61例心力衰竭患者血管紧张素受体脑啡肽酶抑制剂沙库巴曲缬沙坦的应用分析
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摘要
目的:了解心力衰竭患者血管紧张素受体脑啡肽酶抑制剂沙库巴曲缬沙坦的使用情况,为该药的规范化应用提供参考。方法:通过医院信息系统调取2017年10月-2018年6月苏州大学附属第一医院心血管内科使用沙库巴曲缬沙坦治疗心力衰竭住院患者的电子病历资料,对其适应证、禁忌证、用法用量、与血管紧张素转换酶抑制剂(ACEI)或血管紧张素Ⅱ受体拮抗药(ARB)的转换情况、不良反应和靶剂量达标率等进行统计分析。结果:共有61例患者使用了沙库巴曲缬沙坦,其中7例(11.48%)为无适应证用药,5例(8.20%)存在禁忌证用药;34例初始剂量不合理(55.74%),4例给药频次不合理(6.56%),与ACEI转换不合理的有7例(11.48%),与ARB转换不合理的有2例(3.28%);9例患者(14.75%)出现了不良反应;所有患者均未达到目标剂量,但有27例患者(44.26%)血压达标。结论:61例患者沙库巴曲缬沙坦的使用与《2016年急、慢性心力衰竭诊断和治疗指南》《2017年心力衰竭管理指南》的要求存在一定差距,主要表现在适应证、禁忌证、用法用量和药物转换等方面,尤其是初始给药剂量普遍较低。建议今后应通过实时审方和定期点评等手段进一步规范该药的临床应用。
OBJECTIVE: To investigate the clinical application of angiotensin receptor enkephalinase inhibitor sacubitril valsartan in patients with heart failure,and to provide reference for its standardized use. METHODS:The electronic medical records of inpatients with heart failure using sacubitril valsartan in cardiovascular medicine department of the First Affiliated Hospital of Soochow University were collected from hospital information system during Oct. 2017 to Jun. 2018. Those medical records were analyzed statistically in respects of indication,contraindications,usage and dosage,conversion with angiotensin converting enzyme inhibitor(ACEI)or angiotensin Ⅱ receptor antagonist(ARB),ADR and standard-reaching rate of target dose,etc. RESULTS:A total of 61 patients were given sacubitril valsartan,among which there were 7 cases(11.48%) without indication and 5 cases(8.20%) with contraindications. There were 34 cases(55.74%) with unreasonable initial dose,4 cases(6.56%) with unreasonable frequency,7 cases(11.48%) with unreasonable conversion with ACEI,2 cases(3.28%) with unreasonable conversion with ARB. 9 cases(14.75%) suffered from ADR. All patients did not reach the target dose,but 27 patients(44.26%) met the target blood pressure. CONCLUSIONS:There is still a certain gap between clinical application of sacubitril valsartan and 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure and 2017 Guideline for the Management of Heart Failure, mainly involving indication, contraindications, usage and dosage, drug conversion, etc. Specially the initial dosage is generally low. It is suggested that its clinical application should be further standardized by means of real-time checking and regular evaluation.
OBJECTIVE: To investigate the clinical application of angiotensin receptor enkephalinase inhibitor sacubitril valsartan in patients with heart failure,and to provide reference for its standardized use. METHODS:The electronic medical records of inpatients with heart failure using sacubitril valsartan in cardiovascular medicine department of the First Affiliated Hospital of Soochow University were collected from hospital information system during Oct. 2017 to Jun. 2018. Those medical records were analyzed statistically in respects of indication,contraindications,usage and dosage,conversion with angiotensin converting enzyme inhibitor(ACEI)or angiotensin Ⅱ receptor antagonist(ARB),ADR and standard-reaching rate of target dose,etc. RESULTS:A total of 61 patients were given sacubitril valsartan,among which there were 7 cases(11.48%) without indication and 5 cases(8.20%) with contraindications. There were 34 cases(55.74%) with unreasonable initial dose,4 cases(6.56%) with unreasonable frequency,7 cases(11.48%) with unreasonable conversion with ACEI,2 cases(3.28%) with unreasonable conversion with ARB. 9 cases(14.75%) suffered from ADR. All patients did not reach the target dose,but 27 patients(44.26%) met the target blood pressure. CONCLUSIONS:There is still a certain gap between clinical application of sacubitril valsartan and 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure and 2017 Guideline for the Management of Heart Failure, mainly involving indication, contraindications, usage and dosage, drug conversion, etc. Specially the initial dosage is generally low. It is suggested that its clinical application should be further standardized by means of real-time checking and regular evaluation.
引文
[1]李小荣,郑旭辉,李新立.血管紧张素受体脑啡肽酶抑制剂在心力衰竭治疗中的研究进展及展望[J].中国循环杂志,2018,33(2):195-198.
[2]MCMURRAY JJ,PACKER M,DESAI AS,et al.Angiotensin-neprilysin inhibition versus enalapril in heart failure[J].N Engl J Med,2014,371(11):993-1004.
[3]PONIKOWSKI P,VOORS AA,ANKER SD,et al.2016ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure:The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology(ESC)Developed with the special contribution of the Heart Failure Association(HFA)of the ESC[J].Eur Heart J,2016,37(27):2129-2200.
[4]YANCY CW,JESSUP M,BOZKURT B,et al.2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHAGuideline for the Management of Heart Failure:a Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America[J].J Card Fail,2017,23(8):628-651.
[5]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.
[6]LEVY D,KENCHAIAH S,LARSON MG,et al.Longterm trends in the incidence of and survival with heart failure[J].N Engl J Med,2002,347(18):1397-1402.
[7]ROGER VL,WESTON SA,REDFIELD MM,et al.Trends in heart failure incidence and survival in a community-based population[J].JAMA,2004,292(3):344-350.
[8]YANCY CW,JESSUP M,BOZKURT B,et al.2013 AC-CF/AHA guideline for the management of heart failure:a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines[J].Circulation,2013,62(16):147-239.
[9]GO AS,MOZAFFARIAN D,ROGER VL,et al.Heart disease and stroke statistics-2014 update:a report from the American Heart Association[J].Circulation,2014,129(3):28-292.
[10]GU J,NOE A,CHANDRA P,et al.Pharmacokinetics and pharmacodynamics of LCZ696,a novel dual-acting angiotensin receptor-neprilysin inhibitor(ARNi)[J].J Clin Pharmacol,2010,50(4):401-414.
[11]MILLS J,VARDENY O.The role of neprilysin inhibitors in cardiovascular disease[J].Curr Heart Fail Rep,2015,12(6):389-394.
[12]ROULEAU JL,PFEFFER MA,STEWART DJ,et al.Comparison of vasopeptidase inhibitor,omapatrilat,and lisinopril on exercise tolerance and morbidity in patients with heart failure:IMPRESS randomised trial[J].Lancet,2000,356(9230):615-620.
[13]PACKER M,CALIFF RM,KONSTAM MA,et al.Comparison of omapatrilat and enalapril in patients with chronic heart failure:the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events(OVERTURE)[J].Circulation,2002,106(8):920-926.
[14]RUILOPE LM,DUKAT A,B?HM M,et al.Blood-pressure reduction with LCZ696,a novel dual-acting inhibitor of the angiotensinⅡreceptor and neprilysin:a randomised,double-blind,placebo-controlled,active comparator study[I].Lancet,2010,375(9722):1255-1266.
[15]MCMURRAY JJ,PACKER M,DESAI AS,et al.Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure:rationale for and design of the prospective comparison of ARNI with ACEIto Determine Impact on Global Mortality and Morbidity in Heart Failure Trial(PARADIGM-HF)[J].Eur J Heart Fail,2013,15(9):1062-1073.
[16]CANNON JA,SHEN L,JHUND PS,et al.Dementia-related adverse events in PARADIGM-HF and other trials in heart failure with reduced ejection fraction[J].Eur J Heart Fail,2017,19(1):129-137.
[17]KOSTIS JB,PACKER M,BLACK HR,et al.Omapatrilat and enalapril in patients with hypertension:the Omapatrilat Cardiovascular Treatment vs.Enalapril(OCTAVE)trial[J].Am J Hypertens,2004,17(2):103-111.
[18]FRYER RM,SEGRETI J,BANFOR PN,et al.Effect of bradykinin metabolism inhibitors on evoked hypotension in rats:rank efficacy of enzymes associated with bradykinin-mediated angioedema[J].Br J Pharmacol,2008,153(5):947-955.
[19]VON LUEDER TG,SANGARALINGHAM SJ,WANGBH,et al.Renin-angiotensin blockade combined with natriuretic peptide system augmentation:novel therapeutic concepts to combat heart failure[J].Circ Heart Fail,2013,6(3):594-605.
[20]中华医学会心血管病学分会,中国心肌炎心肌病协作组.中国扩张型心肌病诊断和治疗指南[J].临床心血管病杂志,2018,34(5):421-434.
[21]COHN JN,TOGNONI G.A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure[J].N Engl J Med,2001,345(23):1667-1675.
[22]PFEFFER MA,MCMURRAY JJ,VELAZQUEZ EJ,et al.Valsartan,captopril,or both in myocardial infarction complicated by heart failure,left ventricular dysfunction,or both[J].N Engl J Med,2003,349(20):1893-1906.
[23]崔晓通,周京敏,葛均波.PARADIGM-HF研究结果解读[J].中国循环杂志,2018,33(2):203-205.
[24]李静,谢诚.慢性心力衰竭患者神经内分泌抑制剂应用调查与分析[J].中国全科医学,2014,17(7):839-845.
[2]MCMURRAY JJ,PACKER M,DESAI AS,et al.Angiotensin-neprilysin inhibition versus enalapril in heart failure[J].N Engl J Med,2014,371(11):993-1004.
[3]PONIKOWSKI P,VOORS AA,ANKER SD,et al.2016ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure:The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology(ESC)Developed with the special contribution of the Heart Failure Association(HFA)of the ESC[J].Eur Heart J,2016,37(27):2129-2200.
[4]YANCY CW,JESSUP M,BOZKURT B,et al.2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHAGuideline for the Management of Heart Failure:a Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America[J].J Card Fail,2017,23(8):628-651.
[5]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.
[6]LEVY D,KENCHAIAH S,LARSON MG,et al.Longterm trends in the incidence of and survival with heart failure[J].N Engl J Med,2002,347(18):1397-1402.
[7]ROGER VL,WESTON SA,REDFIELD MM,et al.Trends in heart failure incidence and survival in a community-based population[J].JAMA,2004,292(3):344-350.
[8]YANCY CW,JESSUP M,BOZKURT B,et al.2013 AC-CF/AHA guideline for the management of heart failure:a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines[J].Circulation,2013,62(16):147-239.
[9]GO AS,MOZAFFARIAN D,ROGER VL,et al.Heart disease and stroke statistics-2014 update:a report from the American Heart Association[J].Circulation,2014,129(3):28-292.
[10]GU J,NOE A,CHANDRA P,et al.Pharmacokinetics and pharmacodynamics of LCZ696,a novel dual-acting angiotensin receptor-neprilysin inhibitor(ARNi)[J].J Clin Pharmacol,2010,50(4):401-414.
[11]MILLS J,VARDENY O.The role of neprilysin inhibitors in cardiovascular disease[J].Curr Heart Fail Rep,2015,12(6):389-394.
[12]ROULEAU JL,PFEFFER MA,STEWART DJ,et al.Comparison of vasopeptidase inhibitor,omapatrilat,and lisinopril on exercise tolerance and morbidity in patients with heart failure:IMPRESS randomised trial[J].Lancet,2000,356(9230):615-620.
[13]PACKER M,CALIFF RM,KONSTAM MA,et al.Comparison of omapatrilat and enalapril in patients with chronic heart failure:the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events(OVERTURE)[J].Circulation,2002,106(8):920-926.
[14]RUILOPE LM,DUKAT A,B?HM M,et al.Blood-pressure reduction with LCZ696,a novel dual-acting inhibitor of the angiotensinⅡreceptor and neprilysin:a randomised,double-blind,placebo-controlled,active comparator study[I].Lancet,2010,375(9722):1255-1266.
[15]MCMURRAY JJ,PACKER M,DESAI AS,et al.Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure:rationale for and design of the prospective comparison of ARNI with ACEIto Determine Impact on Global Mortality and Morbidity in Heart Failure Trial(PARADIGM-HF)[J].Eur J Heart Fail,2013,15(9):1062-1073.
[16]CANNON JA,SHEN L,JHUND PS,et al.Dementia-related adverse events in PARADIGM-HF and other trials in heart failure with reduced ejection fraction[J].Eur J Heart Fail,2017,19(1):129-137.
[17]KOSTIS JB,PACKER M,BLACK HR,et al.Omapatrilat and enalapril in patients with hypertension:the Omapatrilat Cardiovascular Treatment vs.Enalapril(OCTAVE)trial[J].Am J Hypertens,2004,17(2):103-111.
[18]FRYER RM,SEGRETI J,BANFOR PN,et al.Effect of bradykinin metabolism inhibitors on evoked hypotension in rats:rank efficacy of enzymes associated with bradykinin-mediated angioedema[J].Br J Pharmacol,2008,153(5):947-955.
[19]VON LUEDER TG,SANGARALINGHAM SJ,WANGBH,et al.Renin-angiotensin blockade combined with natriuretic peptide system augmentation:novel therapeutic concepts to combat heart failure[J].Circ Heart Fail,2013,6(3):594-605.
[20]中华医学会心血管病学分会,中国心肌炎心肌病协作组.中国扩张型心肌病诊断和治疗指南[J].临床心血管病杂志,2018,34(5):421-434.
[21]COHN JN,TOGNONI G.A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure[J].N Engl J Med,2001,345(23):1667-1675.
[22]PFEFFER MA,MCMURRAY JJ,VELAZQUEZ EJ,et al.Valsartan,captopril,or both in myocardial infarction complicated by heart failure,left ventricular dysfunction,or both[J].N Engl J Med,2003,349(20):1893-1906.
[23]崔晓通,周京敏,葛均波.PARADIGM-HF研究结果解读[J].中国循环杂志,2018,33(2):203-205.
[24]李静,谢诚.慢性心力衰竭患者神经内分泌抑制剂应用调查与分析[J].中国全科医学,2014,17(7):839-845.