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A multicenter randomized controlled study of nafamostat mesylate for anticoagulation therapy on hemodialysis

  • ZHUANG Bing ,
  • YE Hong ,
  • CAO Hong-Di ,
  • BIAN Xue-Qin ,
  • ZHONG Hua ,
  • LUO Yuan ,
  • PENG Kan-Fu ,
  • SHI Hui ,
  • YANG Jun-Wei
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  • Center for Kidney Disease, The Second Affiliated Hospital, Nanjing Medical University, Nanjing 210003, China; 2Department of Nephrology, The First Affiliated Hospital, Army Medical University, Chongqing 400038, China; 3Department of Nephrology, The Affiliated Hospital of Nantong University, Nantong 226001, China

Received date: 2022-04-11

  Revised date: 2022-08-04

  Online published: 2022-10-12

Abstract

Objective To observe the safety and efficacy of nafamostat mesylate for anticoagulation in maintenance hemodialysis patients. Methods Patients on hemodialysis were randomly divided into two groups, nafamostat mesylate for injection group and sodium heparin injection group, respectively. The safety and efficacy of nafamostat were evaluated.Results The anticoagulation efficiency of nafamostat mesylate for injection group and sodium heparin injection group was 97.2% and 98.2%, respectively (χ2=0.000,P=0.992); The effect of nafamostat mesylate for injection group on activated clotting time (ACT) during dialysis was less than that of sodium heparin injection group.The ACT values at the arterial side of the two groups were significantly different (1h, t=-15.333, P<0.001; 2h, Z=-10.317, P<0.001; 3h,t=-12.733, P<0.001; the end of dialysis, Z=-6.796, P<0.001),the venous side of the two groups were significant statistical differences in ACT values(1h, t=-17.833, P<0.001; 2h, t=-15.604, P<0.001; 3h, Z=-10.066, P<0.001; the end of dialysis,Z=-4.399, P<0.001);After the end of hemodialysis, the nafamostat mesylate group for injection had less effect on activated partial thromboplastin time (Z=-4.971, P<0.001) and thrombin time (Z =5.770, P<0.001) than the heparin sodium injection group ; The incidence of adverse reactions in nafamostat mesylate for injection group was lower than heparin sodium injection group (χ2=15.239,P<0.001). Conclusion The anticoagulant effect of nafamostat mesylate is non-inferior to sodium heparin , and the incidence of adverse reactions is lower.It could be used safely and effectively in the anticoagulation of hemodialysis.

Cite this article

ZHUANG Bing , YE Hong , CAO Hong-Di , BIAN Xue-Qin , ZHONG Hua , LUO Yuan , PENG Kan-Fu , SHI Hui , YANG Jun-Wei . A multicenter randomized controlled study of nafamostat mesylate for anticoagulation therapy on hemodialysis[J]. Chinese Journal of Blood Purification, 2022 , 21(10) : 739 -743 . DOI: 10.3969/j.issn.1671-4091.2022.10.008

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