本文選題：有限取樣法　切入點：霉酚酸　出處：《中國藥學雜志》2015年23期 　論文類型：期刊論文

【摘要】：目的建立有限取樣法估算霉酚酸(MPA)在自身免疫性疾病(AID)患者的體內暴露藥量(AUC)。方法24例AID患者服用霉酚酸醋(MMF)0.75 g,q12 h,達穩(wěn)態(tài)后,檢測服藥前即刻、服藥后0.5,1,1.5,2,4,6,8和12h活性代謝物MPA的血藥濃度梯形法計算各例實測AUC_(0-12 h);將24例患者數(shù)據(jù)資料隨機平分為模型資料組與驗證資料組,對模型資料組的數(shù)據(jù)采用多元線性回歸法分別擬合1~4個采血點估算AUC_(0-12 h)的數(shù)學模型對初選模型用驗證資料組數(shù)據(jù)檢驗預測偏差和精密度,并結合臨床實際情況選擇最佳模型。結果 12h谷濃度建立的單點預測模型r~2值為0.957平均預測誤差及絕對預測誤差分別為-3.93與11.93,均15%;0.5,1.5,6,8 h或1.5,6,8,12h四點擬合的模型與AUC_(0-12 h)的相關性均達0.996,驗證后預測誤差在±15%以內的例數(shù)為9例;另有2點模型與3點模型,預測效果介于上述兩種模型之間。結論結合臨床實際情況,精確度較高的四點模型AUC=3.19+0.49c_(0.5h)、+1.76c_(1.5h)+2.95c_(6h)+5.46c_(8h)適用于晨起服藥后取血監(jiān)測的住院患者;相對簡便的單點模型AUC=10.82+13.37c_(12 h)適用于夜間服藥次日晨起入院監(jiān)測的門診患者。Bland-Altman分析顯示,兩種模型均能較好預測使用MMF+甲潑尼龍二聯(lián)免疫抑制方案的中國成年AID患者的MPA AUC。
[Abstract]:Objective to establish a limited sampling method to estimate the exposure of mycophenolate mofetil (MPA) in vivo to patients with autoimmune disease (AIDD). Methods 24 patients with AID were treated with MMFX 0.75 g / q12 h. The serum concentration of active metabolite MPA was calculated by trapezoid method after taking the drug, and 24 patients were randomly divided into model data group and validation data group, and 24 patients were randomly divided into model data group and validation data group, and 24 patients were randomly divided into model data group and validation data group, and 24 patients were randomly divided into model data group and validation data group, and 24 patients were randomly divided into two groups. Multiple linear regression method was used to fit 1 ~ 4 blood sampling points to estimate AUC_(0-12 h in the model group. The prediction deviation and precision of the primary model were tested with the data of the validation data group. Results the average prediction error and absolute prediction error of single point prediction model established by 12h valley concentration were -3.93 and 11.93, respectively. The correlation was 0.996, and the number of cases whose prediction error was less than 鹵15% after verification was 9 cases. There were two and three models, the prediction effect was between the above two models. Conclusion the four-point model AUC=3.19 0.49cStamp 0.5hm, 1.76cStamp 1.5h) 2.95cSta6h) is suitable for the in-patients who take blood for monitoring after taking medicine in the morning. Bland-Altman analysis showed that the two models could be used to predict the MPA of Chinese adult AID patients using MMF methylprednisolone immunosuppressive regimen.
【作者單位】： 同濟大學附屬楊浦醫(yī)院臨床藥學與藥理學研究室;同濟大學附屬楊浦醫(yī)院腎內科;
【基金】：國家自然科學基金青年項目資助項目(81302741) 上海市楊浦區(qū)“百醫(yī)登高”計劃資助項目
【分類號】：R969.4

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