Huang Na, Tam Yat Hoi, Zhang Zhitong, Kao Xingyu, Yang Zhen, Xu Weixian, Yuan Kang, He Mingfeng, Chen Jingli
The Eighth Clinical Medical College of Guangzhou University of Chinese Medicine, Foshan, 528000, China.
South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, 510000, China.
Phytomedicine. 2025 Jan;136:156311. doi: 10.1016/j.phymed.2024.156311. Epub 2024 Dec 4.
Sepsis is a critical condition characterized by multi-organ dysfunction (MODS) that presents significant treatment challenges. Traditional Chinese medicine (TCM), particularly Dachaihu decoction (DCH), has shown potential in addressing sepsis-related complications.
To comprehensively evaluate the efficacy and safety of DCH in the treatment of sepsis.
Eligible septic patients were randomly assigned to either the DCH or control group in a 1:1 ratio. The intervention course lasted for 3 days. Primary outcomes were 28-day all-cause mortality, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Secondary outcomes were assessed through various clinical parameters, including: (1) inflammatory markers; (2) liver function indices; (3) renal function markers; (4) gastrointestinal function metrics and (5) coagulation parameters.
70 septic patients were included in the full analysis set. No significant difference in 28-day all-cause mortality was observed between the control and DCH groups (10 (28.6 %) vs. 9 (25.7 %), p = 0.788). However, DCH significantly reduced SOFA score (-3.0 (interquartile range, IQR, -5.5, -2.0) vs. 0.0 (IQR, -3.5, 0.0), p = 0.025), APACHE II score (-4.0 (IQR, -8.0, -2.0) vs. 0.0 (IQR, -2.0, 2.0), p < 0.001), aspartate transaminase (-12.70 (IQR, -76.15, -3.35) vs. 2.40 (IQR, -8.05, 10.55), p = 0.001), total bilirubin (-2.30 (IQR, -7.45, 3.62) vs. 1.80 (IQR, -2.35, 11.25), p = 0.028), acute gastrointestinal injury grade (R¯, 26.04 vs. 44.96, p < 0.001), gastrointestinal dysfunction score (-5.0 (IQR, -6.0, -2.5) vs. -1.0 (IQR, -2.0, 0.5), p < 0.001), serum intestinal fatty acid-binding protein (-334.5 (IQR, -375.4, -288.8) vs. -34.8 (IQR, -104.2, -34.0), p < 0.001), and increased citrulline levels (6.97 (IQR, 6.76, 7.62) vs. 0.70 (IQR, -1.30, 2.83), p < 0.001), and also inhibiting platelet loss (-2.0 (IQR, -30.5, 45.5) vs. -26.0 (IQR, -65.0, 9.5), p = 0.043). Additionally, DCH demonstrated improvements in inflammation, renal function, and coagulation, with fewer serious adverse events reported in the DCH group (2.44 % vs. 7.32 %, p = 0.305).
DCH is both effective and safe in treating septic MODS. Nonetheless, further research is required to refine study designs and enhance outcomes for septic patients.
脓毒症是一种以多器官功能障碍（MODS）为特征的危急病症，带来了重大的治疗挑战。传统中医（TCM），尤其是大柴胡汤（DCH），在应对脓毒症相关并发症方面已显示出潜力。
全面评估大柴胡汤治疗脓毒症的疗效和安全性。
符合条件的脓毒症患者按1:1比例随机分配至大柴胡汤组或对照组。干预疗程持续3天。主要结局指标为28天全因死亡率、序贯器官衰竭评估（SOFA）和急性生理与慢性健康状况评分II（APACHE II）。次要结局指标通过各种临床参数进行评估，包括：（1）炎症标志物；（2）肝功能指标；（3）肾功能标志物；（4）胃肠功能指标和（5）凝血参数。
70例脓毒症患者纳入全分析集。对照组和大柴胡汤组之间28天全因死亡率无显著差异（10例（28.6%）对9例（25.7%），p = 0.788）。然而，大柴胡汤显著降低了SOFA评分（-3.0（四分位间距，IQR，-5.5，-2.0）对0.0（IQR，-3.5，0.0），p = 0.025）、APACHE II评分（-4.0（IQR，-8.0，-2.0）对0.0（IQR，-2.0，2.0），p < 0.001）、天冬氨酸转氨酶（-12.70（IQR，-76.15，-3.35）对2.40（IQR，-8.05，10.55），p = 0.001）、总胆红素（-2.30（IQR，-7.45，3.62）对1.80（IQR，-2.35，11.25），p = 0.028）、急性胃肠损伤分级（R¯，26.04对44.96，p < 0.001）、胃肠功能障碍评分（-5.0（IQR，-6.0，-2.5）对-1.0（IQR，-2.0，0.5），p < 0.001）、血清肠脂肪酸结合蛋白（-334.5（IQR，-375.4，-288.8）对-34.8（IQR，-104.2，-34.0），p < 0.001），并提高了瓜氨酸水平（6.97（IQR，6.76，7.62）对0.70（IQR，-1.30，2.83），p < 0.001），还抑制了血小板损失（-2.0（IQR，-30.5，45.5）对-26.0（IQR，-65.0，9.5），p = 0.043）。此外，大柴胡汤在炎症、肾功能和凝血方面表现出改善，大柴胡汤组报告的严重不良事件较少（2.44%对7.32%，p = 0.305）。
大柴胡汤治疗脓毒症合并MODS有效且安全。尽管如此，仍需要进一步研究以优化研究设计并改善脓毒症患者的结局。
