Therapeutic drug monitoring for traditional Chinese medicine: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Miao ^1,2,3,4,5 , CHEN Jingjing ^1,2,3,4 , ZENG Linan ^1,2,3,4 , HUANG Liang ^1,2,3,4 , CHEN Zhe ^1,2,3,4 , JIANG Zhimei ^1,2,3,4 , DIAO Sha ^1,2,3,4 ,  ZHANG Lingli ^1,2,3,4

1. Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, P. R. China;
3. NMPA Key Laboratory for Technical Research on Drug Products in Vitro and in Vivo Correlation, Chengdu 610041, P. R. China;
4. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu 610041, P. R. China;
5. West China School of Pharmacy, Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

ZHANG Lingli, Email: zhanglingli@scu.edu.cn

Keywords：

Traditional Chinese medicine; Therapeutic drug monitoring; Research status; Systematic review

DOI：

10.7507/1672-2531.202206020

Video：

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Objective To systematically review the research status of therapeutic drug monitoring (TDM) for traditional Chinese medicine. Methods PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM, VIP databases, official websites of governments and societies associated with TDM were electronically searched to collect studies on TDM for traditional Chinese medicine from inception to January, 2022. Two reviewers independently screened literature and extracted data. Then, a qualitative systematic review was conducted. Results A total of 13 studies were included, all of which came from China and were small sample size studies. The studied population consisted mainly of healthy volunteers (85%), followed by patients of coronary artery disease with blood stasis pattern (31%), patients of rheumatoid arthritis (8%), and patients of acquired immune deficiency syndrome (8%). There were two types of medicine, including proprietary Chinese medicine (69%) and Chinese herbal pieces (31%). The research topics were all theoretical research of TDM, mainly concentration detection methods (77%), followed by influence factors of blood drug concentration (15%), the selection of specimen (15%), the selection of monitoring object (8%) and the concentration reference range (8%). There was no clinical practice study on TDM of traditional Chinese medicine. Conclusion TDM of traditional Chinese medicine is still in the exploratory stage in China. Published studies are mainly on the theoretical research of TDM, and no relevant studies is on clinical practice of TDM of traditional Chinese medicine.

Citation： ZHANG Miao, CHEN Jingjing, ZENG Linan, HUANG Liang, CHEN Zhe, JIANG Zhimei, DIAO Sha, ZHANG Lingli. Therapeutic drug monitoring for traditional Chinese medicine: a systematic review. Chinese Journal of Evidence-Based Medicine, 2023, 23(1): 21-26. doi: 10.7507/1672-2531.202206020 Copy

1.	中华医学会儿科学分会临床药理学组. 儿童治疗性药物监测专家共识. 中华儿科杂志, 2015, 53(9): 650-659.
2.	冯宇飞, 刘佩莉, 李秋红. 中药治疗药物监测现状与展望. 时珍国医国药, 2007, 18(5): 1255-1256.
3.	王萍, 方晓艳, 魏珍珍, 等. 基于数据挖掘的中药外用不良反应分析及思考. 中药药理与临床, 2021, 37(1): 221-229.
4.	李纯, 韩华, 冯宇飞, 等. 中药治疗药物监测及个体化给药的研究现状与展望. 江苏中医药, 2008, 40(6): 91-92.
5.	李楠. “证, 药, 效"为基础的现代中药药动学研究及治疗药物监测的现状及展望. 中国药师, 2015, 18(7): 1140-1144.
6.	刘晓玲, 陈纪藩, 唐洪梅, 等. 类风湿病患者口服通痹灵片后士的宁血药浓度观察分析. 广州中医药大学学报, 1996, (Z1): 69-71.
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10.	黄敬群. 方剂治疗药物监测(Ⅱ). 西安: 第四军医大学, 2003.
11.	孟华. 方剂治疗药物监测(Ⅳ). 西安: 第四军医大学, 2003.
12.	王雁梅. RP-HPLC法监测生化汤制剂及其药代动力学研究. 西安: 第四军医大学, 2005.
13.	段京莉, 樊晓霞, 翟所迪. 库仑阵列电化学HPLC法测定人血浆中灯盏乙素的浓度. 中国药房, 2007, 18(17): 1318-1319.
14.	冯怡, 邓远辉, 曾星, 等. 液相色谱-串联质谱法测定人血浆中的龙胆苦苷浓度. 药物分析杂志, 2007, 27(2): 157-160.
15.	何俊, 王焱, 任晓亮, 等. HPLC-MS法快速测定健康人体血浆中环维黄杨星D的浓度及其药代动力学研究. 天津中医药, 2008, 25(5): 419-421.
16.	Yang L, Xu SJ, Wu ZF, et al. Determination of ginsenoside-Rg(1) in human plasma and its application to pharmacokinetic studies following intravenous administration of 'Shenmai' injection. Phytother Res, 2009, 23(1): 65-71.
17.	万凤. 酶联免疫吸附方法测定人唾液中葛根素, 栀子苷浓度及其药代动力学. 北京: 北京中医药大学, 2014.
18.	李春杏. 1. 免疫无应答HIV患者血浆中雷公藤3个单体成分药物浓度及其与异常免疫激活关系初探. 2. 高效液相色谱法测定血清、脑脊液及胰液中利奈唑胺药物浓度. 北京: 北京协和医学院, 2015.
19.	Pippenger CE. Therapeutic drug monitoring: an overview. Ther Drug Monit, 1979, 1(1): 3-9.
20.	张相林. 我国治疗药物监测发展及展望. 中国药理学与毒理学杂志, 2015, 29(5): 741-743.
21.	中国药理学会治疗药物监测研究专业委员会. 治疗药物监测工作规范专家共识(2019版). 中国医院用药评价与分析, 2019, 19(8): 897-898,902.
22.	王菁, 刘璐, 郑恒, 等. 治疗药物监测的研究进展. 中国医院药学杂志, 2017, 37(1): 1-8.
23.	杨冬爱, 陈琳琳. 治疗药物监测的方法学研究进展. 中国医药科学, 2016, 6(8): 38-40,113.
24.	陆宇, 朱慧. 抗结核药治疗药物监测临床应用专家共识. 中国防痨杂志, 2021, 43(9): 867-873.
25.	印晓星. 治疗药物监测. 北京: 人民军医出版社, 2011.
26.	Patsalos PN, Spencer EP, Berry DJ. Therapeutic drug monitoring of antiepileptic drugs in epilepsy: a 2018 update. Ther Drug Monit, 2018, 40(5): 526-548.
27.	王又红, 陈天朝, 潘灏白. 借鉴西医临床药学经验开展中医临床药学. 中国药事, 1997, (4): 53-54.

1. 中华医学会儿科学分会临床药理学组. 儿童治疗性药物监测专家共识. 中华儿科杂志, 2015, 53(9): 650-659.
2. 冯宇飞, 刘佩莉, 李秋红. 中药治疗药物监测现状与展望. 时珍国医国药, 2007, 18(5): 1255-1256.
3. 王萍, 方晓艳, 魏珍珍, 等. 基于数据挖掘的中药外用不良反应分析及思考. 中药药理与临床, 2021, 37(1): 221-229.
4. 李纯, 韩华, 冯宇飞, 等. 中药治疗药物监测及个体化给药的研究现状与展望. 江苏中医药, 2008, 40(6): 91-92.
5. 李楠. “证, 药, 效"为基础的现代中药药动学研究及治疗药物监测的现状及展望. 中国药师, 2015, 18(7): 1140-1144.
6. 刘晓玲, 陈纪藩, 唐洪梅, 等. 类风湿病患者口服通痹灵片后士的宁血药浓度观察分析. 广州中医药大学学报, 1996, (Z1): 69-71.
7. 孙世仁. 方剂治疗药物监测(Ⅰ)—川芎复方的制剂学及其临床药动学监测. 西安: 第四军医大学, 2002.
8. 徐睿. 方剂治疗药物监测—冠心Ⅱ号临床药动, 药效监测. 重庆: 第三军医大学, 2002.
9. 郭军. 方剂治疗药物监测(Ⅲ). 西安: 第四军医大学, 2003.
10. 黄敬群. 方剂治疗药物监测(Ⅱ). 西安: 第四军医大学, 2003.
11. 孟华. 方剂治疗药物监测(Ⅳ). 西安: 第四军医大学, 2003.
12. 王雁梅. RP-HPLC法监测生化汤制剂及其药代动力学研究. 西安: 第四军医大学, 2005.
13. 段京莉, 樊晓霞, 翟所迪. 库仑阵列电化学HPLC法测定人血浆中灯盏乙素的浓度. 中国药房, 2007, 18(17): 1318-1319.
14. 冯怡, 邓远辉, 曾星, 等. 液相色谱-串联质谱法测定人血浆中的龙胆苦苷浓度. 药物分析杂志, 2007, 27(2): 157-160.
15. 何俊, 王焱, 任晓亮, 等. HPLC-MS法快速测定健康人体血浆中环维黄杨星D的浓度及其药代动力学研究. 天津中医药, 2008, 25(5): 419-421.
16. Yang L, Xu SJ, Wu ZF, et al. Determination of ginsenoside-Rg(1) in human plasma and its application to pharmacokinetic studies following intravenous administration of 'Shenmai' injection. Phytother Res, 2009, 23(1): 65-71.
17. 万凤. 酶联免疫吸附方法测定人唾液中葛根素, 栀子苷浓度及其药代动力学. 北京: 北京中医药大学, 2014.
18. 李春杏. 1. 免疫无应答HIV患者血浆中雷公藤3个单体成分药物浓度及其与异常免疫激活关系初探. 2. 高效液相色谱法测定血清、脑脊液及胰液中利奈唑胺药物浓度. 北京: 北京协和医学院, 2015.
19. Pippenger CE. Therapeutic drug monitoring: an overview. Ther Drug Monit, 1979, 1(1): 3-9.
20. 张相林. 我国治疗药物监测发展及展望. 中国药理学与毒理学杂志, 2015, 29(5): 741-743.
21. 中国药理学会治疗药物监测研究专业委员会. 治疗药物监测工作规范专家共识(2019版). 中国医院用药评价与分析, 2019, 19(8): 897-898,902.
22. 王菁, 刘璐, 郑恒, 等. 治疗药物监测的研究进展. 中国医院药学杂志, 2017, 37(1): 1-8.
23. 杨冬爱, 陈琳琳. 治疗药物监测的方法学研究进展. 中国医药科学, 2016, 6(8): 38-40,113.
24. 陆宇, 朱慧. 抗结核药治疗药物监测临床应用专家共识. 中国防痨杂志, 2021, 43(9): 867-873.
25. 印晓星. 治疗药物监测. 北京: 人民军医出版社, 2011.
26. Patsalos PN, Spencer EP, Berry DJ. Therapeutic drug monitoring of antiepileptic drugs in epilepsy: a 2018 update. Ther Drug Monit, 2018, 40(5): 526-548.
27. 王又红, 陈天朝, 潘灏白. 借鉴西医临床药学经验开展中医临床药学. 中国药事, 1997, (4): 53-54.

Chinese Journal of Evidence-Based Medicine

Therapeutic drug monitoring for traditional Chinese medicine: a systematic review

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