某三甲精神专科医院口服利培酮患者血药浓度监测结果分析  

Analysis of serum concentration monitoring results in patients with oralrisperidone in a grade A psychological hospital

作　　者：牛梦溪 庄红艳[2] 仇琪[1,4] Meng-Xi NIU;Hong-Yan ZHUANG;Qi QIU(Pharmaceutical Department,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China;Pharmaceutical Department,Beijing Anding Hospital,Capital Medical University,Beijing 100088,China;The National Clinical Research Center for Mental Disorders&Beijing Key Laboratory of Mental Disorders,Beijing Anding Hospital,Capital Medical University,Beijing 100069,China;College of Pharmacy,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学附属北京安贞医院药事部,北京100029 [2]首都医科大学附属北京安定医院药事部,北京100088 [3]首都医科大学附属北京安定医院国家精神心理疾病临床医学研究中心和精神疾病诊断与治疗北京市重点实验室,北京100069 [4]首都医科大学药学院,北京100069

出　　处：《药物流行病学杂志》2023年第7期721-729,共9页Chinese Journal of Pharmacoepidemiology

基　　金：首都卫生发展科研专项项目(2020-1-2031);北京市属医院科研培育计划(PZ2020031)。

摘　　要：目的 分析某三甲精神专科医院口服使用利培酮患者的血药浓度监测现状,探讨影响利培酮血药浓度的客观因素。方法 收集2019年5—7月某院口服利培酮制剂患者稳态血药浓度检测结果及其病例资料,回顾性分析每日给药剂量、体重指数(BMI)、年龄、性别、合并用药与血药浓度的关系,以及不同人群的血药浓度相关数据。结果共纳入299例次利培酮血药浓度结果数据,62.88%在治疗参考浓度范围(20~60 ng·mL^(-1))内。老年患者(≥60岁)中位值血药浓度和每日给药剂量均低于中青年患者(P <0.001),但代谢能力无明显差异,且不受年龄和性别影响。低体重患者的给药剂量和血药浓中位值与体重正常、超重和肥胖的患者组间差异无统计学意义,而代谢物/母药比值高于体重正常、超重和肥胖的患者(P <0.001)。女性患者的每日给药剂量低于男性患者(P=0.01),浓度/剂量比值高于男性患者(P <0.001),且浓度/剂量比值在老年组(P=0.04)与非老年组(P <0.001)的男女患者比较的结果一致,差异有统计学意义。合并丙戊酸治疗患者的代谢物/母药浓度比值高于利培酮单药治疗患者(P=0.003)。血药浓度低于治疗参考浓度范围下限组合并用药中位值为1,高于上限组为0,两组差异有统计学意义(P=0.023)。结论 患者年龄、给药剂量、性别、BMI与合并用药会直接或间接影响患者的血药浓度。BMI低于正常范围患者利培酮代谢过程可能存在抑制。女性患者、合并丙戊酸钠也可能影响利培酮的体内代谢。Objective To analyze the current status of blood concentration monitoring in patients using risperidone orally in a grade A psychological hospital,and to explore the objective factors affecting the blood concentration of risperidone.Methods All the results of risperidone serum concentration with oral administration and related patient information and case data in the hospital from May,2019 to July,2019 were collected.Retrospective analysis was used to explore the relationship between daily dose administered,body mass index(BMI),age,gender,combined medications and blood concentration,and data related to blood concentration in different populations.Results Pharmacokinetic data from 299 inpatients met inclusion criteria,with 62.88%demonstrating risperidone concentrations within the therapeutic reference concentration range(20-60 ng·mL^(-1)).The median valece of risperidone concentrations and doses were lower in geriatric(≥60 years)versus young and middle-aged patients(both P<0.01),though no differences in metabolizing capacity were observed by age or sex.The administered dose and median blood concentration in low body weight patients showed no statistically significant difference compared to patients with normal,overweight and obese body weight,while the metabolite/parent drug ratio was higher than that of patients with normal,overweight and obese body weight(P<0.001).The daily dosage of female patients was lower than that of male patients(P=0.01).The concentration/dosage ratio of female patients was higher than that of male patients(P<0.001).The concentration/dosage ratio was consistent with the results comparing male and female patients in both elderly(P=0.04)and non-elderly(P<0.001)groups,with the difference being statistically significant.The metabolite/parent drug ratio of patients combined valproate therapy was higher than that of patients treated with risperidone alone(P=0.003).The median value of combined medications was 1 in the group with blood concentration below the lower limit of the therapeutic rang

关 键 词：利培酮 9-羟基利培酮 治疗药物监测 影响因素 

分 类 号：R969.1[医药卫生—药理学]