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GDMT方案加用维立西呱治疗射血分数降低型心力衰竭的有效

          性和安全性
                           Δ

          赵兴媛 ,陈祥燕 ,胡 楠 ,王莉英 ,薛 晖 ,夏宗玲 (1. 苏州大学附属第三医院药学部,江苏 常州
                                                              1, 2 #
                 1*
                           1
                                             2
                                                     2
                                   1, 2
          213003;2.常州市第一人民医院药学部,江苏 常州 213003)
          中图分类号  R972;R541.6      文献标志码  A      文章编号  1001-0408(2025)17-2165-05
          DOI  10.6039/j.issn.1001-0408.2025.17.14
          摘  要  目的  评估指南指导的药物治疗(GDMT)方案加用维立西呱治疗射血分数降低型心力衰竭(HFrEF)的有效性和安全性。
          方法  回顾性选择2023年1月至2024年5月在常州市第一人民医院接受规范化诊疗的HFrEF患者346例为研究对象,分为标准治
          疗组(n=215)和维立西呱组(n=131)。标准治疗组患者采用GDMT方案,维立西呱组患者采用GDMT加用维立西呱方案。采用
          倾向评分匹配(PSM)法平衡组间混杂因素,并评估两组患者有效性(包括结局指标和预后判断指标)和安全性(不良事件发生情
          况)。绘制主要和次要结局事件的Kaplan-Meier生存曲线,并通过单因素、多因素Cox回归分析筛选主要结局复合终点事件的影
          响因素。结果  PSM后,标准治疗组和维立西呱组患者各100例,两组患者的基线资料比较,差异均无统计学意义(P>0.05)。随
          访1年,标准治疗组和维立西呱组患者的主要结局复合终点事件累积发生率、因心力衰竭住院事件累积发生率、治疗前后的氨基
          末端脑利钠肽前体变化值差异均有统计学意义(P<0.05)。两组患者的不良事件发生率比较,差异无统计学意义(P>0.05)。多
          因素Cox回归分析结果显示,患者左室射血分数≤35%是1年内发生复合终点事件的危险因素[风险比(HR)=2.090,95%置信区
          间(CI)(1.175,3.718),P=0.012],使用维立西呱是 1 年内发生复合终点事件的保护因素[HR=0.505,95%CI(0.284,0.899),P=
          0.020]。结论  与GDMT方案比较,GDMT加用维立西呱方案可改善HFrEF患者的临床症状及预后,且安全性良好。
          关键词  维立西呱;射血分数降低型心力衰竭;真实世界研究;预后

          Efficacy  and  safety  of  vericiguat  added  to  GDMT  regimen  in  the  treatment  of  heart  failure  with  reduced
          ejection fraction
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                         1
                                          1
          ZHAO Xingyuan ,CHEN Xiangyan ,HU Nan ,WANG Liying ,XUE Hui ,XIA Zongling (1.  Dept.  of
                                                    1, 2
          Pharmacy, the Third Affiliated Hospital of Soochow University, Jiangsu Changzhou 213003, China;2. Dept. of
          Pharmacy, the First People’s Hospital of Changzhou, Jiangsu Changzhou 213003, China)
          ABSTRACT   OBJECTIVE  To  evaluate  the  efficacy  and  safety  of  guideline-directed  medical  therapy (GDMT)  combined  with
          vericiguat in treating heart failure with reduced ejection fraction (HFrEF). METHODS A retrospective study was conducted on 346
          patients  with  HFrEF  who  received  standardized  diagnosis  and  treatment  at  the  First  People’s  Hospital  of  Changzhou  from  January
          2023  to  May  2024.  They  were  divided  into  standard  treatment  group (n=215)  and  vericiguat  group (n=131).  Patients  in  the
          standard  treatment  group  received  GDMT,  while  patients  in  the  vericiguat  group  received  GDMT  combined  with  vericiguat.
          Propensity  score  matching (PSM)  was  used  to  balance  confounding  factors  between  two  groups,  and  the  effectiveness (including
          outcome and prognostic indicators) and safety (occurrence of adverse events) of both groups were evaluated. Kaplan-Meier survival
          curves for primary and secondary outcome events were drawn, and the influential factors of primary outcome events were screened
          through  univariate  and  multivariate  Cox  regression  analysis.  RESULTS  After  PSM,  there  were  100  patients  in  the  standard
          treatment  group  and  100  patients  in  the  vericiguat  group,  and  there  was  no  statistically  significant  differences  in  baseline  data
          between  two  groups (P>0.05).  During  a  1-year  follow-up,  there  were  statistically  significant  differences  in  the  cumulative
          incidence  of  major  outcome  events  between  the  standard  treatment  group  and  the  vericiguat  group,  cumulative  incidence  of
          hospitalization  events  due  to  heart  failure,  changes  in  N-terminal  pro-B-type  natriuretic  peptide  levels  before  and  after  treatment
          between  the  standard  treatment  group  and  the  vericiguat  group (P<0.05).  There  was  no  statistically  significant  difference  in  the
          incidence  of  adverse  events  between  the  two  groups (P>0.05).  Multivariate  Cox  regression  analysis  results  showed  that  left
          ventricular ejection fraction ≤35% was a risk factor for the occurrence of major outcome events within 1 year [hazard ratio (HR)=
          2.090,  95%  confidence  interval (CI):  1.175-3.718,  P=0.012],  while  the  use  of  vericiguat  was  a  protective  factor  for  the
                                                             occurrence  of  major  outcome  events  within  1  year (HR=
             Δ 基金项目 常州市青年医学创新人才培养项目(No.KY201129);            0.505,  95%CI:  0.284-0.899,  P=0.020).  CONCLUSIONS
          常州市科技计划应用基础研究计划项目(No.CJ20242024);江苏省医
                                                             Compared  with  GDMT,  GDMT  combined  with  vericiguat  can
          院协会医院药事管理研究专项(No.JSYGY-2-2024-YS48)
             * 第一作者 硕 士 研 究 生 。 研 究 方 向 :临 床 药 学 。 E-mail:   improve  the  clinical  symptoms  and  prognosis  of  HFrEF
          zxy83889@163.com                                   patients, and has good safety.
             # 通信作者 主任药师,硕士生导师。研究方向:临床药学、药物经                 KEYWORDS     vericiguat;  heart  failure  with  reduced  ejection
          济学。E-mail: lysaxia@163.com                         fraction; real-world research; prognosis


          中国药房  2025年第36卷第17期                                              China Pharmacy  2025 Vol. 36  No. 17    · 2165 ·
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