204例精神分裂症患者服用利培酮分散片的血药浓度监测及其影响因素分析  

Plasma Concentration Monitoring and Influential Factors Analysis of Risperidone Dispersible Tablets in 204 Schizophrenia Patients

作　　者：贾晓妮[1] 张燕[2] 张晓红[1] 陈建波[1] 成昱霖[1] 支媗[1] JIA Xiaoni;ZHANG Yan;ZHANG Xiaohong;CHEN Jianbo;CHENG Yulin;ZHI Xuan(Dept.of Pharmacy,Xi’an Mental Health Center,Xi’an 710100,China;Pharmacy Laboratory,Xi’an Mental Health Center,Xi’an 710100,China)

机构地区：[1]西安市精神卫生中心药剂科,西安710100 [2]西安市精神卫生中心药学实验室,西安710100

出　　处：《中国药房》2018年第17期2407-2411,共5页China Pharmacy

基　　金：国家自然科学青年科学基金资助项目(No.81202938);陕西省卫生和计划生育委员会卫生科研项目(No.2016D048)

摘　　要：目的:评价精神分裂症患者服用利培酮分散片后的血药浓度监测结果,分析其影响因素,并制订利培酮分散片的血药浓度参考值范围,为临床合理用药提供参考。方法:选取西安市精神卫生中心2017年1-12月服用利培酮分散片系统治疗并且进行血药浓度(以利培酮与9-羟基利培酮血药谷浓度之和计)监测的精神分裂症患者204例,采用SPSS 22.0软件进行统计,分析血药浓度的影响因素(性别、年龄、日剂量、联合用药),统计不同血药浓度范围内患者第4周精神分裂阳性和阴性症状量表(PANSS)减分率>49%和发生不良反应的区间比例。结果:204例患者服用利培酮分散片后的血药浓度中位数为50.55 ng/m L(34.83～73.50ng/m L);患者性别、联用或单用药物对血药浓度无明显影响(P>0.05);患者年龄对血药浓度有显著影响(P<0.05);利培酮分散片日剂量与血药浓度呈线性关系(P<0.05);血药浓度<20、20～<30、30～<45、45～<60、60～<90、90～<120、≥120 ng/m L的患者第4周PANSS减分率>49%的区间比例分别为13.33%、34.78%、53.33%、47.83%、38.10%、38.89%、20.00%,发生不良反应的区间比例分别为0、0、2.22%、2.17%、11.90%、16.67%、46.67%。结论:利培酮分散片血药浓度受患者年龄、日剂量等因素的影响,个体差异较大,推荐患者在血药浓度20～60 ng/m L范围内进行治疗。OBJECTIVE:To evaluate the results of plasma concentration monitoring of schizophrenia patients after giving Risperidone dispersible tablets,analyze its influential factors and formulate plasma concentration reference value of Risperidone dispersible tablets,and to provide reference of rational drug use in the clinic.METHODS:Totally 204 schizophrenia patients,who used Risperidone dispersible tablets and received plasma concentration monitoring(by trough concentration of risperidone and 9-hydroxyrisperidone)in Xi’an Mental Health Center from Jan.-Dec.2017,were collected.The plasma concentration of influential factors as gender,age,daily dose and drug combination were analyzed statistically by using SPSS 22.0 software.The proportion of 4th week PANSS reduction rate>49%and ADR were analyzed statistically among patients with different plasma concentrations.RESULTS:Median value of plasma concentration of Risperidone dispersible tablets was 50.55 ng/mL in 204 patients after medication(34.83-73.50 ng/mL).The gender,drug combination or drug alone had no significant effect on plasma concentration(P>0.05).Patient’s age had no significant effect on plasma concentration(P<0.05).There is a linear relationship between daily dose of Risperidone dispersible tablets and blood concentration(P<0.05).The proportion of 4th week PANSS reduction rate>49%were 13.33%,34.78%,53.33%,47.83%,38.10%,38.89%and 20.00%for patients with plasma concentration of<20,20~<30,30~<45,45~<60,60~<90,90~<120 and≥120 ng/mL;the proportion of ADR were 0,0,2.22%,2.17%,11.90%,16.67%and 46.67%,respectively.CONCLUSIONS:The plasma concentration of Risperidone dispersible tablets is affected by age,daily dose and other factors,and there are great individual differences.It is recommended that patients are treated at a plasma concentration of 20-60 ng/mL.

关 键 词：利培酮分散片 精神分裂症 血药浓度监测 影响因素 

分 类 号：R969.1[医药卫生—药理学]