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目的:探讨大剂量甲氨蝶呤应用于血液系统疾病中的血药浓度与患者病理生理状态的关系,发现影响药物体内消除的因素,为甲氨蝶呤群体药动学研究提供线索。并统计不良反应,为临床安全应用大剂量甲氨蝶呤提供依据。方法:收集2014年1月至2016年2月共1 050例甲氨蝶呤血药浓度监测结果,全面收集病例信息,分析血药浓度与年龄、体重指数、给药剂量、输注时间、肝肾功能、尿量、尿pH、白蛋白等因素的关系,并汇总分析不良反应发生情况。结果:1 050例甲氨蝶呤血药浓度的检测结果中,停药后20h血药浓度651例(占62.00%)<1.0μmol·L~(-1),312例(占29.71%)在1~5μmol·L~(-1),87例(占8.29%)≥5.0μmol·L~(-1)。结论:患者的年龄、体质量指数、给药剂量、输注时间、尿量、总胆红素水平、肌酐清除率以及白蛋白水平对血药浓度分布的影响具有统计学意义,而丙氨酸氨基转移酶水平、尿p H值对于血药浓度分布的影响没有统计学显著性。
OBJECTIVE: To investigate the relationship between the concentration of methotrexate in blood system diseases and the pathophysiological status of patients, and to find the factors that affect the elimination of drugs in vivo so as to provide clues for the study on the pharmacokinetics of methotrexate. And statistical adverse reactions, to provide a basis for the clinical safety of high-dose methotrexate. Methods: A total of 1 050 methotrexate plasma concentration monitoring results were collected from January 2014 to February 2016, and the case information was collected. The blood concentration and age, body mass index, dose, infusion time, Renal function, urine output, urine pH, albumin and other factors, and a summary of the incidence of adverse reactions. Results: The plasma concentrations of methotrexate in 1 050 cases were 651 (62.00%) <1.0 μmol·L -1 and 312 (29.71%) at 20 h after drug withdrawal 1 ~ 5μmol·L ~ (-1), 87 cases (8.29%) ≥5μmol·L ~ (-1). Conclusion: The age, body mass index, administration dose, infusion time, urine volume, total bilirubin level, creatinine clearance rate and albumin level had a significant effect on plasma concentration distribution, while alanine The aminotransferase levels and urine p H values had no statistical significance for the plasma concentration profile.