沙库巴曲缬沙坦在心力衰竭患者临床应用中的观察
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摘要
目的:总结分析沙库巴曲缬沙坦在真实世界临床实际中治疗扩张型心肌病心力衰竭患者的情况、疗效和安全性。方法:本研究是一项前瞻性注册观察性研究。连续性纳入85例诊断为扩张型心肌病心力衰竭的患者,首先给予患者血管紧张素转化酶抑制剂、β受体阻滞剂及醛固酮受体拮抗剂等进行常规治疗,再停用血管紧张素转化酶抑制剂36h,改用沙库巴曲缬沙坦钠片口服,50mg/次,2次/d,根据患者的血压及耐受情况,逐步调整剂量为400mg/d或至最大耐受量,连续治疗12个月,观察真实世界心力衰竭患者使用沙库巴曲缬沙坦治疗的剂量、治疗效果及其对患者血压、心脏结构和功能、血常规和肾功能等生化指标的影响。结果:沙库巴曲缬沙坦平均使用剂量为136.18mg/d,治疗的总有效率为73%。患者治疗后左心室射血分数(LVEF)明显提高(△■=5.84%,P=0.000),左心室舒张末期内径(LVEDD)(△■=-3.05mm,P=0.000)、收缩压(△■=-9.01mmHg,1mmHg=0.133kPa,P=0.000)、血红蛋白(△■=-8.14g/L,P=0.026)均明显降低。治疗对患者肝肾功能及血脂无明显影响。结论:在真实世界的扩张型心肌病心力衰竭患者治疗中,沙库巴曲缬沙坦使用剂量偏低,但也可以取得较好的治疗效果。在使用过程中除了需要关注患者血压,还需要关注血红蛋白的下降情况。
Objective:To summarize and analyze the use,efficacy and safety of sacubitril valsartan in the treatment of heart failure patients with dilated cardiomyopathy in the real world clinical practice.Method:This study was a prospective registry observational study.A total of 50 patients diagnosed as dilated cardiomyopathy heart failure were continuously included.First,patients were given routine treatment including angiotensin converting enzyme inhibitors,βreceptor blockers,and aldosterone receptor antagonists.The angiotensin converting enzyme inhibitor was discontinued for 36 hours,then sacubitril valsartan was taken orally,50 mg/time,twice a day,the dose was gradually adjusted to 400 mg/d or the maximum tolerance according to the patient's blood pressure and tolerance.For 12 consecutive months,the dose,therapeutic effect and biochemical indicators such as blood pressure,cardiac structure and function,blood routine and renal function of patients were observed.Result:The average dosage of sacubitril valsartan was 136.18 mg/d,and the total effective rate was 73%.After treatment,the left ventricular ejection fraction was significantly increased(△■=5.84%,P=0.000),while the left ventricular end-diastolic diameter(△■=-3.05 mm,P=0.000),systolic blood pressure(△■=-9.01 mmHg,1 mmHg=0.133 kPa,P=0.000)and hemoglobin(△■=-8.14 g/L,P=0.026)were significantly decreased.The treatment had no significant effect on liver and kidney function and blood lipid.Conclusion:In the treatment of dilated cardiomyopathy patients with heart failure in the real world,the dosage of sakubatril valsartan is low,but it can also achieve a good therapeutic effect.It needs to pay attention to the blood pressure and the decline of hemoglobin in the treatment.
Objective:To summarize and analyze the use,efficacy and safety of sacubitril valsartan in the treatment of heart failure patients with dilated cardiomyopathy in the real world clinical practice.Method:This study was a prospective registry observational study.A total of 50 patients diagnosed as dilated cardiomyopathy heart failure were continuously included.First,patients were given routine treatment including angiotensin converting enzyme inhibitors,βreceptor blockers,and aldosterone receptor antagonists.The angiotensin converting enzyme inhibitor was discontinued for 36 hours,then sacubitril valsartan was taken orally,50 mg/time,twice a day,the dose was gradually adjusted to 400 mg/d or the maximum tolerance according to the patient's blood pressure and tolerance.For 12 consecutive months,the dose,therapeutic effect and biochemical indicators such as blood pressure,cardiac structure and function,blood routine and renal function of patients were observed.Result:The average dosage of sacubitril valsartan was 136.18 mg/d,and the total effective rate was 73%.After treatment,the left ventricular ejection fraction was significantly increased(△■=5.84%,P=0.000),while the left ventricular end-diastolic diameter(△■=-3.05 mm,P=0.000),systolic blood pressure(△■=-9.01 mmHg,1 mmHg=0.133 kPa,P=0.000)and hemoglobin(△■=-8.14 g/L,P=0.026)were significantly decreased.The treatment had no significant effect on liver and kidney function and blood lipid.Conclusion:In the treatment of dilated cardiomyopathy patients with heart failure in the real world,the dosage of sakubatril valsartan is low,but it can also achieve a good therapeutic effect.It needs to pay attention to the blood pressure and the decline of hemoglobin in the treatment.
引文
[1]陈伟伟,高润霖,刘力生,等.《中国心血管病报告2017》概要[J].中国循环杂志,2018,33(1):1-8.
[2]Savarese G,Costanzo P,Cleland JGF,et al.A Meta-analysis reporting effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients without heart failure[J].J Am Coll Cardiol,2013,61(2):131-142.
[3]McNally EM,Golbus JR,Puckelwartz MJ.Genetic mutations and mechanisms in dilated cardiomyopathy[J].J Clin Invest,2013,123(1):19-26.
[4]Mogensen UM,K9ber L,Kristensen SL,et al.The effects of sacubitril/valsartan on coronary outcomes in PARADIGM-HF[J].Am Heart J,2017,188:35-41.
[5]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,2018,5(34):421-434.
[6]卢永昕.如何应用循证医学为基础的新指南优化心力衰竭的治疗?[J].临床心血管病杂志,2018,34(2):105-107.
[7]刘炳林.药物临床试验中有效性指标的分类[J].中国新药杂志,2016,25(10):1103-1107.
[8]Ponikowski P,Voors AA,Anker SD,et al.2016ESCGuidelines 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.
[9]中华医学会心血管病学分会心力衰竭学组,中国医师协会心力衰竭专业委员会,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2018[J].中华心血管病杂志,2018,46(10):760-789.
[10]周红,黄思兵.沙库巴曲缬沙坦治疗慢性心功能不全的临床效果观察[J].中国当代医药,2018,25(19):51-53.
[11]余正雷.沙库巴曲缬沙坦治疗顽固性心力衰竭的效果观察[J].海峡药学,2018,30(12):194-195.
[12]张小红,薛竟宜,李俭强,等.沙库巴曲缬沙坦治疗心力衰竭的临床应用[J].临床心血管病杂志,2018,12(34):1215-1218.
[13]Hubers SA,Brown NJ.Combined angiotensin receptor antagonism and neprilysin inhibition[J].Circulation,2016,133(11):1115-1124.
[2]Savarese G,Costanzo P,Cleland JGF,et al.A Meta-analysis reporting effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients without heart failure[J].J Am Coll Cardiol,2013,61(2):131-142.
[3]McNally EM,Golbus JR,Puckelwartz MJ.Genetic mutations and mechanisms in dilated cardiomyopathy[J].J Clin Invest,2013,123(1):19-26.
[4]Mogensen UM,K9ber L,Kristensen SL,et al.The effects of sacubitril/valsartan on coronary outcomes in PARADIGM-HF[J].Am Heart J,2017,188:35-41.
[5]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,2018,5(34):421-434.
[6]卢永昕.如何应用循证医学为基础的新指南优化心力衰竭的治疗?[J].临床心血管病杂志,2018,34(2):105-107.
[7]刘炳林.药物临床试验中有效性指标的分类[J].中国新药杂志,2016,25(10):1103-1107.
[8]Ponikowski P,Voors AA,Anker SD,et al.2016ESCGuidelines 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.
[9]中华医学会心血管病学分会心力衰竭学组,中国医师协会心力衰竭专业委员会,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2018[J].中华心血管病杂志,2018,46(10):760-789.
[10]周红,黄思兵.沙库巴曲缬沙坦治疗慢性心功能不全的临床效果观察[J].中国当代医药,2018,25(19):51-53.
[11]余正雷.沙库巴曲缬沙坦治疗顽固性心力衰竭的效果观察[J].海峡药学,2018,30(12):194-195.
[12]张小红,薛竟宜,李俭强,等.沙库巴曲缬沙坦治疗心力衰竭的临床应用[J].临床心血管病杂志,2018,12(34):1215-1218.
[13]Hubers SA,Brown NJ.Combined angiotensin receptor antagonism and neprilysin inhibition[J].Circulation,2016,133(11):1115-1124.