华蟾素片联合肝动脉化疗栓塞术治疗原发性肝细胞癌的临床疗效及其影响因素分析

doi:10.16139/j.1007-9610.2024.04.13

摘要/Abstract

摘要：

目的：评价华蟾素片联合肝动脉化疗栓塞术(TACE)治疗原发性肝细胞癌（HCC）效果及其影响因素。方法：按照纳入和排除标准收集108例HCC病人的临床资料，随机分为试验组和对照组。试验组采用华蟾素片联合TACE治疗，对照组采用单纯TACE治疗。以无进展生存期（PFS）和总生存期（OS）作为评价指标，采用COX回归分析评价两组生存预后及其影响因素。结果：试验组OS 13.5个月，对照组OS 9.2个月；试验组PFS 6.8个月，对照组PFS 5.3个月，组间比较，差异均有统计学意义（P均<0.05）。多因素COX回归分析显示，Child-Pugh分级和肝硬化是HCC病人PFS预后独立的危险因素；Child-Pugh分级是HCC病人OS预后独立的危险因素；ALBI是HCC病人OS预后的保护因素。结论：华蟾素片联合TACE治疗HCC有效延缓肝癌进展，延长病人PFS和OS，其中Child-Pugh分级、肝硬化和ALBI是影响HCC病人预后的重要因素。

关键词: 肝细胞癌, 华蟾素, 肝动脉化疗栓塞术, 影响因素

Abstract:

Objective To evaluate the efficacy of Huachansu tablets combined with transarterial chemoembolization (TACE) for treatment of primary hepatocellular carcinoma (HCC) and prognostic influence factors. Methods One hundred and eight patients with HCC were recruited according to the inclusion and exclusion criteria. Patients were randomly divided into treatment group and control group. The treatment group was treated with Huachansu tablets combined with TACE, and the control group was treated with TACE alone, with overall survival time (OS) and progression-free survival time (PFS) as the evaluation indexes. The COX regression analysis was used to evaluate the survival and prognostic effects and their influence factors in both groups. Results A total of 108 HCC patients were enrolled. The OS was 13.5 months in treatment group and 9.2 months in control group; the PFS was 6.8 months in treatment group and 5.3 months in control group, and the differences were significant statistically (all P<0.05). Multivariate COX regression analysis showed that Child-Pugh grade and cirrhosis were the independent risk factors for PFS in HCC patients. Child-Pugh grade were the independent risk factors for OS in HCC patients. ALBI is a protective factor for OS in HCC patients. Conclusions The treatment of HCC by Huachansu tablets combined with TACE can delay the progression of HCC and prolong PFS and OS of the patients with HCC. Child-Pugh grade, cirrhosis status, and ALBI were important factors affecting the prognosis of the patients with HCC.

Key words: Hepatocellular carcinoma(HCC), Huachansu tablet, Transarterial chemoembolization(TACE), Influencing factor

中图分类号:

R735.7

程健珊, 张弢, 吴珺玮, 高惠峰, 陈敬贤, 孟志强. 华蟾素片联合肝动脉化疗栓塞术治疗原发性肝细胞癌的临床疗效及其影响因素分析[J]. 外科理论与实践, 2024, 29(04): 351-357.

CHENG Chienshan, ZHANG Tao, WU Junwei, GAO Huifeng, CHEN Jingxian, MENG Zhiqiang. Analysis of the efficacy and influence factors for treatment of primary hepatocellular carcinoma by Huachansu tablets combined with transarterial chemoembolization[J]. Journal of Surgery Concepts & Practice, 2024, 29(04): 351-357.

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Independent variable	Assignment
Gender	Male=1，Female=2
Hepatitis B virus (HBV） infection	No=1，Yes=2
Barcelona clinic liver cancer （BCLC）staging	Stage A=1，Stage B=2
Child-Pugh staging	Stage A=1，Stage B=2
Liver cirrhosis	No=1，Yes=2
AFP grouping	<400(μg/L)=1，≥400(μg/L)=2
Group	Treatment group=1, Control group=2

Variate	ALL(n=108)	Treatment group(n=54)	Control group(n=54)	P value
OS	10.70(8.90,17.00)	13.50(9.30,21.60)	9.20(4.30,16.30)	0.010
PFS	6.00(5.30,7.00)	6.80(6.00,8.50)	5.25(3.20,6.50)	0.012
SII（systemic inflammation index）	335.59(250.42,443.81)	304.30(224.82,525.92)	360.01(250.42,537.92)	0.576
Age(years)	53.30±10.33	53.65±10.06	52.94 ±10.69	0.725
Tumor size before treatment (mm)	71.07±44.27	72.50±50.30	69.65 ±37.72	0.740
Tumor size after treatment(mm)	73.15±51.67	72.77±54.23	73.55 ±49.41	0.939
Change in tumor size(mm)	1.07±31.43	-0.77±35.72	2.98 ±26.48	0.545
FIB(fibrinogen)	3.14±1.14	3.20±1.20	3.08 ±1.09	0.589
NLR (neutrophil/lymphocyte ratio)	2.74±2.10	2.72±2.40	2.77 ±1.77	0.898
PLR (platelet/lymphocyte ratio)	126.47±91.87	128.57±100.77	124.37 ±82.93	0.813
LMR (lymphocyte/monocyte ratio)	4.16±2.12	4.21±2.17	4.10 ±2.08	0.787
APRI (aspartate aminotransferase/platelet ratio)	0.39±0.34	0.35±0.24	0.42 ±0.42	0.265
ALBI (albumin/bilirubin ratio)	-2.66±0.56	-2.71±0.59	-2.62 ±0.53	0.419
Gender				0.081
Male	60(55.56%)	35(64.81%)	25(46.30%)
Female	48(44.44%)	19(35.19%)	29(53.70%)
HBV infection				0.674
No	6( 5.56%)	2(3.70%)	4(7.41%)
Yes	102(94.44%)	52(96.30%)	50(92.59%)
Child-Pugh staging				1.000
Stage A	71(65.74%)	35(64.81%)	36(66.67%)
Stage B	37(34.26%)	19(35.19%)	18(33.33%)
Liver cirrhosis				0.759
No	12(11.11%)	7(12.96%)	5(9.26%)
Yes	96(88.89%)	47(87.04%)	49(90.74%)
BCLC staging				0.648
Stage A	25(23.15%)	11(20.37%)	14(25.93%)
Stage B	83(76.85%)	43(79.63%)	40(74.07%)
AFP grouping (μg/L)				0.826
<400	28(25.93%)	15(27.78%)	13(24.07%)
≥400	80(74.07%)	39(72.22%)	41(75.93%)

Variable	Univariate		Multivariate
Variable	HR(95% CI)	P value	HR(95% CI)	P value
Age(yeras)	0.984(0.963,1.005)	0.135	--	--
Gender	1.118(0.750,1.666)	0.583	--	--
HBV infection	1.708(0.746,3.912)	0.205	--	--
BCLC staging	1.044(0.657,1.659)	0.855	--	--
Tumor size before treatment (mm)	1.002(0.998,1.007)	0.271	--	--
Tumor size after treatment(mm)	1.003(0.999,1.007)	0.188	--	--
NLR (neutrophil/lymphocyte ratio)	1.280(0.868,1.886)	0.213	--	--
PLR (platelet/lymphocyte ratio)	0.916(0.619,1.355)	0.659	--	--
LMR (lymphocyte/monocyte ratio)	0.902(0.613,1.329)	0.602	--	--
SII (systemic inflammation index)	1.080(0.731,1.595)	0.698	--	--
APRI (aspartate aminotransferase/platelet ratio)	0.999(0.677,1.475)	0.997	--	--
ALBI (albumin/bilirubin ratio)	0.813(0.561,1.179)	0.275	--	--
FIB (fibrinogen)	1.005(0.839,1.203)	0.960	--	--
Child-Pugh staging	2.447(1.603,3.736)	<0.001	1.952(1.264,3.014)	0.003
Liver cirrhosis	4.547(2.093,9.879)	<0.001	4.691(1.824,12.065)	0.001
AFP grouping	1.840(1.134,2.987)	0.014	0.726(0.412,1.282)	0.270
Group	1.539(1.034,2.290)	0.034	1.303(0.871,1.950)	0.198

Variable	Univariate		Multivariate
Variable	HR(95% CI)	P value	HR(95% CI)	P value
Age(yeras)	0.979(0.957,1.001)	0.066	--	--
Gender	1.246(0.814,1.908)	0.312	--	--
HBV infection	2.174(0.876,5.392)	0.094	--	--
AFP grouping	1.452(0.894,2.359)	0.132	--	--
BCLC staging	1.163(0.704,1.921)	0.555	--	--
Tumor size before treatment (mm)	1.001(0.996,1.006)	0.642	--	--
Tumor size after treatment(mm)	0.863(0.775,0.961)	0.007	--	--
NLR (neutrophil/lymphocyte ratio)	1.259(0.826,1.921)	0.284	--	--
PLR (platelet/lymphocyte ratio)	1.013(0.662,1.551)	0.952	--	--
LMR (lymphocyte/monocyte ratio)	1.093(0.715,1.670)	0.683	--	--
SII (systemic inflammation index)	1.156(0.757,1.766)	0.502	--	--
APRI (aspartate aminotransferase/platelet ratio)	1.023(0.671,1.559)	0.916	--	--
FIB (fibrinogen)	0.963(0.800,1.159)	0.690	--	--
Child-Pugh staging	2.036(1.313,3.158)	0.001	1.637(1.029,2.604)	0.037
Liver cirrhosis	2.035(1.049,3.949)	0.036	1.571(0.786,3.138)	0.201
ALBI (albumin/bilirubin ratio)	0.568(0.388,0.832)	0.004	0.616(0.417,0.911)	0.015
Group	1.612(1.055,2.464)	0.027	1.531(1.001,2.342)	0.049

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