Traditional Chinese medicine Chaiqinchengqi decoction for patients with acute pancreatitis: A randomized clinical trial

作者：Lihui Deng, Zhiyao Chen, Tao Jin, Fei Cai, Yanqiu He, Yuxin Shen, Shihang Zhang, Jia Guo, Xiaonan Yang, Lin Yang, Huimin Lü, Chunhui Wang, Wen-Fu Tang, Ziqi Lin, Lan Li, Qingyuan Tan, Ping Zhu, Xiaoxin Zhang, Na Shi, Cheng Hu, Zixing Huang, Dan Du, Wei Huang, Zhongwei Zhang, Shu Zhang, Qing Xia · 发表于：Phytomedicine · 年份：2025 · DOI：10.1016/j.phymed.2025.156393 · 被引用次数：14 · 研究领域：Pancreatitis Pathology and Treatment、Sepsis Diagnosis and Treatment、Pancreatic and Hepatic Oncology Research

BACKGROUND: Chaiqinchengqi decoction, a traditional Chinese medicine, has shown promising effects in in vitro, animal and preliminary small human studies for acute pancreatitis, but evidence of clinical practice is limited. PURPOSE: To investigate whether Chaiqinchengqi decoction could improve clinical outcomes in patients with acute pancreatitis. STUDY DESIGN: Prospective, pragmatic, randomized controlled trial. (Chictr.org.cn registration number: ChiCTR2000034325) METHODS: This trial was conducted at West China Hospital of Sichuan University, China. Patients with acute pancreatitis were randomly assigned to receive either Chaiqinchengqi decoction or placebo by oral and rectal enemas in addition to guideline-directed administrations using a 1:1 ratio. The intervention of Chaiqinchengqi and placebo was determined by the grading of acute gastrointestinal injury. Patients were assessed within 24 and 48 hours, and on 3, 5, and 7 days after admission, or organ failure normalized. Survivors were followed up at 1, 3, and 6 months after discharge. Primary outcome was the duration of respiratory failure to 28 days after enrollment. Secondary outcomes included other organ failure, local complications, 6-month all-cause mortality, inflammatory indicators, and related interventions. RESULTS: Among 248 patients enrolled, Chaiqinchengqi decoction shortened the duration of respiratory failure compared with the placebo (median [IQR], 1.0 [0.0 to 5.0] vs 3.0 [1.0-8.0] days; median difference...