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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.

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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