多柔比星长循环脂质体经乳腺导管注射后患者体内血药浓度变化的研究

 目的 探讨多柔比星长循环脂质体经乳腺导管给药后患者体内血药浓度变化的情况。方法 15名女性乳腺癌患者随机分为50、20、10 mg 3个剂量组，经乳腺导管给药，于规定的时间点采集外周静脉血，通过本实验室建立的高效液相荧光检测法测定血药浓度。结果 低剂量和中剂量组血样采集时间最长至给药后96 h，给药后72 h血药浓度平均值分别达到852.91和1 148.59 ng·mL-1，高剂量组血样采集至用药后72 h，血药浓度平均值达到3 921.88 ng·mL-1。结论 患者体内血药浓度与多柔比星长循环脂质体乳腺导管给药量之间存在正相关性；与传统的外周静脉滴注相比，经乳腺导管给药后，多柔比星长循环脂质体呈现不同的药动学特征。

Plasma Concentration of Doxorubicin after Intraductal Administration of Doxorubicin Long-Circulating Liposome in Patients with Breast Cancer

OBJECTIVE To study the distribution of doxorubicin in human blood after intraductal administration. METHODS Doxorubicin long-circulating liposome was given through intraductal administration in three different dose groups of 10, 20 and 50 mg to 15 female breast cancer patients randomly, and blood was collected and the concentration was determined by HPLC with fluorescence detector. RESULTS In the group treated with low and middle doses, the blood samples were collected for 96 h after administration, and the average plasma concentrations at 96 h were 760.26 and 1 199.90 ng·mL-1 respectively. In the group treated with high dose, the blood samples were collected for 72 h after administration, and the average plasma concentration of doxorubicin was 3 921.88 ng·mL-1 at 72 h. CONCLUSION The plasma concentration of doxorubicin was positively correlated with the dosage. Compared with intravenous injection, the pharmacokinetic profile of doxorubicin long-circulating liposome shows significant difference.