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甲磺酸萘莫司他用于维持性血液透析患者抗凝治疗的有效性和安全性:一项基于RCT的Meta分析

Efficacy and safety of nafamostat mesilate for anticoagulation therapy in maintenance hemodialysis patients:A Meta-analysis based on randomized controlled trials
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摘要 目的采用Meta分析研究甲磺酸萘莫司他(nafamostat mesilate,NM)用于维持性血液透析患者抗凝治疗的有效性和安全性。方法从中国知网、中国生物医学文献服务系统、维普网、万方数据知识服务平台、PubMed、Embase、Cochrane Library和Medline数据库中检索有关NM用于维持性血液透析患者抗凝治疗的随机对照试验(randomized controlled trial,RCT),汇总分析抗凝有效率、活化凝血时间(activated clotting time,ACT)、活化部分凝血活酶时间(activated partial thromboplastin time,APTT)、凝血酶时间(thrombin time,TT)、凝血酶原时间(prothrombin time,PT)、纤维蛋白原(fibrinogen,FIB)和不良反应发生率。结果共纳入4项RCT,总病例数490例。Meta分析结果显示,试验组患者的抗凝有效率高于对照组(RR=1.09,95%CI:1.04~1.15,P=0.0005);透析期间试验组透析血液管路采血部位A点(MD=–38.47,95%CI:–43.49~–33.45,P<0.00001)和C点(MD=–43.75,95%CI:–48.30~–39.20,P<0.00001)的ACT均低于对照组;透析结束后15min,两组患者的PT(MD=–0.12,95%CI:–0.28~0.03,P=0.11)、FIB(MD=0.06,95%CI:–0.06~0.18,P=0.36)比较差异均无统计学意义,实验组患者的APTT(MD=–6.49,95%CI:–7.73~–5.24,P<0.00001)和TT(MD=–9.68,95%CI:–11.17~–8.19,P<0.00001)均短于对照组,不良反应发生率低于对照组(RR=0.21,95%CI:0.11~0.40,P<0.00001)。结论与肝素抗凝相比,NM用于维持性血液透析患者的抗凝治疗具有一定优势,且减少不良反应的发生,但仍需更多高质量的临床试验证实。 Objective To study the efficacy and safety of nafamostat mesilate(NM)in anticoagulant therapy for maintenance hemodialysis patients by using Meta-analysis.Methods Randomized controlled trials(RCT)were retrieved from CNKI,SinoMed,VIP,Wanfang Data Knowledge Service Platform,PubMed,Embase,Cochrane Library,and Medline databases regarding the use of NM for anticoagulant therapy in maintenance hemodialysis patients.The effective rate of anticoagulation,activated clotting time(ACT),activated partial thromboplastin time(APTT),thrombin time(TT),prothrombin time(PT),fibrinogen(FIB),and incidence of adverse reactions were summarized and analyzed.Results Four RCT were included,with a total of 490 cases.Meta-analysis results showed that the effective rate of anticoagulation in experimental group was higher than that in control group(RR=1.09,95%CI:1.04-1.15,P=0.0005).During dialysis,the ACT at point A(MD=–38.47,95%CI:–43.49-–33.45,P<0.00001)and point C(MD=–43.75,95%CI:–48.30-–39.20,P<0.00001)of the blood collection site of the dialysis blood pipeline in experimental group were lower than those in control group.After 15 minutes of dialysis,there were no statistically significant differences in PT(MD=–0.12,95%CI:–0.28-0.03,P=0.11)and FIB(MD=0.06,95%CI:–0.06-0.18,P=0.36)between two groups of patients.The APTT(MD=-6.49,95%CI:–7.73-–5.24,P<0.00001)and TT(MD=–9.68,95%CI:–11.17-–8.19,P<0.00001)in experimental group were both shorter than those in control group,and the incidence of adverse reactions was lower than that in control group(RR=0.21,95%CI:0.11-0.40,P<0.00001).Conclusion Compared with heparin anticoagulation,NM has certain advantages in anticoagulant therapy for maintenance hemodialysis patients,and can reduce the occurrence of adverse reactions.However,more high-quality clinical trials are still needed for confirmation.
作者 陈锦棠 潘子毅 沈小棋 宁苑灵 林娟娟 CHEN Jintang;PAN Ziyi;SHEN Xiaoqi;NING Yuanling;LIN Juanjuan(Department of Nephrology,People’s Hospital of Beihai,Beihai 536000,Guangxi,China;Department of Pharmacy,People’s Hospital of Beihai,Beihai 536000,Guangxi,China)
出处 《中国现代医生》 2025年第34期72-78,共7页 China Modern Doctor
关键词 甲磺酸萘莫司他 维持性血液透析 随机对照试验 META分析 Nafamostat mesilate Maintenance hemodialysis Randomized controlled trial Meta-analysis
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