磺达肝癸钠治疗中国非ST段抬高急性冠状动脉综合征疗效与安全性的系统评价  被引量:1

Systematic review of efficacy and safety of fondaparinux in the treatment of non-ST-elevation acute coronary syndrome in China

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作  者:谢星星 张杰[2] 范小冬 刘易陇 黄飞鸿 余彬 范玲 XIE Xingxing;ZHANG Jie;FAN Xiaodong;LIU Yilong;HUANG Feihong;YU Bin;FAN Ling(Dept.of Pharmacy,Ya’an People’s Hospital,Sichuan Ya’an 625000,China;Dept.of Pharmacy,Nanbu County People’s Hospital,Sichuan Nanchong 637300,China;Dept.of Pharmacy,Xichong County People’s Hospital,Sichuan Nanchong 637200,China;Dept.of Pharmacy,Leshan People’s Hospital,Sichuan Leshan 614000,China;Dept.of Pharmacology,Southwest Medical University,Sichuan Luzhou 646000,China;Dept.of Pharmacy,Mianyang Central Hospital,Sichuan Mianyang 621000,China)

机构地区:[1]雅安市人民医院药剂科,四川雅安625000 [2]四川省南部县人民医院药学部,四川南充637300 [3]四川省西充县人民医院药学部,四川南充637200 [4]乐山市人民医院药学部,四川乐山614000 [5]西南医科大学药理学系,四川泸州646000 [6]绵阳市中心医院药学部,四川绵阳621000

出  处:《中国药房》2022年第7期879-884,共6页China Pharmacy

基  金:国家自然科学基金资助项目(No.82004073);四川省医学会(恒瑞)科研基金专项科研课题(No.2021HR26);四川省医学会高血压疾病(泰阁)专项科研课题(No.2019TG28)。

摘  要:目的 系统评价磺达肝癸钠对比低分子肝素(那曲肝素、依诺肝素)治疗中国非ST段抬高急性冠状动脉综合征(NSTE-ACS)患者的疗效与安全性。方法 计算机检索PubMed、Medline、Embase、EBSCO、中国知网、万方医学网、维普中文期刊全文数据库及相关临床试验注册网中关于磺达肝癸钠(试验组)与低分子肝素(那曲肝素、依诺肝素)(对照组)治疗NSTE-ACS的临床回顾性队列研究(RCS),检索时限从建库至2021年8月。采用纽卡斯尔-渥太华量表(NOS)进行文献质量评价。结局指标包括主要疗效指标(住院期间急性心肌梗死、再发心绞痛发生率)、次要疗效指标[住院期间再次靶血管血运重建、凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)]、安全性指标(住院期间严重心血管事件、严重出血、轻微出血及严重穿刺部位并发症发生率)、联合终点指标(30、180 d联合终点)。采用RevMan 5.3软件对各效应指标进行Meta分析。结果 最终纳入17篇RCS,共4 946例NSTE-ACS患者,其中试验组2 507例,对照组2 439例。文献质量NOS评估结果显示,高质量研究有8篇,占47.06%。Meta分析结果显示,2组患者住院期间急性心肌梗死发生率、再发心绞痛发生率、再次靶血管血运重建、PT、严重心血管事件发生率差异无统计学意义(P>0.05);APTT(MD=1.34,95%CI为0.22~2.45,P<0.05)、严重出血发生率(RR=0.47,95%CI为0.30~0.74,P<0.05)、轻微出血发生率(RR=0.48,95%CI为0.32~0.71,P<0.05)、严重穿刺部位并发症发生率(RR=0.48,95%CI为0.25~0.95,P<0.05)、30 d联合终点(RR=0.57,95%CI为0.46~0.72,P<0.05)、180 d联合终点(RR=0.73,95%CI为0.54~0.98,P<0.05)差异有统计学意义。结论 磺达肝癸钠治疗中国NSTE-ACS患者具有与低分子肝素(那曲肝素、依诺肝素)相当的疗效,且在预防出血、严重穿刺部位并发症等安全性方面有更明显的优势。OBJECTIVE To systematically evaluate the efficacy and safety of fondaparinux versus low molecular weight heparin(nadroparin,enoxaparin) in the treatment of non-ST-elevation acute coronary syndrome(NSTE-ACS). METHODS The computer searched PubMed, Medline, Embase, EBSCO, CNKI, Wanfang medical network, VIP Chinese Journal Full-text Database and relevant clinical trial registration network for the clinical retrospective cohort study(RCS)of fondaparinux(as trial group)and low molecular weight heparin(natroparin,enoxaparin)(as control group)in the treatment of NSTE-ACS. The retrieval time limit was from the establishment of the database to August 2021. Newcastle Ottawa scale(NOS) was used to evaluate the quality of literature. Outcome indicators included primary efficacy indicators(incidence of acute myocardial infarction and recurrent angina pectoris during hospitalization),secondary efficacy indicators [revascularization of target vessels during hospitalization, prothrombin time(PT), activated partial thromboplastin time(APTT)],safety indicators(incidence of serious cardiovascular events,severe bleeding,slight bleeding and severe puncture site complications during hospitalization), combined endpoint indicators(30 and 180 days combined endpoint). Rev Man 5.3 software was used for Meta-analysis of each effect index. RESULTS Finally,17 RCS articles were included,involving 4 946 patients with NSTE-ACS,including 2 507 in the trial group and 2 439 in the control group.The results of NOS literature quality evaluation showed that there were 8 high-quality studies, accounting for 47.06%. The results of Meta-analysis showed that there was no significant difference in the incidence of acute myocardial infarction,recurrent angina pectoris, revascularization of target vessels, PT and serious cardiovascular events between 2 groups(P>0.05);there was significant difference in the APTT(MD=1.34,95% CI of 0.22-2.45,P<0.05),the incidence of severe bleeding(RR=0.47,95%CI of 0.30-0.74,P<0.05),the incidence of slight bleeding(RR=0.48,95%CI

关 键 词:非ST段抬高急性冠状动脉综合征 磺达肝癸钠 低分子肝素 血栓栓塞 系统评价 

分 类 号:R969.3[医药卫生—药理学] R972[医药卫生—药学]

 

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