不同剂量沙库巴曲缬沙坦对心肌梗死后心室重构的疗效及安全性评价
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(南方医科大学附属何贤纪念医院心内科,广东省广州市 510000)

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伍金雷,硕士,主治医师,研究方向为心力衰竭,E-mail:13719466113@163.com。通信作者卓裕丰,博士,主任医师,研究方向为心力衰竭,E-mail:13560227590@163.com。

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番禺区重点学科医疗卫生项目(2021-Z04-008);番禺区科技计划项目(2021-04-048)


Efficacy and safety of sacubitril/valsartan with different doses in patients with ventricular remodeling after myocardial infarction
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Department of Cardiology, Hexian Memorial Affiliated Hospital of Southern Medical University, Guangzhou, Guangdong 510000, China)

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    摘要:

    目的]观察急性心肌梗死(AMI)患者治疗前后心室重构相关指标的变化及药物不良反应情况,评价不同剂量沙库巴曲缬沙坦治疗AMI后心力衰竭患者的疗效及安全性。 [方法]选取2018年3月—2022年3月的174例急性ST段抬高型心肌梗死(STEMI)合并左心室射血分数(LVEF)<50%的患者按随机分配接受最大耐受剂量的沙库巴曲缬沙坦(滴定至200 mg或最大耐受剂量,Bid,n=80)或低剂量沙库巴曲缬沙坦(50 mg,Bid,n=94)治疗,同时接受常规治疗。评价患者从基线检查(治疗前)至出院后12个月的血清氨基末端脑钠肽前体(NT-proBNP)、超声心动图各参数及药物不良反应(症状性低血压、高钾血症、肾功能下降、血管性水肿等)的变化。 [结果]经治疗后最大耐受剂量组与低剂量组左心房内径(LAD)对比治疗前差异均有统计学意义(P<0.05),但两组间差异无统计学意义(P>0.05);两组左心室舒张期末内径(LVEDD)与治疗前比较均显著下降(P<0.05),但两组间差异无统计学意义(P>0.05);两组左心室射血分数(LVEF)与治疗前比较均显著升高(P<0.05),程度相似(P>0.05);最大耐受剂量组血清NT-proBNP水平下降幅度高于低剂量组,差异有统计学意义(P<0.05);最大耐受量组药物相关不良反应发生率更高(17.5%比2.1%,P<0.05)。 [结论]与低剂量组相比,最大耐受剂量组在改善心肌梗死后心力衰竭患者心脏重构和左心室射血功能上并没有显示出显著优势,虽然可能通过进一步降低NT-proBNP水平减少心血管事件发生,但严格滴定最大耐受剂量与频繁发生药物不良反应密切相关。

    Abstract:

    Aim To observe the changes in indexes of ventricular remodeling and adverse drug reactions in patients with acute myocardial infarction (AMI) before and after treatment, and evaluate the efficacy and safety of different doses of sarcubatrix/valsartan in the treatment of heart failure patients after AMI. Methods 174 patients with acute ST-segment elevation myocardial infarction (STEMI) and subnormal left ventricular ejection fraction (LVEF) <50% from March 2018 to March 2022 were randomly allocated to receive maximal tolerated dose of sacubitril/valsartan (titrated up to maximal tolerated dose or 200 mg, Bid, n=80) or low dose sacubitril/valsartan (50 mg, Bid, n=94) treatment, they also received conventional treatment. The changes in echocardiographic parameters, serum N-terminal pro-brain natriuretic peptide(NT-proBNP) and adverse drug reactions (symptomatic hypotension, hyperkalemia, kidney function decline and angioedema, et al) from baseline to 12 months after discharge were assessed. Results After treatment, there was statistically significant difference in left atrial diameter (LAD) of maximum tolerated dose group and low dose group compared with baseline (P<0.05), however, there was no statistically significant difference between the two groups (P>0.05). The left ventricular end diastolic diameter (LVEDD) were significantly decreased in two groups compared with baseline (P<0.05), but there was no statistically significant difference between the two groups (P>0.05). The left ventricular ejection fraction(LVEF) were significantly increased in both groups compared with baseline (P<0.05), but there was no statistically significant difference between the two groups (P>0.05). The decrease of serum NT-proBNP levels was higher in maximum tolerated dose group than that in low dose group (P<0.05). The incidence of drug-related adverse reactions was higher in the maximum tolerated group (17.5% vs 2.1%, P<0.05). Conclusion Compared with low dose sacubitril/valsartan group, the maximum tolerated dose group did not show significant advantages in improving cardiac remodeling and LVEF. Although it may be possible to reduce cardiovascular events by further reducing NT-proBNP levels, strict titration of the maximum tolerable dose was closely related to frequent adverse drug reactions.

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伍金雷,卓裕丰,陈钦修,程宏基,谢文杰,何惠芳,冯燕玲.不同剂量沙库巴曲缬沙坦对心肌梗死后心室重构的疗效及安全性评价[J].中国动脉硬化杂志,2023,(10):885~890.

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  • 收稿日期:2023-03-09
  • 最后修改日期:2023-08-28
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  • 在线发布日期: 2023-11-08