奥氮平不同给药次数治疗精神分裂症的有效性及安全性  

Efficacy and safety of olanzapine with different administration frequency in the treatment of schizophrenia

作　　者：张燕[1,2,3] 崔小花 苏艳丽[1,2,3] 丁靖[1,2,3] 王慧 孙丽莎[1,2,3] ZHANG Yan;CUI Xiao-hua;SU Yan-li;DING Jing;WANG Hui;SUN Li-sha(Xi’an Mental Health Center,Shaanxi Xi’an 710100,China;Xi’an Key Laboratory of Pharmacy/Mental Health,Shaanxi Xi’an 710100,China;Mental Health Center Affiliated to Xi’an Jiaotong University,Shaanxi Xi’an 710100,China)

机构地区：[1]西安市精神卫生中心,陕西西安710100 [2]西安市药学(精神卫生)重点实验室,陕西西安710100 [3]西安交通大学附属精神卫生中心,陕西西安710100

出　　处：《中国医院药学杂志》2022年第20期2162-2165,2194,共5页Chinese Journal of Hospital Pharmacy

基　　金：科技创新平台建设/重点实验室建设项目(编号:201805051ZD2CG35);科技资源开放共享平台/陕西省抗精神障碍治疗药物检测研究中心(编号:2022PT-03)。

摘　　要：目的:阐明奥氮平不同给药次数治疗精神分裂症的有效性及安全性,获得奥氮平不同给药次数的有效浓度范围及警戒浓度值。方法:纳入符合《国际疾病分类第十版》(ICD-10)精神分裂症诊断标准,采用奥氮平治疗14 d以上的患者作为研究对象。收集年龄、性别、奥氮平日给药剂量、浓度、给药天数、给药次数/日、合并用药、量表评分以及不良反应。分析奥氮平给药次数与收集指标的关系,确定奥氮平不同给药次数的有效浓度范围,结合不良反应发生率确定奥氮平警戒浓度值。结果:奥氮平的给药次数与日给药剂量(β_(1))、浓度(β_(2))、减分率(β_(3))具有相关性(r=0.381、0.102、-0.082,均P<0.01),多元回归方程为y=0.882+0.041β_(1)-0.002β_(2)-0.002β_(3);根据检出率值最大原则,奥氮平浓度qd和bid给药分别对应的10,90 ng·mL^(-1)和15,110 ng·mL^(-1)的界值,检出率数值均大于总病例的上限界值2.02;当奥氮平浓度≥130 ng·mL^(-1)界值时,不良反应发生率≥70%。结论:当奥氮平剂量相同时,给药次数增加,峰浓度降低,有效浓度范围更宽,对于奥氮平大剂量使用时更安全。奥氮平qd和bid给药有效浓度范围分别是10~90 ng·mL^(-1)和15~110 ng·mL^(-1),最佳疗效浓度范围为15~45 ng·mL^(-1),安全使用警戒浓度值应小于130 ng·mL^(-1)。OBJECTIVE To study the efficacy and safety of olanzapine with different administration frequency in the treatment of schizophrenia,and to provide the effective concentration range with different times of administration and alert concentration value of olanzapine.METHODS Patients who met the diagnostic criteria of the International Classification of Diseases(10th Edition)(ICD-10)for schizophrenia and were treated with olanzapine for more than 14 days were included in the study.The age,gender,daily dose,concentration of olanzapine,administration frequency,concomitant medication,scale scores and adverse reactions were collected.The relationship between olanzapine administration times and the collection indexes was analyzed to determine the effective concentration range of olanzapine for different times of administration,and the alert concentration value of olanzapine was determined in combination with the incidence of adverse drug reactions.RESULTS The administration times of olanzapine and daily dosage(β_(1)),concentration(β_(2)),reduction score rate(β_(3))were correlation(r=0.381,0.102,-0.082,P<0.01).The multiple regression equation was y=0.882+0.041β_(1)-0.002β_(2)-0.002β_(3).According to the principle of maximum detection rate,the detection rate values of 15,90 ng·mL^(-1) of qd and 15,110 ng·mL^(-1) of bid of olanzapine concentration were higher than the upper limit of 2.02 for 1000 cases.According to the principle of maximum detection rate,the detection rate boundary values of olanzapine concentration at 10 and90 ng·mL^(-1) of qd as well as 15 and110 ng·mL^(-1) of bid,were higher than the upper limit boundary value of 2.02 of total cases.When the concentration of olanzapine is≥130 ng·mL^(-1),the incidence of adverse reactions is≥70%.CONCLUSION When olanzapine is used at the same dose,the administration frequency increases,the peak concentration decreases and the effective concentration range is wider.Bid is safer when used at olanzapine high dose.The effective concentration ranges of qd and bid w

关 键 词：奥氮平 给药次数 有效浓度范围 警戒浓度值 界值 

分 类 号：R971.4[医药卫生—药品]