Deng Lihui, Chen Zhiyao, Jin Tao, Cai Fei, He Yanqiu, Shen Yuxin, Zhang Shihang, Guo Jia, Yang Xiaonan, Yang Lin, Lu Huimin, Wang Chunhui, Tang Wenfu, Lin Ziqi, Li Lan, Tan Qingyuan, Zhu Ping, Zhang Xiaoxin, Shi Na, Hu Cheng, Huang Zixing, Du Dan, Huang Wei, Zhang Zhongwei, Zhang Shu, Xia Qing
West China Centre of Excellence for Pancreatitis, Institute of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, PR China..
Department of Clinical Pharmacology, West China Hospital, Sichuan University, Chengdu, PR China..
Phytomedicine. 2025 Mar;138:156393. doi: 10.1016/j.phymed.2025.156393. Epub 2025 Jan 23.
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.
To investigate whether Chaiqinchengqi decoction could improve clinical outcomes in patients with acute pancreatitis.
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.
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, -1.0; 95% CI, -2.0 to 0.0, P=.001). There were significant differences in the duration of circulatory failure, the incidence of new-onset respiratory and cardiovascular and failure, the incidence of new organ failure, severity, intensive care unit need, pain visual analogue scale, pancreatitis activity scoring system, and EQ-5D-5L.
Chaiqinchengqi decoction as an adjunctive therapy significantly reduced the duration of respiratory failure and improved 6-month clinical outcomes of acute pancreatitis in addition to guideline-directed treatments. Further study is needed to elucidate the mechanism of action.
柴芩承气汤是一种中药，在急性胰腺炎的体外、动物及初步小型人体研究中已显示出有前景的疗效，但临床实践证据有限。
探讨柴芩承气汤是否能改善急性胰腺炎患者的临床结局。
前瞻性、实用性、随机对照试验。（中国临床试验注册中心注册号：ChiCTR2000034325）
本试验在中国四川大学华西医院进行。急性胰腺炎患者按1:1比例随机分配，在遵循指南指导治疗的基础上，口服及直肠灌肠给予柴芩承气汤或安慰剂。柴芩承气汤和安慰剂的干预根据急性胃肠损伤分级确定。患者在入院后24小时和48小时、3天、5天和7天或器官功能衰竭恢复正常时进行评估。存活者在出院后1个月、3个月和6个月进行随访。主要结局是入组后至28天呼吸衰竭的持续时间。次要结局包括其他器官功能衰竭、局部并发症、6个月全因死亡率、炎症指标及相关干预措施。
在纳入的248例患者中，与安慰剂相比，柴芩承气汤缩短了呼吸衰竭的持续时间（中位数[四分位间距]，1.0[0.0至5.0]天对3.0[1.0 - 8.0]天；中位数差异，-1.0；95%可信区间，-2.0至0.0，P = 0.001）。在循环衰竭持续时间、新发呼吸和心血管功能衰竭发生率、新器官功能衰竭发生率、严重程度、重症监护病房需求、疼痛视觉模拟评分、胰腺炎活动评分系统及EQ - 5D - 5L方面存在显著差异。
柴芩承气汤作为辅助治疗，除遵循指南指导治疗外，还显著缩短了急性胰腺炎患者呼吸衰竭的持续时间并改善了6个月的临床结局。需要进一步研究以阐明其作用机制。
