In the intensive care units of Japan, nafamostat mesilate (NM) is the most used anticoagulant of continuous blood purification, with the rate of up to 85%. Its biggest characteristic is not to reduce the life of the filter in the group of patients with high risk of bleeding, and it can be safely used. However, there are not a few reports about severe anaphylaxis, when the symptoms of anaphylaxis is recognized after the start of continuous renal replacement therapy, it should be kept in mind that it is NM hypersensitivity. In addition, for an expensive drug, it may be required to be limited in the cases of risk of bleeding complications. NM has been developed for nearly 30 years, so it has high reliability in Japan. However, in the same case, regional citrate anticoagulation is recommended internationally. It may need a randomized controlled trial with regional citrate anticoagulation to prove the real effectiveness of NM.
ObjectiveTo evaluate the economics of nafamostat mesylate compared with unfractionated heparin for continuous renal replacement therapy anticoagulation. MethodsA decision tree model was constructed to calculate the cost difference between the two anticoagulation methods. Survival analysis data comes from retrospective literature in Asian countries. The cost data comes from procurement data and the prices of medical and health services in some regions. A 72-hour scenario analysis is performed and a sensitivity analysis is performed on key parameters. ResultsThe basic analysis results showed that compared with the unfractionated heparin group, the total cost difference of nafamostat in the 144-hour CRRT treatment was 5 350.34 yuan, and the unfractionated heparin was more economical. In the 72-hour scenario analysis, unfractionated heparin is also more economical. Univariate sensitivity analysis showed that the cost of single-use hemodialysis filters and supporting pipelines and the cost of plasma antithrombin Ⅲ activity (AT-Ⅲ) measurement had a greater impact on the change of the cost difference. The results of probability sensitivity analysis show that the model structure is stable and robust. When the unit price of nafamostat is about 110.82 yuan/piece, the cost of nafamostat and unfractionated heparin in 144-hour CRRT treatment is both 19 185.37 yuan, and the cost difference is 0.ConclusionWhen the unit price of nafamostat mesylate drops to a sufficiently low level, it could have an advantageous health economy.
Objective To evaluate the efficacy and safety of in vitro anticoagulation with nafamostat mesilate in continuous renal replacement therapy (CRRT) in patients with sepsis complicated with acute kidney injury (AKI). Methods The study subjects were sepsis patients with AKI who underwent CRRT in West China Hospital of Sichuan University and were at high risk of bleeding. CRRT patients who received in vitro anticoagulation with nafamostat mesilate between July 2021 and January 2022 were included in the nafamostat group. The medical records of CRRT patients who did not use anticoagulants between January 2020 and December 2020 were retrospectively collected as a control group. The general situation, the lifespan of the first CRRT filter, the number of filters used within 72 hours of treatment, laboratory tests before and after treatment, and the occurrence of adverse reactions during treatment of the two groups of patients were analyzed. Results There were 42 patients in the control group and 21 patients in the nafamostat group. There was no statistically significant difference in age, gender, body mass index, mean arterial pressure, primary disease, Sequential Organ Failure Assessment score, Acute Physiology and Chronic Health Evaluation Ⅱ score, or pre-treatment laboratory test results between the two groups of patients (P>0.05). Kaplan-Meier survival analysis showed that the lifespan of the first filter was longer in the nafamostat group than in the control group (hazard ratio=0.408, P<0.05). The number of filters used by the control group patients after 72 hours of treatment was greater than that of the nafamostat group patients (2.1±0.6 vs. 1.3±0.5, P<0.05). After 72 hours of treatment, serum creatinine levels [(99.4±15.7) vs. (127.6±20.5)] μmol/L], urea nitrogen [(4.5±1.9) vs. (6.8±2.3) mmol/L], cystatin C [(1.0±0.2) vs. (1.2±0.2) mg/L], uric acid [(86.5±15.3) vs. (105.3±20.3) μmol/L] in the nafamostat group were lower than those of the control group (P<0.05), and there was no statistically significant difference in the results of other laboratory tests (P>0.05). There was no statistically significant difference in adverse reactions between the two groups of patients (P>0.05). Conclusion For patients with sepsis complicated with AKI who undergo CRRT and are at high risk of bleeding, nafamostat mesilate may be a safe and effective anticoagulant for in vitro anticoagulation.
Objective To evaluate the efficacy and safety of nafamostat mesylate as an in vitro anticoagulant in continuous renal replacement therapy (CRRT) using oXiris filters for patients with sepsis-associated acute kidney injury (SA-AKI). Methods SA-AKI patients at high risk of bleeding who received oXiris filter-CRRT at West China Hospital of Sichuan University between November 2021 and January 2023 were included in the study. Patients who received nafamostat mesylate as an anticoagulant were categorized into the nafamostat group, while patients who did not receive any anticoagulant during the same period were categorized into the control group. A comparative analysis was conducted between the two groups regarding general conditions, the lifespan of the first filter in CRRT, the number and percentage of cases with the first filter lasting 24, 48, and 72 h, activated clotting time (ACT) before and during treatment (both pre-filter and post-filter), laboratory test results before and after treatment, incidence of adverse reactions during treatment, and clinical outcomes of the patients. The mean ± standard deviation was used for normal distribution, and the median (lower quartile, upper quartile) was used for non-normal distribution. Results A total of 118 patients were included in the study, with 90 in the control group and 28 in the nafamostat group. There was no statistically significant difference in the general conditions or pre-treatment laboratory test indicators between the two groups (P>0.05). Kaplan-Meier survival analysis showed that the lifespan of the first filter was longer in the nafamostat group compared to the control group (hazard ratio=0.524, P=0.001). The percentage of patients whose first filter lasted 24 h was higher in the nafamostat group than that in the control group (60.7% vs. 25.7%, P=0.001); however, there was no statistically significant difference between the two groups for the first filter lasting 48 h or 72 h (P>0.05). During CRRT treatment, the mean post-filter ACT was longer in the nafamostat group than that in the control group [(216.7±43.2) vs. (181.6±35.5) s, P<0.001], and the mean post-filter ACT was longer than the pre-filter ACT in the nafamostat group [(216.7±43.2) vs. (183.3±37.7) s, P=0.005]. After the treatment, the international normalized ratio [1.5 (1.1, 1.8) vs. 1.7 (1.4, 2.4)], interleukin-6 levels [(235.5±80.9) vs. (500.5±112.7) pg/mL] were lower, and platelet count [48.0 (31.8, 73.0)×109/L vs. 29.0 (11.0, 61.8)×109/L] was higher in the nafamostat group compared to the control group (P<0.05). There was no statistically significant difference in other laboratory test indicators (P>0.05). The clinical outcomes of the patients did not show statistically significant difference between the two groups (P>0.05). Conclusion Nafamostat mesilate may be an effective and safe anticoagulant in SA-AKI patients at high risk of bleeding underwent oXiris filter-CRRT, and its in vitro anticoagulant effect is better than that without anticoagulant.