Parecoxib sequential with imrecoxib for occurrence and remission of severe acute pancreatitis: a multicentre, double-blind, randomised, placebo-controlled trial

IF 23 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gut Pub Date : 2025-04-29 DOI:10.1136/gutjnl-2024-334038

Luming Huang, Zhe Feng, Wenjuan Yang, Yin Zhu, Jing Li, Libin Huang, Rui Wang, Lan Peng, Mingshun He, Yingmei Tang, Ping Chen, Cheng Lan, Xiaoqing Zhou, Lin Zhou, Cheng Ye, Linhao Zhang, Jingsun Jiang, Yanting Ye, Rui Wang, Yan He, Yan Liu, Hui Gong, Huifang Xiong, Liang Xia, Haiyan Xu, Bin Zhang, Rongfang Tu, Chun Du, Lujia Cui, Jinhang Gao, Zhiyin Huang, Chengwei Tang

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引用次数: 0

Abstract

Background There is no effective drug treatment for the organ failure (OF) caused by severe acute pancreatitis (SAP). Objective We aimed to evaluate the efficacy of cyclooxygenase-2 inhibitors (COX-2-Is) on the treatment of SAP and its safety. Design In this multicentre, double-blind, randomised, placebo-controlled, investigator-initiated trial, 348 patients with acute pancreatitis aged 18–75 years, <1 week from onset of illness to admission, and Acute Physiology and Chronic Health Evaluation II Score ≥7 or modified Marshall Score ≥2, were randomly assigned (1:1) to the COX-2-Is group (parecoxib sequential with imrecoxib) or the placebo group. SAP occurrence, duration of OF, local complications, clinical outcomes and serum inflammatory mediators were measured. Results Compared with the placebo group, SAP occurrence was reduced by 20.7% (77.6% vs 61.5%, p=0.001) and the persistent OF duration in SAP was shortened by 2 days (p<0.001) after COX-2-Is treatment. For patients enrolled within or after 48 hours from symptom onset, SAP occurrence was reduced by 23.8% (p=0.001) and 8.5% (p=0.202), and the persistent OF duration in SAP was shortened by 3 days (p=0.001) and 2 days (p=0.010) after COX-2-Is treatment, respectively. The occurrence of local complications in the COX-2-Is group was significantly lower than those in the placebo group, 33.7% vs 49.1%, p=0.004. The serum levels of inflammatory mediators and 30-day mortality (from 8.6% to 3.4%) were significantly reduced after COX-2-Is treatment, p<0.05. The incidence of adverse events was similar between the two treatment groups. Conclusion Parecoxib sequential with imrecoxib was effective and well tolerated in reducing the occurrence and duration of SAP and local complications through suppression of systemic inflammatory response, leading to decreased morbidity. Data are available upon reasonable request. Anonymised data can be made available upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place from the corresponding author CT (shcqcdmed@163.com).

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帕瑞昔布序贯联合非瑞昔布治疗严重急性胰腺炎的发生和缓解：一项多中心、双盲、随机、安慰剂对照试验

背景对于严重急性胰腺炎（SAP）引起的器官衰竭（OF），目前尚无有效的药物治疗方法。目的评价环氧化酶-2抑制剂（COX-2-Is）治疗SAP的疗效及安全性。在这项多中心、双盲、随机、安慰剂对照、研究者启动的试验中，348例年龄在18-75岁、从发病到入院<1周、急性生理和慢性健康评估II评分≥7或修改的马歇尔评分≥2的急性胰腺炎患者被随机（1:1）分配到COX-2-Is组（帕瑞昔布序列与非瑞昔布）或安慰剂组。测量SAP的发生、of的持续时间、局部并发症、临床结果和血清炎症介质。结果与安慰剂组相比，COX-2-Is治疗后SAP发生率降低了20.7% (77.6% vs 61.5%, p=0.001)， SAP患者持续OF持续时间缩短了2天（p<0.001）。在症状出现48小时内或48小时后入组的患者中，SAP的发生率分别减少了23.8% （p=0.001）和8.5% (p=0.202)，并且在COX-2-Is治疗后SAP的持续OF持续时间分别缩短了3天（p=0.001）和2天（p=0.010）。COX-2-Is组局部并发症发生率明显低于安慰剂组，分别为33.7%和49.1%,p=0.004。COX-2-Is治疗后血清炎症介质水平和30天死亡率（由8.6%降至3.4%）显著降低，p<0.05。两个治疗组的不良事件发生率相似。结论帕瑞昔布序贯非瑞昔布可通过抑制全身炎症反应减少SAP的发生、持续时间和局部并发症，降低发病率，且耐受性良好。如有合理要求，可提供资料。匿名数据可以在合理的要求下提供，并获得相应的人类研究伦理批准和通信作者CT的数据传输协议（shcqcdmed@163.com）。

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来源期刊

Gut 医学-胃肠肝病学

CiteScore

45.70

自引率

2.40%

发文量

284

审稿时长

1.5 months

期刊介绍： Gut is a renowned international journal specializing in gastroenterology and hepatology, known for its high-quality clinical research covering the alimentary tract, liver, biliary tree, and pancreas. It offers authoritative and current coverage across all aspects of gastroenterology and hepatology, featuring articles on emerging disease mechanisms and innovative diagnostic and therapeutic approaches authored by leading experts. As the flagship journal of BMJ's gastroenterology portfolio, Gut is accompanied by two companion journals: Frontline Gastroenterology, focusing on education and practice-oriented papers, and BMJ Open Gastroenterology for open access original research.