Your browser doesn't support javascript.
loading
Immune enhancement in patients with predicted severe acute necrotising pancreatitis: a multicentre double-blind randomised controlled trial.
Ke, Lu; Zhou, Jing; Mao, Wenjian; Chen, Tao; Zhu, Yin; Pan, Xinting; Mei, Hong; Singh, Vikesh; Buxbaum, James; Doig, Gordon; He, Chengjian; Gu, Weili; Lu, Weihua; Tu, Shumin; Ni, Haibin; Zhang, Guoxiu; Zhao, Xiangyang; Sun, Junli; Chen, Weiwei; Song, Jingchun; Shao, Min; Tu, Jianfeng; Xia, Liang; He, Wenhua; Zhu, Qingyun; Li, Kang; Yao, Hongyi; Wu, Jingyi; Fu, Long; Jiang, Wendi; Zhang, He; Lin, Jiajia; Li, Baiqiang; Tong, Zhihui; Windsor, John; Liu, Yuxiu; Li, Weiqin.
Afiliación
  • Ke L; Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
  • Zhou J; National Institute of Healthcare Data Science, Nanjing University, Nanjing, 210010, Jiangsu, China.
  • Mao W; Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
  • Chen T; Department of Critical Care Medicine, Jinling Hospital, Nanjing Medical University, Nanjing, 210010, Jiangsu, China.
  • Zhu Y; Department of Critical Care Medicine, Jinling Hospital, Nanjing Medical University, Nanjing, 210010, Jiangsu, China.
  • Pan X; Department of Public Health, Policy and Systems, Institute of Population Health, Whelan Building, Quadrangle, The University of Liverpool, Liverpool, L69 3GB, UK.
  • Mei H; Pancreatic Disease Centre, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.
  • Singh V; Department of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, 266000, Shandong, China.
  • Buxbaum J; Department of Critical Care Medicine, The Affiliated Hospital of Zunyi Medical University, Zunyi, 536000, Guizhou, China.
  • Doig G; Pancreatitis Centre, Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
  • He C; Division of Gastroenterology, Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, USA.
  • Gu W; Northern Clinical School, Royal, North Shore Hospital, University of Sydney, Sydney, Australia.
  • Lu W; Department of Critical Care Medicine, the Affiliated Nanhua Hospital, University of South China, Hengyang, 421002, Hunan, China.
  • Tu S; Department of Critical Care Medicine, Affiliated Hospital 2 of Nantong University, Nantong, 226000, Jiangsu, China.
  • Ni H; Department of Intensive Care Unit, The First Affiliated Hospital of Wannan Medical College, Wuhu, 241001, Anhui, China.
  • Zhang G; Department of Emergency Medicine, Shangqiu First People's Hospital, Shangqiu, 476000, Henan, China.
  • Zhao X; Department of Emergency Medicine, Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine, Nanjing, 210010, Jiangsu, China.
  • Sun J; Department of Emergency Medicine, The First Affiliated Hospital and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, 471003, Henan, China.
  • Chen W; Department of Intensive Care Unit, Qilu Hospital of Shandong University, Qingdao, 266000, Shandong, China.
  • Song J; Department of Intensive Care Unit, Luoyang Central Hospital, Zhengzhou University, Luoyang, 471100, Henan, China.
  • Shao M; Department of Gastroenterology, Clinical Medical College, Yangzhou University, Yangzhou, Jiangsu, China.
  • Tu J; Department of Critical Care Medicine, 94Th Hospital of PLA, Nanchang, 330006, Jiangxi, China.
  • Xia L; Department of Intensive Care Unit, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, Anhui, China.
  • He W; Department of Emergency Medicine, Zhejiang Provincial People's Hospital, Hangzhou, 310014, Zhejiang, China.
  • Zhu Q; Pancreatic Disease Centre, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.
  • Li K; Pancreatic Disease Centre, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.
  • Yao H; Department of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, 266000, Shandong, China.
  • Wu J; Department of Critical Care Medicine, The Affiliated Hospital of Zunyi Medical University, Zunyi, 536000, Guizhou, China.
  • Fu L; Department of Critical Care Medicine, the Affiliated Nanhua Hospital, University of South China, Hengyang, 421002, Hunan, China.
  • Jiang W; Department of Intensive Care Unit, The First Affiliated Hospital of Wannan Medical College, Wuhu, 241001, Anhui, China.
  • Zhang H; Department of Emergency Medicine, Shangqiu First People's Hospital, Shangqiu, 476000, Henan, China.
  • Lin J; Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
  • Li B; Department of Critical Care Medicine, Jinling Hospital, Medical School of Southeast University, Nanjing, 210002, Jiangsu, China.
  • Tong Z; Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
  • Windsor J; Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
  • Liu Y; Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China. njzyantol@aliyun.com.
  • Li W; Surgical and Translational Research Centre, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1142, New Zealand.
Intensive Care Med ; 48(7): 899-909, 2022 07.
Article en En | MEDLINE | ID: mdl-35713670
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 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. RESULTS: 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%). CONCLUSION: The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pancreatitis Aguda Necrotizante Tipo de estudio: Clinical_trials / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Intensive Care Med Año: 2022 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pancreatitis Aguda Necrotizante Tipo de estudio: Clinical_trials / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Intensive Care Med Año: 2022 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos