Clinical Evidence and Mechanistic Plausibility of Chinese Patent Medicines for Sepsis: An Evidence Map

Sepsis is a life-threatening syndrome with limited specific therapeutic options. Chinese patent medicines (CPMs) are widely used as adjunctive therapies in China, although the available clinical evidence, predominantly from injectable formulations, remains fragmented. This evidence map integrated review-level clinical evidence with in vivo findings to assess evidence certainty and mechanistic plausibility. Eighteen meta-analyses and 337 eligible animal studies were identified; 237 animal studies corresponding to interventions with at least one moderate-certainty clinical outcome entered the focused mechanistic analysis. No review-outcome estimate was rated as high certainty, and 27 of 152 review-outcome estimates (17.8%) were rated as moderate certainty. Moderate-certainty evidence was concentrated mainly in Xuebijing and Shenfu, with fewer moderate-certainty signals for Shengmai, Shenmai, Yiqifumai, Shuxuetong, and Xiyanping. In animal models, Xuebijing and Shenfu were associated with inflammatory and immune regulation, endothelial or barrier protection, mitochondrial function, and programmed cell death, while Shengmai, Shenmai, and Yiqifumai showed more limited pathway-level associations involving oxidative stress, cardiovascular protection, and ferroptosis. Overall, the animal evidence suggested overlapping biological pathways, but risk of bias was generally unclear or high and did not establish causal mechanisms in humans. This evidence map provides a structured framework linking clinical evidence certainty with mechanistic plausibility and highlights important evidence gaps. Given the limited certainty of the clinical evidence, these findings should be considered hypothesis-generating and require confirmation in rigorous clinical trials, systematic safety evaluations, and methodologically robust translational studies.