从室间质量评价分析神经精神科治疗药物监测的发展现状
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摘要
目的:分析神经精神科治疗药物监测(TDM)的发展现状,为提高神经精神科TDM质量提供依据。方法:从卫生部临床检验中心网站(http://www.clinet.com.cn)提取2008-2017年TDM室间质量评价中神经精神科药物相关数据,对TDM项目、参评实验室数量、监测方法等进行统计分析。结果:截至2017年底,卫生部临床检验中心开展神经精神科TDM项目共5项,涉及4种药物,包括3项血清TDM(卡马西平、丙戊酸、苯妥英),生化常规中的锂离子监测(碳酸锂)以及2014年新增加的药动学实验室生物样本监测(血浆卡马西平);参评实验室数量从2008年的209家增加至2017年的603家,其中卡马西平(血清、血浆)和丙戊酸每年参评实验室数量均保持良好的增长趋势,截至2017年底,卡马西平(血清、血浆)和丙戊酸均突破200家,苯妥英也有107家,但是碳酸锂仅有27家。在参评实验室的监测方法中,使用偏振荧光免疫分析法(FPIA)的实验室逐年递减,截至2017年底,已不足10家;而使用吖啶酯直接化学发光法、酶增强免疫分析法(EMIT)、高效液相色谱法(HPLC)的实验室数量稳步增加,截至2017年底,使用吖啶酯直接化学发光法的实验室最多,EMIT、HPLC次之。结论:由参评实验室数量的不断增加,可以看出实验室人员的质量控制意识日趋增强,但由于TDM监测方法的繁杂性限制了室间质量评价的药物种类,建议相关部门尽快制订室间质量评价的指导方针、质量控制标准与操作规范等,以确保不同神经精神科药物TDM结果的准确性。
OBJECTIVE:To analyze the development status of neuropsychotropic therapeutic drug monitoring(TDM),and to provide reference for improving the quality of TDM in neuropsychiatry department. METHODS: The laboratory data of neuropsychotropic TDM external quality assessment(EQA)were collected from Website of Clinical Laboratory Center of Ministry of Health(http://www.clinet.com.cn)during 2008-2017,and then analyzed statistically in respects of TDM project,the number of involved laboratory,monitoring method,etc. RESULTS:By the end of 2017,the Clinical Laboratory Center of the Ministry of Health had conducted 5 neuropsychiatric TDM projects involving 4 drugs,including 3 items of serum TDM(carbamazepine,valproic acid,phenytoin),lithium ion monitoring(lithium carbonate) in biochemical routine and newly added pharmacokinetic laboratory biological sample monitoring(carbamazepine) in 2014. From 2008 to 2017,the number of involved laboratories increased from 209 to 603,with carbamazepine(serum,plasma)and valproic acid showing good annual growth trend,exceeding200 and phenytoin 107,but only 27 in lithium carbonate until 2017. Among all monitoring methods of involved laboratories,the number of laboratories which adopted fluorescence polarization immunoassay(FPIA)decreased year by year. By the end of 2017,there were fewer than 10 laboratories. The number of laboratories using acridinium direct chemiluminescence,enzyme-multiplied immunoassay technique(EMIT),and high performance liquid chromatography(HPLC) had steadily increased. By the end of2017,acridinium direct chemiluminescence was the most used in laboratory,followed by EMIT and HPLC. CONCLUSIONS:Due to the increasing number of participating laboratories,it can be seen that the consciousness of quality control of laboratory personnel is increasing day by day;but the complexity of TDM monitoring methods limits the types of drugs used in external quality evaluation. It is suggested to formulate guidelines,quality control standards and operation rules as soon as possible,so as to ensure the accuracy of test results.
OBJECTIVE:To analyze the development status of neuropsychotropic therapeutic drug monitoring(TDM),and to provide reference for improving the quality of TDM in neuropsychiatry department. METHODS: The laboratory data of neuropsychotropic TDM external quality assessment(EQA)were collected from Website of Clinical Laboratory Center of Ministry of Health(http://www.clinet.com.cn)during 2008-2017,and then analyzed statistically in respects of TDM project,the number of involved laboratory,monitoring method,etc. RESULTS:By the end of 2017,the Clinical Laboratory Center of the Ministry of Health had conducted 5 neuropsychiatric TDM projects involving 4 drugs,including 3 items of serum TDM(carbamazepine,valproic acid,phenytoin),lithium ion monitoring(lithium carbonate) in biochemical routine and newly added pharmacokinetic laboratory biological sample monitoring(carbamazepine) in 2014. From 2008 to 2017,the number of involved laboratories increased from 209 to 603,with carbamazepine(serum,plasma)and valproic acid showing good annual growth trend,exceeding200 and phenytoin 107,but only 27 in lithium carbonate until 2017. Among all monitoring methods of involved laboratories,the number of laboratories which adopted fluorescence polarization immunoassay(FPIA)decreased year by year. By the end of 2017,there were fewer than 10 laboratories. The number of laboratories using acridinium direct chemiluminescence,enzyme-multiplied immunoassay technique(EMIT),and high performance liquid chromatography(HPLC) had steadily increased. By the end of2017,acridinium direct chemiluminescence was the most used in laboratory,followed by EMIT and HPLC. CONCLUSIONS:Due to the increasing number of participating laboratories,it can be seen that the consciousness of quality control of laboratory personnel is increasing day by day;but the complexity of TDM monitoring methods limits the types of drugs used in external quality evaluation. It is suggested to formulate guidelines,quality control standards and operation rules as soon as possible,so as to ensure the accuracy of test results.
引文
[1]《中国全科医学》编辑部.全科医生小词典-治疗药物监测[EB/OL].(2015-03-17)[2018-06-22].http://www.chinagp.net/news/?1540.html.
[2]张相林.我国治疗药物监测发展及展望[J].中国药理学与毒理学杂志,2015,29(5):741-743.
[3]凌树森.治疗药物监测新理论与新方法[M].北京:中国医药科技出版社,2002:209-241.
[4]闫颖,张顺利,钟堃,等.2010-2012年度治疗药物监测室间质评结果分析[J].中国药物警戒,2013,10(12):755-759.
[5]果伟,郭桂欣,孙川,等.碳酸锂与丙戊酸在三级精神病专科医院治疗药物监测现状调查与分析[J].中国新药杂志,2013,22(11):1347-1352.
[6]许倍铭,陈冰.新型抗癫痫药物的治疗药物监测研究进展[J].中国药房,2017,28(35):5036-5040.
[7]HIEMKE C,BERGEMANN N,CLEMENT HW,et al.Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology:update 2017[J].Pharmacopsychiatry,2018,51(1/2):9-62.
[8]WANG P,YIN T,MA HY,et al.Effects of CYP3A4/5 and ABCB1 genetic polymorphisms on carbamazepine metabolism and transport in Chinese patients with epilepsy treated with carbamazepine in monotherapy and bitherapy[J].Epilepsy Research,2015.DOI:10.1016/j.eplepsyres.2015.09.001.
[9]PATTEET L,MAUDENS KE,MORRENS M,et al.Determination of common antipsychotics in quantisal-collected oral fluid by UPLC-MS/MS:method validation and applicability for therapeutic drug monitoring[J].Therapeutic Drug Monitoring,2016,38(1):87-97.
[10]PATTEET L,MAUDENS KE,SABBE B,et al.High throughput identification and quantification of 16 antipsychotics and 8 major metabolites in serum using ultra-high performance liquid chromatography-tandem mass spectrometry[J].Clinica Chimica Acta,2014,429(1):51-58.
[11]王蓓丽,郭玮,潘柏申.国外医学检验实验室自建检测方法监管现状[J].中华检验医学杂志,2016,39(1):55-59.
[12]潘柏申.我国医学检验实验室自建检测方法发展与管理的期望[J].中华检验医学杂志,2016,39(1):1-3.
[13]中华医学会检验医学分会.我国医学检验部门自建检测方法发展与管理建议[J].中华检验医学杂志,2017,40(3):162-164.
[14]TRIVEDI MH,RUSH AJ,GAYNES BN,et al.Maximizing the adequacy of medication treatment in controlled trials and clinical practice:star|[ast]|d measurement-based care[J].Neuropsychopharmacology,2007,32(12):2479-2489.
[15]HIEMKE C,BAUMANN P,BERGEMANN N,et al.AG-NP consensus guidelines for therapeutic drug monitoring in psychiatry:update 2011[J].Pharmacopsychiatry,2011,44(6):195-235.
[16]HIEMKE C,BAUMANN P,BERGEMANN N,et al.AG-NP精神科治疗药物监测共识指南:2011[J].实用药物与临床,2016,19(10):1193-1218.
[17]GUO W,GUO G X,SUN C,et al.Therapeutic drug monitoring of psychotropic drugs in China:a nationwide survey[J].Therapeutic Drug Monitoring,2013,35(6):816-822.
[18]高永双,张嘉萱,倪晓佳,等.广东省氯氮平治疗药物监测室间质评实施的研究[J].中国药师,2016,19(9):1791-1793.
[19]房文通,潘祺琦,罗璨,等.省级药事管理质控体系的建立与江苏省61家医院临床药学发展现状[J].中国药房,2018,29(1):94-97.
[2]张相林.我国治疗药物监测发展及展望[J].中国药理学与毒理学杂志,2015,29(5):741-743.
[3]凌树森.治疗药物监测新理论与新方法[M].北京:中国医药科技出版社,2002:209-241.
[4]闫颖,张顺利,钟堃,等.2010-2012年度治疗药物监测室间质评结果分析[J].中国药物警戒,2013,10(12):755-759.
[5]果伟,郭桂欣,孙川,等.碳酸锂与丙戊酸在三级精神病专科医院治疗药物监测现状调查与分析[J].中国新药杂志,2013,22(11):1347-1352.
[6]许倍铭,陈冰.新型抗癫痫药物的治疗药物监测研究进展[J].中国药房,2017,28(35):5036-5040.
[7]HIEMKE C,BERGEMANN N,CLEMENT HW,et al.Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology:update 2017[J].Pharmacopsychiatry,2018,51(1/2):9-62.
[8]WANG P,YIN T,MA HY,et al.Effects of CYP3A4/5 and ABCB1 genetic polymorphisms on carbamazepine metabolism and transport in Chinese patients with epilepsy treated with carbamazepine in monotherapy and bitherapy[J].Epilepsy Research,2015.DOI:10.1016/j.eplepsyres.2015.09.001.
[9]PATTEET L,MAUDENS KE,MORRENS M,et al.Determination of common antipsychotics in quantisal-collected oral fluid by UPLC-MS/MS:method validation and applicability for therapeutic drug monitoring[J].Therapeutic Drug Monitoring,2016,38(1):87-97.
[10]PATTEET L,MAUDENS KE,SABBE B,et al.High throughput identification and quantification of 16 antipsychotics and 8 major metabolites in serum using ultra-high performance liquid chromatography-tandem mass spectrometry[J].Clinica Chimica Acta,2014,429(1):51-58.
[11]王蓓丽,郭玮,潘柏申.国外医学检验实验室自建检测方法监管现状[J].中华检验医学杂志,2016,39(1):55-59.
[12]潘柏申.我国医学检验实验室自建检测方法发展与管理的期望[J].中华检验医学杂志,2016,39(1):1-3.
[13]中华医学会检验医学分会.我国医学检验部门自建检测方法发展与管理建议[J].中华检验医学杂志,2017,40(3):162-164.
[14]TRIVEDI MH,RUSH AJ,GAYNES BN,et al.Maximizing the adequacy of medication treatment in controlled trials and clinical practice:star|[ast]|d measurement-based care[J].Neuropsychopharmacology,2007,32(12):2479-2489.
[15]HIEMKE C,BAUMANN P,BERGEMANN N,et al.AG-NP consensus guidelines for therapeutic drug monitoring in psychiatry:update 2011[J].Pharmacopsychiatry,2011,44(6):195-235.
[16]HIEMKE C,BAUMANN P,BERGEMANN N,et al.AG-NP精神科治疗药物监测共识指南:2011[J].实用药物与临床,2016,19(10):1193-1218.
[17]GUO W,GUO G X,SUN C,et al.Therapeutic drug monitoring of psychotropic drugs in China:a nationwide survey[J].Therapeutic Drug Monitoring,2013,35(6):816-822.
[18]高永双,张嘉萱,倪晓佳,等.广东省氯氮平治疗药物监测室间质评实施的研究[J].中国药师,2016,19(9):1791-1793.
[19]房文通,潘祺琦,罗璨,等.省级药事管理质控体系的建立与江苏省61家医院临床药学发展现状[J].中国药房,2018,29(1):94-97.