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125I腔内照射联合仑伐替尼治疗进展期肝外胆管癌的效果和安全性分析

朱兴书 陈鹏飞 张萌帆 李方正 陈金威 张文广 段旭华 任建庄 韩新巍

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Citation:

125I腔内照射联合仑伐替尼治疗进展期肝外胆管癌的效果和安全性分析

DOI: 10.3969/j.issn.1001-5256.2023.10.019
基金项目: 

河南省医学科技攻关计划(联合共建)项目 (LHGJ20190155);

河南省医学科技攻关计划(省部共建)项目 (SBGJ202002072);

河南省自然科学基金项目 (202300410461)

伦理学声明:本研究方案于2023年3月6日经郑州大学第一附属医院伦理委员会审批通过,批号:2023-KY-0064,符合《赫尔辛基宣言》,患者均签署知情同意书。
利益冲突声明:本文不存在任何利益冲突。
作者贡献声明:朱兴书负责收集数据,资料分析,撰写及修改论文;陈鹏飞、张萌帆负责修改论文;李方正、陈金威参与收集数据与资料分析;任建庄、段旭华、张文广拟定课题设计,写作思路,指导撰写文章;韩新巍负责写作思路并最后定稿。
详细信息
    通信作者:

    任建庄, rjzjrk@126.com (ORCID: 0000-0001-7003-8678)

Efficacy and safety of 125I intraluminal irradiation combined with lenvatinib in treatment of progressive extrahepatic cholangiocarcinoma

Research funding: 

Henan Province Medical Science and Technology Tackling Program (joint construction) Project (LHGJ20190155);

Henan Province Medical Science and Technology Tackling Program (provincial ministry co-construction) Project (SBGJ202002072);

Henan Province Natural Science Foundation Project (202300410461)

More Information
    Corresponding author: REN Jianzhuang, rjzjrk@126.com (ORCID: 0000-0001-7003-8678)
  • 摘要:   目的  探讨125I腔内照射联合仑伐替尼治疗进展期肝外胆管癌的有效性和安全性。  方法  回顾性纳入2018年1月—2021年11月于郑州大学第一附属医院介入科就诊的进展期肝外胆管癌患者25例。根据治疗方式分为两组,125I腔内照射联合仑伐替尼组患者13例(联合组)和单纯125I腔内照射组12例(对照组)。记录技术成功率、肝功能变化、支架通畅情况、生存期和不良事件的发生情况。正态分布的计量资料两组间比较采用成组t检验,偏态分布的计量资料两组比较采用Wilcoxon秩和检验,计数资料组间比较采用Fisher确切概率法。采用Kaplan-Meier和Log-rank检验评估生存期和支架通畅情况。  结果  两组所有患者均成功植入胆道支架和125I粒子,技术成功率100%。治疗1个月后,两组患者血清TBil、DBil、ALT和AST显著改善,与治疗前比较差异均有统计学意义(P值均<0.05)。对照组和联合组的中位支架通畅期分别为7.0和9.5个月,差异有统计学意义(P=0.022),中位生存期分别为11.5和15.6个月,差异有统计学意义(P=0.008)。治疗过程中联合组未出现不可耐受的不良事件。  结论  125I腔内照射联合仑伐替尼对比单纯125I腔内照射治疗进展期肝外胆管癌具有更好的疗效,是一种安全、有效的治疗方案。

     

  • 图  1  49岁男性胆管恶性肿瘤伴梗阻性黄疸患者活检和介入治疗过程

    注: a,透视下造影可见胆总管中下段严重狭窄,对比剂通过困难(箭头);b,透视下活检钳张开(箭头);c, 透视下活检钳夹取病理组织(箭头);d,引入8.5F内外引流管,远端成袢于十二指肠,行胆汁引流;e,病理结果证实为胆管癌后,行胆道支架(箭头)植入;f,自制粒子链(箭头)经胆道引流管进入病灶内,完全覆盖病灶;g、h、i粒子链置入3天内单光子发射计算机断层成像图示冠状位(g)、矢状位(h)、横轴位(i)放射剂量分布。

    Figure  1.  Biopsy and interventional procedure in a 49-year-old male patient with biliary malignancy with obstructive jaundice

    图  2  两组患者的生存期比较

    Figure  2.  Comparison of survival between the two groups of patients

    图  3  两组患者的支架通畅时间比较

    Figure  3.  Comparison of stent patency times between the two groups

    表  1  两组患者基线资料对比

    Table  1.   Comparison of information between the two groups

    指标 联合组(n=13) 对照组(n=12) P
    性别(例) >0.05
    6 5
    7 7
    年龄(例) 0.378
    ≥65岁 11 8
    <65岁 2 4
    Child-Pugh分级(例) 0.434
    A级 5 7
    B级 8 5
    类型(例) 0.238
    远端胆管癌 9 5
    肝门部胆管癌 4 7
    ECOG评分(例) 0.695
    0分 8 6
    1分 5 6
    下载: 导出CSV

    表  2  两组间治疗后1个月肝功能指标对比

    Table  2.   Comparison of liver function indicators between the two groups at 1 month after treatment

    组别 例数 TBil(μmol/L) DBil(μmol/L) ALT(U/L) AST(U/L)
    联合组 13 17.13±10.56 11.96±8.20 24.00(19.50~40.00) 32.38±9.36
    对照组 12 26.15±11.51 16.52±10.43 34.50(24.50~49.75) 35.25±11.93
    统计值 t=-2.044 t=-1.221 Z=-1.279 t=-0.671
    P 0.053 0.234 0.201 0.509
    下载: 导出CSV

    表  3  两组患者治疗前、治疗后1个月肝功能指标组内比较

    Table  3.   Comparison of liver function indicators before and after 1month of treatment in two groups

    组别 例数 TBil(μmol/L) DBil(μmol/L) ALT(U/L) AST(U/L)
    联合组 13
    术前 208.49±114.88 170.77±111.77 122.0(98.5~194.5) 132.0(96.5~193.5)
    术后 17.13±10.56 11.96±8.20 24.0(19.5~40.0) 30.0(27.0~38.0)
    统计值 t=6.076 t=5.188 Z=-4.026 Z=-4.338
    P <0.01 <0.01 <0.01 <0.01
    对照组 12
    术前 206.54±95.76 173.54±83.70 173.50±66.03 162.58±51.87
    术后 26.15±11.51 16.52±10.43 36.67±15.92 35.25±11.93
    t 6.816 6.747 6.977 7.902
    P <0.01 <0.01 <0.01 <0.01
    下载: 导出CSV

    表  4  联合组不良事件的发生情况

    Table  4.   Occurrence of adverse events in the combined group

    不良事件 1~2级[例(%)] 3~4级[例(%)] 不良事件总发生率(%)
    高血压 5(38.5) 1(7.7) 46.2
    乏力 6(46.2) 0(0.0) 46.2
    AST或ALT升高 2(15.4) 0(0.0) 15.4
    皮疹 1(7.7) 0(0.0) 7.7
    腹痛 1(7.7) 1(7.7) 7.7
    腹泻 2(15.4) 0(0.0) 15.4
    食欲减退 4(30.8) 0(0.0) 30.8
    恶心 4(30.8) 0(0.0) 30.8
    血小板下降 1(7.7) 0(0.0) 7.7
    蛋白尿 1(7.7) 1(7.7) 15.4
    手足综合征 3(23.1) 0(0.0) 23.1
    下载: 导出CSV
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