摘要
目的评价微粒子酶免分析法(MEIA)测定他克莫司(FK506)血药浓度的质量,确定本实验室条件下FK506治疗药物监测的质量控制方法。方法以标准质控为样本,考察微粒子酶免分析法在本实验室条件下测定FK506的方法学性质;根据临床检验质控设计评价方法对本实验室2005年度质控数据进行统计学分析,并建立新的质控规则。结果MEIA在本实验室条件下的方法学参数为回收率为86.18%~100.40%,RSD为5.06%~11.49%;2005年本院随行质控数据RSD为12.95%~20.09%;适合本实验室该项测定的质控规则是12.0s(2)/8x-规则。结论MEIA方法具有良好的准确度和精密度,适于临床开展治疗药物监测,但应建立合理的质量控制规则。
Abstract
OBJECTIVE To evaluation the quality of FK506 TDM by MEIA and choose the best quality control rule for FK506 TDM under this lab. METHODS Standard control was used,while the validation of MEIA method under this lab was investigated. The quality control data of last year were statistical analyzed according to quality control procedure of Ministry of Public Health,and a new quality control method was built. RESULTS The recoveries of low,middle and high concentration control were between 86.18%~100.40% and RSDs were between 5.06%~11.49%;12.0s(2)/8 was the most suitable method for this lab. CONCLUSION MEIA method has good accuracy and precision,so it is suitable for clinical TDM,but reasonable quality control method should be set up first.
关键词
微粒子酶免疫分析法 /
他克莫司 /
质量控制
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Key words
MEIA method /
FK506 /
quality control
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谭昀杜熙;顾健;杨薇;张春燕.
微粒子酶免分析法测定他克莫司血药浓度的质量评价及质控规则设计[J]. 中国药学杂志, 2007, 42(15): 1188-1191
TN Yun-du-xi;GU Jin;YNG Wei;ZHNG Chun-yn.
Quality Evaluation and Design of Quality Control Rule for FK506 TDM by MEIA [J]. Chinese Pharmaceutical Journal, 2007, 42(15): 1188-1191
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参考文献
[1] WEN A D,DOU K F,GUAN W X, et al. Determination of the level of Tacrolimus in whole blood with MEIA and its clinical application[J] . Pharm J Chin PLA(解放军药学学报),2001,17(6):303-306.
[2] HUANG W F,LIU H. Practice Medicine Analyses Technology and Application(实用医学分析技术与应用)[M] .Beijing:People′s Medicine Publishing House(人民卫生出版社),2002:649-672.
[3] Ch.P(2005) Vol Ⅱ(中国药典2005年版,二部)[S] . 2005:Appendix 174.
[4] WANG Z G,LI X P,WU P Y. Assessment and selection of quality control procedure to clinical chemical analyzer[J] . Central China Med J(华中医学杂志),2002 ,26(1):6-8.
[5] CONG Y L.Clinical Laboratory Management(临床试验室管理学)[M] . Beijing:China Medicine Technology Press(中国医药科技出版社),2004:153.
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脚注
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