倪晓佳,高永双,王占璋,张明,尚德为,胡晋卿,邱畅,申灵芳,温预关
NI Xiaojia,GAO Yongshuang,WANG Zhanzhang,ZHANG Ming,SHANG Dewei,HU Jinqing,QIU Chang,SHEN Lingfang,WEN Yuguan

• 1:广州市惠爱医院
• 2:中山市第三人民医院

摘要(Abstract)：

目的建立广东省精神科治疗药物监测质控平台,提高省内治疗药物监测检测水平。方法配备低(100 ng/m L)、中(500 ng/m L)和高(1 000 ng/m L)浓度氯氮平及低(1μg/m L)、中(5μg/m L)和高(15μg/m L)浓度的卡马西平质控血清,评价即将开展治疗药物监测医院的质量控制情况;反馈检测结果,对结果不理想的医院通过质控平台进行技术支持;再次发放血清质控品,评价质控平台技术支持的作用。结果第1次质控氯氮平低、中、高的合格率分别为25%、75%、75%,卡马西平低、中、高的合格率分别为25%、25%、75%,第2次合格率均为100%。结论广东省精神科治疗药物监测质控平台的建立对提升广东省治疗药物监测检测水平有十分重大意义。
OBJECTIVE To build a platform for psychiatric therapeutic drug monitoring and improve the quality of nosocomial therapeutic drug monitoring in Guangdong province. METHODS Low,middle and high levels of quality control samples in serum were prepared for clozapine( 100 ng / m L,500 ng / m L and 1 000 ng / m L) and carbamazepine( 1 μg / m L,5 μg / m L,15 μg / m L) separately and then delivered to target hospitals. Test results were collected and added up to investigate the general quality of psychiatric therapeutic drug monitoring. For laboratory which could not meet the requirements,3 steps were taken. Firstly,professional staff in this platform was sent to provide technical supports and solve the problem. Then,serum quality control samples were distributed again.Finally,re-examined results were compared to the previous values to evaluate the efficiency of the psychiatric therapeutic drug monitoring quality control platform. RESULTS Pass percentages for the first detection were 25%,75% and 75% in 3 levels of clozapine and 25%,25% and 75% in carbamazepine,while the re-examined pass ratios were 100%. CONCLUSION The Guangdong psychiatric therapeutic drug monitoring quality control platform showed great help for the assurance of detection accuracy.

关键词(KeyWords)： 治疗药物监测;精神科;质控平台
TDM;psychiatric;QC platform

Abstract:

Keywords:

基金项目(Foundation): 广东省医院药学研究基金(2014A08);; 中山市科技计划项目(2014A1FC148);; 广州市医药卫生科技项目(20151A011039)

作者(Author): 倪晓佳,高永双,王占璋,张明,尚德为,胡晋卿,邱畅,申灵芳,温预关
NI Xiaojia,GAO Yongshuang,WANG Zhanzhang,ZHANG Ming,SHANG Dewei,HU Jinqing,QIU Chang,SHEN Lingfang,WEN Yuguan

参考文献(References)：

• [1]Ostad Haji E,Hiemke C,Pfuhlmann B.Therapeutic drug monitoring for antidepressant drug treatment[J].Curr Pharm Des,2012,18(36):5818-5827.
• [2]贾晶莹,张梦琪,桂雨舟,等.液相色谱-串联质谱法同时测定7种抗抑郁类和5种抗精神病类药物的血药浓度[J].中国药物应用与监测,2010,05:272-275.
• [3]刘伟忠,陈清霞,黄伟侨,等.高效液相色谱法同时测定人血浆中帕罗西汀与氯氮平浓度[J].今日药学,2013,23(1):36-39.
• [4]储小曼,周燕,凌树森.药物冻干质控血清的制备及质量评价[J].中国医院药学杂志,2001,21(5):270-273.
• [5]Hiemke C,Baumann P,Bergemann N,et al.AGNP consensus guidelines for therapeutic drug monitoring in psychiatry:update2011[J].Pharmacopsychiatry,2011,44(6):195-235.
• [6]Patteet L,Morrens M,Maudens KE,et al.Therapeutic drug monitoring of common antipsychotics[J].Ther Drug Monit,2012,34(6):629-651.