EMIT法檢測環孢素血藥濃度的動態飄逸校正系數研究

周清武

中圖分類號 R917；R979.5 文獻標志碼 A 文章編號 1001-0408（2018）08-1078-05

DOI 10.6039/j.issn.1001-0408.2018.08.16

摘 要 目的：探討酶放大免疫測定技術（EMIT）檢測環孢素血藥濃度的動態飄逸校正系數。方法：針對EMIT法檢測環孢素藥物濃度的動態飄逸現象，以質量濃度為100 ng/mL的環孢素定標液為待測樣品，選擇其第58、101次檢測結果來進行動態飄逸相關系數的推擬；分別以上述系數對第1、20、45、77、106、115次檢測結果進行校正，考察校正質量濃度與真實質量濃度的差異。結果：推擬得動態飄逸系數k=（1+0.001 235×n0.419 5）n，動態飄逸校正系數k′ =1/[（1+0.001 235×n0.419 5）n]。各次檢測結果經校正后，其校正質量濃度與真實質量濃度的相對誤差在±4%之內。結論：推擬所得的動態飄逸校正系數可用于環孢素質控樣品濃度的動態校正，有助于環孢素血藥濃度的準確檢測。

關鍵詞 酶放大免疫測定技術；環孢素；血藥濃度；動態飄逸；校正系數

ABSTRACT OBJECTIVE： To explore the dynamic upwarp state correction coefficient of cyclosporine blood concentration determined by EMIT. METHODS： The dynamic upwarp state of cyclosporine concentration was determined by EMIT. The cyclosporine calibration reagents with concentration of 100 ng/mL was used as the sample to be measured， the 58th and 101st test results were selected to simulate the dynamic upwarp state related coefficients， and the 1st， 20th， 45th， 77th， 106th， 115th test results were corrected by above coefficients. The difference of correction quality concentration with real quality concentration was investigated. RESULTS： The dynamic upwarp state coefficient [k=（1+0.001 235×n0.419 5）n] and dynamic upwarp state correction coefficient {k′ =1/[（1+0.001 235×n0.419 5）n} were obtained. After determination results were corrected， relative error of corrected quality concentration with real quality concentration was within ±4%. CONCLUSIONS： The obtained dynamic upwarp state correction coefficient can be used for dynamic calibration of cyclosporine quality control concentration， which contribute to correct determination of blood concentration of cyclosporine.

KEYWORDS EMIT； Cyclosporine； Blood concentretion； Dynamic upwarp state； Correction coefficient

環孢素是臨床常用的免疫抑制劑之一，主用于肝、腎、骨髓等器官/組織移植以及再生障礙性貧血、腎病綜合征、干燥綜合征等異常免疫性疾病的治療[1-6]。由于環孢素的生物利用度及肝消除等個體差異大、治療窗窄，容易導致治療無效或中毒[7-8]，故需通過治療藥物監測（Therapeutic drug monitoring，TDM）來指導其臨床個體化合理用藥。

酶放大免疫測定技術（Enzyme multiplied immunoassay technique， EMIT）是目前臨床TDM的主要手段之一，具有自動化程度高，可多品種、多樣本連續檢測，檢測時間短，樣品處理簡單，規律性強等特點，且當試劑瓶中的試劑較多時，相鄰質控樣品檢測的重現性較好[9]。但該法所用試劑昂貴，且當試劑瓶中的試劑較少時，檢測結果會出現偏差，重現性較差[10-12]。……