国产载药微球经动脉化疗栓塞治疗不可切除原发性肝癌的临床研究

Clinical investigation on transarterial chemoembolization with indigenous drug-eluting beads in treatment of unresectable hepatocellular carcinoma

目的:比较国产CalliSpheres~载药微球经动脉化疗栓塞(DEB-TACE)与常规经动脉化疗栓塞(cTACE)治疗不可切除原发性肝癌的近期临床疗效和安全性。方法:42例不可切除原发性肝癌患者接受经导管动脉化疗栓塞(TACE)中使用CalliSphere~ DEB-TACE或cTACE治疗,在介入前1周及介入后1个月、3个月、6个月行MRI检查,对患者的随访影像资料和临床资料等进行汇总和分析,采用国际通用的改良实体瘤评价标准进行评价,比较两种方法在患者肿瘤反应、复发情况、并发症及不良反应发生率的差异。结杲:DEB-TACE组与cTACE组在介入治疗后1个月、3个月、6个月疾病缓解率、疾病控制率、治疗后并发症发生及肿瘤复发情况差异均无统计学意义(均P>0.05),且DEB-TACE组局部胆道损伤和胆汁瘤发生率以及瘤体外新发病灶发生率差异均无统计学意义(均P>0.05)。结论:DEB-TACE与cTACE治疗用于不可切除原发性肝癌患者在肿瘤反应、治疗后并发症及肿瘤复发方面等结果相似。DEB-TACE治疗较cTACE治疗可能更易发生肝脏局部的并发症。

Objective： To evaluate the efficacy and safety of drug-eluding beads transarterial chemoembolization （ DEB-TACE ） in treatment of unrecectable hepatocellular carcinoma （HCC）. Methods： The clinical data of 42 consecutive HCC patients undergoing TACE were retrospectively analyzed, including 20 cases received conventional TACE （cTACE group） and 22 cases received TACE with epirubicine- loaded microspheres （CalliSpheres） （DEB-TACE group）. MRI scans were performed 1 week before and 1, 3 and 6 months after initial therapy. The response to treatment, disease recurrence, complications and adverse effects were documented and compared between two groups. Results： There were no significant differences in 1-month, 3-month and 6-month objective response rate （ CR ＋ PR） and disease control rate （ CR ＋ PR ＋ SD）, disease recurrence, complications and adverse effects of interventional therapy between cTACE group and DEB-TACE group. Additionally, there were no significant differences about locoregional biliary injuries, intrahepatic bilorna, and newly detected intra- or extrahepatic HCC on MRI between cTACE group and DEB- TACE group. Conclusion： There were no cTACE group and DEB-TACE group with recurrence, complications and side effects. statistically significant differences between regard to the short-term response, disease Hepatic-locoregional complications may be more frequent in DEB-TACE group than those in cTACE group.