甲磺酸萘莫司他体外抗凝在尿毒症患者连续性肾脏替代治疗中的安全性和有效性

doi:10.3969/j.issn.1004-583X.2026.03.007

摘要/Abstract

摘要：

目的探讨尿毒症急危重症患者行连续性肾脏替代治疗(continuous renal replacement therapy, CRRT)使用甲磺酸萘莫司他(nafamostat mesylate,NM)体外抗凝的安全性和有效性。方法纳入2024年7月-2025年8月于北京市石景山医院肾内科行CRRT的患者58例,随机分为NM 组(观察组)和肝素钠注射液组(对照组),对不同时段、不同采血点活化部分凝血活酶时间(APTT)、血小板(PLT)、丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、血钾(K)等指标进行统计学分析,并观察滤器使用寿命、出血、过敏等不良反应发生情况,充分评估NM在CRRT使用中的安全性和有效性。结果 ①两组一般资料差异无统计学意义(P>0.05);②两组抗凝有效率相当,差异无统计学意义(P>0.05);③观察组A点不同时间段APTT与C点CRRT结束15 minAPTT差异无统计学意义(P>0.05);④观察组A点CRRT0 h与CRRT结束15 min后C点PLT、ALT、AST差异无统计学意义(P>0.05),血K相比差异有统计学意义(P<0.05);⑤两组A点CRRT4 h及CRRT结束时APTT差异有统计学意义(P<0.05),B点各时间段APTT差异无统计学意义(P>0.05);⑥两组C点CRRT结束15 min PLT比较,差异有统计学意义(P<0.05),血钾、转氨酶等差异均无统计学意义(P>0.05);⑦两组出血发生率差异有统计学意义(P<0.05);⑧两组不良反应发生率差异无统计学意义(P>0.05)。结论注射用甲磺酸萘莫司他具有很好的体外抗凝效果,对凝血功能影响小,不良反应发生率低,安全性高。

关键词: 连续性肾替代疗法, 注射用甲磺酸萘莫司他, 尿毒症, 抗凝

Abstract:

Objective To evaluate the safety and efficacy of nafamostat mesylate (NM) as an extracorporeal anticoagulant in critically ill uremic patients undergoing continuous renal replacement therapy (CRRT). Methods From July 2024 to August 2025, 58 patients who received CRRT in the Nephrology Department of Beijing Shijingshan Hospital were enrolled and randomized into an NM group (observation group) and a heparin sodium injection group (control group). Activated partial thromboplastin time (APTT), platelet count (PLT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum potassium (K) were measured at different time points and at three blood-sampling sites (A, B, C) and analyzed statistically. Filter lifespan and adverse events including hemorrhage and allergy were recorded to comprehensively assess the safety and efficacy of NM during CRRT. Results ① Baseline characteristics were comparable between the two groups (P>0.05). ② Anticoagulation efficacy was similar between groups, with no statistically significant difference (P>0.05). ③ In the NM group, APTT measured at site A at different time points did not differ significantly from APTT measured at site C at 15 min after CRRT termination (P>0.05). ④ In the NM group, comparisons between site A at CRRT 0 h and site C at 15 min after CRRT termination showed no significant differences for PLT, ALT, or AST (P>0.05); however, serum K differed significantly (P<0.05). ⑤ Between the two groups, APTT at site A at CRRT 4 h and at CRRT termination differed significantly (P<0.05), whereas APTT at site B showed no significant differences across time points (P>0.05). ⑥ At site C, 15 min after CRRT termination, PLT differed significantly between groups (P<0.05), while serum potassium and transaminases showed no significant differences (P>0.05). ⑦ The incidence of hemorrhage differed significantly between the two groups (P<0.05). ⑧ The overall incidence of adverse reactions did not differ significantly between groups (P>0.05). Conclusion Intravenous nafamostat mesylate provides effective extracorporeal anticoagulation during CRRT with minimal systemic impact on coagulation parameters, a low rate of adverse reactions, and good safety.

Key words: continuous renal replacement therapy, intravenous nafamostat mesylate, uremia, anticoagulation

中图分类号:

R459.5

邵素荣, 郭燕. 甲磺酸萘莫司他体外抗凝在尿毒症患者连续性肾脏替代治疗中的安全性和有效性[J]. 临床荟萃, 2026, 41(3): 235-240.

Shao Surong, Guo Yan. Safety and efficacy of nafamostat mesylate as extracorporeal anticoagulation during continuous renal replacement therapy in uremic patients[J]. Clinical Focus, 2026, 41(3): 235-240.

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https://www.lchc.cn/CN/Y2026/V41/I3/235

图/表 9

参考文献 15

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项目	观察组(n=29)	对照组(n=29)	t/χ²值	P值
年龄(岁)	64.00±9.81	64.10±9.66	-0.040	0.968
男性[例(%)]	17(58.6)	16(55.2)	-0.261	0.795
APTT(s)	27.17±1.64	28.27±3.00	-1.742	0.089
PLT(×10⁹/L)	165.38±51.75	167.10±64.27	-1.113	0.911
血K(mmol/L)	4.82±0.72	5.08±0.72	-1.329	0.189
ALT(U/L)	19.83±7.53	18.48±10.38	0.565	0.575
AST(U/L)	20.41±7.72	19.55±9.01	2.661	0.060
原发病[例(%)]
糖尿病性肾病	10(34.48)	11(37.93)	0.075	0.785
慢性肾小球肾炎	12(41.38)	10(34.48)	0.293	0.588
高血压性肾病	4(13.79)	6(20.69)	0.483	0.487
其他	3(10.35)	2(6.90)	0.345	0.557

项目	观察组(n=29)	对照组(n=29)	t/χ²值	P值
年龄(岁)	64.00±9.81	64.10±9.66	-0.040	0.968
男性[例(%)]	17(58.6)	16(55.2)	-0.261	0.795
APTT(s)	27.17±1.64	28.27±3.00	-1.742	0.089
PLT(×10⁹/L)	165.38±51.75	167.10±64.27	-1.113	0.911
血K(mmol/L)	4.82±0.72	5.08±0.72	-1.329	0.189
ALT(U/L)	19.83±7.53	18.48±10.38	0.565	0.575
AST(U/L)	20.41±7.72	19.55±9.01	2.661	0.060
原发病[例(%)]
糖尿病性肾病	10(34.48)	11(37.93)	0.075	0.785
慢性肾小球肾炎	12(41.38)	10(34.48)	0.293	0.588
高血压性肾病	4(13.79)	6(20.69)	0.483	0.487
其他	3(10.35)	2(6.90)	0.345	0.557

组别	例数	0级	Ⅰ级	Ⅱ级	Ⅲ级	抗凝有效率
观察组	29	25(86.2)	2(6.9)	2(6.9)	0	27(93.1)
对照组	29	25(86.2)	3(10.3)	1(3.5)	0	28(96.6)
χ²值						0.352
P值						0.553

组别	例数	0级	Ⅰ级	Ⅱ级	Ⅲ级	抗凝有效率
观察组	29	25(86.2)	2(6.9)	2(6.9)	0	27(93.1)
对照组	29	25(86.2)	3(10.3)	1(3.5)	0	28(96.6)
χ²值						0.352
P值						0.553

变量	A采血点			C采血点血滤结束15 min	F值	P值
变量	CRRT 0 h	CRRT 4 h	CRRT结束	C采血点血滤结束15 min	F值	P值
APTT(s)	27.16±1.64	27.77±1.93	28.85±2.44	27.73±2.74	2.901	0.061