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他克莫司治疗儿童激素耐药型肾病综合征期间出现急性肾损伤

          的危险因素及预测模型研究
                                                     Δ


                                           3 #
          刘育青 ,朱 磊 ,韩兆欢 ,赵 蕾 (1.徐州市儿童医院药学部,江苏 徐州 221006;2.徐州市儿童医院重症
                                   1
                           2
                 1*
          医学科,江苏 徐州 221006;3.徐州医科大学附属医院药学部,江苏 徐州 221000)
          中图分类号  R969.3;R692      文献标志码  A      文章编号  1001-0408(2026)01-0066-06
          DOI  10.6039/j.issn.1001-0408.2026.01.12

          摘   要  目的  探讨儿童激素耐药型肾病综合征(SRNS)患者在接受他克莫司治疗期间出现急性肾损伤(AKI)的危险因素,并构
          建其预测模型。方法  回顾性选取 2022 年 1 月 1 日至 2023 年 12 月 31 日在徐州市儿童医院确诊为 SRNS 并接受他克莫司治疗的
          155例患儿作为研究对象。通过调阅病历系统收集患儿的各类临床资料,将用药期间发生AKI的患儿作为AKI组(n=26),未发
          生AKI的患儿作为对照组(n=129)。采用单因素和多因素Logistic回归分析筛选出独立危险因素,并基于显著变量构建临床预测
          模型,同时绘制列线图、校准曲线、受试者操作特征曲线及决策曲线以评价模型性能。结果  单因素分析显示,血尿素氮(BUN)、血
          肌酐(Scr)、估算肾小球滤过率(eGFR)、他克莫司最大谷浓度(cmin )、CYP3A5*3/*3基因型、并发感染、并发高血压以及使用非甾体
          抗炎药是SRNS患儿接受他克莫司治疗期间发生AKI的影响因素(P<0.05);多因素Logistic回归分析显示,BUN≥9.58 mmol/L、
          Scr≥125 μmol/L、eGFR<37 mL/(min·1.73 m²)、他克莫司最大cmin≥11.26 ng/mL、CYP3A5*3/*3基因型、并发感染及并发高血压是
          影响 SRNS 患儿接受他克莫司治疗期间发生 AKI 的独立危险因素(P<0.05)。构建的临床预测模型的曲线下面积=0.747,预测
          AKI发生情况与实际AKI发生情况较为吻合,并且在预测患儿AKI发生时具有良好的临床净获益。结论  基线肾功能受损(BUN
          升高、Scr升高及eGFR下降)、他克莫司最大cmin偏高、CYP3A5*3/*3基因型、治疗过程中并发感染和高血压是SRNS患儿使用他克
          莫司治疗期间发生AKI的独立危险因素。所建临床预测模型为实施风险分层管理提供了科学依据。
          关键词  他克莫司;激素耐药型肾病综合征;儿童;急性肾损伤;危险因素;风险预测模型

          Study  on  the  risk  factors  and  predictive  model  for  acute  kidney  injury  during  tacrolimus  treatment  for
          pediatric steroid-resistant nephrotic syndrome
                               2
          LIU  Yuqing ,ZHU  Lei ,HAN  Zhaohuan ,ZHAO  Lei(1.  Dept.  of  Pharmacy,  Xuzhou  Children’s  Hospital,
                                               1
                     1
                                                           3
          Jiangsu  Xuzhou  221006,  China;2.  Dept.  of  Critical  Care  Medicine,  Xuzhou  Children’s  Hospital,  Jiangsu
          Xuzhou  221006,  China;3.  Dept.  of  Pharmacy,  the Affiliated  Hospital  of  Xuzhou  Medical  University,  Jiangsu
          Xuzhou 221000, China)
          ABSTRACT    OBJECTIVE  To  explore  the  risk  factors  for  acute  kidney  injury (AKI)  in  children  with  steroid-resistant  nephrotic
          syndrome (SRNS) during tacrolimus treatment and construct a predictive model. METHODS A retrospective selection was made of
          155 children diagnosed with SRNS and treated with tacrolimus at Xuzhou Children’s Hospital from January 1, 2022, to December
          31, 2023, serving as the study subjects. Various clinical data of the children were collected by reviewing the medical record system.
          Children  who  developed  AKI  during  medication  were  assigned  to  the  AKI  group (n=26),  and  those  who  did  not  develop  AKI
          were  assigned  to  the  control  group (n=129).  Univariate  and  multivariate  Logistic  regression  analyses  were  used  to  screen
          independent  risk  factors.  A  clinical  predictive  model  was  constructed  based  on  significant  variables,  and  nomogram,  calibration
          curve,  receiver  operator  characteristic  curve,  and  decision  curve  were  drawn  to  evaluate  the  model’s  performance.  RESULTS
          Univariate analysis showed that blood urea nitrogen (BUN), serum creatinine (Scr), estimated glomerular filtration rate (eGFR),
          the  maximum  trough  concentration (cmin )  of  tacrolimus,  CYP3A5*3/*3  genotype,  concurrent  infection,  concurrent  hypertension,
          and  the  use  of  non-steroidal  anti-inflammatory  drugs  were  influencing  factors  for  AKI  in  children  with  SRNS  during  tacrolimus
          treatment (P<0.05).  Multivariate  Logistic  regression  analysis  revealed  that  BUN≥9.58  mmol/L,  Scr≥125  μmol/L,  eGFR<37
                                                              mL/(min·1.73  m),  tacrolimus  maximum  cmin≥11.26  ng/mL,
                                                                           2
              Δ 基金项目 江苏省卫生健康委科研项目(No.M2021083);徐州市            CYP3A5*3/*3  genotype,  concurrent  infection,  and  concurrent
          科技项目(No.KC23202)                                    hypertension  were  independent  risk  factors  for AKI  in  children
             *第一作者 副主任药师,硕士。研究方向:儿童合理用药及个体
                                                              with  SRNS  during  tacrolimus  treatment  (P<0.05).  The
          化给药。E-mail:lyqxzj2012@163.com
              #  通信作者 副 主 任 药 师 。 研 究 方 向 :医 院 药 学 。 E-mail:  constructed  clinical  predictive  model  had  an  area  under  the
          xuzhouzhaolei2008@163.com                           curve  of  0.747,  showing  good  agreement  between  predicted


          · 66 ·    China Pharmacy  2026 Vol. 37  No. 1                                中国药房  2026年第37卷第1期
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