达格列净联合沙库巴曲缬沙坦钠治疗急性心肌梗死介入术后心力衰竭患者的临床研究OA北大核心CSTPCD
Clinical trial of dapagliflozin combination with sacubitril/valsartan sodium in the treatment of patients with heart failure after acute myocardial infarction intervention
目的 观察达格列净片联合沙库巴曲缬沙坦钠片治疗急性心肌梗死(AMI)介入术后心力衰竭(HF)患者的疗效.方法 将AMI介入术后HF患者随机分为对照组与试验组.对照组给予常规抗心力衰竭治疗+沙库巴曲缬沙坦钠片(首次50 mg,后逐渐增至每次200mg,bid)口服;试验组在对照组治疗的基础上,联合达格列净每次10 mg,qd,口服.2组均治疗6个月.比较2组患者的临床疗效、心脏功能[左心室射血分数(LVEF)、左心室重构指数(LVRI)、6 min步行距离(6MWD)]、心力衰竭标志物[脑钠肽(BNP)、氨基末端脑利钠肽前体(NT-proBNP)、肌钙蛋白(Tn)]、血清相关生化指标[可溶性人基质裂解素-2(ST2)、血管紧张素2(AT-Ⅱ)、可溶性细胞间黏附分子-1(sICAM-1)]变化,统计主要不良心血管事件(MACE)发生率及治疗期间药物不良反应率.结果 试验期间脱落6例,最终对照组、试验组均纳入46例.治疗后,试验组和对照组的总有效率分别为91.30％和76.09％,在统计学上差异有统计学意义(P＜0.05).治疗后,对照组和试验组的LVEF分别为(51.38±4.82)％和(54.43±4.63)％,LVRI 分别为(1.47±0.15)和(1.35±0.17)g·mL-1,6MWD分别为(390.53±40.32)和(362.61±38.51)m,BNP 分别为(28.34±2.47)和(26.51±2.16)pmol·L-1,NT-proBNP 分别为(262.61±53.18)和(227.68±46.73)ng·L-1,sICAM-1 分别为(84.61±7.14)和(74.68±7.08)μg·L-1;试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P＜0.05).随访期间,试验组的MACE发生率(6.52％)显著低于对照组(21.74％;P＜0.05).2组患者的药物不良反应主要有肾功能损害、低血压、泌尿生殖系统感染和高血钾,试验组(13.04％)与对照组(10.87％)比较,在统计学上差异无统计学意义(P＞0.05).结论 达格列净片联合沙库巴曲缬沙坦钠片可明显改善AMI介入术后HF患者心功能及相关指标,降低MACE发生率.
Objective To observe the efficacy of dapagliflozin tablets combination with sacubitril/valsartan sodium tablets in the treatment of patients with heart failure(HF)after acute myocardial infarction(AMI)intervention.Methods Patients with HF after AMI intervention were randomly divided into control group and treatment group.The control group was given conventional anti-heart failure therapy+sacubitril/valsartan sodium tablets(50 mg for the first time,then gradually increased to 200 mg each time,twice a day),and the treatment group was additionally treated with dapagliflozin(10 mg every time,once a day)on the basis of the control group,and the course of treatment was 6 months.The two groups were compared in terms of clinical efficacy,cardiac function[left ventricular ejection fraction(LVEF),left ventricular remodeling index(LVRI),6-minute walking distance(6MWD)],heart failure markers[brain natriuretic peptide(BNP),N-terminal pro-brain natriuretic peptide(NT-proBNP),troponin(Tn)],and serum related biochemical indicators[soluble human stromelysin-2(ST2),angiotensin 2(AT-Ⅱ),soluble intercellular adhesion molecule-1(sICAM-1)],incidence rates of major adverse cardiovascular events(MACE)during follow-up and adverse drug reactions during treatment.Results Six cases dropped out during treatment,and finally 46 cases were included in control group and treatment group,respectively.After treatment,the effective rates of treatment in treatment group(91.30％)was significantly higher than that in control group(76.09％,P＜0.05).After treatment,the LVEF values in control group and treatment group were(51.38±4.82)％and(54.43±4.63)％;LVRI values were(1.47±0.15)and(1.35±0.17)g·mL-1;6MWD values were(390.53±40.32)and(362.61±38.51)m;the BNP levels were(28.34±2.47)and(26.51±2.16)pmol·L-1;NT-proBNP levels were(262.61±53.18)and(227.68±46.73)ng·L-1;sICAM-1 levels were(84.61±7.14)μg·L-1 and(74.68±7.08)μg·L1,and there were statistical differences between both groups(all P＜0.05).During follow-up,the incidence rate of MACE in treatment group(6.52％)was significantly lower than that in control group(21.74％,P＜0.05).The main adverse drug reactions in the two groups were renal dysfunction,hypotension,urogenital infection and hyperkalemia,but there was no significant difference in the incidence of adverse reactions between treatment group(13.04％)and control group(10.87％,P＞0.05).Conclusion Dapagliflozin tablets combined with sacubitril/valsartan sodium tablets can significantly improve cardiac function and related indicators and reduce the incidence of MACE in patients with HF after AMI intervention.
李美美;林晖莉;陈少鹏;洪新宝
福建医科大学附属第二医院心血管内科,福建泉州 362000
药学
达格列净片沙库巴曲缬沙坦钠片急性心肌梗死心力衰竭临床疗效心功能主要不良心血管事件
dapagliflozin tabletsacubitril/valsartan sodium tabletacute myocardial infarctionheart failureclinical efficacycardiac functionmajor adverse cardiovascular event
《中国临床药理学杂志》 2024 (007)
954-958 / 5
福建省自然科学基金资助项目(2023J01747)
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