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

doi:10.3785/j.issn.1008-9292.2017.02.07

浙江大学学报（医学版）

2017, Vol. 46

Issue (1): 44-51 DOI: 10.3785/j.issn.1008-9292.2017.02.07

原著

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

陈刚^1,²(

),张鼎²,应亚草²,王志峰²,陶伟²,朱皓²,张景峰^1,^*(

),彭志毅^1,^*(

)

⁽¹⁾ 浙江大学医学院附属第一医院放射科, 浙江杭州 310003
⁽²⁾ 宁波市中医院放射科, 浙江宁波 315010

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

CHEN Gang^1,²(

),ZHANG Ding²,YING Yacao²,WANG Zhifeng²,TAO Wei²,ZHU Hao²,ZHANG Jingfeng^1,^*(

),PENG Zhiyi^1,^*(

)

⁽¹⁾ Department of Radiology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China
⁽²⁾ Department of Radiology, Traditional Chinese Medicine Hospital of Ningbo, Ningbo 315010, China

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摘要： 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CalliSpheres^? 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。

结果

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。

关键词： 癌, 肝细胞/药物疗法; 肝肿瘤/药物疗法; 药物洗脱支架; 化学栓塞, 治疗性; 肝动脉; 微球体; 治疗结果; 病例对照研究

Abstract: 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 biloma, and newly detected intra-or extrahepatic HCC on MRI between cTACE group and DEB-TACE group.

Conclusion

There were no statistically significant differences between cTACE group and DEB-TACE group with regard to the short-term response, disease recurrence, complications and side effects. Hepatic-locoregional complications may be more frequent in DEB-TACE group than those in cTACE group.

Key words: Carcinoma, hepatocellular/drug therapy Liver neoplasms/drug therapy Drug-eluting stents Chemoembolization, therapeutic Hepatic artery Microspheres Treatment outcome Case-control studies

收稿日期: 2016-12-20 出版日期: 2017-07-06

CLC:

R735.7

基金资助: 国家卫计委—浙江省共建重大科研计划(WSK2014-2-009)

通讯作者: 张景峰,彭志毅 E-mail: chengang09@126.com;jingfengzhang73@163.com;pengzhiyi2010@163.com

作者简介: 陈刚 (1987-), 男, 硕士研究生, 主要从事胸腹部疾病的影像诊断和介入治疗; E-mail: chengang09@126.com|张景峰 (1973-), 男, 博士, 副主任医师, 主要从事肿瘤影像诊断和介入治疗. E-mail: jingfengzhang73@163.com|彭志毅 (1961-), 男, 硕士, 主任医师, 硕士生导师, 主要从事医学影像诊断和外周肿瘤以及脑血管介入治疗. E-mail: pengzhiyi2010@163.com

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引用本文:

陈刚,张鼎,应亚草,王志峰,陶伟,朱皓,张景峰,彭志毅. 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[J]. 浙江大学学报（医学版）, 2017, 46(1): 44-51.

CHEN Gang,ZHANG Ding,YING Yacao,WANG Zhifeng,TAO Wei,ZHU Hao,ZHANG Jingfeng,PENG Zhiyi. Clinical investigation on transarterial chemoembolization with indigenous drug-eluting beads in treatment of unresectable hepatocellular carcinoma. J Zhejiang Univ (Med Sci), 2017, 46(1): 44-51.

链接本文:

http://www.zjujournals.com/med/CN/10.3785/j.issn.1008-9292.2017.02.07 或 http://www.zjujournals.com/med/CN/Y2017/V46/I1/44

表1 cTACE组与DEB-TACE组患者临床特征分析

表2 cTACE组与DEB-TACE组患者治疗后肿瘤反应率比较

表3 cTACE组与DEB-TACE组患者治疗后肿瘤复发率比较

表4 cTACE组与DEB-TACE组治疗后不良反应、并发症发生率及肝功能指标比较

图1 一例患者胆道铸型的MRI表现患者男性，54岁，乙型病毒性肝炎.患者治疗前T1WI (A) 显示胆管右后支未见异常 (箭头所示)，首次DEB-TACE治疗后3个月T1WI (B) 呈高信号 (箭头所示)，T2WI (C) 呈低信号 (箭头所示).

图2 一例患者胆汁瘤及胆管扩张的MRI表现图 1同一患者.患者治疗前T2WI (A) 正常；治疗后3个月T2WI (B) 显示胆汁瘤形成 (蓝箭头所示) 及胆道铸型远端胆管扩张 (红箭头所示)；增强扫描门静脉期 (C) 胆汁瘤未见强化 (蓝箭头所示)，扩张胆管未见强化 (红箭头所示).

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