Narrative review of Shenfu Injection for sepsis-induced gastrointestinal injury and septic shock

Shenfu Injection (SFI) is a standardized botanical drug derived from two Chinese medicinal herbs Panax ginseng C.A.Mey. and Aconitum carmichaelii Debeaux. SFI is historically used for “restoring yang and reversing collapse.” It is now widely applied in the treatment of septic shock. The gastrointestinal tract is considered the “engine” of sepsis, and its injury can lead to mucosal barrier disruption and secondary infection. The aim of this narrative review was to summarize the mechanistic basis, preclinical findings and available clinical evidence regarding the role of SFI in sepsis-induced acute gastrointestinal injury (AGI), while critically appraising the strengths and limitations of the current evidence base. A structured literature search of major English- and Chinese-language databases was performed. Preclinical and clinical studies were screened according to predefined inclusion criteria. Due to substantial heterogeneity in study design, models, interventions and outcomes, a quantitative meta-analysis was not performed. Research indicates SFI exerts effects through multiple targets: inhibiting the Toll-like receptor 4/Nuclear factor kappa B signaling (TLR4/NF-κB) pathway to reduce intestinal inflammation; upregulating tight junction (TJ) proteins such as zonula occludens-1 (ZO-1) and Occludin, reducing epithelial cell apoptosis, and modulating immune molecules to protect the physical and immune barriers of the intestinal mucosa; improving microcirculation and tissue perfusion; and potentially modulating gut microbiota composition. Although available clinical studies suggest potential benefits in selected physiological and surrogate endpoints, but most are constrained by small sample size, single-center design, and insufficient methodological reporting. Careful attention is also warranted to safety considerations, particularly aconite-related toxicity, standardization of preparation, and quality control, also warrant careful attention. Overall, SFI shows potential in stabilizing hemodynamics and maintaining the intestinal barrier, but current clinical evidence remains insufficient to support definitive efficacy claims. Validation through high-quality multicenter randomized controlled trials and further mechanistic studies are needed.