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血清地高辛浓度超警戒值的危险因素分析及风险预测模型构建
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          邱素君 ,蔡艺美 ,刘金泳 ,王红珊 (1.广州市第一人民医院南沙医院药学科,广州 511457;2.广州市第一
          人民医院南沙医院门诊部,广州 511457;3.广州市第一人民医院南沙医院感染管理科,广州 511457)
          中图分类号  R969.3      文献标志码  A      文章编号  1001-0408(2026)06-0788-06
          DOI  10.6039/j.issn.1001-0408.2026.06.16

          摘   要  目的  分析血清地高辛浓度(SDC)超警戒值发生的危险因素,并构建风险预测模型。方法  回顾性收集 2020 年 9 月至
          2025年3月于广州市第一人民医院及广州市第一人民医院南沙医院规律口服地高辛并完成治疗药物监测的住院患者的临床资
          料。以SDC>2.0 ng/mL的患者作为超警戒值组,SDC≤2.0 ng/mL的患者作为非超警戒值组,在单因素分析的基础上采用多因素
          Logistic回归分析筛选SDC超警戒值发生的独立危险因素,据此建立风险预测模型并绘制列线图。通过受试者操作特征(ROC)
          曲线评价模型的区分度;绘制校准曲线评价模型的校准度;采用Hosmer-Lemeshow检验评价模型的拟合优度;采用决策曲线分析
         (DCA)评估模型的临床应用价值。结果  共纳入254例患者,其中49例(19.29%)患者的SDC超警戒值。单因素分析和多因素Lo‐
          gistic回归分析显示,单位体重日剂量增加、年龄增长、合并冠心病、血肌酐水平升高、合并使用胺碘酮、合并使用去乙酰毛花苷为
          SDC超警戒值发生的独立危险因素(P<0.05)。模型ROC曲线下面积为0.869(95%置信区间为0.818~0.920),敏感度为0.796,特
          异性为 0.842;Hosmer-Lemeshow 检验的 P 值为 0.570,校准曲线与理想曲线贴合紧密,平均绝对误差为 0.012;当风险阈值概率为
          6%~82%时,使用模型的临床净获益较高。结论  单位体重日剂量增加、年龄增长、合并冠心病、血肌酐水平升高、合并使用胺碘
          酮、合并使用去乙酰毛花苷是SDC超警戒值发生的独立危险因素;基于上述因素建立的风险预测模型可用于预测SDC超警戒值
          的发生风险。
          关键词  地高辛;血清药物浓度;超警戒值;危险因素;列线图;预测模型

          Analysis of risk factors for serum digoxin concentration exceeding the warning threshold and construction
          of prediction model
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          QIU Sujun ,CAI Yimei ,LIU Jinyong ,WANG Hongshan(1.  Dept.  of  Pharmacy,  Nansha  Branch,  Guangzhou
          First  People’s  Hospital,  Guangzhou  511457,  China;2.  Dept.  of  Outpatient,  Nansha  Branch,  Guangzhou  First
          People’s  Hospital,  Guangzhou  511457,  China;3.  Dept.  of  Infection  Management,  Nansha  Branch,  Guangzhou
          First People’s Hospital, Guangzhou 511457, China)
          ABSTRACT    OBJECTIVE To analyze the risk factors associated with serum digoxin concentration (SDC) exceeding the warning
          threshold  and  to  construct  a  risk  prediction  model.  METHODS  Clinical  data  were  retrospectively  collected  from  hospitalized
          patients  who  received  regular  oral  digoxin  and  completed  therapeutic  drug  monitoring  at  Guangzhou  First  People’s  Hospital  and
          Nansha  Branch  of  Guangzhou  First  People’s  Hospital  between  September  2020  and  March  2025.  Patients  with  SDC>2.0  ng/mL
          were  classified  as  exceeding  the  warning  threshold  group,  while  those  with  SDC≤2.0  ng/mL  were  classified  as  the  non-exceeding
          the  warning  threshold  group.  Based  on  univariate  factor  analysis,  multivariate  Logistic  regression  analysis  was  used  to  identify
          independent risk factors for SDC exceeding the warning threshold. A prediction model was developed and a nomogram was plotted
          accordingly.  The  discriminative  ability  of  the  model  was  evaluated  by  receiver  operating  characteristic (ROC)  curve  analysis,  and
          the calibration curve were plotted to assess the calibration of the model. The Hosmer-Lemeshow test was employed to evaluate the
          goodness  of  fit  of  the  model,  and  clinical  utility  was  evaluated  by  decision  curve  analysis (DCA).  RESULTS  A  total  of  254
          patients  were  included,  among  whom  49  patients (19.29%)  had  SDC  exceeding  the  warning  threshold.  Univariate  factor  analysis
          and  multivariate  Logistic  regression  analysis  showed  that  increased  daily  dose  per  kilogram  of  body  weight,  advanced  age,
          concomitant  coronary  heart  disease,  elevated  serum  creatinine  levels,  concomitant  use  of  amiodarone,  and  concomitant  use  of
          deslanoside  were  independent  risk  factors  for  SDC  exceeding  the  warning  threshold (P<0.05).  The  area  under  the  ROC  curve  of
          the model was  0.869 (95%  confidence interval:  0.818-0.920),  with a sensitivity of  0.796  and a specificity of  0.842. The Hosmer-
          Lemeshow  test  showed  good  calibration (P=0.570). The  calibration  curve  was  closely  aligned  with  the  ideal  curve,  with  a  mean
                                                              absolute  error  of  0.012.  The  model  provided  a  higher  net
              Δ 基金项目 广东省医院药学研究基金(济民可信药学信息化专                   benefit  across  a  threshold  probability  range  of  6%  to  82%.
          项基金)项目(No.2019YX07)                                 CONCLUSIONS  The  increased  daily  dose  per  kilogram  of
             *第一作者 主管药师,硕士。研究方向:医院药学。E-mail:
                                                              body  weight,  advanced  age,  concomitant  coronary  heart
          qiusujun@163.com
              # 通信作者 主任药师,硕士。研究方向:临床药学。E-mail:                disease,  elevated  serum  creatinine  levels,  concomitant  use  of
          whscc@126.com                                       amiodarone,  and  concomitant  use  of  deslanoside  are


          · 788 ·    China Pharmacy  2026 Vol. 37  No. 6                               中国药房  2026年第37卷第6期
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