分析基于ClinicalTrials.gov数据库的MASLD干预性临床试验登记
Hui Du1, Jihan Huang2, Youhua Wang1
1Department of Infectious, Longhua Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, #725 Wanping South Road, Xuhui District, Shanghai, 200032, People's Republic of China.
BMC gastroenterology
|March 7, 2025
概括
这项研究分析了与代谢功能障碍相关的脂肪性肝病 (MASLD) 临床试验. 目前的研究重点是针对炎症和新陈代谢的药物干预,为未来的MASLD治疗开发提供了洞察力.
科学领域:
- 肝病学和临床试验设计
- 药理学研究和药物开发
背景情况:
- 与代谢功能障碍相关的脂肪性肝病 (MASLD) 发病率在全球范围内正在上升.
- 目前正在进行广泛的药物研究和临床试验,以开发MASLD疗法.
研究的目的:
- 检查MASLD疗法的设计原则和研究目标.
- 为临床试验参与者和MASLD研究中的决策者提供指导.
主要方法:
- 在clinicaltrials.gov的系统搜索中,发现了1209个针对MASLD的干预性临床试验.
- 根据临床阶段,设计,干预和结果指标来评估试验.
主要成果:
- 关于MASLD的研究显著增加,在2013-2024年期间注册了83.54%的试验.
- 平行设计 (72.21%) 主导着MASLD试验,主要结局包括组织学改善,脂肪含量和不良事件.
- 药物干预侧重于代谢/能量平衡,炎症和脂质减少,针对PPAR,FXR,ACC和GLP-1.
结论:
- 全球MASLD临床试验主要以药物为重点.
- 针对炎症和代谢途径的干预仍然是MASLD药物开发的主要策略.
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