早期应用左西孟旦治疗急性非ST段抬高型心肌梗死合并NT-proBNP水平升高患者的安全性与疗效分析(EMS-AHF研究)  

Safety and efficacy of the early administration of levosimendan in patients with acute non-ST-segment elevation myocardial infarction and elevated NT-proBNP levels:An Early Management Strategy of Acute Heart Failure(EMS-AHF)

作　　者：徐峰[1] 边圆 张国强[3] 高璐瑶 刘玉法[4] 刘同祥[5] 李刚[3] 宋瑞雪 苏立军[4] 周衍菊[5] 崔家玉[6] 燕宪亮 郭方明[8] 张焕轶[9] 李庆辉[10] 赵敏[11] 马礼坤 由倍安[13] 王革 孔立[15] 马建亮 周新福[16] 常泽龙 唐振宇[1] 于丹玉 程凯[1] 薛丽[1] 李笑[1] 庞佼佼 王甲莉[1] 张海涛 于学忠[18] 陈玉国[1] Xu Feng;Bian Yuan;Zhang Guoqiang;Gao Luyao;Liu Yufa;Liu Tongxiang;Li Gang;Song Ruixue;Su Lijun;Zhou Yanju;Cui Jiayu;Yan Xianliang;Guo Fangming;Zhang Huanyi;Li Qinghui;Zhao Min;Ma Likun;You Beian;Wang Ge;Kong Li;Ma Jianliang;Zhou Xinfu;Chang Zelong;Tang Zhenyu;Yu Danyu;Cheng Kai;Xue Li;Li Xiao;Pang Jiaojiao;Wang Jiali;Zhang Haitao;Yu Xuezhong;Chen Yuguo(Department of Emergency Medicine,Qilu Hospital of Shandong University,Acute Heart Failure Unit(AHFU),Shandong Provincial Clinical Research Center for Emergency and Critical Care Medicine,Institute of Emergency and Critical Care Medicine of Shandong University,Key Laboratory of Emergency and Critical Care Medicine of Shandong Province,Key Laboratory of Cardiopulmonary-Cerebral Resuscitation Research of Shandong Province,Shandong Provincial Engineering Laboratory for Emergency and Critical Care Medicine,Jinan 250012,China;Department of Emergency Medicine,Cheeloo College of Medicine,Shandong University,Jinan 250012,China;Department of Emergency,China-Japan Friendship Hospital,Beijing 100029,China;Department of Emergency,Zibo Central Hospital,Zibo 255036,China;Department of Emergency,Weifang People′s Hospital,Weifang 261041,China;Department of Cardiology,Binzhou People′s Hospital,Binzhou 256600,China;Emergency Medicine Department,the Affiliated Hospital of Xuzhou Medical University,Xuzhou 221002,China;Department of Cardiology,Yantaishan Hospital,Yantai 264003,China;Department of Cardiology,the Central Hospital of Taian,Taian 271000,China;Department of Cardiology,Shenli Oilfield Central Hospital,Dongying 257000,China;Department of Emergency Medicine,Shengjing Hospital of China Medical University,Shenyang 110004,China;Department of Cardiology,the First Affiliated Hospital of USTC(Anhui Provincial Hospital),Hefei 230001,China;Department of Cardiology,Qilu Hospital of Shandong University(Qingdao),Qingdao 266031,China;Department of Emergency Medicine,Qilu Hospital of Shandong University(Qingdao),Qingdao 266031,China;Department of Emergency Center,Affiliated Hospital,Sha

机构地区：[1]山东大学齐鲁医院急诊科急性心衰单元(AHFU),山东省急危重症临床医学研究中心,山东大学急危重症医学研究所,山东省卫生系统急危重症医学重点实验室,山东省高等学校心肺脑复苏研究重点实验室,山东省急危重症防治工程实验室,济南250012 [2]山东大学齐鲁医学院急诊医学系,济南250012 [3]中日友好医院急诊科,北京100029 [4]淄博市中心医院急救部,淄博255036 [5]潍坊市人民医院急诊科,潍坊261041 [6]滨州市人民医院心血管内科,滨州256600 [7]徐州医科大学附属医院急诊医学科,徐州221002 [8]烟台市烟台山医院心血管内科,烟台264003 [9]泰安市中心医院心内科,泰安271000 [10]山东省胜利油田中心医院心内科,东营257000 [11]中国医科大学附属盛京医院急诊科,沈阳110004 [12]中国科学技术大学附属第一医院(安徽省立医院)心内科,合肥230001 [13]山东大学齐鲁医院心内科(青岛),青岛266031 [14]山东大学齐鲁医院急诊科(青岛),青岛266031 [15]山东中医药大学附属医院急诊科,济南250011 [16]威海市立医院心内科,威海264200 [17]中国医学科学院阜外医院心外科ICU中心、国家心血管病中心,北京100037 [18]中国医学科学院北京协和医学院北京协和医院急诊科,北京100730

出　　处：《中华内科杂志》2023年第4期374-383,共10页Chinese Journal of Internal Medicine

基　　金：国家科技基础资源调查专项(2018FY100600);国家重点研发计划(2020YFC1512700,2020YFC1512705,2020YFC1512703);山东省重点研发计划(2021ZLGX02)。

摘　　要：目的:探讨首次医疗接触24 h内应用左西孟旦对急性非ST段抬高型心肌梗死(NSTEMI)合并N末端B型利钠肽原(NT-proBNP)水平升高患者的安全性与疗效。方法:全国多中心、开放标签、随机对照研究。2017年10月至2021年10月纳入山东大学齐鲁医院、北京中日友好医院等14家中心255例经急诊或门诊入院的NSTEMI合并NT-proBNP升高的患者,通过区组随机分组(block=4)按1︰1随机分为左西孟旦组(129例)和对照组(126例)。其中男性142例、女性113例,年龄65(58~70)岁。主要结局指标为随机化后第3天NT-proBNP水平及第5天NT-proBNP较基线的变化率。次要结局指标为第5天NT-proBNP水平下降超过30%的比例、住院期间和6个月的主要不良心血管事件(MACE)、用药期间的安全性及卫生经济学指标。计量资料组间比较采用t检验或非参数检验,计数资料组间比较采用χ^(2)检验。结果:第3天NT-proBNP水平,左西孟旦组低于对照组,但差异无统计学意义[866(455,1960)比1118(459,2417)ng/L;Z=-1.25,P=0.21],第5天NT-proBNP较基线变化率,左西孟旦组显著高于对照组[67.6%(33.8%,82.5%)比54.8%(7.3%,77.9%);Z=-2.14,P=0.03]。左西孟旦组与对照组第5天NT-proBNP较基线下降超过30%的比例差异无统计学意义[77.5%(100/129)比69.0%(87/126);χ^(2)=2.34,P=0.13],两组患者住院期间及6个月MACE差异无统计学意义[4.7%(6/129)比7.1%(9/126);χ^(2)=0.72,P=0.40;14.7%(19/129)比12.7%(16/126);χ^(2)=0.22,P=0.64]。住院期间对照组有4例发生全因死亡[0(0/129)比3.2%(4/126),P=0.06],但两组患者6个月生存率差异无统计学意义(log-rank test,P=0.18)。用药期间(第0~1天)两组均未发生休克、心室颤动、室性心动过速等不良事件或严重不良事件。卫生经济学方面,住院总费用[34591.00(15527.46,59324.80)比37144.65(16066.90,63919.00)元;Z=-0.26,P=0.80]及总住院时长[9(8,12)比10(7,13)d;Z=0.72,P=0.72]左西孟旦组均低于对照组,但差异无统计学意义。结论:NObjectives To investigated the safety and efficacy of treating patients with acute non-ST-segment elevation myocardial infarction(NSTEMI)and elevated levels of N-terminal pro-hormone B-type natriuretic peptide(NT-proBNP)with levosimendan within 24 hours of first medical contact(FMC).Methods This multicenter,open-label,block-randomized controlled trial(NCT03189901)investigated the safety and efficacy of levosimendan as an early management strategy of acute heart failure(EMS-AHF)for patients with NSTEMI and high NT-proBNP levels.This study included 255 patients with NSTEMI and elevated NT-proBNP levels,including 142 males and 113 females with a median age of 65(58-70)years,and were admitted in the emergency or outpatient departments at 14 medical centers in China between October 2017 and October 2021.The patients were randomly divided into a levosimendan group(n=129)and a control group(n=126).The primary outcome measure was NT-proBNP levels on day 3 of treatment and changes in the NT-proBNP levels from baseline on day 5 after randomization.The secondary outcome measures included the proportion of patients with more than 30%reduction in NT-proBNP levels from baseline,major adverse cardiovascular events(MACE)during hospitalization and at 6 months after hospitalization,safety during the treatment,and health economics indices.The measurement data parameters between groups were compared using the t-test or the non-parametric test.The count data parameters were compared between groups using theχ²test.Results On day 3,the NT-proBNP levels in the levosimendan group were lower than the control group but were statistically insignificant[866(455,1960)vs.1118(459,2417)ng/L,Z=-1.25,P=0.21].However,on day 5,changes in the NT-proBNP levels from baseline in the levosimendan group were significantly higher than the control group[67.6%(33.8%,82.5%)vs.54.8%(7.3%,77.9%),Z=-2.14,P=0.03].There were no significant differences in the proportion of patients with more than 30%reduction in the NT-proBNP levels on day 5 between the levosime

关 键 词：左西孟旦 利钠肽 脑 心肌梗死 心力衰竭 早期干预 

分 类 号：R542.22[医药卫生—心血管疾病]