摘要
目的:系统评价高效液相色谱法(high performance liquid chromatography,HPLC)与常见免疫法分别监测环孢素(cyclosporin A,Cs A)血药浓度的效果。方法:计算机检索Pub Med、Embase、the Cochrane Library、中国生物医学文献数据库、中国知网、维普数据库和万方数据库,搜集比较HPLC与免疫法监测Cs A血药浓度的二次研究、队列研究、基础研究及综述,同时检索各试剂盒说明书等资料,检索时限均为建库至2017年4月。由2名研究者独立筛选文献、提取资料,对研究结果进行描述性分析。结果:共纳入文献22篇,皆为基础研究。系统评价结果显示,4种免疫法[荧光偏振免疫法(fluorescent polarization immunoassay,FPIA)、放射免疫法(radioimmunoassay,RIA)、克隆酶供体免疫分析法(cloned enzyme donor immunoassay,CEDIA)及酶放大免疫分析法(enzyme multiplied immunoassay technique,EMIT)]与HPLC相比的所需样本体积(μl)分别为(213±197)_(FPIA)vs.(1 125±629)_(HPLC)、(88±75)_(RIA)vs.(1 050±737)_(HPLC)、100_(CEDIA)vs.1 000_(HPLC)及100_(EMIT)vs.1 000_(HPLC);HPLC与FPIA、RIA、CEDIA及EMIT的相关性方程与相关系数分别为C_(FPIA)=1.54 C_(HPLC)+2.31(r=0.941)、C_(RIA)=1.26 CHPLC+55.92(r=0.908)、C_(CEDIA)=1.19 CHPLC-12.10(r=0.961)及C_(EMIT)=1.04 C_(HPLC)+16.10(r=0.936),HPLC与FPIA、RIA、CEDIA及EMIT的相关性均较强(r>0.9);FPIA、RIA、CEDIA及EMIT的Cs A血药浓度测定值分别比HPLC测定值高(44.14±38.95)%、(50.91±72.05)%、(15.40±4.90)%及(14.28±5.74)%,Cs A血药浓度测定值由高至低依次为RIA>FPIA>CEDIA>EMIT>HPLC。结论:HPLC所需样本体积远大于4种免疫法,免疫法更适用于儿童Cs A治疗药物监测;HPLC的Cs A血药浓度测定值低于FPIA、RIA、CEDIA及EMIT,但HPLC与4种免疫法测定值的相关性较强,监测时可将4种免疫法的测定值统一转化为HPLC的测定值,方便医师分析Cs A血药浓度监测结果,有助于准确调整用药方案。
OBJECTIVE： To systematically review the effects of high performance liquid chromatography（ HPLC）and common immunoassay in respectively monitoring the plasma concentration of cyclosporin A（ Cs A）. METHODS：Secondary studies,cohort studies,fundamental researches and overviews on comparison of effects between HPLC and immunoassay in monitoring the plasma concentration of Cs A were retrieved from Pub Med,Embase,the Cochrane Library,CBM,CNKI,VIP and Wanfang data of kits instructions from base-building to Apr. 2017 were also retrieved.Literature screening and data extracting were conducted by 2 independent researchers, and the results weredescriptively analyzed. RESULTS： A total of 22 fundamental researches were involved. Results of systematic review indicated the required sample volumes（ μl） of four immunoassays [fluorescent polarization immunoassay（ FPIA）,radioimmunoassay（ RIA）, cloned enzyme donor immunoassay（ CEDIA） and enzyme multiplied immunoassay technique（ EMIT） ] compared with those of HPLC were respectively（ 213 ± 197）_（FPIA）vs.（ 1 125 ± 629）_（HPLC）,（ 88 ±75）_（RIA）vs.（ 1 050 ± 737）_（HPLC）,100 _（CEDIA）vs. 1 000 _（HPLC） and 100 _（EMIT）vs. 1 000 _（HPLC）; the coherency equations and correlation coefficients between HPLC and FPIA,RIA,CEDIA,EMIT were respectively C_（FPIA）= 1. 54 C_（HPLC）＋ 2. 31（ r = 0. 941）,C_（RIA）= 1. 26 C_（HPLC）＋ 55. 92（ r = 0. 908）,C_（CEDIA）= 1. 19 C_（HPLC）-12. 10（ r = 0. 961） and C_（EMIT）=1. 04 C_（HPLC）＋ 16. 10（ r = 0. 936）,all with strongly correlation coefficients（ r 0. 9）; the determined values of Cs A plasma concentrations of FPIA,RIA,CEDIA and EMIT were respectively（ 44. 14 ± 38. 95） %,（ 50. 91 ± 72. 05） %,（ 15. 40 ± 4. 90） % and（ 14. 28 ± 5. 74） % higher than that of the HPLC,the determined values of Cs A plasma concentrations from high to low were respectively RIA FPIA CEDIA EMIT HPLC. CONCLUSIONS： The required sample volume of HPLC is much larger than that of the 4 immunoassays,so that immunoassay is more suitable for therapeutic drug monitoring of children Cs A; the determined value of HPLC is lower than that of FPIA,RIA,CEDIA and EMIT,while with strong correlations,the determined values of the four immunoassays can be translated into that of the HPLC in order to make the results analysis of Cs A plasma concentrations convenient for physicians,which also benefit the adjustments of therapeutic regimens.
作者
蒋志美
张伶俐
罗婷
詹琳
陈卓
刘丹
杨春松
JIANG Zhimei1,2,3, ZHANG Linglia1,2,3, LUO Ting1,2,3,ZHAN Lin1,2,3, CHEN Zhuo4, LIU Dan1,2,3,YANG Chunsong1,2,3(1. Dept. of Pharmaey, West China Seeond University Hospital, Siehuan University, Siehuan Chengdu 610041, China; 2. Centre of Evidenee-based Pharmacy, West China Seeond University Hospital, Siehuan University, Siehuan Chengdu 610041, China; 3. Key Laboratory of Birth Defeet and Related Diseases of Women and Children, Ministry of Edueation, Siehuan Chengdu 610041, China; 4. Drug Clinical Trial Organization, West China Second University Hospital,Siehuan University, Siehuan Chengdu 610041, Chin)
出处
《中国医院用药评价与分析》
2018年第3期289-294,共6页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
国家自然科学基金青年科学基金项目(No.71503177)
关键词
环孢素
治疗药物监测
HPLC
免疫法
Cyclosporin A
Therapeutic drug monitoring
HPLC
Immunoassay
作者简介
蒋志美,药师。研究方向:生物药剂学与药动学。E-mail:jiangzhimei1988@126.com;通信作者:张伶俐,主任药师,博士,博士生导师。研究方向:循证药物决策与管理、循证临床药学研究与实践。E-mail:zhanglingli@SOU.edu.cn
