{"title":"口服利福昔明预防重症急性胰腺炎感染胰腺坏死和死亡率的效果：一项开放标签随机对照试验","authors":"Shivam Kalia, Preetam Nath, Anil Chandra Anand, Shivam Gupta, Abhishek Verma, Bipadabhanjan Mallick, Dibyalochan Praharaj, Sarat Chandra Panigrahi, Saroj Kanta Sahu, Suprabhat Giri, Subrat Kumar Acharya","doi":"10.1016/j.pan.2025.09.009","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Infection of pancreatic necrosis is associated with high mortality in patients with acute pancreatitis. Selective gut decontamination may have a favourable impact on outcomes in patients with acute pancreatitis but its efficacy remains unproven. This study aimed to assess the efficacy of rifaximin, a broad-spectrum poorly absorbed oral antibiotic with a highly favourable safety profile in preventing infection of pancreatic necrosis and overall mortality in patients with predicted severe acute pancreatitis.</p><p><strong>Methods: </strong>It was an investigator-initiated open-label randomized controlled trial. Eligible patients hospitalized with predicted severe acute pancreatitis were randomized to standard treatment plus rifaximin 550 mg per oral twice daily for 14 days or standard treatment alone. The primary endpoints of the study were the development of infected pancreatic necrosis and in-hospital mortality.</p><p><strong>Results: </strong>One hundred patients were randomized to standard treatment plus rifaximin versus standard treatment alone. There was no difference in the primary endpoints: incidence of infected pancreatic necrosis (31 versus 35, p = 0.507) and mortality (9 versus 14, p = 0.603) between the two groups. The median length of ICU stay (3 versus 5 days, p = 0.209) and, incidence of organ failure (56 % versus 60 %, p = 0.525), were also similar in the two groups. Patients who received rifaximin had significantly lower median duration of hospitalization (8 days compared to 11.5 days, p = 0.002) than those who did not.</p><p><strong>Conclusion: </strong>Rifaximin did not have a significant effect on either the development of infected pancreatic necrosis or mortality in patients with predicted severe acute pancreatitis. However, the length of hospital stay was significantly shorter in the rifaximin group.</p><p><strong>Clinical trial registration: </strong>This study has been registered in India's clinical trial registry under the registration number CTRI/2020/02/023459).</p>","PeriodicalId":19976,"journal":{"name":"Pancreatology","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of oral rifaximin for prevention of infected pancreatic necrosis and mortality in severe acute pancreatitis: An open-label randomized controlled trial.\",\"authors\":\"Shivam Kalia, Preetam Nath, Anil Chandra Anand, Shivam Gupta, Abhishek Verma, Bipadabhanjan Mallick, Dibyalochan Praharaj, Sarat Chandra Panigrahi, Saroj Kanta Sahu, Suprabhat Giri, Subrat Kumar Acharya\",\"doi\":\"10.1016/j.pan.2025.09.009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Infection of pancreatic necrosis is associated with high mortality in patients with acute pancreatitis. 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There was no difference in the primary endpoints: incidence of infected pancreatic necrosis (31 versus 35, p = 0.507) and mortality (9 versus 14, p = 0.603) between the two groups. The median length of ICU stay (3 versus 5 days, p = 0.209) and, incidence of organ failure (56 % versus 60 %, p = 0.525), were also similar in the two groups. Patients who received rifaximin had significantly lower median duration of hospitalization (8 days compared to 11.5 days, p = 0.002) than those who did not.</p><p><strong>Conclusion: </strong>Rifaximin did not have a significant effect on either the development of infected pancreatic necrosis or mortality in patients with predicted severe acute pancreatitis. 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引用次数: 0
摘要
在急性胰腺炎患者中，胰腺坏死感染与高死亡率相关。选择性肠道净化可能对急性胰腺炎患者的预后有有利影响，但其疗效尚未得到证实。本研究旨在评估利福昔明的疗效，利福昔明是一种广谱吸收差的口服抗生素，在预防预测的严重急性胰腺炎患者的胰腺坏死感染和总死亡率方面具有高度有利的安全性。方法：这是一项研究者发起的开放标签随机对照试验。预测严重急性胰腺炎住院的符合条件的患者随机接受标准治疗加利福昔明550 mg /次口服，每天两次，持续14天或单独接受标准治疗。该研究的主要终点是感染性胰腺坏死的发展和住院死亡率。结果：100例患者随机分为标准治疗加利福昔明组和单独标准治疗组。两组的主要终点无差异：感染性胰腺坏死发生率（31 vs 35, p = 0.507）和死亡率（9 vs 14, p = 0.603）。两组患者在ICU的中位住院时间（3天对5天，p = 0.209）和器官衰竭发生率（56%对60%，p = 0.525）也相似。接受利福昔明治疗的患者的中位住院时间显著低于未接受利福昔明治疗的患者（8天比11.5天，p = 0.002）。结论：利福昔明对预测的严重急性胰腺炎患者感染性胰腺坏死的发展和死亡率均无显著影响。然而，利福昔明组的住院时间明显缩短。临床试验注册：本研究已在印度临床试验注册中心注册，注册号为CTRI/2020/02/023459)。
Effect of oral rifaximin for prevention of infected pancreatic necrosis and mortality in severe acute pancreatitis: An open-label randomized controlled trial.
Introduction: Infection of pancreatic necrosis is associated with high mortality in patients with acute pancreatitis. Selective gut decontamination may have a favourable impact on outcomes in patients with acute pancreatitis but its efficacy remains unproven. This study aimed to assess the efficacy of rifaximin, a broad-spectrum poorly absorbed oral antibiotic with a highly favourable safety profile in preventing infection of pancreatic necrosis and overall mortality in patients with predicted severe acute pancreatitis.
Methods: It was an investigator-initiated open-label randomized controlled trial. Eligible patients hospitalized with predicted severe acute pancreatitis were randomized to standard treatment plus rifaximin 550 mg per oral twice daily for 14 days or standard treatment alone. The primary endpoints of the study were the development of infected pancreatic necrosis and in-hospital mortality.
Results: One hundred patients were randomized to standard treatment plus rifaximin versus standard treatment alone. There was no difference in the primary endpoints: incidence of infected pancreatic necrosis (31 versus 35, p = 0.507) and mortality (9 versus 14, p = 0.603) between the two groups. The median length of ICU stay (3 versus 5 days, p = 0.209) and, incidence of organ failure (56 % versus 60 %, p = 0.525), were also similar in the two groups. Patients who received rifaximin had significantly lower median duration of hospitalization (8 days compared to 11.5 days, p = 0.002) than those who did not.
Conclusion: Rifaximin did not have a significant effect on either the development of infected pancreatic necrosis or mortality in patients with predicted severe acute pancreatitis. However, the length of hospital stay was significantly shorter in the rifaximin group.
Clinical trial registration: This study has been registered in India's clinical trial registry under the registration number CTRI/2020/02/023459).
期刊介绍：
Pancreatology is the official journal of the International Association of Pancreatology (IAP), the European Pancreatic Club (EPC) and several national societies and study groups around the world. Dedicated to the understanding and treatment of exocrine as well as endocrine pancreatic disease, this multidisciplinary periodical publishes original basic, translational and clinical pancreatic research from a range of fields including gastroenterology, oncology, surgery, pharmacology, cellular and molecular biology as well as endocrinology, immunology and epidemiology. Readers can expect to gain new insights into pancreatic physiology and into the pathogenesis, diagnosis, therapeutic approaches and prognosis of pancreatic diseases. The journal features original articles, case reports, consensus guidelines and topical, cutting edge reviews, thus representing a source of valuable, novel information for clinical and basic researchers alike.
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