左西孟旦在急性前壁心肌梗死合并心力衰竭患者中的应用
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摘要
目的评估直接经皮冠状动脉介入(PPCI)术后急性ST段抬高型心肌梗死(STEMI)合并心力衰竭患者应用左西孟旦的有效性和安全性。方法连续纳入2015—2016年武汉亚洲心脏病医院急性前壁心肌梗死PPCI围术期(72 h)出现急性左心衰竭(包括心原性休克)的患者87例,按照随机数字表法分为研究组(左西孟旦治疗,44例)和对照组(标准药物治疗,43例),主要终点为呼吸困难评分。结果两组的年龄、性别、病史、实验室检查和心功能等基线资料相似,但研究组的中位肌钙蛋白I峰值显著高于对照组(90. 8μg/L比58. 5μg/L,χ~2=2. 098,P=0. 042)。与对照组比较,研究组患者治疗后的呼吸困难评分从第3天开始显著改善(P<0. 05)、N末端B型利钠肽原第5天显著下降[(3 184.0±1 573.0)ng/L比(5 063. 0±1 938. 0)ng/L,χ~2=2. 398,P=0. 021]。6个月随访时,两组的心原性死亡与因心力衰竭再次住院复合事件发生率无显著差异(29. 5%比37. 2%,χ~2=0. 575,P=0. 448),但研究组的低血压发生率明显高于对照组(39. 5%比18. 6%,χ~2=4. 261,P=0. 039)。两组的药物安全性事件发生率相似(P> 0. 05)。结论左西孟旦能安全、有效、快速地改善PPCI术后急性前壁心肌梗死合并心力衰竭患者的呼吸困难症状,但不能减少6个月复合临床终点事件,且需注意监测血压。
Objective To evaluate the efficacy and safety of levosimendan in patients with acute ST-segment elevation myocardial infarction(STEMI) complicated with heart failure undergoing primary percutaneous coronary intervention(PPCI). Methods A total of consequent 87 patients with acute anterior STEMI patients with heart failure within 72 h during peri-operative period of PPCI(including cardiogenic shock) were enrolled from 2015 to 2016 in Wuhan Asia Heart Hospital. The participants were randomly assigned to levosimendan group(study group, 44 cases) or optimal medication group(43 cases).The primary endpoint was dyspnea score. Results Baseline data such as age, sex, history, laboratory data and cardiac function were similar in the two groups. The median troponin I(Tn I) was significantly higher in study group(90. 8 μg/Lvs. 58. 5 μg/L,χ~2= 2. 098,P= 0. 042). Compared with control group,the study group had a significant improvement in the dyspnea score(P< 0. 05), and the N-terminal B-type natriuretic peptide decreased significantly [(3 184. 0 ±1 573. 0)ng/Lvs.(5 063. 0 ± 1 938. 0)ng/L,χ~2=2. 398,P= 0. 021]. At 6-month follow up, composite outcome( cardiac death and re-hospitalization for heart failure) in the study group was similar with the control group(29. 5%vs. 37. 2%,χ~2= 0. 575,P=0. 448). Hypotension incidence was significantly higher in the study than control group(39. 5%vs.18. 6%,χ~2= 4. 261,P= 0. 039). The incidence of drug safety events was similar between the two groups(P> 0. 05). Conclusions Levosimendan may improve symptom of dyspnea in PPCI-treated anterior STEMI patients complicated with heart failure, but can not reduce the6-month composite clinical endpoint,and should pay attention to monitoring blood pressure.
Objective To evaluate the efficacy and safety of levosimendan in patients with acute ST-segment elevation myocardial infarction(STEMI) complicated with heart failure undergoing primary percutaneous coronary intervention(PPCI). Methods A total of consequent 87 patients with acute anterior STEMI patients with heart failure within 72 h during peri-operative period of PPCI(including cardiogenic shock) were enrolled from 2015 to 2016 in Wuhan Asia Heart Hospital. The participants were randomly assigned to levosimendan group(study group, 44 cases) or optimal medication group(43 cases).The primary endpoint was dyspnea score. Results Baseline data such as age, sex, history, laboratory data and cardiac function were similar in the two groups. The median troponin I(Tn I) was significantly higher in study group(90. 8 μg/Lvs. 58. 5 μg/L,χ~2= 2. 098,P= 0. 042). Compared with control group,the study group had a significant improvement in the dyspnea score(P< 0. 05), and the N-terminal B-type natriuretic peptide decreased significantly [(3 184. 0 ±1 573. 0)ng/Lvs.(5 063. 0 ± 1 938. 0)ng/L,χ~2=2. 398,P= 0. 021]. At 6-month follow up, composite outcome( cardiac death and re-hospitalization for heart failure) in the study group was similar with the control group(29. 5%vs. 37. 2%,χ~2= 0. 575,P=0. 448). Hypotension incidence was significantly higher in the study than control group(39. 5%vs.18. 6%,χ~2= 4. 261,P= 0. 039). The incidence of drug safety events was similar between the two groups(P> 0. 05). Conclusions Levosimendan may improve symptom of dyspnea in PPCI-treated anterior STEMI patients complicated with heart failure, but can not reduce the6-month composite clinical endpoint,and should pay attention to monitoring blood pressure.
引文
[1]中华医学会心血管病学分会,中华心血管病杂志编辑委员会.急性ST段抬高型心肌梗死诊断和治疗指南[J].中华心血管病杂志,2015,43(5):380-393.DOI:10.3760/cma.j.issn.0253-3758.2015.05.003.Chinese Society of Cardiology,Editorial Board of Chinese Journal of Cardiology.Guideline for the Diagnosis and Management of Acute ST-elevation Myocardial Infarction[J].Chin J Cardiol,2015,43(5):380-393.DOI:10.3760/cma.j.issn.0253-3758.2015.05.003.
[2]中华医学会心血管病学分会,中华心血管病杂志编辑委员会.中国心力衰竭诊断和治疗指南2014[J].中华心血管病杂志,2014,42(2):98-122.DOI:10.3760/cma.j.issn.0253-3758.2014.02.004.Chinese Society of Cardiology,Editorial Board of Chinese Journal of Cardiology.2014 China Guideline for the Diagnosis and Management of Heart Failure[J].Chin J Cardiol,2014,42(2):98-122.DOI:10.3760/cma.j.issn.0253-3758.2014.02.004.
[3]Moiseyev VS,Poder P,Andrejevs N,et al.Safety and efficacy of a novel calcium sensitizer,levosimendan,in patients with left ventricular failure due to an acute myocardial infarction.Arandomized,placebo-controlled,double-blind study(RUSSLAN)[J].Eur Heart J,2002,23(18):1422-1432.
[4]Parissis JT,Rafouli-Stergiou P,Paraskevaidis I,et al.Levosimendan:from basic science to clinical practice[J].Heart Fail Rev,2009,14(4):265-275.DOI:10.1007/s10741-008-9128-4.
[5]Maharaj R,Metaxa V.Levosimendan and mortality after coronary revascularisation:a meta-analysis of randomised controlled trials[J].Crit Care,2011,15(3):R140.DOI:10.1186/cc10263.
[6]张宇辉,卿恩明,张健,等.国产左西孟旦与多巴酚丁胺治疗急性失代偿性心力衰竭患者血液动力学和疗效对比观察[J].中华医学杂志,2012,92(8):555-558.DOI:10.3760/cma.j.issn.0376-2491.2012.08.014.Zhang YH,Qin EM,Zhang J,et al.Hemodynamic and efficacies of domestic levosimendan versus dobutamine in patients with acutedecompensated heart failure[J].Chin J Cardiol,2012,92(8):555-558.DOI:10.3760/cma.j.issn.0376-2491.2012.08.014.
[7]Husebye T,Eritsland J,Müller C,et al.Levosimendan in acute heart failure following primary percutaneous coronary interventiontreated acute ST-elevation myocardial infarction.Results from the LEAF trial:a randomized,placebo-controlled study[J].Eur JHeart Fail,2013,15(5):565-572.
[8]Mebazaa A,Nieminen MS,Packer M,et al.Levosimendan vs dobutamine for patients with acute decompensated heart failure:the SURVIVE Randomized Trial[J].JAMA,2007,297(17):1883-1891.DOI:10.1093/eurjhf/hfs215.
[9]Omerovic E,R?munddal T,Albertsson P,et al.Levosimendan neither improves nor worsens mortality in patients with cardiogenic shock due to ST-elevation myocardial infarction[J].Vasc Health Risk Manag,2010,6:657-663.
[10]Pollesello P,Parissis J,Kivikko M,et al.Levosimendan metaanalyses:Is there a pattern in the effect on mortality?[J].Int JCardiol,2016,209(2016):77-83.DOI:10.1016/j.ijcard.2016.02.014.
[2]中华医学会心血管病学分会,中华心血管病杂志编辑委员会.中国心力衰竭诊断和治疗指南2014[J].中华心血管病杂志,2014,42(2):98-122.DOI:10.3760/cma.j.issn.0253-3758.2014.02.004.Chinese Society of Cardiology,Editorial Board of Chinese Journal of Cardiology.2014 China Guideline for the Diagnosis and Management of Heart Failure[J].Chin J Cardiol,2014,42(2):98-122.DOI:10.3760/cma.j.issn.0253-3758.2014.02.004.
[3]Moiseyev VS,Poder P,Andrejevs N,et al.Safety and efficacy of a novel calcium sensitizer,levosimendan,in patients with left ventricular failure due to an acute myocardial infarction.Arandomized,placebo-controlled,double-blind study(RUSSLAN)[J].Eur Heart J,2002,23(18):1422-1432.
[4]Parissis JT,Rafouli-Stergiou P,Paraskevaidis I,et al.Levosimendan:from basic science to clinical practice[J].Heart Fail Rev,2009,14(4):265-275.DOI:10.1007/s10741-008-9128-4.
[5]Maharaj R,Metaxa V.Levosimendan and mortality after coronary revascularisation:a meta-analysis of randomised controlled trials[J].Crit Care,2011,15(3):R140.DOI:10.1186/cc10263.
[6]张宇辉,卿恩明,张健,等.国产左西孟旦与多巴酚丁胺治疗急性失代偿性心力衰竭患者血液动力学和疗效对比观察[J].中华医学杂志,2012,92(8):555-558.DOI:10.3760/cma.j.issn.0376-2491.2012.08.014.Zhang YH,Qin EM,Zhang J,et al.Hemodynamic and efficacies of domestic levosimendan versus dobutamine in patients with acutedecompensated heart failure[J].Chin J Cardiol,2012,92(8):555-558.DOI:10.3760/cma.j.issn.0376-2491.2012.08.014.
[7]Husebye T,Eritsland J,Müller C,et al.Levosimendan in acute heart failure following primary percutaneous coronary interventiontreated acute ST-elevation myocardial infarction.Results from the LEAF trial:a randomized,placebo-controlled study[J].Eur JHeart Fail,2013,15(5):565-572.
[8]Mebazaa A,Nieminen MS,Packer M,et al.Levosimendan vs dobutamine for patients with acute decompensated heart failure:the SURVIVE Randomized Trial[J].JAMA,2007,297(17):1883-1891.DOI:10.1093/eurjhf/hfs215.
[9]Omerovic E,R?munddal T,Albertsson P,et al.Levosimendan neither improves nor worsens mortality in patients with cardiogenic shock due to ST-elevation myocardial infarction[J].Vasc Health Risk Manag,2010,6:657-663.
[10]Pollesello P,Parissis J,Kivikko M,et al.Levosimendan metaanalyses:Is there a pattern in the effect on mortality?[J].Int JCardiol,2016,209(2016):77-83.DOI:10.1016/j.ijcard.2016.02.014.