摘要
目的探究口服利培酮的首发精神分裂症(SZ)患者利培酮血药浓度-剂量比与临床疗效的关系。方法回顾性研究2021年3月至2024年3月厦门医学院附属仙岳医院精神科住院部收治的100例口服利培酮治疗的首发SZ患者临床资料。治疗4周后,比较不同利培酮日剂量组(1、2、3、4、5、6 mg)患者血浆总利培酮浓度[利培酮+9-羟基利培酮(9-OH-利培酮)]浓度、利培酮/9-OH-利培酮、血浆总利培酮浓度-剂量比(C/D)值。采用阳性与阴性症状量表(PANSS)评定临床疗效,采用副反应量表(TESS)评定精神药物的不良反应。根据服药4周后SZ患者血浆总利培酮浓度结果,比较不同血浆总利培酮浓度(<20.00 ng/mL、20.01~60.00 ng/mL、≥60.01 ng/mL)的SZ患者利培酮/9-OH-利培酮值、C/D值、总有效率和不良反应发生情况。根据服药4周后SZ患者C/D值结果,比较不同C/D值(<5.00 mg·mL^(-1)·d^(-1)、5.01~10.00 mg·mL^(-1)·d^(-1)、10.01~15.00 mg·mL^(-1)·d^(-1)、15.01~20.00 mg·mL^(-1)·d^(-1)和≥20.01 mg·mL^(-1)·d^(-1))SZ患者的总有效率和不良反应发生情况。采用Spearman相关性分析血浆总利培酮浓度、利培酮/9-OH-利培酮、C/D与总有效率和不良反应发生率的相关性。结果不同剂量利培酮治疗后,血浆总利培酮浓度[1 mg:(25.57±9.81)ng/mL,2 mg:(30.54±12.14)ng/mL,3 mg:(38.99±13.20)ng/mL,4 mg:(39.64±10.75)ng/mL,5 mg:(50.33±16.32)ng/mL,6 mg:(43.17±12.63)ng/mL]比较,差异有统计学意义(P<0.05),而利培酮/9-OH-利培酮、C/D值比较,差异均无统计学意义(P>0.05)。不同血浆总利培酮浓度的利培酮/9-OH-利培酮[<20.00 ng/mL:0.13(0.09,0.34),20.01~60.00 ng/mL:0.35(0.10,0.60),≥60.01 ng/mL:0.74(0.25,1.06)]、C/D值[<20.00 ng/mL:7.10(5.20,9.15)mg·mL^(-1)·d^(-1),20.01~60.00 ng/mL:11.25(9.20,14.05)mg·mL^(-1)·d^(-1),≥60.01 ng/mL:17.55(15.45,21.30)mg·mL^(-1)·d^(-1)]比较,差异均有统计学意义(P<0.05);不同血浆总利培酮浓度组患者的总有效率和不良反应发生率比较,差异均无统计学意义(P>0.05)。不同C/D值组患者总有效率(<5.00 mg·mL^(-1)·d^(-1):37.50%,5.01~10.00 mg·mL^(-1)·d^(-1):77.14%,10.01~15.00 mg·mL^(-1)·d^(-1):59.38%,15.01~20.00 mg·mL^(-1)·d^(-1):50.00%,≥20.01 mg·mL^(-1)·d^(-1):44.44%)和不良反应发生率(<5.00 mg·mL^(-1)·d^(-1):0,5.01~10.00 mg·mL^(-1)·d^(-1):0,10.01~15.00 mg·mL^(-1)·d^(-1):6.25%,15.01~20.00 mg·mL^(-1)·d^(-1):25.00%,≥20.01 mg·mL^(-1)·d^(-1):55.56%)比较,差异均有统计学意义(P<0.05)。Spearman相关性分析显示,C/D与患者口服利培酮治疗的总有效率、不良反应发生率相关(P<0.05),而与血浆总利培酮浓度、利培酮/9-OH-利培酮无明显相关性(P>0.05)。结论SZ患者中C/D值可作为利培酮个体化治疗的参考指标,C/D为5.01~15.00 mg·mL^(-1)·d^(-1)临床疗效高,不良反应少。
Objective To investigate the relationship betweenclinical efficacy of oral risperidone and the blood concentration to dose ratio of risperidone in patients with schizophrenia(SZ).Methods A retrospective study was conducted on 100 patients with SZ treated with oral risperidone admitted to the Department of Psychiatry,Xianyue Hospital Affiliated with Xiamen Medical College from March 2021 to March 2024.After 4 weeks of treatment,the plasma total risperidone concentration[risperidone+9-hydroxyrisperidone(9-OH-risperidone)]concentration,risperidone/9-OH-risperidone,plasma total risperidone concentration-dose ratio(C/D)values of patients in different risperidone daily dose groups(1,2,3,4,5,6 mg)were compared.The positive and negative symptom scale(PANSS)was used to evaluate the clinical efficacy,and the treatment emergent symptom scale(TESS)was used to evaluate the adverse reactions of psychotropic drugs.According to the results of plasma total risperidone concentration in SZ patients after 4 weeks of medication,the risperidone/9-OH-risperidone value,C/D value,total effective rate and adverse reactions of SZ patients with different plasma total risperidone concentrations(<20.00 ng/mL,20.01-60.00 ng/mL,≥60.01 ng/mL)were compared.According to the results of C/D value of SZ patients after 4 weeks of medication,the total effective rate and adverse reactions of SZ patients with different C/D values(<5.00 mg·mL^(-1)·d^(-1),5.01-10.00 mg·mL^(-1)·d^(-1),10.01-15.00 mg·mL^(-1)·d^(-1),15.01-20.00 mg·mL^(-1)·d^(-1)and≥20.01 mg·mL^(-1)·d^(-1))were compared.Spearman correlation analysis was used to evaluate the relationship between clinical efficacy,adverse reactions with plasma total risperidone concentration,risperidone/9-OH-risperidone,and C/D ratio.Results After treatment with different doses of risperidone,there were statistically significant differences in plasma total risperidone concentrations[1 mg:(25.57±9.81)ng/mL,2 mg:(30.54±12.14)ng/mL,3 mg:(38.99±13.20)ng/mL,4 mg:(39.64±10.75)ng/mL,5 mg:(50.33±16.32)ng/mL,6 mg:(43.17±12.63)ng/mL](P<0.05),but there were no statistically significant differences in risperidone/9-OH-risperidone or C/D value(P>0.05).There were statistically significant differences in risperidone/9-OH-risperidone among different plasma total risperidone concentrations[<20.00 ng/mL:0.13(0.09,0.34),20.01~60.00 ng/mL:0.35(0.10,0.60),≥60.01 ng/mL:0.74(0.25,1.06)]and C/D value[<20.00 ng/mL:7.10(5.20,9.15)mg·mL^(-1)·d^(-1),20.01~60.00 ng/mL:11.25(9.20,14.05)mg·mL^(-1)·d^(-1),≥60.01 ng/mL:17.55(15.45,21.30)mg·mL^(-1)·d^(-1)](P<0.05).There were no statistically significant differences in the total effective rate and the incidence of adverse reactions among different plasma total risperidone concentrations(P>0.05).There were statistically significant differences in the total effective rate(<5.00 mg·mL^(-1)·d^(-1):37.50%,5.01-10.00 mg·mL^(-1)·d^(-1):77.14%,10.01-15.00 mg·mL^(-1)·d^(-1):59.38%,15.01-20.00 mg·mL^(-1)·d^(-1):50.00%,≥20.01 mg·mL^(-1)·d^(-1):44.44%)and the incidence of adverse reactions(<5.00 mg·mL^(-1)·d^(-1):0,5.01-10.00 mg·mL^(-1)·d^(-1):0,10.01-15.00 mg·mL^(-1)·d^(-1):6.25%,15.01-20.00 mg·mL^(-1)·d^(-1):25.00%,≥20.01 mg·mL^(-1)·d^(-1):55.56%)among different different C/D value,the differences were statistically significant(P<0.05).Spearman correlation analysis revealed that C/D value were correlated with the total response rate and incidence of adverse reactions in patients treated with oral risperidone(P<0.05),but plasma total risperidone concentrations,risperidone/9-OH-risperidone was not significantly correlated(P>0.05).Conclusion The C/D value in SZ patients can be used as a reference indicator for individualized treatment of risperidone.C/D ratio of 5.01-15.00 mg·mL^(-1)·d^(-1)has high clinical efficacy and few adverse reactions.
作者
庄缘
吕凤芹
黄颖华
ZHUANG Yuan;LYU Feng-qin;HUANG Ying-hua(Department of Pharmacy,Xiamen Xianyue Hospital,Xianyue Hospital Affiliated with Xiamen Medical College,Fujian Psychiatric Center,Fujian Clinical Research Center for Mental Disorders,Xiamen Fujian 361012,China)
出处
《临床和实验医学杂志》
2025年第10期1043-1047,共5页
Journal of Clinical and Experimental Medicine
基金
福建卫生健康青年科研课题(编号:2020QNB071)。
关键词
精神分裂症
利培酮
血药浓度-剂量比
临床疗效
相关性
Schizophrenia
Risperidone
Blood drug concentration dose ratio
Clinical efficacy
Relevance
