基于治疗药物监测的氨磺必利剂量校正浓度影响因素分析

Analysis of influential factors for dose-corrected trough concentration of amisulpride based on therapeutic drug monitoring

目的分析氨磺必利剂量校正浓度(C/D)的影响因素,为该药的临床合理应用提供参考。方法回顾性收集河北医科大学第一医院精神卫生中心2021年3-11月进行氨磺必利治疗药物监测的精神分裂症住院患者的末次血药浓度监测结果及相关病历资料,分析其年龄、性别、体质量指数(BMI)、血清肌酐水平、联合用药对氨磺必利C/D值的影响。结果共纳入精神分裂症住院患者133例,其氨磺必利中位剂量为600.00 mg/d,中位血清浓度为332.57 ng/mL,中位C/D值为0.61 ng·d/(mL·mg);49例患者的血清药物浓度在相关指南推荐参考范围(100~320 ng/mL)内,27例患者超过实验室警戒水平(640 ng/mL)。不同性别患者的给药剂量、血清药物浓度、C/D值比较,差异均无统计学意义(P>0.05);未成年患者的血清药物浓度显著低于成年患者(P<0.05),但其给药剂量、C/D值与成年患者比较,差异均无统计学意义(P>0.05);肥胖(BMI>28 kg/m^(2))患者的氨磺必利C/D值显著低于正常(BMI为18.5~23.9 kg/m^(2))患者;联用奥氮平、丙戊酸钠、苯二氮卓类药物均不会影响患者的氨磺必利C/D值(P>0.05);患者的血清肌酐水平与氨磺必利给药剂量不相关(r=0.081,P>0.05),但与该药的C/D值呈正相关(r=0.285,P<0.05)。结论患者的年龄、BMI、血清肌酐水平与氨磺必利的C/D值密切相关。临床在应用氨磺必利治疗精神分裂症时,应充分考虑患者的年龄、体质量、血清肌酐等因素,为患者制定个体化用药方案,以保证治疗的安全、有效。

OBJECTIVE To analyze the influential factors for dose-corrected trough concentration(C/D)of amisulpride,and to provide reference for rational use of it in clinic.METHODS The results of the last serum concentration monitoring and relevant medical data of schizophrenic inpatients who were monitored for the treatment of amisulpride in the Mental Health Center of the First Hospital of Hebei Medical University from March to November 2021 were collected retrospectively and analyzed the effects of age,sex,body mass index(BMI),serum creatinine level,and combined medication on the C/D value of amisulpride.RESULTS A total of 133 schizophrenic inpatients were included,and median dose of amisulpride was 600.00 mg/d,median serum concentration was 332.57 ng/mL,and median value of C/D was 0.61 ng·d/(mL·mg).The serum concentration of 49 patients was within the recommended range of relevant guideline(100-320 ng/mL),and 27 patients exceeded the laboratory warning concentration(640 ng/mL).There was no statistical significance in drug dose,serum concentration or C/D value among the patients of different genders(P>0.05).The serum concentration of minor patients was significantly lower than that of adult patients(P<0.05),but there was no statistical significance in drug dose or C/D value between minor patients and adult patients(P>0.05).The C/D value of amisulpride in obese patients(BMI>28 kg/m^(2))was significantly lower than that in normal patients(BMI 18.5-23.9 kg/m^(2));the combination of olanzapine,sodium valproate and benzodiazepines did not affect the C/D value of amisulpride(P>0.05);the level of serum creatinine in patients was not related to the dose of amisulpride(r=0.081,P>0.05),but was positively related to the C/D value of the drug(r=0.285,P<0.05).CONCLUSIONS The age,BMI and serum creatinine level of patients are closely related to the C/D value of amisulpride.In the clinical treatment of schizophrenia with amisulpride,we should fully consider the patient’s age,body mass,serum creatinine and other factors,and develop a personalized drug regimen for patients to ensure the safety and effectiveness of treatment.