Objective  To systematically review the efficacy and safety of nafamostat mesylate for anticoagulation during blood purification in patients at high risk of bleeding, and to provide a reference for clinical treatment.

Methods  Databases including the Cochrane Library, PubMed, Web of Science, Embase, CNKI, WanFang Data, and SinoMed were searched electronically for randomized controlled trials (RCTs) comparing nafamostat mesylate with other conventional anticoagulation regimens (such as unfractionated heparin, low molecular heparin, sodium citrate, or no anticoagulant, etc.) for blood purification in high-risk bleeding patients, the retrieval period was from the establishment of the database to October 31, 2025. Two researchers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was performed using RevMan 5.4 software.

Results  A total of 10 RCTs involving 666 patients were included. Meta-analysis results showed that, compared with other anticoagulation regimens, nafamostat mesylate significantly improved anticoagulation efficacy [RR=1.29, 95% CI (1.06, 1.56), P=0.01] and prolonged dialyzer lifespan [MD=9.35, 95% CI (2.18, 16.52), P=0.01]. Furthermore, there were no significant differences between the groups in the incidence of dialyzer clotting, bleeding complications, adverse reactions, in-hospital mortality, or coagulation parameters (APTT, PT) (P>0.05).

Conclusion  For patients undergoing blood purification who are at high risk of bleeding, nafamostat mesylate is an effective and safe anticoagulant option. It ensures anticoagulation efficacy without increasing the risk of bleeding. However, due to the limitations in the quantity and quality of the included studies, the above conclusions need to be further verified by more high-quality, large-sample studies.

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