Current Status of Serum Theophylline Standardization in Clinical Laboratories

DU Yuanyuan; ZHANG Qiaoxuan; HAN Liqiao

doi:10.12338/j.issn.2096-9015.2024.0115

Article Contents

Article Navigation > Metrology Science and Technology > 2024 > Accepted Manuscript

DU Yuanyuan, ZHANG Qiaoxuan, HAN Liqiao. Current Status of Serum Theophylline Standardization in Clinical Laboratories[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2024.0115

Citation:

DU Yuanyuan, ZHANG Qiaoxuan, HAN Liqiao. Current Status of Serum Theophylline Standardization in Clinical Laboratories[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2024.0115

DU Yuanyuan, ZHANG Qiaoxuan, HAN Liqiao. Current Status of Serum Theophylline Standardization in Clinical Laboratories[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2024.0115

Citation:

DU Yuanyuan, ZHANG Qiaoxuan, HAN Liqiao. Current Status of Serum Theophylline Standardization in Clinical Laboratories[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2024.0115

PDF( 508 KB)

Current Status of Serum Theophylline Standardization in Clinical Laboratories

doi: 10.12338/j.issn.2096-9015.2024.0115

DU Yuanyuan^{1, 2
,},
ZHANG Qiaoxuan¹,
HAN Liqiao^{1
,
,}

1.
Department of Laboratory Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou 510120, China
2.
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510405, China

Received Date: 2024-04-08
Accepted Date: 2024-05-22
Rev Recd Date: 2024-06-04

Available Online: 2024-07-04

Abstract

Abstract

Theophylline is a widely used medication for treating asthma and chronic obstructive pulmonary disease (COPD). It’s essential to accurately monitor the blood concentration of theophylline, due to the significant inter-individual variability and its narrow therapeutic window. Currently, immunoassays, high-performance liquid chromatography (HPLC), and liquid chromatography-tandem mass spectrometry (LC-MS/MS) are commonly used as routine methods for measuring serum theophylline in clinical laboratories. However, there is significant difference among the measurement results of these methods. The reference measurement procedure for serum theophylline in the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database is the isotope dilution gas chromatography-mass spectrometry (ID-GC/MS) method. The primary reference material was developed by the UK Laboratory of the Government Chemist (LGC) and China National Institute of Metrology (NIM). No secondary reference material with serum matrix was reported. To ensure the reliability and harmonization of measurement results, it is important to establish a comprehensive traceability chain for the standardization of serum theophylline.
- metrology,
- theophylline,
- routine methods,
- standardization,
- reference measurement procedure,
- reference material

FullText(HTML)

References(43)

References

[1]	高梓琪, 满佳旭, 武思敏, 等. 茶碱研究进展[J]. 云南民族大学学报(自然科学版), 2022, 31(1): 35-40.
[2]	周明祎, 陈秋晨, 付婴子, 等. 氨茶碱在大鼠体内的药代动力学研究[J]. 化学与生物工程, 2011, 28(10): 72-74. doi: 10.3969/j.issn.1672-5425.2011.10.019
[3]	田娟, 李娟娟, 李园, 等. 新生儿呼吸暂停应用纳洛酮联合氨茶碱的疗效分析[J]. 临床医学研究与实践, 2018, 3(2): 48-49.
[4]	颜佩, 叶连宝, 陈伟强. 慢性阻塞性肺病药物治疗靶点及其药物研发进展[J]. 中国药科大学学报, 2021, 52(2): 144-155. doi: 10.11665/j.issn.1000-5048.20210202
[5]	中华医学会呼吸病学分会哮喘学组. 支气管哮喘防治指南(2020年版)[J]. 中华结核和呼吸杂志, 2020, 43(12): 1023-1048. doi: 10.3760/cma.j.cn112147-20200618-00721
[6]	Barnes PJ, Pauwels RA. Theophylline in the management of asthma: time for reappraisal?[J]. European Respiratory Journal, 1994, 7(3): 579-91. doi: 10.1183/09031936.94.07030579
[7]	陈林. 茶碱临床应用的研究进展[J]. 医学文选, 2001(4): 526-528.
[8]	周宏基, 李雅兰. 支气管扩张剂的临床应用研究进展[J]. 实用临床医药杂志, 2020, 24(16): 117-121.
[9]	王玉娇. 茶碱类药物的研究进展及应用[J]. 中国医药指南, 2016, 14(21): 26-27.
[10]	赵斌, 解学超, 王振华, 等. 茶碱类平喘药不良反应文献的回顾性分析[J]. 中国现代应用药学, 2014, 31(5): 638-642.
[11]	刘文忠, 张传宝, 李海朝. 茶碱类平喘药不良反应发生情况研究[J]. 中西医结合心血管病电子杂志, 2017, 5(7): 58-59. doi: 10.3969/j.issn.2095-6681.2017.07.042
[12]	Marta RA, Wu R, Eldridge KR, et al. Infrared vibrational spectra as a structural probe of gaseous ions formed by caffeine and theophylline[J]. Phys Chem Chem Phys, 2010, 12(14): 3431-3442. doi: 10.1039/b921102k
[13]	朱瑞萱, 张淼, 王朋倩, 等. 免疫分析法用于中药活性成分检测和质量控制研究进展[J]. 中国新药杂志, 2021, 30(4): 339-346.
[14]	王菁, 刘璐, 郑恒, 等. 治疗药物监测的研究进展[J]. 中国医院药学杂志, 2017, 37(1): 1-8.
[15]	臧宁, 岑美婷, 张意钗, 等. 荧光偏振免疫分析法与化学发光酶免疫法测定人血浆茶碱浓度的比较[J]. 北方药学, 2015, 12(8): 94-95.
[16]	范毅, 刘梦. 高效液相色谱法和化学发光酶免疫分析法测定茶碱的血药浓度[J]. 中国药业, 2011, 20(21): 6-7. doi: 10.3969/j.issn.1006-4931.2011.21.003
[17]	Thompson RD, Nagasawa HT, Jenne JW. Determination of theophylline and its metabolites in human urine and serum by high-pressure liquid chromatography[J]. Journal of Laboratory and Clinical Medicine, 1974, 84(4): 584-593.
[18]	Adams RF, Vandemark FL, Schmidt GJ. More sensitive high-pressure liquid-chromatographic determiantion of theophylline in serum[J]. Clinical Chemistry, 1976, 22(11): 1903-1906. doi: 10.1093/clinchem/22.11.1903
[19]	贾永娟, 赵俊平, 金燕, 等. 在线固相萃取-高效液相色谱法测定血清中的茶碱[J]. 中国医院药学杂志, 2018, 38(3): 258-261.
[20]	王丽琼, 余敏灵. HPLC测定茶碱类口服固体制剂中的茶碱[J]. 华西药学杂志, 2023, 38(3): 332-335.
[21]	金静怡, 裘福荣, 张珏. 液相色谱串联质谱技术在精准医疗中的应用进展[J]. 中华预防医学杂志, 2022, 56(11): 1675-1684. doi: 10.3760/cma.j.cn112150-20211207-01128
[22]	李继扬, 向平. 液相色谱-质谱联用测定血液中茶碱浓度[J]. 中国临床药学杂志, 2009, 18(3): 139-142.
[23]	孙旭颖, 张美微, 李水军. 液相色谱-串联质谱法监测血清茶碱浓度及室间质量评价[J]. 检验医学, 2014, 29(11): 1144-1150. doi: 10.3969/j.issn.1673-8640.2014.11.016
[24]	Dai HR, Guo HL, Wang WJ, et al. From "wet" matrices to "dry" blood spot sampling strategy: a versatile LC-MS/MS assay for simultaneous monitoring caffeine and its three primary metabolites in preterm infants[J]. Clinical Chemistry and Laboratory Medicine, 2023, 62(1): 97-110.
[25]	魏淑芬, 迟佐英, 罗瑞祥, 等. 分光光度法测定茶碱血药浓度和唾药浓度的研究[J]. 中国医院药学杂志, 1991(6): 19-21,50.
[26]	吴文铭. 紫外可见分光光度计及其应用[J]. 生命科学仪器, 2009, 7(4): 61-63. doi: 10.3969/j.issn.1671-7929.2009.04.015
[27]	Jiang W, Aman R, Ali Z, et al. Bio-SCAN V2: A CRISPR/dCas9-based lateral flow assay for rapid detection of theophylline[J]. Front Bioeng Biotechnol, 2023, 11: 1118684. doi: 10.3389/fbioe.2023.1118684
[28]	刘筱雪, 周伟燕, 黄晨蓉, 等. 全国医疗及相关机构治疗药物监测项目开展情况调查[J]. 医药导报, 2022, 41(11): 1699-1710.
[29]	国家卫生健康委临床检验中心[EB/OL]. [2024-04-20]. https://nccl.clinet.com.cn/.
[30]	费阳, 王薇, 王治国. 室间质量评价计划与临床检验的标准化/一致化[J]. 中华检验医学杂志, 2015, 38(5): 359-340. doi: 10.3760/cma.j.issn.1009-9158.2015.05.019
[31]	ISO/IEC Guide 99. International vocabulary of metrology-Basic and general concepts and associated terms (VIM)[S]. International Organization for Standardization, 2007.
[32]	居漪. 检验医学参考测量系统的研究与应用[J]. 检验医学, 2021, 36(3): 237-239. doi: 10.3969/j.issn.1673-8640.2021.03.001
[33]	International Organization of Standardization. ISO 15193: In vitro diagnostic medical devices–measurement of quantities in samples of biological origin–Requirements for content and presentation of reference measurement procedures[S]. Genova: ISO, 2009.
[34]	JCTLM Database: higher-order reference materials, method and services[EB/OL]. [2024-04-20]. https://www.jctlmdb.org/#/app/home.
[35]	Désage M, Soubeyrand J, Soun A, et al. Automated theophylline assay using gas chromatography and a mass-selective detector[J]. Journal of Chromatographic Science, 1984, 336(2): 285-291.
[36]	Thienpont LM, Van Nieuwenhove B, Stöckl D, et al. Candidate reference method for determining serum theophylline applied to target-setting in external quality assessment and routine method evaluation[J]. Clinical Chemistry, 1994, 40(8): 1503-1511. doi: 10.1093/clinchem/40.8.1503
[37]	Kress M, Meissner D, Kaiser P, et al. The measurement of theophylline in human serum or plasma using gas chromatography and isotope dilution-mass spectrometry (GC-IDMS) taking other substituted xanthines into consideration[J]. Clinical Laboratory, 2002, 48(9-10): 535-540.
[38]	International Organization for Standardization. ISO 15194: In vitro diagnostic medical devices–measurement of quantities in samples of biological origin–Requirements for certified reference materials and the content of supporting documentation[S]. Genova: ISO, 2009.
[39]	International Organization for Standardization. ISO 15195: Laboratory medicine–Requirements for the competence of calibration laboratories using reference measurement procedures[S]. 2nd Edition. Genova: ISO, 2018.
[40]	International Organization for Standardization / International Electrotechnical Commission. ISO/IEC 17025: 2017—General requirements for the competence of testing and calibration laboratories[S]. Third edition. ISO, 2017.
[41]	China National Accreditation Service for Conformity Assessment[EB/OL]. [2024-04-20]. https://www.cnas.org.cn/.
[42]	External quality control for Reference Laboratories[EB/OL]. [2024-04-20]. http://dgkl-rfb.de:81/.
[43]	郭琦, 周伟燕, 张天娇, 等. 治疗药物监测样本检测质量现状和标准化构想[J]. 中华检验医学杂志, 2021, 44(8): 674-678. doi: 10.3760/cma.j.cn114452-20210511-00300