Efficacy and safety of naphlimostat mesylate versus sodium citrate in CRRT for EICU patients with coagulation dysfunction: A STROBE-compliant observational study

萘莫司他甲磺酸盐与柠檬酸钠在凝血功能障碍的EICU患者CRRT治疗中的疗效和安全性:一项符合STROBE标准的观察性研究

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Abstract

This study aimed to evaluate the safety of naphlimostat mesylate (NM) as an anticoagulant in vitro for emergency intensive care unit patients with coagulation dysfunction undergoing continuous renal replacement therapy (CRRT). Patients requiring CRRT and presenting with coagulation dysfunction, admitted to Dazhou Central Hospital's emergency intensive care unit in Sichuan Province between September 2021 and January 2023, were included. Patients were randomly assigned to either the NM group (experimental) or the sodium citrate group (control). Data on patient demographics, changes in coagulation factors, hemoglobin, platelets, inflammatory markers, and electrolytes during treatment were collected for both groups. A total of 89 patients participated, with 49 in the NM group and 40 in the sodium citrate group. Complete data were available for 39 patients in the NM group and 36 in the sodium citrate group. Data on filter usage, alterations in coagulation factors, hemoglobin, platelets, inflammatory markers, and electrolytes were collected throughout the treatment period. A total of 117 filters were used across both groups. The median filter duration was 25.5 (range 16.0-43.5) hours in the NM group and 28.5 (range 18.0-46.5) hours in the sodium citrate group. There was no statistically significant difference in daily filter usage between the groups (1.16 ± 0.76 vs 1.00 ± 0.55, P > .05). NM demonstrated comparable anticoagulant efficacy to sodium citrate. Posttreatment, there were no significant differences between groups in prothrombin time (PT) (35.95 ± 33.14 vs 23.71 ± 19.37), activated partial thromboplastin time (55.65 ± 20.82 vs 55.65 ± 20.82), international normalized ratio (3.05 ± 2.83 vs 4.91 ± 10.60), hemoglobin (82.10 ± 15.01 vs 93.10 ± 26.86), platelet count (66.70 ± 59.87 vs 70.10 ± 48.85), serum sodium (138.80 ± 5.92 vs 142.00 ± 3.59), serum potassium (4.00 ± 0.52 vs 3.96 ± 0.61), serum calcium (1.13 ± 0.19 vs 0.99 ± 0.28), white blood cell count (10.82 ± 5.81 vs 12.54 ± 6.32), and neutrophil count (8.73 ± 5.05 vs 10.89 ± 5.94) levels (all P > .05). NM is a safe and effective extracorporeal anticoagulant, demonstrating comparable anticoagulant efficacy to sodium citrate without increasing the risk of bleeding in patients with coagulation abnormalities undergoing CRRT.

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