You J H, Chen J, Zhou L, Du S H, Lu H Y, Sun S J, Li J M, Shen Z X
Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China.
Zhonghua Xue Ye Xue Za Zhi. 2019 Nov 14;40(11):939-942. doi: 10.3760/cma.j.issn.0253-2727.2019.11.010.
To analyze the correlation between plasma trough level of generic imatinib and its metabolism and clinical outcomes in Chinese patients with chronic myeloid leukemia in chronic phase (CML-CP) . The 21 patients with CML-CP who enrolled in a clinical trial YMTN 1.0 from Oct 11(th), 2012 to May 8(th), 2013 and received generic imatinib were as study subjects. The correlation between steady plasma trough levels of imatinib and its metabolism with clinical response, age, weight and body surface area (BSA) were evaluated. ①The mean steady plasma trough level of generic imatinib and its metabolism was (1 185.07±417.91) μg/L and (251.53±76.50) μg/L, respectively. ②Age, weight and BSA has no significant effects on plasma trough level of generic imatinib and its metabolism (>0.05) . ③Patients with steady plasma trough level of generic imatinib more than 1 000 μg/L are possible to have higher major molecular response (MMR) /complete molecular response (CMR) rate than those below 1 000 μg/L (42% 0, <0.05) . Plasma trough levels of generic imatinib varied in CML patients. The steady plasma trough levels of generic imatinib is maybe related to molecular response in CML patients.
分析中国慢性期慢性髓性白血病（CML-CP）患者中伊马替尼仿制药的血浆谷浓度与其代谢及临床结局之间的相关性。选取2012年10月11日至2013年5月8日参加临床试验YMTN 1.0并接受伊马替尼仿制药治疗的21例CML-CP患者作为研究对象。评估伊马替尼的稳定血浆谷浓度与其代谢与临床反应、年龄、体重和体表面积（BSA）之间的相关性。①伊马替尼仿制药的平均稳定血浆谷浓度及其代谢产物分别为（1185.07±417.91）μg/L和（251.53±76.50）μg/L。②年龄、体重和BSA对伊马替尼仿制药的血浆谷浓度及其代谢产物无显著影响（>0.05）。③伊马替尼稳定血浆谷浓度超过1000μg/L的患者比低于1000μg/L的患者可能具有更高的主要分子反应（MMR）/完全分子反应（CMR）率（42%对0，<0.05）。CML患者中伊马替尼仿制药的血浆谷浓度存在差异。伊马替尼的稳定血浆谷浓度可能与CML患者的分子反应有关。
