Real-time tissue elastography-based noninvasive prediction model for liver fibrosis in patients with chronic hepatitis B: a prospective study

doi:10.3877/cma.j.issn.1672-6448.2018.01.007

Abstract

Abstract:

Objective

To further improve the value of clinical application of a quantitative analysis method called LF-index (LFI) which based on real-time tissue elastography (RTE).

Methods

We prospectively enrolled 116 consecutive patients with chronic hepatitis B (CHB) and all patients underwent a liver biopsy and RTE between January 2015 and December 2015 at the First affiliated hospital of Wenzhou Medical University. Univariate and multivariate analyses were performed, and the prediction models for predicting significant fibrosis and cirrhosis were derived from independent predictors.

Results

(1) In multivariate analyses, spleno-portal index (SPI) (OR=13.956, P=0.002) and LFI (OR=6.283, P=0.023) were confirmed as independent predictors of significant fibrosis. In multivariate analyses of patients with and without cirrhosis, we found significant differences in the γ-Glutamyl transferase (GGT) (OR=1.012, P=0.049), SPI (OR=5.676, P=0.002) and LFI (OR=14.102, P=0.001). (2) A novel model called LFI-SPI score (LSPS) for prediction of significant fibrosis was developed (area under receiver operating characteristic curve [AUROC]=0.87), showing the superiority of diagnostic accuracy than LFI (AUROC=0.76, P=0.0109), aspartate aminotransferase to platelet ratio index (APRI) (AUROC=0.64, P=0.0031), fibrosis-4 index (FIB-4) (AUROC=0.67, P= 0.0044) and Fibroscan (AUROC=0.68, P=0.0021). (3) We also developed a LFI-SPI-GGT score (LSPGS) for predicting cirrhosis, with an AUROC of 0.93. The diagnostic accuracy of LSPGS was similar to that of Fibroscan (AUROC=0.85, P=0.134), and was superior to LFI (AUROC=0.81, P=0.0113), APRI (AUROC=0.67, P<0.0001), and FIB-4 (AUROC=0.72, P=0.0005).

Conclusions

We developed new formulas, LSPS and LSPGS for predicting significant fibrosis and cirrhosis in this prospective study. LSP score was mainly used for screening of significant liver fibrosis, and LSPG score was mainly used to exclude cirrhosis.

Key words: Hepatitis B, chronic, Liver cirrhosis, Elasticity imaging techniques

Shihao Xu, Li Ying, Qiao Li, Shuting Lin, Yuanping Hu. Real-time tissue elastography-based noninvasive prediction model for liver fibrosis in patients with chronic hepatitis B: a prospective study[J]. Chinese Journal of Medical Ultrasound (Electronic Edition), 2018, 15(01): 31-42.

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Figures/Tables 13

References 43

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参数		无或轻微肝纤维化组F0~2（33例）	重度肝纤维化组F3~6（83例）	统计值	P值
临床信息		?	?	?	?
?	男性[例（%）]	15（45.5）	56（67.5）	χ²=3.315	0.069
?	年龄（岁，±s）	36.33±7.86	38.82±8.33	t=1.258	0.212
?	体质量指数（kg/m²，±s）	22.46±3.83	22.97±2.93	t=0.657	0.513
生化指标		?	?	?	?
?	丙氨酸转氨酶（U/L，±s）	48.08±26.36	47.46±21.64	t=0.845	0.401
?	天冬氨酸转氨酶（U/L，±s）	64.96±27.53	63.89±29.92	t=0.948	0.346
?	γ-谷氨酸转肽酶（U/L，±s）	48.50±29.11	47.46±23.72	t=1.398	0.166
?	白蛋白（g/L，±s）	41.87±3.87	40.42±3.85	t=-1.557	0.123
?	总胆红素（μmol/L，±s）	11.35±4.84	16.17±14.62	t=0.929	0.356
?	白细胞（×1000/mm³，±s）	6.24±1.51	5.73±1.61	t=-1.325	0.189
?	血小板（×1000/mm³，±s）	196.25±37.01	180.07±69.00	t=-1.087	0.280
?	空腹血糖（mmol/L，±s）	5.20±1.09	5.52±1.52	t=0.933	0.354
?	HBV-DNA（log¹⁰ IU/L，±s）	6.34±2.19	6.07±1.81	t=-0.585	0.560
?	HbeAg阳性率[例（%）]	13（54.2%）	34（55.7%）	χ²=2.643	0.102
超声参数（±s）		?	?	?	?
?	门静脉内径（mm）	10.87±1.70	11.58±1.47	t=1.902	0.061
?	门静脉平均流速（cm/s）	22.80±5.36	21.40±7.02	t=-0.882	0.380
?	肝动脉内径（mm）	3.24±0.45	3.42±0.62	t=2.728	0.008
?	肝动脉最大流速（cm/s）	67.81±25.41	73.22±27.81	t=0.985	0.328
?	肝动脉阻力指数	0.73±0.052	0.75±0.082	t=0.648	0.519
?	脾脏厚径（mm）	31.27±4.80	33.52±6.17	t=1.842	0.069
?	脾脏长径（mm）	89.50±6.80	93.98±10.38	t=1.954	0.054
?	脾脏指数	30.15±7.03	36.53±9.76	t=2.914	0.005
?	脾门指数	1.21±0.27	2.02±0.87	t=4.412	<0.001
?	脾动脉内径（mm）	4.10±0.71	4.43±0.86	t=1.704	0.092
?	脾动脉最大流速（cm/s）	73.48±19.37	73.75±22.37	t=0.053	0.958
?	脾动脉阻力指数	0.60±0.070	0.61±0.060	t=0.635	0.527
?	脾静脉内径（mm）	5.97±1.08	6.17±1.23	t=0.684	0.496
?	脾静脉平均流速（cm/s）	19.28±8.47	16.91±5.46	t=-1.529	0.130
APRI（±s）		21.91±21.71	29.60±7.17	t=1.167	0.247
FIB-4（±s）		1.08±0.67	1.62±1.03	t=2.389	0.019
肝脏硬度（kPa，±s）		6.84±2.46	10.00±7.17	t=2.101	0.039
LF指数（±s）		1.83±0.33	2.26±0.49	t=3.960	<0.001

参数		无或轻微肝纤维化组F0~2（33例）	重度肝纤维化组F3~6（83例）	统计值	P值
临床信息		?	?	?	?
?	男性[例（%）]	15（45.5）	56（67.5）	χ²=3.315	0.069
?	年龄（岁，±s）	36.33±7.86	38.82±8.33	t=1.258	0.212
?	体质量指数（kg/m²，±s）	22.46±3.83	22.97±2.93	t=0.657	0.513
生化指标		?	?	?	?
?	丙氨酸转氨酶（U/L，±s）	48.08±26.36	47.46±21.64	t=0.845	0.401
?	天冬氨酸转氨酶（U/L，±s）	64.96±27.53	63.89±29.92	t=0.948	0.346
?	γ-谷氨酸转肽酶（U/L，±s）	48.50±29.11	47.46±23.72	t=1.398	0.166
?	白蛋白（g/L，±s）	41.87±3.87	40.42±3.85	t=-1.557	0.123
?	总胆红素（μmol/L，±s）	11.35±4.84	16.17±14.62	t=0.929	0.356
?	白细胞（×1000/mm³，±s）	6.24±1.51	5.73±1.61	t=-1.325	0.189
?	血小板（×1000/mm³，±s）	196.25±37.01	180.07±69.00	t=-1.087	0.280
?	空腹血糖（mmol/L，±s）	5.20±1.09	5.52±1.52	t=0.933	0.354
?	HBV-DNA（log¹⁰ IU/L，±s）	6.34±2.19	6.07±1.81	t=-0.585	0.560
?	HbeAg阳性率[例（%）]	13（54.2%）	34（55.7%）	χ²=2.643	0.102
超声参数（±s）		?	?	?	?
?	门静脉内径（mm）	10.87±1.70	11.58±1.47	t=1.902	0.061
?	门静脉平均流速（cm/s）	22.80±5.36	21.40±7.02	t=-0.882	0.380
?	肝动脉内径（mm）	3.24±0.45	3.42±0.62	t=2.728	0.008
?	肝动脉最大流速（cm/s）	67.81±25.41	73.22±27.81	t=0.985	0.328
?	肝动脉阻力指数	0.73±0.052	0.75±0.082	t=0.648	0.519
?	脾脏厚径（mm）	31.27±4.80	33.52±6.17	t=1.842	0.069
?	脾脏长径（mm）	89.50±6.80	93.98±10.38	t=1.954	0.054
?	脾脏指数	30.15±7.03	36.53±9.76	t=2.914	0.005
?	脾门指数	1.21±0.27	2.02±0.87	t=4.412	<0.001
?	脾动脉内径（mm）	4.10±0.71	4.43±0.86	t=1.704	0.092
?	脾动脉最大流速（cm/s）	73.48±19.37	73.75±22.37	t=0.053	0.958
?	脾动脉阻力指数	0.60±0.070	0.61±0.060	t=0.635	0.527
?	脾静脉内径（mm）	5.97±1.08	6.17±1.23	t=0.684	0.496
?	脾静脉平均流速（cm/s）	19.28±8.47	16.91±5.46	t=-1.529	0.130
APRI（±s）		21.91±21.71	29.60±7.17	t=1.167	0.247
FIB-4（±s）		1.08±0.67	1.62±1.03	t=2.389	0.019
肝脏硬度（kPa，±s）		6.84±2.46	10.00±7.17	t=2.101	0.039
LF指数（±s）		1.83±0.33	2.26±0.49	t=3.960	<0.001

参数		非肝硬化F0~4（84例）	肝硬化F5~6（32例）	统计值	P值
临床信息		?	?	?	?
?	男性[例（%）]	50（59.5）	21（65.6）	χ²=0.217	0.641
?	年龄（岁，±s）	37.39±8.14	40.09±8.33	t=1.350	0.181
?	体质量指数（kg/m²，±s）	22.45±3.05	23.83±3.43	t=1.787	0.078
生化指标		?	?	?	?
?	丙氨酸转氨酶（U/L，±s）	44.44±30.97	45.83±29.41	t=0.123	0.902
?	天冬氨酸转氨酶（U/L，±s）	61.11±28.36	62.74±25.24	t=0.544	0.588
?	γ-谷氨酸转肽酶（U/L，±s）	30.89±21.39	72.35±58.61	t=3.155	0.002
?	白蛋白（g/L，±s）	41.48±3.71	39.08±3.92	t=-2.610	0.011
?	总胆红素（μmol/L，±s）	12.43±5.58	20.78±18.46	t=1.626	0.108
?	白细胞（×1000/mm³，±s）	5.95±1.50	5.69±1.84	t=-0.668	0.506
?	血小板（×1000/mm³，±s）	196.71±61.85	152.09±45.00	t=-3.101	0.003
?	空腹血糖（mmol/L，±s）	5.39±1.17	5.52±1.96	t=0.369	0.713
?	HBV-DNA（log ¹⁰ IU/L，±s）	6.16±1.99	6.11±1.74	t=-0.104	0.917
?	HbeAg阳性率[例（%）]	36（58.1%）	12（52.2%）	χ²=0.237	0.627
超声参数（±s）		?	?	?	?
?	门静脉内径（mm）	11.16±1.65	11.95±1.16	t=2.096	0.039
?	门静脉平均流速（cm/s）	22.32±6.29	20.37±7.29	t=-1.216	0.227
?	肝动脉内径（mm）	3.35±0.52	3.65±0.61	t=4.524	0.004
?	肝动脉最大流速（cm/s）	70.76±24.11	74.21±19.17	t=0.617	0.539
?	肝动脉阻力指数	0.75±0.053	0.72±0.11	t=-1.551	0.125
?	脾脏厚径（mm）	32.19±4.96	34.57±5.25	t=2.103	0.038
?	脾脏长径（mm）	90.57±7.68	98.50±12.09	t=3.584	0.001
?	脾脏指数	31.51±7.25	43.39±9.49	t=6.158	<0.001
?	脾门指数	1.51±0.66	2.54±0.80	t=6.037	<0.001
?	脾动脉内径（mm）	4.20±0.76	4.71±0.92	t=2.573	0.012
?	脾动脉最大流速（cm/s）	73.36±21.31	74.55±22.30	t=0.226	0.822
?	脾动脉阻力指数	0.63±0.083	0.64±0.075	t=-0.592	0.555
?	脾静脉内径（mm）	5.89±1.08	6.71±1.29	t=2.972	0.004
?	脾静脉平均流速（cm/s）	18.50±6.76	15.11±5.00	t=-2.190	0.031
APRI（±s）		24.85±27.65	34.37±26.11	t=1.430	0.156
FIB-4（±s）		1.27±0.85	2.00±1.09	t=3.210	0.002
肝脏硬度（kPa，±s）		7.20±2.72	14.25±9.80	t=5.200	<0.001
LF指数（±s）		2.00±0.42	2.52±0.46	t=4.971	<0.001

参数		非肝硬化F0~4（84例）	肝硬化F5~6（32例）	统计值	P值
临床信息		?	?	?	?
?	男性[例（%）]	50（59.5）	21（65.6）	χ²=0.217	0.641
?	年龄（岁，±s）	37.39±8.14	40.09±8.33	t=1.350	0.181
?	体质量指数（kg/m²，±s）	22.45±3.05	23.83±3.43	t=1.787	0.078
生化指标		?	?	?	?
?	丙氨酸转氨酶（U/L，±s）	44.44±30.97	45.83±29.41	t=0.123	0.902
?	天冬氨酸转氨酶（U/L，±s）	61.11±28.36	62.74±25.24	t=0.544	0.588
?	γ-谷氨酸转肽酶（U/L，±s）	30.89±21.39	72.35±58.61	t=3.155	0.002
?	白蛋白（g/L，±s）	41.48±3.71	39.08±3.92	t=-2.610	0.011
?	总胆红素（μmol/L，±s）	12.43±5.58	20.78±18.46	t=1.626	0.108
?	白细胞（×1000/mm³，±s）	5.95±1.50	5.69±1.84	t=-0.668	0.506
?	血小板（×1000/mm³，±s）	196.71±61.85	152.09±45.00	t=-3.101	0.003
?	空腹血糖（mmol/L，±s）	5.39±1.17	5.52±1.96	t=0.369	0.713
?	HBV-DNA（log ¹⁰ IU/L，±s）	6.16±1.99	6.11±1.74	t=-0.104	0.917
?	HbeAg阳性率[例（%）]	36（58.1%）	12（52.2%）	χ²=0.237	0.627
超声参数（±s）		?	?	?	?
?	门静脉内径（mm）	11.16±1.65	11.95±1.16	t=2.096	0.039
?	门静脉平均流速（cm/s）	22.32±6.29	20.37±7.29	t=-1.216	0.227
?	肝动脉内径（mm）	3.35±0.52	3.65±0.61	t=4.524	0.004
?	肝动脉最大流速（cm/s）	70.76±24.11	74.21±19.17	t=0.617	0.539
?	肝动脉阻力指数	0.75±0.053	0.72±0.11	t=-1.551	0.125
?	脾脏厚径（mm）	32.19±4.96	34.57±5.25	t=2.103	0.038
?	脾脏长径（mm）	90.57±7.68	98.50±12.09	t=3.584	0.001
?	脾脏指数	31.51±7.25	43.39±9.49	t=6.158	<0.001
?	脾门指数	1.51±0.66	2.54±0.80	t=6.037	<0.001
?	脾动脉内径（mm）	4.20±0.76	4.71±0.92	t=2.573	0.012
?	脾动脉最大流速（cm/s）	73.36±21.31	74.55±22.30	t=0.226	0.822
?	脾动脉阻力指数	0.63±0.083	0.64±0.075	t=-0.592	0.555
?	脾静脉内径（mm）	5.89±1.08	6.71±1.29	t=2.972	0.004
?	脾静脉平均流速（cm/s）	18.50±6.76	15.11±5.00	t=-2.190	0.031
APRI（±s）		24.85±27.65	34.37±26.11	t=1.430	0.156
FIB-4（±s）		1.27±0.85	2.00±1.09	t=3.210	0.002
肝脏硬度（kPa，±s）		7.20±2.72	14.25±9.80	t=5.200	<0.001
LF指数（±s）		2.00±0.42	2.52±0.46	t=4.971	<0.001

参数		OR值	95%CI	P值
临床信息		?	?	?
?	男性（%）	2.423	0.923~6.357	0.072
?	年龄（岁）	1.038	0.979~1.101	0.211
?	体重指数（kg/m²）	1.054	0.903~1.230	0.508
生化指标		?	?	?
?	丙氨酸转氨酶（U/L）	1.008	0.989~1.026	0.418
?	天冬氨酸转氨酶（U/L）	1.004	0.995~1.104	0.369
?	γ-谷氨酸转肽酶（U/L）	1.011	0.995~1.027	0.191
?	白蛋白（g/L）	0.901	0.789~1.029	0.126
?	总胆红素（μmol/L）	1.061	0.962~1.169	0.236
?	白细胞（×1000/mm³）	0.821	0.611~1.103	0.190
?	血小板（×1000/mm³）	0.996	0.988~1.004	0.295
?	空腹血糖（mmol/L）	1.213	0.807~1.823	0.354
?	HBV-DNA（log¹⁰ IU/L）	0.927	0.721~1.192	0.555
?	HbeAg阳性率（%）	1.066	0.413~2.751	0.896
超声参数		?	?	?
?	门静脉内径（mm）	1.352	0.981~1.863	0.066
?	门静脉平均流速（cm/s）	0.968	0.901~1.040	0.376
?	肝动脉内径（mm）	3.417	1.326~8.811	0.011
?	肝动脉最大流速（cm/s）	1.011	0.989~1.033	0.325
?	肝动脉阻力指数	1.069	0.980~1.166	0.134
?	脾脏厚径（mm）	1.102	0.991~1.226	0.074
?	脾脏长径（mm）	1.061	0.998~1.128	0.057
?	脾脏指数	1.098	1.025~1.176	0.007
?	脾门指数	20.532	4.116~102.418	<0.001
?	脾动脉内径（mm）	1.723	0.909~3.266	0.096
?	脾动脉最大流速（cm/s）	1.001	0.979~1.023	0.957
?	脾动脉阻力指数	1.045	0.979~1.115	0.184
?	脾静脉内径（mm）	1.153	0.769~1.727	0.491
?	脾静脉平均流速（cm/s）	0.947	0.881~1.018	0.141
APRI		1.105	0.989~1.403	0.259
FIB-4		2.267	1.091~4.711	0.028
肝脏硬度（kPa）		1.230	1.041~1.454	0.015
LF指数		11.345	2.787~46.179	0.001

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