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胸腺肽α1对急性主动脉夹层手术中免疫反应和器官功能的影响:PANDA II试验方案。

Effect of thymosin α1 on Immune response and organ function in acute aortic dissection surgery: PANDA II trial protocol.

作者信息

Liu Hong, Qian Si-Chong, Zhang Ying-Yuan, Tang Cheng-Bin, Yue Hong-Hua, Fan Guo-Liang, Zhao Xin, Jiang Yi-Yao, Huang Fu-Hua, Zeng Zhi-Hua, Wang Wei, Lu Xu-Ran, Luo Xiao-Kang, Bai Xiang-Feng, Zheng Xiang-Xiang, Xie Peng, Ma Chao, Zhao Sheng, Zhang Hong-Jia

机构信息

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

Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.

出版信息

Future Cardiol. 2025 Jun;21(7):447-454. doi: 10.1080/14796678.2025.2505401. Epub 2025 May 14.

DOI:10.1080/14796678.2025.2505401
PMID:40367062
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12143670/
Abstract

This multicenter randomized controlled trial evaluates the efficacy of thymosin alpha 1 (Tα1) supplementation in preventing organ dysfunction following acute type A aortic dissection (ATAAD) repair. Over 330 patients will be equally assigned to receive either Tα1 plus standard care or placebo with standard management. The primary endpoint involves calculating the difference in mean postoperative Sequential Organ Failure Assessment (SOFA) scores between groups, measured daily from postoperative days 7. By targeting post-operative immune system imbalance, this study aims to establish a novel therapeutic approach for reducing systemic inflammatory response syndrome (SIRS)-mediated organ injury and improving long-term outcomes in this high-risk population. Results will be disseminated through peer-reviewed publications and international conferences.: ClinicalTrials.gov Registry (NCT05339529).

摘要

这项多中心随机对照试验评估了补充胸腺肽α1(Tα1)在预防急性A型主动脉夹层(ATAAD)修复术后器官功能障碍方面的疗效。超过330名患者将被平均分配接受Tα1加标准护理或安慰剂加标准管理。主要终点是计算两组术后平均序贯器官衰竭评估(SOFA)评分的差异,从术后第7天开始每天测量。通过针对术后免疫系统失衡,本研究旨在建立一种新的治疗方法,以减少全身炎症反应综合征(SIRS)介导的器官损伤,并改善这一高危人群的长期预后。研究结果将通过同行评审出版物和国际会议进行传播。:ClinicalTrials.gov注册库(NCT05339529)。

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本文引用的文献

1
Protective effect of ulinastatin against negative inflammatory response and organ dysfunction in acute aortic dissection surgery: The PANDA trial.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
Cell Rep Med. 2025 Jan 21;6(1):101888. doi: 10.1016/j.xcrm.2024.101888.
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CD36-mediated ferroptosis destabilizes CD4 T cell homeostasis in acute Stanford type-A aortic dissection.CD36 介导的铁死亡破坏急性斯坦福 A 型主动脉夹层中 CD4 T 细胞的动态平衡。
Cell Death Dis. 2024 Sep 12;15(9):669. doi: 10.1038/s41419-024-07022-9.
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Inflammatory Trajectory and Anti-Inflammatory Pharmacotherapy in Frozen Elephant Trunk-Treated Acute Type I Aortic Dissection.冰冻象鼻术治疗急性I型主动脉夹层的炎症轨迹与抗炎药物治疗
J Soc Cardiovasc Angiogr Interv. 2024 Apr 5;3(7):101935. doi: 10.1016/j.jscai.2024.101935. eCollection 2024 Jul.
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Prognostic implication of residual inflammatory trajectories in acute type I aortic dissection: dual-center prospective cohort study.急性 I 型主动脉夹层残留炎症轨迹的预后意义:双中心前瞻性队列研究。
Int J Surg. 2024 Jun 1;110(6):3346-3356. doi: 10.1097/JS9.0000000000001245.
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Chinese Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Registry protocol: rationale, design and methodology.中国主动脉病和动脉病(5A)注册研究方案:原理、设计与方法。
BMC Cardiovasc Disord. 2024 Feb 21;24(1):120. doi: 10.1186/s12872-024-03760-y.
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The use of alpha 1 thymosin as an immunomodulator of the response against SARS-Cov2.将α1胸腺素用作针对新冠病毒(SARS-CoV2)免疫反应的免疫调节剂。
Immun Ageing. 2023 Jul 5;20(1):32. doi: 10.1186/s12979-023-00351-x.
7
Inflammatory risk stratification individualizes anti-inflammatory pharmacotherapy for acute type A aortic dissection.炎症风险分层使急性A型主动脉夹层的抗炎药物治疗个体化。
Innovation (Camb). 2023 May 25;4(4):100448. doi: 10.1016/j.xinn.2023.100448. eCollection 2023 Jul 10.
8
Thymosin α1 and Its Role in Viral Infectious Diseases: The Mechanism and Clinical Application.胸腺肽 α1 及其在病毒感染性疾病中的作用:机制与临床应用。
Molecules. 2023 Apr 17;28(8):3539. doi: 10.3390/molecules28083539.
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Int Immunopharmacol. 2023 May;118:110055. doi: 10.1016/j.intimp.2023.110055. Epub 2023 Mar 22.
10
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Int Immunopharmacol. 2023 Apr;117:109744. doi: 10.1016/j.intimp.2023.109744. Epub 2023 Feb 20.