Efficacy and safety of Xuebijing combined with ulinastatin in the treatment of sepsis complicated by acute lung injury: a meta-analysis.

OBJECTIVE: To evaluate the efficacy and safety of Xuebijing injection combined with ulinastatin in patients with sepsis complicated by acute lung injury. METHODS: PubMed, Web of Science, the Cochrane Library, VIP Database, China National Knowledge Infrastructure and Wanfang Database were searched from inception to January 2026. Two reviewers independently screened studies, extracted data and assessed the risk of bias using the revised Cochrane Risk-of-Bias Tool for Randomized Trials, Version 2, for randomized controlled trials (RCTs) and the Risk Of Bias In Non-randomized Studies of Interventions tool for the retrospective study. Meta-analyses were performed using R version 4.2.0. RESULTS: Thirteen studies involving 1,158 patients (670 in the combination therapy group and 488 in the control group) were included. Compared with control therapy, Xuebijing plus ulinastatin significantly reduced TNF-α, IL-6, HMGB-1, PCT and CRP levels; improved the oxygenation index; reduced the extravascular lung water index and Acute Physiology and Chronic Health Evaluation II score and shortened mechanical ventilation duration (all P < 0.05). The total effective rate (RD 0.179, 95% CI 0.101-0.257; NNT = 5.6; P < 0.001) and 28-day survival rate (RD 0.118, 95% CI 0.002-0.234; NNT = 8.5; P = 0.047) were significantly higher in the combination group, whereas the incidence of adverse events did not differ significantly between groups (RD -0.004, 95% CI -0.049-0.042; P = 0.881). Sensitivity analyses supported the robustness of the findings. CONCLUSION: Xuebijing combined with ulinastatin may reduce inflammation, improve lung function and disease severity, shorten mechanical ventilation duration and increase response and survival rates without increasing adverse events. Owing to heterogeneity in treatment regimens and inclusion criteria, these findings require validation in large-scale, multicenter RCTs.