注射用紫杉醇脂质体与紫杉醇注射液在肿瘤患者中的药动学对比研究

A comparison of pharmacokinetics between paclitaxel liposome for injection and commercial paclitaxel injection in patients with cancer

目的:探究比较注射用紫杉醇脂质体和紫杉醇注射液在肿瘤患者中的药动学研究。方法:选取20例肿瘤患者,分成两组,脂质体组滴注注射用紫杉醇脂质体175 mg/ml,注射液组滴注紫杉醇注射液,抽取患者血样,采用交叉设计的方法,进行分析高效液相色谱-质谱串联测定血药浓度,比较两组的药动学参数。结果:血浆清除率脂质体组为(12.3±2.6)L/(h.m2),注射液组为(8.1±1.0)L/(h.m2)。两组药动学参数差异有统计学意义(P<0.05)。结论:紫杉醇脂质体的药动学参数优于常规注射液,脂质体在组织亲和性、缓释性、靶向性、安全性方面更具优势。

Objective Research compared with injection of paclitaxel liposome and Paclitaxel injection in patients with tumors in pharmacokinetic studies.Methods The choice 20 cases of tumor patients,divided into two groups,liposome group drip infusion of paclitaxel liposome 175 mg/ml,infusion of Paclitaxel injection,drawing blood samples of patients,using a crossover design method,were analyzed with high performance liquid chromatography-mass spectrometry determination of blood drug concentration of series,compared with two groups of pharmacokinetic parameters.Results Plasma clearance of liposomes was （12.3 ± 2.6）L/（h.m2）,injection group was （8.1 ± 1.0）L/（h-m2）.Two groups of pharmacokinetic parameters of the difference was statistically significant（P 〈 0.05）.Conclusion Paclitaxel liposome pharmacokinetic parameters is better than that of conventional injection, liposomes in tissue affinity, slow release,targeted, safety more advantages.