血药浓度数据处理软件辅助判读抗抑郁药治疗药物监测结果的一致性及临床应用价值研究  

Consistency and clinical utility of serum concentration data processing software-assisted interpretation of antidepressant therapeutic drug monitoring results

作　　者：王瀚 果伟[1] 范安豫阳 吕楠 朱雪泉[1] 张群磊 何强 符芳刚 冯立 张玲[1] 王刚[1] Wang Han;Guo Wei;Fan Anyuyang;Lyu Nan;Zhu Xuequan;Zhang Qunlei;He Qiang;Fu Fanggang;Feng Li;Zhang Ling;Wang Gang(Beijing Anding Hospital,Capital Medical University&National Medical Center for Mental Disorders&National Clinical Research Centre for Mental Disorders,Beijing 100088,China;Psychology Department,Shandong Mental Health Center,Jinan 250000,China;Psychology Department,Hainan Provincial Anning Hospital,Haikou 570100,China)

机构地区：[1]首都医科大学附属北京安定医院、国家精神疾病医学中心、国家精神心理疾病临床医学研究中心,北京100088 [2]山东省精神卫生中心临床心理科,济南250000 [3]海南省安宁医院精神科,海口570100

出　　处：《神经疾病与精神卫生》2024年第8期539-544,共6页Journal of Neuroscience and Mental Health

基　　金：北京市科技计划项目(Z231100004623011)。

摘　　要：目的评价血药浓度数据处理软件智能化判读抗抑郁药治疗药物监测(TDM)结果与参考标准的一致性,并判断其在辅助初级精神科医师识别异常TDM结果方面的临床应用价值。方法选取2024年3月1—31日于首都医科大学附属北京安定医院住院治疗的226例抑郁症患者为研究对象。首先验证“软件”判读TDM结果与参考标准的一致性。随后,从3个临床中心招募10名通过考核且一致性良好的初级医师进行TDM结果判读。所有TDM结果随机平均分配,每名医师对同一病例的TDM结果进行先后2次判读,一次为单独医师判读,另一次为“软件”辅助医师(软件+医师)判读。采用配对χ^(2)检验分析两种判读方式与参考标准的差异以及两种判读方式的灵敏度、特异度及准确度差异,并采用受试者工作特征(ROC)曲线曲线下面积(AUC)比较两种判读方式的应用效能。结果226例患者的TDM结果中,有109例(48.23%)异常。“软件”识别异常TDM结果与参考标准的一致率为100%。单独医师判读的准确率为65.93%(95%CI=59.35%~72.08%),低于“软件”辅助下的准确率99.12%(95%CI=96.84%~99.89%),差异有统计学意义(χ^(2)=75.00,P<0.001)。配对χ^(2)检验结果显示,软件+医师联合判读异常TDM结果的敏感度(χ^(2)=64.00,P<0.001)及特异度(χ^(2)=6.23,P<0.05)均优于单独医师判读。两种判读方式的AUC比较结果显示,软件+医师联合判读的准确性优于单独医师判读(0.991比0.647),差异有统计学意义(Z=12.51,P<0.001)。结论血药浓度数据处理软件判读TDM结果与参考标准具有高度一致性,有助于提高初级精神科医生对异常TDM结果的识别与原因解析。Objective To evaluate the consistency between the intelligent interpretation of antidepressant therapeutic drug monitoring(TDM)results using blood drug concentration data processing software and reference standards,and assess its clinical utility in assisting junior psychiatrists in identifying abnormal TDM results.Methods From March 1 to 31,2024,226 patients with depressive disorder hospitalized at Beijing Anding Hospital affiliated with Capital Medical University were selected as research subjects.Firstly,the consistency between the TDM results interpreted by the software and the reference standards was verified.Subsequently,10 junior physicians who passed the assessment and had good consistency were recruited from three clinical centers for TDM result interpretation.All TDM results were randomly and evenly distributed,and each physician interpreted the TDM results of the same case twice in sequence,once by an independent physician and once by software assisted physician(software+physician).Pairedχ^(2)test was used to analyze the differences between two interpretation methods and reference standards,as well as the differences in sensitivity,specificity,and accuracy.The area under the receiver operating characteristic(ROC)curve(AUC)was used to compare the efficiency of two interpretation methods.Results Among the TDM results of which of 226 patients,109(48.23%)were abnormal.The consistency rate between the abnormal TDM results identified by the software and the reference standard was 100%.The accuracy of individual physician interpretation was 65.93%(95%CI=59.35%-72.08%),lower than the assistance of"software",of which the accuracy was 99.12%(95%CI=96.84%-99.89%),and the difference was statistically significant(χ^(2)=75.00,P<0.001).Pairedχ^(2)test showed that the sensitivity(χ^(2)=64.00,P<0.001)and specificity(χ^(2)=6.23,P<0.05)of the software+physician combined interpretation of abnormal TDM results were superior to those of independent physician interpretation,and the differences were statistically signifi

关 键 词：抗抑郁药 药物监测 血药浓度数据处理软件 一致性 

分 类 号：R969.1[医药卫生—药理学]