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
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北京市科技计划项目(Z231100004623011)


Consistency and clinical utility of serum concentration data processing software-assisted interpretation of antidepressant therapeutic drug monitoring results
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    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 χ2 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(χ2 =75.00,P< 0.001)。配对 χ2 检验结果显示,软件 + 医 师联合判读异常 TDM 结果的敏感度(χ2 =64.00,P< 0.001)及特异度(χ2 =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。

    Abstract:

    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). Paired χ2 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 (χ2 =75.00, P < 0.001). Paired χ2 test showed that the sensitivity (χ2 =64.00, P < 0.001) and specificity (χ2 =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 significant. The comparison of AUC between the two interpretation methods showed that the accuracy of software + physician combined interpretation was better than that of independent physician interpretation (0.991 vs 0.647), and the difference was statistically significant (Z=12.51, P< 0.001). Conclusions The serum concentration data processing software shows high consistency between the TDM results and the reference standards, which helps to improve the identification and cause analysis of abnormal TDM results by junior psychiatrists.

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王瀚,果伟,范安豫阳,吕楠,朱雪泉,张群磊,何强,符芳刚,冯立,张玲,王刚.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[J].神经疾病与精神卫生,2024,24(8):539-544
DOI :10.3969/j. issn.1009-6574.2024.08.002.

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  • 在线发布日期: 2024-09-09