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目的建立一种方便可行的环孢素A(Cs A)药物浓度测定方法,并对该院2012—2014年间异基因造血干细胞移植(alloHSCT)患者的Cs A浓度监测结果加以分析,为临床使用Cs A的有效性和安全性提供参考。方法采用高效液相色谱法(HPLC),血样经预处理后采用Ultimate XB-C18色谱柱分离;流动相为乙腈—水(85∶15);流速1.2 m L·min-1;柱温65℃;检测波长λ=214 nm。结果 Cs A血药浓度在50~1 000μg·L-1范围内,标准曲线线性关系良好(r=0.999 8),相对回收率为96.65%~101.82%,绝对回收率为91.78%~94.34%,日间及日内精密度RSD均小于4%。监测allo-HSCT患者共44例,其中23例Cs A平均血药浓度在目标浓度范围内(200~400μg·L-1);累计检测635例次,其中430例次在目标浓度范围内(200~400μg·L-1)。结论该方法方便、快速、可行,可用于临床Cs A样本的测定。allo-HSCT患者体内Cs A浓度与发生移植物抗宿主病(GVHD)、药品不良反应(ADR)概率有相关性,平均血药浓度小于200μg·L-1的患者组更易发生移植物抗宿主病(GVHD),而平均血药浓度大于400μg·L-1的患者组更易发生药物相关ADR反应,对allo-HSCT患者进行Cs A浓度监测具有重要的临床意义。
Objective To establish a convenient and feasible method for the determination of CsA concentration and to analyze the results of CsA concentration monitoring in patients with alloHSCT from 2012 to 2014 in this hospital. A for the validity and safety of reference. Methods The samples were separated by Ultimate XB-C18 column with acetonitrile-water (85:15) at a flow rate of 1.2 m L · min-1. The column temperature was 65 ℃ ; Detection wavelength λ = 214 nm. Results The concentration of CsA in the range of 50-1 000 μg · L-1 showed a good linearity (r = 0.999 8) with a relative recovery of 96.65% -101.82% and an absolute recovery of 91.78% -94.34% The RSDs were less than 4% during the day and the day. A total of 44 patients with allo-HSCT were monitored. The mean serum concentration of CsA in 23 patients was within the target concentration range (200-400 μg · L -1), 635 cases were detected cumulatively, of which 430 cases were within the target concentration range of 200 ~ 400 μg · L-1). Conclusion The method is convenient, rapid and feasible and can be used for the determination of clinical CsA samples. The level of CsA in allo-HSCT patients was correlated with the incidence of graft-versus-host disease (GVHD) and adverse drug reaction (ADR). Patients with mean serum concentration less than 200μg · L-1 were more likely to develop graft versus host disease (GVHD). However, patients with mean serum concentration greater than 400 μg · L-1 were more likely to develop drug-related ADR. It is of great clinical significance to monitor CsA concentration in allo-HSCT patients.