乌司他丁对急性主动脉夹层手术中负面炎症反应和器官功能障碍的保护作用：PANDA试验

Protective effect of ulinastatin against negative inflammatory response and organ dysfunction in acute aortic dissection surgery: The PANDA trial.

作者信息

Liu Hong, Qian Si-Chong, Zhu Kai, Diao Yi-Fei, Xu Xiu-Fan, Tang Zhi-Wei, Fan Guo-Liang, Yue Hong-Hua, Chen Jun-Quan, Yang Ji-Nong, Zhang Ying-Yuan, Ma Chao, Liu Xiang, Wu Ying, Wu Zhong, Liu Nan, Li Ao, Ni Bu-Qing, Shao Yong-Feng, Zhao Sheng, Li Hai-Yang, Zhang Hong-Jia

机构信息

Department of Cardiovascular Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.

Department of Cardiovascular Surgery, National Clinical Research Center for Cardiovascular Diseases, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.

出版信息

Cell Rep Med. 2025 Jan 21;6(1):101888. doi: 10.1016/j.xcrm.2024.101888.

DOI:10.1016/j.xcrm.2024.101888

PMID:39842406

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11866440/

Abstract

Ulinastatin is a protease-inhibiting drug with anti-inflammatory and other pharmacological properties. Little is known regarding its role following acute type A aortic dissection (ATAAD) surgery. We perform a randomized controlled trial to investigate the protective effect of ulinastatin against negative inflammatory response and organ dysfunction in ATAAD surgery (PANDA). The primary outcome of mean daily Sequential Organ Failure Assessment (SOFA) score from baseline to 7 days of surgery is 8.80 (SD, 4.11) in the ulinastatin group and 8.61 (SD, 4.47) in the control group (mean difference between groups was 0.04; 95% confidence interval [CI], -0.24 to 0.33; p = 0.765). Systemic inflammatory response syndrome (SIRS) within 7 days of surgery is lower in the ulinastatin group than in the control group (p < 0.001). Additional ulinastatin to standard treatment is likely to reduce SIRS rates instead of preventing organ dysfunction, highlighting the potential importance of the benefits of anti-inflammatory pharmacotherapeutics. The trial is registered on clinicaltrials.org (NCT04711889).

摘要

乌司他丁是一种具有抗炎及其他药理特性的蛋白酶抑制药物。关于其在急性A型主动脉夹层（ATAAD）手术后的作用，目前所知甚少。我们开展了一项随机对照试验，以研究乌司他丁对ATAAD手术中负面炎症反应和器官功能障碍的保护作用（PANDA试验）。在乌司他丁组，从基线至术后7天的每日序贯器官衰竭评估（SOFA）评分均值为8.80（标准差，4.11），对照组为8.61（标准差，4.47）（组间均值差异为0.04；95%置信区间[CI]，-0.24至0.33；p = 0.765）。术后7天内，乌司他丁组的全身炎症反应综合征（SIRS）发生率低于对照组（p < 0.001）。在标准治疗基础上加用乌司他丁可能会降低SIRS发生率，而非预防器官功能障碍，这凸显了抗炎药物治疗益处的潜在重要性。该试验已在clinicaltrials.org上注册（NCT04711889）。