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J Zhejiang Univ (Med Sci)  2017, Vol. 46 Issue (1): 44-51    DOI: 10.3785/j.issn.1008-9292.2017.02.07
    
Clinical investigation on transarterial chemoembolization with indigenous drug-eluting beads in treatment of unresectable hepatocellular carcinoma
CHEN Gang1,2(),ZHANG Ding2,YING Yacao2,WANG Zhifeng2,TAO Wei2,ZHU Hao2,ZHANG Jingfeng1,*(),PENG Zhiyi1,*()
(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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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 wordsCarcinoma, hepatocellular/drug therapy      Liver neoplasms/drug therapy      Drug-eluting stents      Chemoembolization, therapeutic      Hepatic artery      Microspheres      Treatment outcome      Case-control studies     
Received: 20 December 2016      Published: 06 July 2017
CLC:  R735.7  
Corresponding Authors: ZHANG Jingfeng,PENG Zhiyi     E-mail: chengang09@126.com;jingfengzhang73@163.com;pengzhiyi2010@163.com
About author: ZHANG Jingfeng. E-mail: jingfengzhang73@163.com|PENG Zhiyi. E-mail: pengzhiyi2010@163.com
Cite this article:

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.

URL:

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


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

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 
[n(%)]
相关指标 cTACE组 DEB-TACE组 合计
性别?男性 17(85.0) 19(86.4) 36(85.7)
???女性 3(15.0) 3(13.6) 6(14.3)
肿瘤负荷
?单叶 8(40.0) 12(54.5) 20(47.6)
?双叶 12(60.0) 10(45.5) 22(52.4)
?多发结节 (≥4个病灶) 9(45.0) 13(59.1) 22(52.4)
Okuda分期?Ⅰ 10(50.0) 12(54.5) 22(52.4)
????? Ⅱ 10(50.0) 10(45.5) 20(47.6)
Child-Pugh分级?A 17(85.0) 15(68.2) 32(76.2)
??????? B 3(15.0) 7(31.8) 10(23.8)
巴塞罗那肝癌分期?A 2(10.0) 5(22.7) 7(16.7)
?????????B 12(60.0) 9(40.9) 21(50.0)
?????????C 6(30.0) 8(36.4) 14(33.3)
门脉癌栓或转移?有 5(25.0) 7(31.8) 12(28.6)
????????无 15(75.0) 15(68.2) 30(71.4)
Tab 1 Analysis of clinical characteristics of cTACE and DEB-TACE groups
[n(%)]
组别 随访时间 n CR PR SD PD CR+PR CR+PR+SD
cTACE组 1个月 16 2(12.5) 7(43.8) 4(25.0) 3(18.8) 9(56.3) 13(81.2)
3个月 16 0(0.0) 7(43.8) 5(31.3) 4(25.0) 7(43.8) 12(75.0)
6个月 16 0(0.0) 4(25.0) 6(37.5) 6(37.5) 4(25.0) 10(62.5)
DEB-TACE组 1个月 17 3(17.6) 9(52.9) 4(23.5) 1(5.9) 12(70.6) 16(94.1)
3个月 17 3(17.6) 7(41.2) 3(17.6) 4(23.5) 10(58.8) 13(76.5)
6个月 17 2(11.8) 2(11.8) 6(35.3) 7(41.2) 4(23.5) 10(58.8)
Tab 2 Tumor response after cTACE and DEB-TACE
[n(%)]
组别 随访时间 n 局部复发 新发病灶或肝外转移
cTACE组 3个月 16 2(12.5) 2(12.5)
6个月 16 4(25.0) 5(31.2)
DEB-TACE组 3个月 17 0(0.0) 4(23.5)
6个月 17 2(11.8) 7(41.2)
Tab 3 Tumor recurrence after cTACE and DEB-TACE
[n(%) 或 ($\overline x$±s)]
组别 n 不良反应及并发症
体温大于38° 腹痛 使用止痛药 使用吗啡 恶心 呕吐 乏力 局部胆道损伤
cTACE组209(45.0)11(55.0)3(15.0)0(0.0)5(25.0)4(20.0)7(35.0)0(0.0)
DEB-TACE组228(36.4)8(36.4)5(22.7)1(4.5)3(13.6)3(13.6)3(13.6)2(9.1)
P0.5690.2260.8081.0000.5870.8900.2070.489
组别n肝功能指标
白蛋白
(g/L)
ALT
(U/L)
AST
(U/L)
总胆红素
(μmol/L)
胆碱酯酶
(U/L)
凝血酶原
时间 (s)
甲胎蛋白
(ng/mL)
cTACE组2037.2±3.7130.0±51.1167.0±118.722.0±3.55171.2±1181.112.0±0.796.6(42.2~7277.6)
DEB-TACE组2236.6±7.491.1±76.5104.5±89.324.5±13.94914.1±2031.513.0±2.066.1(15.1~4894.9)
P0.7490.1020.2480.5450.8230.3390.507
Tab 4 Complications and side effects of interventional therapy after cTACE and DEB-TACE
Fig 1 MR image of biliary cast
Fig 2 MR image of intrahepatic biloma and bile duct dilatation
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