经肝动脉化疗栓塞术中应用三氧化二砷载药微球与三氧化二砷碘化油治疗不可切除原发性肝癌的成本效益分析

王文辉; 段旭华; 李浩; 琚书光; 王满周; 任建庄; 韩新巍

doi:10.3969/j.issn.1001-5256.2021.09.024

经肝动脉化疗栓塞术中应用三氧化二砷载药微球与三氧化二砷碘化油治疗不可切除原发性肝癌的成本效益分析

DOI: 10.3969/j.issn.1001-5256.2021.09.024

郑州大学第一附属医院放射介入科，郑州 450052

基金项目:

中国健康促进基金会 (XM_2018_011_0006_01);

河南省重点研发与推广专项(科技攻关)项目 (202102310462)

利益冲突声明：本研究不存在研究者、伦理委员会成员、受试者监护人以及与公开研究成果有关的利益冲突，特此声明。

作者贡献声明：王文辉负责收集数据，资料分析，撰写论文，修改论文; 李浩参与收集数据; 琚书光参与资料分析; 王满周负责修改论文; 段旭华、任建庄负责拟定课题设计，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:
段旭华，xuhuaduan@163.com

中图分类号: 735.7
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出版历程
- 收稿日期: 2021-01-21
- 录用日期: 2021-02-08
- 出版日期: 2021-09-20

A cost-effect analysis of transarterial chemoembolization with CalliSpheres beads loaded with arsenic trioxide versus arsenic trioxide iodized oil emulsion in treatment of unresectable liver cancer

Department of Interventional Radiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China

Research funding:

China foundation for the promotion of health (XM_2018_011_0006_01);

Key R&D and Promotion Special Project (Science and Technology Research) of Henan Province (202102310462)

摘要

摘要: 目的探讨经肝动脉化疗栓塞术(TACE)中应用三氧化二砷(ATO)载药栓塞微球和ATO碘油乳剂栓塞治疗不可切除的肝癌成本效益。方法选择2017年5月—2018年12月在郑州大学第一附属医院就诊的100例中晚期原发性肝癌患者作为研究对象，根据治疗方案不同分为CBATO组(n=45)和cTACE组(n=55)。采用无进展生存期(PFS)进行质量调整寿命年(QALY)的疗效评价，采用欧洲五维健康量表(EQ-5D)指数评估患者的生活质量。计量资料2组间比较采用t检验，计数资料2组间比较采用χ²检验，计算2组患者的手术次数、住院时间、治疗成本和增量成本效果比(ICER)，并进行成本效益分析。结果在PFS内，CBATO组和cTACE组治疗中晚期肝癌的人均住院费用分别为96 446元和91 230.43元。2组间平均手术次数(2.5±0.7 vs 3.4±0.8)和平均住院时间[(5.8±1.2) d vs (7.5±1.8) d]比较，差异均有统计学意义(t值分别为16.911、12.459，P值均＜0.01);CBATO组QALY高于cTACE组(0.804＞0.512)。与cTACE组相比，CBATO组治疗不可切除肝癌的增量成本效益比为17 861.53元/年。结论 CBATO组手术花费虽高于cTACE组，但在减少手术次数和住院时间的同时其临床疗效优于cTACE组，术后患者的生活质量高于cTACE组，具有明显的成本效益优势。
- 肝肿瘤 /
- 化学栓塞, 治疗性 /
- 微球体 /
- 碘化油 /
- 费用效益分析
Abstract: Objective To investigate the cost-effect of transarterial chemoembolization (TACE) with CalliSpheres beads loaded with arsenic trioxide (ATO) (CBATO) versus ATO iodized oil emulsion (conventional TACE, cTACE) in the treatment of unresectable liver cancer. Methods A total of 100 patients with advanced liver cancer who attended The First Affiliated Hospital of Zhengzhou University from May 2017 to December 2018 were enrolled and divided into CBATO group(n=45) and cTACE group(n=55) according to the treatment regimen. Progression-free survival (PFS) was used to evaluate the efficacy of quality-adjusted life year (QALY), and European Quality of Life-5 Dimensions (EQ-5D) index was used to evaluate quality of life. The t-test was used for comparison of continuous data between groups, and the chi-square test was used for comparison of categorical data between groups; the number of surgeries, length of hospital stay, treatment cost, and incremental cost-effectiveness ratio (ICER) were calculated for the two groups, and then a cost-effect analysis was performed. Results Within the PFS time, the per capita hospital cost was 96 446 yuan in the CBATO group and 91 230.43 yuan in the cTACE group. There were significant differences between the two groups in the mean number of surgeries (2.5±0.7 vs 3.4±0.8, t=16.911, P < 0.01) and mean hospital stay (5.8±1.2 days vs 7.5±1.8 days, t=12.459, P < 0.01). The CBATO group had a significantly higher QALY than the cTACE group (0.804 vs 0.512). Compared with the cTACE group, the CBATO group had an ICER of 17 861.53 yuan/QALY for unresectable liver cancer. Conclusion Although CBATO has a higher surgery cost than cTACE, CBATO has a better clinical effect than cTACE and can reduce the number of surgeries and length of hospital stay, with a better postoperative quality of life than cTACE, suggesting that CBATO has marked cost-effect advantages.
- Liver Neoplasms /
- Chemoembolization, Therapeutic /
- Microspheres /
- Iodized Oil /
- Cost-Benefit Analysis

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图 1 CBATO组合cTACE组术后近期疗效比较

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表 1 2组患者的一般资料比较

项目	CBATO组(n=45)	cTACE(n=55)	统计值	P值
年龄(岁)	58.94±9.89	55.14±9.03	t=0.478	0.491
性别[例(%)]			χ²=0.112	0.738
男	41(91.1)	49(89.1)
女	4(8.9)	6(10.9)
病因学[例(%)]			χ²=0.455	0.500
HBV	39(86.7)	50(90.9)
其他	6(13.3)	5(9.1)
ECOG[例(%)]			χ²=0.026	0.872
0	23(51.1)	29(52.7)
1	22(48.9)	26(47.3)
Child分级[例(%)]			χ²=2.899	0.089
A	39(86.7)	40(72.7)
B	6(13.3)	15(27.3)
肝硬化[例(%)]			χ²=1.010	0.315
是	38(84.5)	42(76.4)
否	7(15.5)	13(23.6)
BCLC分期[例(%)]			χ²=0.004	0.952
B	24(53.3)	29(52.7)
C	21(46.7)	26(47.3)
肿瘤大小[例(%)]			χ²=0.134	0.714
≤5 cm	27(60.0)	31(56.4)
＞5 cm	18(40.0)	24(43.6)

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表 2 CBATO组与cTACE组直接医疗费用比较

分类	CBATO组	cTACE组	差异
综合医疗服务费用(元)
床位费	232	376	-144
护理费	169	258	-89
一般医疗服务费	489	1184	-695
诊断费用(元)
实验室诊断费用	929.67	1 489.90	-560.23
影像学诊断费用	2 002.75	2 322.21	-319.46
术中花费(元)
其他术中花费(手术费+器械费)	11 727.04	12 605.94	521.10
栓塞材料费	21 562.43	5 997.89	15 564.54
并发症处理花费(元)	1 466.51	2 598.54	-1 132.03
合计(元)	38 578.4	26 832.48	11 745.92
注：差异为CBATO组的花费减去cTACE组的花费。

下载: 导出CSV

表 3 EQ-5D指数表

时间点	CBATO组(n=45)	cTACE组(n=55)	t值	P值
术前	0.57±0.12	0.60±0.13	1.545	0.219
术后1个月	0.71±0.19	0.67±0.17	6.379	0.014
术后3个月	0.77±0.11	0.70±0.18	28.302	＜0.01
术后6个月	0.76±0.11	0.69±0.10	28.212	＜0.01

下载: 导出CSV

表 4 2组治疗方案成本-效益比较

组别	总成本(元)	效益(%)	成本/效益比	QALY(元/QALY)	ICER(元/QALY)
CBATO组	96 446.00	71.1	1 356.48	0.804	17 861.53
cTACE组	91 230.43	45.6	2 000.67	0.512

下载: 导出CSV

表 5 患者平均住院时间和手术次数对比

组别	手术次数(次)	单次住院天数(d)
CBATO组	2.5±0.7	5.8±1.2
cTACE组	3.4±0.8	7.5±1.8
t值	16.911	12.459
P值	＜0.01	＜0.01

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