Abstract: Background　Risperidone，as an antipsychotic drug，is widely used in the treatment of schizophrenia and other mental disorders. Although the blood concentration of risperidone has been monitored through therapeutic drug surveillance （TDM）technology at home and abroad for many years，there is no consensus on the influence of gender and age differences on the results of its blood concentration. Objective　To analyze the TDM results of risperidone，it provides medication reference for patients with mental disorders such as schizophrenia who are treated with risperidone，promoting the rationalization and individualization of clinical medication. Methods　Based on the hospital information retrieval system，the basic information such as age，gender，blood drug concentration data，monitoring frequency，and the number of monitoring cases of outpatients and inpatients who underwent risperidone blood drug concentration monitoring in Zhongshan Third People's Hospital from 2022 to 2024 was collected. Classification and statistics were conducted based on the risperidone treatment window range recommended by the 2017 Consensus Guidelines for the Monitoring of Therapeutic Drugs of the Society for Neuropsychopharmacology and Pharmacopsychiatry（AGNP）（<20 ng/mL was below the treatment window，20-60 ng/mL was within the treatment window，and >60 ng/mL was above the treatment window）.The risperidone treatment window range recommended by the 2017 Consensus Guideline on therapeutic drug Monitoring of the Association of Neuropsychopharmacology and Pharmacopsychiatry（AGNP）was classified and statistically analyzed（<20 ng/mL was below the treatment window，20-60 ng/mL was within the treatment window，and >60 ng/mL was above the treatment window）. Compare the distribution of risperidone（TDM）in patients of different years，types of visits，age groups，and genders at different treatment Windows and its influence on the blood concentration of risperidone. Data analysis was conducted using SPSS 29.0，and graph drawing was performed using Origin Pro 2021. Results　A total of 2 583 patients were included in this study，and a total of 4 879 monitoring sessions were conducted， among which 1 738 were for females and 3 141 for males. The comparison of the number of risperidone TDM monitoring sessions from 2022 to 2024 showed that the number of monitoring sessions in 2023 increased by 28.61% compared with that in 2022，and in 2024 increased by 71.31% compared with that in 2022，showing a year-on-year increase. Among the 2 583 monitored patients，the proportion of outpatients who received one monitoring was higher than that of inpatients（χ2 =115.48，P<0.001）；The number of inpatients who received monitoring for more than 2 or 3 times was higher than that of outpatients（χ2 =7.22，P=0.007；χ2 =102.68，P<0.001）. There was no statistically significant difference in risperidone blood concentration between outpatients and inpatients（Z=-1.254，P=0.210）. The blood concentration of risperidone in male patients was lower than that in female patients（Z=-11.54，P<0.001）. The comparison of risperidone blood concentrations among patients of different age groups showed statistically significant differences（H=36.56，P<0.001）. From 2022 to 2024，risperidone TDM was monitored 3 445 times（70.61%）within the treatment window，which was lower than 471 times（9.65%）within the treatment window and higher than 963 times（19.74%）within the treatment window. The proportion of monitoring within the treatment window was higher than that of the other two treatment Windows. The difference was statistically significant（χ2 =3 772.19，2 548.73，P<0.001）. The comparison of the monitored blood drug concentrations of risperidone TDM below the treatment window，within the treatment window，and above the treatment window from 2022 to 2024 showed statistically significant differences （H=1 465.03，P<0.001）. There were statistically significant differences in the monitoring ratios of risperidone TDM below the treatment window，within the treatment window，and above the treatment window among patients of different years，age groups，and genders（P<0.001）. The monitored blood drug concentrations of risperidone TDM in male，female and overall samples were 37.4（26.7，52.3）ng/mL，45.3（32.4，60.9）ng/mL and 40.2（28.6，55.6）ng/mL respectively，and the results were all within the range of 20-60 ng/mL. It is consistent with the risperidone treatment window（20-60 ng/mL）recommended by the AGNP consensus.Conclusion　Our fingdings suggest that in clinical practice，individualized treatment with risperidone should be implemented in combination with gender and age differences of patients to increase the proportion of blood drug concentration within the therapeutic window. At the same time，the importance of TDM of risperidone for both outpatients and inpatients should be enhanced，thereby providing a guarantee for the safety and effectiveness of clinical medication.

Key words: Risperidone, Therapeutic drug monitoring, Plasma concentration, Schizophrenia, Therapeutic window, Retrospective analysis

摘要： 背景　利培酮作为一种抗精神病药，被广泛应用于精神分裂症及其他精神障碍疾病的治疗。虽然国内外通过治疗药物监测（TDM）技术监测利培酮血药浓度已多年，但性别、年龄的差异对其血药浓度结果的影响尚未达成共识。目的　通过收集利培酮TDM数据，分析不同就诊类型、性别及年龄患者利培酮TDM在不同治疗窗的分布情况及对利培酮血药浓度的影响，为服用利培酮治疗的精神分裂症等精神疾病患者提供用药参考。方法　基于医院信息检索系统，收集2022—2024年中山市第三人民医院进行利培酮TDM的门诊及住院患者的年龄、性别、血药浓度数据、监测频次、监测例数等基本信息。根据2017年神经精神药理学与药物精神病学协会（AGNP）治疗药物监测共识指南推荐的利培酮治疗窗范围（<20 ng/mL为低于治疗窗，20~60 ng/mL为治疗窗内，>60 ng/mL为高于治疗窗））进行分类统计，比较不同年份、就诊类型、年龄段、性别患者利培酮TDM在不同治疗窗的分布情况及对利培酮血药浓度的影响。数据分析使用SPSS 29.0，图形绘制使用Origin Pro 2021。结果　本研究共纳入2 583例患者，共计监测4 879次，其中女性监测1 738次，男性监测3 141次。2022—2024年利培酮TDM监测次数比较，2023年与2022年监测次数相比增加了28.61%，2024年与2022年监测次数相比增加了71.31%，逐年升高。在2 583例监测患者中，接受1次监测的门诊患者比例高于住院患者（χ2=115.48，P<0.001）；接受2、3次以上监测的住院患者高于门诊患者（χ2=7.22，P=0.007；χ2=102.68，P<0.001）。门诊患者和住院患者的利培酮血药浓度比较，差异无统计学意义（Z=-1.254，P=0.210）；男性患者的利培酮血药浓度低于女性患者（Z=-11.54，P<0.001）；不同年龄段患者利培酮血药浓度比较，差异有统计学意义（H=36.56，P<0.001）。2022—2024年利培酮TDM在治疗窗内监测3 445次（70.61%），低于治疗窗监测471次（9.65%），高于治疗窗监测963次（19.74%），治疗窗内监测比例高于其他两个治疗窗的检测比例，差异有统计学意义（χ2=3 772.19、2 548.73，P<0.001）。2022—2024年利培酮TDM在低于治疗窗、治疗窗内、高于治疗窗的监测血药浓度比较，差异有统计学意义（H=1 465.03，P<0.001）。不同年份、不同年龄段、不同性别患者利培酮TDM在低于治疗窗、治疗窗内、高于治疗窗的监测比例比较，差异均有统计学意义（P<0.001）。男性、女性及总体样本利培酮TDM的监测血药浓度分别为37.4（26.7，52.3）ng/mL、45.3（32.4，60.9）ng/mL、40.2（28.6，55.6）ng/mL，结果均在20~60 ng/mL范围内，与AGNP共识推荐的利培酮治疗窗（20~60 ng/mL）一致。结论　在临床工作中，应考虑性别、年龄差异对利培酮TDM的影响，实施利培酮个体化治疗，以提升血药浓度在治疗窗内的占比，同时重视TDM在门诊及住院患者治疗中的应用，为临床用药的安全、有效提供保障。

关键词: 利培酮, 治疗药物监测, 血药浓度, 精神分裂症, 治疗窗, 回顾性分析