本文選題：嗎替麥考酚酯　切入點(diǎn)：麥考酚鈉腸溶片　出處：《中國醫(yī)院藥學(xué)雜志》2017年10期 　論文類型：期刊論文

【摘要】：目的:探討腎移植術(shù)后早期患者口服嗎替麥考酚酯膠囊(MMF)和麥考酚鈉腸溶片(EC-MPS)的藥動(dòng)學(xué)特點(diǎn),為臨床合理用藥提供依據(jù)。方法:選取26例腎移植患者,按隨機(jī)數(shù)字表法分為MMF組(n=13)和EC-MPS組(n=13),兩組患者分別于術(shù)后第1天給予MMF(750 mg q12 h)或EC-MPS(720 mg q12 h)、他克莫司、甲潑尼龍預(yù)防排斥反應(yīng)。于術(shù)后第7天的早上服藥前及服藥后0.5,1,1.5,2,3,4,6,8,10,12 h采集靜脈血樣3 mL,采用UPLC-UV分析方法測定霉酚酸(MPA)血漿濃度。以DAS 2.0藥動(dòng)學(xué)軟件進(jìn)行藥動(dòng)學(xué)分析,所有與劑量相關(guān)的兩組藥動(dòng)學(xué)參數(shù)分別進(jìn)行了劑量校正(C_(max)/D,C_0/D,AUC_(0-12 h)/D及AUMC_(0-12 h)/D)。用SPSS 17.0軟件進(jìn)行統(tǒng)計(jì)學(xué)分析。結(jié)果:術(shù)后第7天MMF和EC-MPS的主要藥動(dòng)學(xué)參數(shù)t_(max)分別為(1.54±0.9)h和(2.19±1.56)h(P0.05);C_(max)/D分別為(5.12±2.83)mg·L~(-1)·g~(-1)和(9.51±7.38)mg·L~(-1)·g~(-1)(P0.05);AUC_(0-12 h)/D分別為(19.13±7.78)mg·h·L~(-1)·g~(-1)和(25.96±11.78)mg·h·L~(-1)·g~(-1)(P0.05)。兩組患者的藥-時(shí)曲線個(gè)體間差異均較大,大部分患者觀察到有雙峰現(xiàn)象,極個(gè)別患者觀察到有多峰。MMF組和EC-MPS組患者的MPA-AUC_(0-12 h)低暴露組比例分別為84.6%和46.15%,目標(biāo)暴露組比例分別為15.4%和46.15%,僅有1例EC-MPS組患者為高暴露組。結(jié)論:MMF和EC-MPS在早期腎移植患者體內(nèi)的藥動(dòng)學(xué)個(gè)體差異較大,需要常規(guī)監(jiān)測MPA-AUC_(0-12 h),同時(shí)可結(jié)合C_0作為參考,以指導(dǎo)臨床調(diào)整用藥劑量。MMF和EC-MPS常規(guī)劑量下的MPA-AUC_(0-12 h)在早期腎移植患者中偏低,建議增加給藥劑量。
[Abstract]:Objective: to investigate the pharmacokinetic characteristics of Mutimefen capsule (MMF) and mycophenolic sodium enteric-coated tablets (EC-MPS) in early stage of renal transplantation, and to provide evidence for rational drug use in clinic. Methods: 26 patients with renal transplantation were selected. The patients in MMF group and EC-MPS group were given MMF(750 mg q12 h) or EC-MPS(720 mg Q12 h, tacrolimus on the first day after operation. Methylprednisolone was used to prevent rejection. Venous blood samples were collected for 3 mL at the morning of 7 days after operation and before and after taking the drug. The plasma concentration of mycophenolate mofetil was determined by UPLC-UV. The pharmacokinetic analysis was performed with DAS 2.0 pharmacokinetic software. All dose-related pharmacokinetic parameters of the two groups were dose-corrected respectively. The main pharmacokinetic parameters of MMF and EC-MPS on the 7th day after operation were 1.54 鹵0.9h and 2.19 鹵1.56hP0.05C / D, respectively. Statistical analysis was carried out using SPSS 17.0 software. Results: the main pharmacokinetic parameters of MMF and EC-MPS were 1.54 鹵0.9h and 2.19 鹵1.56hP0.05C / D, respectively. The results showed that the main pharmacokinetic parameters of MMF and EC-MPS were 1.54 鹵0.9 h and 2.19 鹵1.56 h / d respectively. And 9.51 鹵7.38 渭 g 路L ~ (-1) 路g ~ (-1) 路g ~ (1)) 路P ~ (0.05) (P ~ (0.05) P = 19.13 鹵7.78 mg 路h 路L ~ (-1) 路g ~ (-1)) and 25.96 鹵11.78 ~ 11.78 mg 路L ~ (-1) 路g ~ (-1) 路g ~ (-1), respectively. Most of the patients observed a bimodal phenomenon. In very few patients, the proportions of MPA-AUC_(0-12 h in low exposure group were 84.6% and 46.15, those in target exposure group were 15.4% and 46.15, respectively. Only one patient in EC-MPS group was in high exposure group. Conclusion\% MMF and EC-MPS are in early stage of renal metastasis. The pharmacokinetics of the patients in vivo varies greatly. Routine monitoring of MPA-AUC_(0-12 hens is needed, and C0 can be used as a reference to guide the clinical adjustment of dosage. MMF and MPA-AUC_(0-12 h under the routine dose of EC-MPS) in early renal transplantation patients. It is suggested to increase the dosage of drugs.
【作者單位】： 鄭州大學(xué)第一附屬醫(yī)院藥學(xué)部;
【基金】：河南省醫(yī)學(xué)科技攻關(guān)計(jì)劃項(xiàng)目(編號:201602037)
【分類號】：R969.1

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