贾晓妮 张燕 张晓红 陈建波 成昱霖 支媗

中图分类号 R969.1 文献标志码 A 文章编号 1001-0408（2018）17-2407-05

DOI 10.6039/j.issn.1001-0408.2018.17.24

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（性別、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/mL（34.83～73.50 ng/mL）；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/mL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/mL范围内进行治疗。

关键词 利培酮分散片；精神分裂症；血药浓度监测；影响因素

ABSTRACT 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 Xian 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）. Patients 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.

KEYWORDS Risperidone dispersible tablets； Schizophrenia； Plasma concentration monitoring； Influential factors

精神分裂症是一种常见的病因未明的严重精神疾病，其高住院率与高致残率是直接导致患者贫困和其家庭因病返贫的重要原因[1]。利培酮广泛作用于各种神经递质受体，尤其对5-羟色胺（5-HT）的2A受体和D2受体均有较强的拮抗作用，因此利培酮临床作用谱广，对阴性症状（情感平淡、言语贫乏等）、阳性症状（被迫妄想、言语性幻听等）都有很好的疗效[2-5]。利培酮口……