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目的比较重酒石酸长春瑞滨注射用乳剂与市售注射液在肿瘤患者的药动学。方法在符合入选标准的肿瘤患者中,采用随机平行对照单次给药的方法进行药动学试验,给药剂量30 mg·m-2,采用LC-MS/MS法测定血浆样品中长春瑞滨的浓度,计算主要药动学参数并进行统计分析。结果重酒石酸长春瑞滨注射用乳剂和市售注射液在肿瘤患者中的主要药动学参数分别为:t1/2(16.78±5.24)和(20.03±24.72)h,CL(22.75±5.81)和(17.71±2.88)L·h-1·m-2,Vc(541.04±223.36)和(486.03±567.17)L·m-2,AUC0-t(1 297.09±308.73)和(1 629.31±309.41)μg·L-1·h,AUC0-∞(1 388.37±318.54)和(1 736.23±299.83)μg·L-1·h,ρmax(1 426.25±397.56)和(2 187.50±828.04)μg·L-1,tmax(0.22±0.04)和(0.29±0.18)h,MRT0-t(6.95±1.08)和(4.94±1.31)h;两制剂AUC0-t、t1/2、tmax、ρmax和Vc均无显著差异(P>0.05)。结论重酒石酸长春瑞滨注射用乳剂和市售注射液相比,在肿瘤患者中具有相似的药动学特征。
OBJECTIVE To compare pharmacokinetics of vinorelbine tartrate injection emulsion with commercially available injection in patients with cancer. Methods The pharmacokinetics test was performed in patients with oncology who met the inclusion criteria by single-dose randomized parallel control. The drug dose was 30 mg · m-2. The plasma concentration of vinorelbine Concentration, calculated the main pharmacokinetic parameters and statistical analysis. Results The main pharmacokinetic parameters of vinorelbine tartrate injection and the commercially available injection in tumor patients were t1 / 2 (16.78 ± 5.24) and (20.03 ± 24.72) h, CL (22.75 ± 5.81) and (17.71 ± 2.88) L · h-1 · m-2, Vc (541.04 ± 223.36) and (486.03 ± 567.17) L · m -2, AUC0-t (1297.09 ± 308.73) and (1629.31 ± 309.41) μg · L-1 · h, AUC0-∞ (1 388.37 ± 318.54) and (1 736.23 ± 299.83) μg · L-1 · h, ρmax (1 426.25 ± 397.56) and (2 187.50 ± 828.04) μg · L -1 , tmax (0.22 ± 0.04), (0.29 ± 0.18) h, MRT0-t (6.95 ± 1.08) and (4.94 ± 1.31) h respectively. There was no significant difference in AUC0-t, t1 / 2, tmax, (P> 0.05). Conclusion The Vinorelbine tartrate injection emulsion has similar pharmacokinetic profiles in cancer patients compared to the commercially available injection.