载药微球治疗中期原发性肝癌25例  

CalliSpheres-loaded microspheres for the treatment of mid-stage hepatocellular carcinoma: analysis of its efficacy and safety in 25 patients

作　　者：王文辉[1] 李宝华[1] 李雷[1] 李双喜[1] 杨旭军 许方裕 WANG Wenhui;LI Baohua;LI Lei;LI Shuangxi;YANG Xujun;XU Fangyu(Department of Intervention,First Hospital of Lanzhou University,Gansu Province 730000,China)

机构地区：[1]兰州大学第一医院介入科,730000

出　　处：《介入放射学杂志》2021年第3期270-274,共5页Journal of Interventional Radiology

摘　　要：目的评估采用国产载药微球(CalliSpheres)TACE治疗中期原发性肝癌的安全性及近期临床疗效。方法25例经临床确诊的中期肝癌患者,在行TACE治疗中使用CalliSpheres载药微球进行栓塞,并对患者基本资料、影像随访、栓塞治疗后的不良反应、并发症和临床疗效等进行总结和分析。结果25例患者随访6~18个月;采用改良实体瘤疗效评价标准(mRECIST),结果显示DEB-TACE术后3个月客观缓解率(ORR)为76%,疾病控制率(DCR)为88%;6个月ORR为56%,DCR为68%;9个月ORR为47.4%,DCR为63.2%;中位疾病无进展生存期(mPFS)为9.0个月;6个月、1年生存率分别为92%、76%;术后平均住院时间为(7.0±1.6)d;术后1 d肝功能显示ALT、AST升高,3 d TBIL达最高值,之后降至正常,与术前比较差异有统计学意义(P<0.05);ALB与术前比较降低,差异有统计学意义(P<0.05);术后所有患者出现不同程度疼痛,部分患者出现发热等栓塞后综合征,其中1例患者出现肝脓肿,经抗感染和经皮肝穿刺引流治疗后好转。结论使用CalliSpheres载药微球栓塞治疗中期肝癌的近期疗效及安全性均较好,远期疗效仍需扩大样本量及国内多中心随机对照研究观察获得。Objective To evaluate the safety and short-term efficacy of transcatheter arterial chemoembolization(TACE)using drug-eluting microsphere(CalliSpheres)in treating mid-stage hepatocellular carcinoma(HCC).Methods A total of 25 patients with clinically-proved mid-stage HCC received TACE treatment using CalliSpheres-loaded microspheres.The patients’basic data,follow-up imaging materials,post-embolization adverse reactions and complications,and clinical curative efficacy were summarized and analyzed.Results All the 25 patients were followed up for 6-18 months.Modified response evaluation criteria in solid tumor(mRECIST)was used to evaluate the curative efficacy.Post-TACE 3-month objective remission rate(ORR)was 76%,the disease control rate(DCR)was 88%.Post-TACE 6-month ORR and DCR were 56%and 68%respectively.Post-TACE 9-month ORR and DCR were 47.4%and 63.2%respectively.The median disease progression-free(DPF)survival was 9.0 months.The 6-month and 12-month survival rates were 92%and 76%respectively.The mean postoperative hospitalization length was(7.0±1.6)days.One day after treatment the liver function testing showed that ALT,AST and TBIL levels began to rise,which reached their peak values on the third day after treatment and then gradually returned to normal.The post-TACE changes in liver function indexes were statistically significant when compared with pre-TACE data(P<0.05).The post-TACE ALB level was significantly decreased when compared with the pre-TACE one(P<0.05).After TACE,all patients developed different degrees of pain,and symptoms of post-embolization syndrome such as fever occurred in some patients,among them one developed liver abscess,which was improved after anti-infection medication and percutaneous hepatic puncture drainage treatment.Conclusion For mid-stage HCC,TACE treatment using CalliSpheres-loaded microspheres is clinically safe with satisfactory short-term efficacy,but further domestic multicenter randomized controlled large sample studies need to be carried out before its longterm efficacy

关 键 词：原发性肝癌 经肝动脉化疗栓塞术 载药微球 

分 类 号：R735.7[医药卫生—肿瘤]