224例氯氮平药物不良反应/事件的临床特点及超说明书用药分析  

Clinical characteristics of 224 cases of adverse drug reactions/events of clozapine and its off-label use

作　　者：陈曼 朱秀清[2] 胡晋卿[2] 温预关[2] CHEN Man;ZHU Xiuqing;HU Jinqing;WEN Yuguan(Department of Pharmacy,Zhuhai Center for Chron-ic Disease Control-the Third People's Hospital of Zhuhai,Zhuhai 519000,China;Department of Pharmacy,the Affiliated Brain Hospital of Guangzhou Medical University-Guangzhou Huiai Hospital,Guangzhou 510370,China)

机构地区：[1]广东省珠海市慢性病防治中心-珠海市第三人民医院药剂科,珠海519000 [2]广州医科大学附属脑科医院-广州市惠爱医院药学部,广州510370

出　　处：《中国临床药学杂志》2020年第1期38-41,共4页Chinese Journal of Clinical Pharmacy

基　　金：广州市科技计划项目创新平台建设计划(编号201805010009);广州市医学重点学科(编号2017-2019)

摘　　要：目的探讨氯氮平所致药物不良反应/事件(ADR/ADE)的发生特点、规律及其超说明书用药情况,为临床合理用药提供参考。方法收集2012-2018年期间上报的怀疑药品为氯氮平的ADR/ADE报告表,并对患者年龄、用药剂量等临床资料进行分析。结果纳入ADR/ADE报告表共224份,其中一般ADR/ADE 207份,严重ADR/ADE 17份。男性145例(64.73%),女性79例(35.27%),男女比例为1.84∶1,年龄16~79岁。累及器官或系统多见于神经系统(32.70%)和消化系统(24.34%),主要临床表现为便秘、锥体外系反应和流涎等。不存在超适应证使用情况,但有22份(9.82%)每日用量超过600 mg。共94份(41.96%)进行治疗药物监测,其中8份为严重ADR/ADE,血药浓度>600μg·L^-1的严重ADR/ADE构成比最高(25.00%)。结论氯氮平因超说明书使用引起的ADR/ADE比例虽然较低,但仍能引起累及不同器官或系统的ADR/ADE。药师需重视氯氮平超说明书用药情况,对有需要的患者进行治疗药物监测,以减少ADR/ADE的发生。AIM To analyze the occurrence characteristics of adverse drug reactions/events(ADR/ADE)of clozapine and its off-label use to provide references of rational drug use.METHODS The ADR/ADE reports of suspected clozapine from 2012 to 2018 were analyzed retrospectively.The analysis of patients'clinical information(including age,dosage,etc.)were conducted.RESULTS A total of 224 ADR/ADE reports including 207 gen-eral cases and 17 serious cases.Among the ADR/ADE reports,145 cases(64.73%)occurred in male patients and 79 cases(35.27%)occurred in female patients,with male/female ratio of 1.84∶1.The age range was 16 to 79 years.Nervous system(32.70%)and digestive system(24.34%)disorders were the most reported ADR/ADE cases,of which constipation,extrapyramidal reactions and salivation were main clinical manifestations.There was no off-label indication use,but a total of 22 cases(9.82%)had daily dose more than 600 mg.A to-tal of 94 cases(41.96%)had therapeutic drug monitoring results,of which 8 cases were serious.The percentage of serious cases that had concentrations above 600μg·L^-1 was the highest(25.00%).CONCLUSION Al-though the percentage of ADR/ADE of clozapine due to its off-label use was very low,ADR/ADE could still occur,involving different organs or systems.Pharmacists should pay attention to therapeutic drug monitoring service for pa-tients so as to reduce the occurrence of ADR/ADE.

关 键 词：氯氮平 药物不良反应/事件 治疗药物监测 超说明书用药 

分 类 号：R95[医药卫生—药学]