载药微球肝动脉化疗栓塞治疗肝细胞癌：疗效及阿霉素药代动力学
Chemoembolization of hepatocellular carcinoma with drug eluting beads: efficacy and doxorubicin pharmacokinetics.
作者信息
Varela María, Real María Isabel, Burrel Marta, Forner Alejandro, Sala Margarita, Brunet Mercé, Ayuso Carmen, Castells Lluis, Montañá Xavier, Llovet Josep M, Bruix Jordi
机构信息
Liver Unit, IMDM, Barcelona Clínic Liver Cancer (BCLC) Group, Hospital Clínic, CIBER HEPAD, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi I Sunyer, IDIBAPS, Barcelona, Spain.
出版信息
J Hepatol. 2007 Mar;46(3):474-81. doi: 10.1016/j.jhep.2006.10.020. Epub 2006 Nov 29.
BACKGROUND/AIMS: This study assesses the safety, pharmacokinetics and efficacy of transarterial chemoembolization using drug eluting beads (DEB), an embolizing device that slowly releases chemotherapy to decrease systemic toxicity.
METHODS
Twenty-seven Child-Pugh A cirrhotics (76% male, 59% HCV) with untreated large/multifocal HCC received chemoembolization with doxorubicin loaded DEBs at doses adjusted for bilirubin and body surface (range: 47-150 mg). Clinical and analytical data were recorded at 24 and 48 h, 7, 14 and 30 days after first and second TACE. Response rate was assessed by CT at 6 months. Blood samples were obtained in 13 patients at 5, 20, 40, 60, 120 min, 6, 24, 48 and 168 h to determine doxorubicin Cmax and AUC.
RESULTS
DEB-TACE was well tolerated with an acceptable safety profile. Two cases developed liver abscess, one leading to death. Response rate was 75% (66.6% on intention-to-treat). Doxorubicin Cmax and AUC were significantly lower in DEB-TACE patients (78.97+/-38.3 ng/mL and 662.6+/-417.6 ng/mLmin) than in conventional TACE (2341.5+/-3951.9 ng/mL and 1812.2+/-1093.7 ng/mLmin, p=0.00002 and p=0.001, respectively). After a median follow-up of 27.6 months, 1- and 2-year survival is 92.5% and 88.9%, respectively.
CONCLUSIONS
Chemoembolization using DEBs is an effective procedure with a favorable pharmacokinetic profile.
背景/目的：本研究评估使用载药微球（DEB）进行经动脉化疗栓塞的安全性、药代动力学和疗效，DEB是一种可缓慢释放化疗药物以降低全身毒性的栓塞装置。
方法
27例Child-Pugh A级肝硬化患者（76%为男性，59%为丙型肝炎病毒感染），患有未经治疗的大/多灶性肝癌，接受了经动脉化疗栓塞，使用载有多柔比星的DEB，剂量根据胆红素和体表面积进行调整（范围：47-150mg）。在首次和第二次经动脉化疗栓塞后的24小时和48小时、7天、14天和30天记录临床和分析数据。6个月时通过CT评估缓解率。在13例患者中于5分钟、20分钟、40分钟、60分钟、120分钟、6小时、24小时、48小时和168小时采集血样，以测定多柔比星的Cmax和AUC。
结果
DEB-TACE耐受性良好，安全性可接受。2例发生肝脓肿，1例导致死亡。缓解率为75%（意向性治疗分析为66.6%）。DEB-TACE患者的多柔比星Cmax和AUC（分别为78.97±38.3ng/mL和662.6±417.6ng/mL·min）显著低于传统TACE（分别为2341.5±3951.9ng/mL和1812.2±1093.7ng/mL·min，p分别为0.00002和0.001）。中位随访27.6个月后，1年和2年生存率分别为92.5%和88.9%。
结论
使用DEB进行化疗栓塞是一种有效的方法，药代动力学特征良好。
Zotero 插件