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·药物与临床·


          替加环素相关药物性胆汁淤积性肝病的影响因素分析及风险预测

          模型构建
                        Δ

          刘丽娜 ,王建青 ,张 伦,俞 军[安徽省公共卫生临床中心(安徽医科大学第一附属医院北区)药学部,合肥
                *
                         #
          230012]


          中图分类号  R969.3      文献标志码  A      文章编号  1001-0408(2025)20-2555-06
          DOI  10.6039/j.issn.1001-0408.2025.20.12

          摘  要  目的  分析替加环素(TGC)相关药物性胆汁淤积性肝病(DIC)的影响因素,并建立风险预测模型。方法  收集2022年8
          月-2024年8月于我院接受TGC治疗的707例住院患者的临床资料,按8∶2的比例将其随机分为训练集(n=566)和测试集(n=
          141)。通过最小绝对收缩和选择算子回归分析筛选预测变量,采用多因素Logistic回归分析筛选TGC相关DIC的独立危险因素,
          并基于上述因素绘制列线图预测模型;采用受试者操作特征曲线(ROC曲线)及其曲线下面积(AUC)评估模型的预测性能,采用
          Hosmer-Lemeshow拟合优度检验和校准曲线评估模型的准确度,采用决策曲线分析评估模型的临床净收益。结果  707例患者中,
          93例患者发生DIC,发生率为13.15%。性别、年龄、TGC大剂量给药、入住重症监护室、TGC用药时间、合并使用抗真菌药伏立康
          唑是TGC相关DIC发生的独立危险因素(P<0.05)。训练集模型ROC曲线的AUC为0.745(95%置信区间为0.687~0.801),灵敏
          度为 76.6%,特异度为 60.3%;测试集模型 ROC 曲线的 AUC 为 0.762(95% 置信区间为 0.650~0.900),灵敏度为 81.3%,特异度为
          72.0%。训练集、测试集模型Hosmer-Lemeshow拟合优度检验的χ 分别为5.187、9.980,P分别为0.737、0.266;校准曲线的平均绝
                                                             2
          对误差分别为0.012、0.038;风险阈值范围分别为4%~45%、4%~28%。结论  患者的年龄、性别、TGC大剂量给药、入住重症监护
          室、TGC用药时间、合并使用抗真菌药伏立康唑是TGC相关DIC发生的独立危险因素;基于以上因素所建的TGC相关DIC预测模
          型的预测性能、准确度均较好。
          关键词  替加环素;药物性胆汁淤积性肝病;药物性肝损伤;影响因素;预测模型

          Analysis  of  influential  factors  and  the  construction  of  a  risk  prediction  model  for  tigecycline-related  drug-
          induced cholestatic liver disease
          LIU Lina,WANG Jianqing,ZHANG Lun,YU Jun[Dept. of Pharmacy, Anhui Public Health Clinical Center (the
          First Affiliated Hospital of Anhui Medical University North District), Hefei 230012, China]

          ABSTRACT   OBJECTIVE  To  analyze  the  influential  factors  of  drug-induced  cholestatic  liver  disease (DIC)  related  to
          tigecycline (TGC),  and  establish  a  prediction  model  for  the  risk  of  this  adverse  reaction.  METHODS  Data  of  707  hospitalized
          patients  who  received  TGC  treatment  in  our  hospital  from August  2022  to August  2024  were  collected  and  randomly  divided  into
          training set (n=566) and test set (n=141) at a ratio of 8∶2. Prediction variables were screened using the least absolute shrinkage
          and  selection  operator  regression  analysis.  Multivariate  Logistic  regression  analysis  was  used  to  screen  the  independent  risk  factors
          for TGC-related DIC, and a nomogram prediction model was drawn based on the above factors. The prediction performance of the
          model was evaluated by the receiver operator characteristic curve (ROC curve) and its area under the curve (AUC). The accuracy
                                                             of the model was assessed by the Hosmer-Lemeshow goodness-
             Δ 基金项目 国家自然科学基金项目(No.82073566);安徽省卫生
                                                             of-fit test and calibration curves. The clinical net benefit of the
          健康科研项目(No.皖卫传〔2023〕515号);安徽省教育厅高等学校省级
          质量工程项目(No.皖教秘高〔2024〕55号);安徽省公共卫生临床中心               prediction  model  were  evaluated  by  decision  curve  analysis.
         (安徽医科大学第一附属医院北区)院内临床重点专科(培育专科)建                     RESULTS  Among  the  707  patients,  93  patients  developed
          设项目(No. 院医字〔2023〕17 号);院科研培育基金项目(No. 院字            DIC,  with  an  incidence  rate  of  13.15%.  Gender,  age,  high-
         〔2022〕4号)                                           dose  administration  of  TGC,  intensive  care  unit  (ICU)
             *第一作者 主管药师,硕士。研究方向:临床药学。E-mail:
                                                             admission,  duration  of  medication  of  TGC,  and  concurrent
          2146158060@qq.com
             # 通信作者 主任药师,教授,博士。研究方向:临床药学。E-mail:             use  of  antifungal  drug  voriconazole  were  independent  risk
          jianqingwang81@126.com                             factors  for  the  occurrence  of TGC-related  DIC (P<0.05). The


          中国药房  2025年第36卷第20期                                              China Pharmacy  2025 Vol. 36  No. 20    · 2555 ·
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