyi Yao; Zigui Zhu; Weili Gu; Weihua Lu; Jingyi Wu; Feng Zhou; Shumin Tu; Long Fu; Bing Xue; Haibin Ni; Xiaofei Huang; Dandan Zhou; Guoxiu Zhang; Lening Ren; Dahuan Li; Xiangyang Zhao; Wei Zhao; Xiaomei Chen; Junli Sun; Keke Xin; Weiwei Chen; Qingcheng Xu; Jingchun Song; Qingbo Zeng; Min Shao; Dongsheng Zhao; Jianfeng Tu; Hongguo Yang; Bin Wu; Huaguang Ye; Mingzhi Chen; Yingjie Chen; Mei Yang; Hong Gao; Qiang Li; Lijuan Zhao; Guobing Chen; Yafei Li; Honghai Xia; Dongliang Yang; Shusheng Zhou; Jiyan Lin; Siyao Liu; Donghuang Hong; Songjing Shi; Zuozheng Wang; Weijie Yao; Yi Sun; Kaixiu Qin; Shan Xu; Lei Yu; Feng Guo; Yongjun Lin; Yun Zhou; Qinghai Jiao; Quanxing Feng; Zhiyong Li
• Keywords: Clinical endpoint; Immunosuppression

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.We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms. Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline). The primary outcome was the development of IPN during the index admission.A total of 508 patients were randomised, of whom 254 were assigned to receive Tα1 and 254 placebo. The vast majority of the participants required admission to the intensive care unit (ICU) (479/508, 94.3%). During the index admission, 40/254(15.7%) patients in the Tα1 group developed IPN compared with 46/254 patients (18.1%) in the placebo group (difference -2.4% [95% CI - 7.4 to 5.1%]; p = 0.48). The results were similar across four predefined subgroups. There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15%), bleeding (6.3% vs. 3.5%), and gastrointestinal fistula (2% vs. 2.4%).The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.