生物信息红外肝病治疗仪对肝硬化患者肝脏血供及肝纤维化的影响

邢枫; 徐列明; 赵长青

doi:10.12449/JCH250918

生物信息红外肝病治疗仪对肝硬化患者肝脏血供及肝纤维化的影响

DOI: 10.12449/JCH250918

邢枫¹,
徐列明²,
赵长青^1, , ,

1.
上海中医药大学附属曙光医院，肝病科，上海 201203
2.
上海中医药大学附属曙光医院，肝病研究所，上海 201203

基金项目:

国家自然科学基金 (81673780)

伦理学声明：本研究于2017年7月10日经由上海中医药大学附属曙光医院伦理委员会审批，批号：2017-535-18-01。

利益冲突声明：本文不存在任何利益冲突。

作者贡献声明：赵长青负责课题设计，资料分析，撰写论文；邢枫参与收集数据，修改论文；徐列明负责拟定写作思路，指导撰写文章并最后定稿。

详细信息

通信作者:
赵长青， cathy090909@126.com （ORCID： 0000-0002-7925-1835）

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出版历程
- 收稿日期: 2024-12-31
- 录用日期: 2025-02-28
- 出版日期: 2025-09-25

Effect of bioinformatics infrared liver disease therapeutic instrument on hepatic blood supply and liver fibrosis in patients with liver cirrhosis

1.
Department of Hepatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine，Shanghai 201203，China
2.
Institute of Liver Diseases, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine，Shanghai 201203，China

Research funding:

National Natural Science Foundation of China (81673780)

More Information

Corresponding author: ZHAO Changqing， cathy090909@126.com （ORCID： 0000-0002-7925-1835）

摘要

摘要: 目的观察生物信息红外肝病治疗仪（BILT肝病治疗仪）对肝硬化患者肝脏门静脉血流及肝、脾硬度的影响，初步探讨BILT肝病治疗仪的疗效和机制。方法纳入2017年10月—2021年12月在上海中医药大学附属曙光医院门诊或住院的代偿期肝硬化患者78例，完成12周疗程者68例，随机分为肝病治疗仪组（治疗组）和模拟治疗仪组（对照组），每组34例。在基础治疗的同时，两组分别予以BILT肝病治疗仪或模拟治疗仪照射，2次/d，30 min/次，疗程12周。比较治疗前后肝功能、肾功能、血常规等实验室指标，肝、脾超声形态，多普勒彩色血流检测（肝门静脉直径、截面积、平均流速、最高流速、平均流量）及肝、脾硬度检测。符合正态分布的计量资料两组间比较采用成组t检验；非正态分布的计量资料两组间比较采用非参数Mann-Whitney U秩和检验；计数资料组间比较采用χ²检验。各组内治疗前后数据，先进行配对样本相关性检验，若显著相关，则采取配对样本t检验或非参数相关样本Wilcoxon符号秩检验。结果配对样本相关性检验显示，脾脏超声衰减参数治疗前后无相关性，提示FibroTouch 对于脾脂肪的检测结果不适用于统计分析。两组12周治疗前后差值的组间比较显示，治疗组12周后门静脉直径、截面积、平均流量的增加值及肝硬度值的降低值均明显优于对照组（P值均<0.05）。两组在0周治疗前和12周治疗后，BILT肝病治疗仪照射30 min的即刻效应比较显示，治疗组门静脉直径、截面积、平均流速、平均流量较照射前均明显增加（P值均<0.05），而对照组照射前后比较，差异均无统计学意义（P值均>0.05）；两组间照射前后差值比较显示，除0周时门静脉最高流速外，治疗组治疗前后差值均大于对照组（P值均<0.05）。两组均无不良事件发生。结论 BILT肝病治疗仪可改善肝硬化患者肝脏门静脉血流并减轻肝硬度/肝纤维化程度。
- 肝硬化 /
- 肝纤维化 /
- 弹性成像技术 /
- 血流动力学
Abstract: Objectives To investigate the effect of the Bioinformatics Infrared Liver Therapeutic （BILT） instrument on portal vein blood flow， liver stiffness， and spleen stiffness in patients with liver cirrhosis， and to preliminarily explore the therapeutic effect and mechanism of the BILT instrument. Methods A total of 78 patients with compensated liver cirrhosis who attended the outpatient service or were hospitalized in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from October 2017 to December 2021 were enrolled， among whom 68 patients completed the 12-week treatment and were randomly divided into BILT group and simulated instrument group， with 34 patients in each group. In addition to basic treatment， the patients in the BILT group received irradiation with the BILT instrument， while those in the simulated instrument group received irradiation with the simulated instrument， for 30 minutes each time， twice a day； the course of treatment was 12 weeks for both groups. The two groups were compared in terms of laboratory markers （liver function， renal function， and routine blood test results）， liver and spleen ultrasound morphology， color Doppler blood flow detection （portal vein diameter， portal vein cross-sectional area， mean portal vein velocity， peak portal vein velocity， and mean portal vein flow）， and liver/spleen stiffness measurement before and after treatment. The independent samples t-test was used for comparison of normally distributed continuous data between two groups， and the non-parametric Mann-Whitney U rank sum test was used for comparison of non-normally distributed continuous data between two groups； the chi-square test was used for comparison of categorical data between groups. The paired samples correlation test was performed for the data before and after treatment within each group， and the paired samples t-test or the non-parametric Wilcoxon signed-rank test was performed for data with significant correlations. Results The paired samples correlation test showed no correlation in spleen attenuation parameter before and after treatment， suggesting that the results of spleen fat measured by FibroTouch could not be used for statistical analysis. After 12 weeks of treatment， compared with the control group， the treatment group had significantly greater increases in portal vein diameter， portal vein cross-sectional area， and mean portal vein flow and a significantly greater reduction in liver stiffness measurement （all P<0.05）. At week 0 before treatment and after 12 weeks of treatment， comparison of the immediate effect after 30 minutes of BILT irradiation showed that the treatment group had significant increases in portal vein diameter， portal vein cross-sectional area， mean portal vein velocity， and mean portal vein flow （all P<0.05）， while the control group showed no significant changes after irradiation （all P>0.05）； compared with the control group， the treatment group had significantly greater changes in all indicators except peak portal vein flow at week 0 （all P<0.05）. No adverse events were observed in either group. Conclusion The BILT instrument can improve portal vein blood flow in the liver and alleviate liver stiffness/fibrosis in patients with liver cirrhosis.
- Liver Cirrhosis /
- Hepatic Fibrosis /
- Elasticity Imaging Techniques /
- Hemodynamics

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表 1 BILT治疗仪治疗肝硬化患者的基线特征

Table 1. Baseline characteristics of cirrhotic patients treated with BILT therapeutic apparatus

项目	治疗组（n=34）	对照组（n=34）	统计值	P值
男［例（%）］	21（61.8）	21（61.8）	χ²=0.000	1.000
年龄（岁）	62.5（49.8～66.0）	56.5（47.8～63.0）	Z=-1.873	0.061
BMI（kg/m²）	23.55±2.44	23.81±2.78	t=-0.387	0.700
Child-Pugh分级（A/B，例）	33/1	30/4	χ²=1.984	0.159
乙型肝炎［例（%）］	22（64.7）	27（79.4）	χ²=1.826	0.177
ALT（U/L）	25.7±13.8	28.1±15.2	t=0.177	0.535
AST（U/L）	31.0±14.5	32.2±11.7	t=0.268	0.724
Alb（g/L）	42.31±3.88	42.25±6.03	t=0.043	0.966
TBil（μmol/L）	18.20±6.74	22.53±13.26	t=-1.525	0.136
BUN（mmol/L）	5.417±1.483	5.705±1.272	t=-0.717	0.477
Cr（μmol/L）	66.1±14.0	70.1±14.8	t=-1.048	0.300
PT（s）	13.85±1.36	13.89±1.49	t=0.013	0.914
INR	1.097±0.117	1.118±0.072	t=-0.806	0.425
PLT（×10⁹/L）	112.4±71.4	115.6±55.8	t=0.878	0.856
WBC（×10⁹/L）	4.540±1.987	4.625±1.800	t=0.527	0.873
Hb（g/L）	136.4±20.7	135.8±21.8	t=0.589	0.911
门静脉直径（cm）	1.10（1.00～1.23）	1.00（1.00～1.20）	Z=-0.536	0.592
门静脉截面积（cm²）	0.895（0.768～1.223）	0.880（0.718～1.135）	Z=-0.417	0.677
门静脉平均流速（cm/s）	16.63±5.17	16.28±5.20	t=0.278	0.782
门静脉最高流速（cm/s）	20.60±5.70	19.87±6.17	t=0.506	0.614
门静脉平均流量（mL/min）	985.2±502.9	896.2±352.8	t=0.844	0.402
LSM（kPa）	18.92±10.99	16.05±8.51	t=1.204	0.233
肝UAP（dB/m）	238.4±22.5	250.9±33.5	t=-1.806	0.076
SSM（kPa）	27.51±11.58	22.74±7.25	t=1.838	0.073
脾UAP（dB/m）	198.5±42.7	206.5±37.4	t=0.783	0.454
注：治疗组ALT、AST、Alb、TBil、PT、INR缺失5例，BUN缺失9例，Cr缺失8例，PLT、WBC、Hb、SSM、脾UAP缺失7例；对照组ALT、AST、TBil缺失7例，BUN缺失12例，Alb、Cr缺失8例，PT、INR缺失6例，PLT、WBC、Hb缺失9例，SSM、脾UAP缺失4例。BUN，血尿素氮；Cr，肌酐；INR，国际标准化比值。

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表 2 BILT肝病治疗仪对肝硬化患者肝脏门静脉血流及肝脾弹性的影响

Table 2. Effects of BILT therapeutic apparatus on hepatic portal vein blood flow and hepatic and splenic elasticity in cirrhotic patients

项目	组别	例数	0周（治疗前）	12周（治疗后）	治疗前后差值	统计值	P值^1）
门静脉直径（cm）	治疗组	34	1.10（1.00～1.23）	1.10（1.00～1.30）	0.00（0.00～0.10）	Z=-2.117	0.034
门静脉直径（cm）	对照组	34	1.00（1.00～1.20）	1.00（1.00～1.20）	0.00（0.00～0.00）
门静脉截面积（cm²）	治疗组	34	0.895（0.768～1.223）	1.000（0.805～1.315）	0.110（-0.005～0.225）	Z=-2.881	0.004
门静脉截面积（cm²）	对照组	34	0.880（0.718～1.135）	0.890（0.680～1.155）	0.000（-0.060～0.055）
门静脉平均流速（cm/s）	治疗组	34	16.63±5.17	17.88±5.02	1.37±4.86	t=1.319	0.192
门静脉平均流速（cm/s）	对照组	34	16.28±5.20	16.08±4.78	-0.08±4.05
门静脉最高流速（cm/s）	治疗组	34	20.60±5.70	21.52±6.17	0.98±6.42	t=0.922	0.361
门静脉最高流速（cm/s）	对照组	34	19.87±6.17	19.49±5.88	-0.29±4.72
门静脉平均流量（mL/min）	治疗组	34	985.2±502.9	1154.7±538.6	190.2±319.4	t=2.425	0.019
门静脉平均流量（mL/min）	对照组	34	896.2±352.8	917.7±396.5	28.1±213.3
LSM（kPa）	治疗组	34	18.92±10.99	15.92±6.85	-3.00±7.69	t=2.026	0.048
LSM（kPa）	对照组	34	16.05±8.51	16.11±7.09	0.06±4.28
肝UAP（dB/m）	治疗组	34	238.4±22.5	237.2±22.2	-1.1±22.7	t=-0.679	0.500
肝UAP（dB/m）	对照组	34	250.9±33.5	245.4±29.7	-5.5±30.0
SSM（kPa）	治疗组	27	27.51±11.58	29.27±15.26	2.41±15.16	t=-0.718	0.476
SSM（kPa）	对照组	30	22.74±7.25	22.63±11.34	-0.12±10.88
脾UAP（dB/m）	治疗组	27	198.5±42.7	214.7±34.3	16.1±45.8
脾UAP（dB/m）	对照组	30	206.5±37.4	208.6±28.6	3.3±41.6
注：1）治疗前后差值的组间比较。

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表 3 BILT肝病治疗仪对肝硬化患者肝脏门静脉血流的即刻效应

Table 3. Immediate effects of BILT therapy apparatus on hepatic portal vein blood flow in cirrhotic patients

组别	例数	门静脉直径（mm）	门静脉截面积（cm²）	门静脉平均流速（cm/s）	门静脉最高流速（cm/s）	门静脉平均流量（mL/min）
治疗组	34
0周
照射前		1.10（1.00～1.23）	0.895（0.768～1.223）	16.63±5.17	20.60±5.70	985.2±502.9
照射后		1.10（1.10～1.30）	0.880（0.718～1.135）	18.36±5.13	22.24±6.53	1187.1±581.6
统计值		Z=-4.894	Z=-4.429	t=-3.036	t=-2.015	t=-5.099
P值		<0.001	<0.001	0.005	0.052	<0.001
12周
照射前		1.10（1.00～1.30）	1.000（0.805～1.315）	17.88±5.02	21.52±6.17	1154.7±538.6
照射后		1.20（1.10～1.30）	1.130（0.900～1.325）	19.22±5.96	23.01±7.05	1360.1±647.8
统计值		Z=-2.566	Z=-2.176	t=-2.216	t=-2.002	t=-4.400
P值		0.026	0.013	0.034	0.054	<0.001
对照组	34
0周
照射前		1.00（1.00～1.20）	0.880（0.718～1.135）	16.28±5.20	19.87±6.17	896.2±352.8
照射后		1.05（1.00～1.20）	0.870（0.720～1.083）	15.91±5.17	19.54±6.11	869.0±358.6
统计值		Z=1.139	Z=1.807	t=0.681	t=0.550	t=0.898
P值		0.257	0.217	0.501	0.586	0.376
12周
照射前		1.00（1.00～1.20）	0.890（0.680～1.155）	16.08±4.78	19.49±5.88	917.7±396.5
照射后		1.00（1.00～1.20）	0.830（0.735～1.145）	15.78±4.48	18.94±4.93	888.2±347.6
统计值		Z=-0.533	Z=0.693	t=0.816	t=1.053	t=1.372
P值		0.751	0.340	0.421	0.300	0.180
即刻效应
0周
治疗组	34	0.05（0.00～0.10）	0.100（0.000～0.198）	1.73±3.33	1.64±4.75	202.0±230.9
对照组	34	0.00（0.00～0.00）	0.000（-0.825～0.035）	-0.37±3.20	-0.32±3.43	-27.2±176.7
统计值		Z=-4.373	Z=-3.641	t=2.660	t=1.956	t=4.596
P值		<0.001	<0.001	0.010	0.055	<0.001
12周
治疗组	34	0.00（0.00～0.10）	0.070（-0.003～0.183）	1.35±3.49	1.49±4.29	205.4±268.2
对照组	34	0.00（0.00～0.10）	-0.020（-0.050～0.010）	-0.31±2.15	-0.55±3.01	-29.6±123.8
统计值		Z=-1.967	Z=-2.864	t=2.314	t=2.244	t=4.570
P值		0.049	0.004	0.024	0.029	<0.001
注：即刻效应，照射前后差值。

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