中国血液净化

中国血液净化 ›› 2022, Vol. 21 ›› Issue (10): 739-743.doi: 10.3969/j.issn.1671-4091.2022.10.008

• 临床研究 • 上一篇    下一篇

注射用甲磺酸萘莫司他用于血液透析抗凝治疗的多中心随机对照研究

庄 冰   叶 红   曹红娣   卞雪芹   仲 华   雒 湲   彭侃夫   施 辉  杨俊伟   

  1. 210003南京，1南京医科大学第二附属医院肾脏病中心
    400038重庆，2中国人民解放军陆军军医大学第一附属医院肾内科
    226001南通，3南通大学附属医院肾内科

  • 收稿日期:2022-04-11 修回日期:2022-08-04 出版日期:2022-10-12 发布日期:2022-10-12
  • 通讯作者: 杨俊伟 E-mail:jwyang@njmu.edu.cn

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 Hui3, YANG Jun-wei   

  1. 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:2022-04-11 Revised:2022-08-04 Online:2022-10-12 Published:2022-10-12
  • Contact: 210003 江苏，1南京医科大学第二附属医院肾脏病中心 E-mail:jwyang@njmu.edu.cn

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摘要： 目的 研究注射用甲磺酸萘莫司他在血液透析治疗抗凝中的安全性和有效性。方法维持性血液透析的患者被随机分为注射用甲磺酸萘莫司他组和肝素钠注射液组，比较血液透析治疗中两组的抗凝效果和安全性。结果 注射用甲磺酸萘莫司他组和肝素钠注射液组均有良好的抗凝效果，抗凝有效率分别为97.2%和98.2%（χ2=0.000，P=0.992）；透析期间注射用甲磺酸萘莫司他组对活化凝血时间（ACT）的影响小于肝素钠注射液组，两组各时间点动脉端的ACT值比较均有明显的统计学差异（透析1小时，t=-15.333，P＜0.001；透析2小时，Z=-10.317，P＜0.001；透析3小时，t=-12.733，P＜0.001；透析结束，Z=-6.796，P＜0.001），两组各时间点静脉端的ACT值比较均有明显的统计学差异（透析1小时，t=-17.833，P＜0.001；透析2小时，t=-15.604，P＜0.001；透析3小时，Z=-10.066，P＜0.001；透析结束，Z=-4.399，P＜0.001）；血液透析结束后注射用甲磺酸萘莫司他组对活化部分凝血活酶时间(Z=-4.971，P＜0.001)和凝血酶时间（Z=5.770，P＜0.001）影响小于肝素钠注射液组；甲磺酸萘莫司他组不良反应发生率低于肝素钠注射液组（χ2=15.239，P＜0.001）。结论 注射用甲磺酸萘莫司他的抗凝效果非劣效于肝素钠注射液，不良反应发生率更低，可安全有效应用于普通血液透析患者的抗凝治疗。

关键词: 血液透析, 甲磺酸萘莫司他, 抗凝

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.

Key words: Hemodialysis, Nafamostat mesylate, Anticoagulation

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