五种肝硬化无创诊断方法对代偿期乙型肝炎肝硬化患者中医证型的诊断价值分析

于中杰; 赵文霞; 冯蕾心; 王晗笑; 刘建鹏

doi:10.3969/j.issn.1001-5256.2022.01.016

五种肝硬化无创诊断方法对代偿期乙型肝炎肝硬化患者中医证型的诊断价值分析

DOI: 10.3969/j.issn.1001-5256.2022.01.016

1.
河南中医药大学第一临床医学院，郑州 450000
2.
河南中医药大学第一附属医院脾胃肝胆科，郑州 450000

基金项目:

河南省中医药科学研究专项重点课题 (2014ZY01012);

国家中医科研专项 (JDZX2012050);

国家中医药管理局全国名老中医药传承工作室建设项目 (ZMM renjiaohan〔2018〕No. 134)

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。

作者贡献声明: 于中杰负责课题设计，资料分析，撰写论文；冯蕾心、刘建鹏、王晗笑参与收集数据，修改论文；赵文霞负责拟定思路，指导撰写文章并定稿。

详细信息

通信作者:
赵文霞，zhao-wenxia@163.com

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出版历程
- 收稿日期: 2021-06-13
- 录用日期: 2021-07-06
- 出版日期: 2022-01-20

Value of five noninvasive diagnostic methods for liver cirrhosis in diagnosis of traditional Chinese medicine syndrome types in patients with compensated hepatitis B cirrhosis

1.
The First Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou 450000, China
2.
Department of Hepatology and Spleen-Stomach, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China

Research funding:

Henan Province Chinese Medicine Science Research Special Key Project (2014ZY01012);

National Scientific Research Project of Traditional Chinese Medicine (JDZX2012050);

The Construction Project of National Famous and Old Traditional Chinese Medicine Inheritance Studio of State Administration of Traditional Chinese Medicine (ZMM renjiaohan〔2018〕No. 134)

摘要

摘要: 目的探讨5种肝硬化无创诊断[FibroScan肝脏硬度值(LSM值)、AST和PLT比值指数(APRI)、肝纤维化4因子指数(FIB-4)、GGT-PLT比值(GPR)、红细胞体积分布宽度-PLT比值(RPR)]在乙型肝炎肝硬化代偿期中与中医证型的相关性。方法回顾性分析2017年1月—2020年1月河南中医药大学第一附属医院确诊为乙型肝炎肝硬化代偿期的327例患者临床相关资料，分为肝郁脾虚证(n=160)、肝胆湿热证(n=84)、肝肾阴虚证(n=13)、脾肾阳虚证(n=5)、瘀血阻络证(n=65)，采集临床相关资料以及血常规、肝功能、LSM值、肝胆脾胰彩超等信息，并对患者进行中医辨证分型，建立APRI、FIB-4、GPR、RPR模型。符合正态分布的计量资料多组间均数比较用单因素方差分析，进一步两两比较采用LSD-t法；不符合正态分布的计量资料多组间比较用多个独立样本Kruskal-Wallis H秩和检验，采用Kruskal-Wallis单因素ANOVE(k样本)进行多重比较；采用二元logistic回归分析进行进中医证型与肝硬化无创诊断的关系；使用受试者工作特征曲线(ROC曲线)评价5种肝硬化无创诊断方法预测乙型肝炎肝硬化代偿期中医证型的诊断能力。结果 logistic回归分析结果显示，在肝胆湿热证中，AST(OR=1.981，95%CI：1.8225~2.139，P＜0.05)、LSM(OR=2.002，95%CI：1.840~2.160，P＜0.05)是代偿期乙型肝炎肝硬化的影响因素；在肝郁脾虚证中，门静脉宽度(OR=4.402，95%CI：4.050~4.754，P＜0.05)、LSM值(OR=3.901，95%CI：3.589~4.213，P＜0.05]、APRI[OR=1.891，95%CI：1.740~2.042，P＜0.05]、FIB-4(OR=1.845，95% CI：1.697~1.993，P＜0.05)是代偿期乙型肝炎肝硬化的影响因素；在瘀血阻络证中，LSM值(OR=2.465，95%CI：2.268~ 2.662, P＜0.05]、APRI(OR=1.298，95%CI：1.194~1.402, P＜0.05)、FIB-4(OR=1.849，95%CI：1.701~1.997, P＜0.05)是代偿期乙型肝炎肝硬化的影响因素；ROC曲线显示，LSM值与RPR模型评估肝胆湿热证的诊断价值明显优于其他诊断方法；LSM值与FIB-4模型评估肝郁脾虚证的诊断价值明显优于其他诊断方法；5种无创诊断方法均能较好地评估瘀血阻络证。结论 5种无创诊断方法可对不同证型具有不同评估优势，对乙型肝炎肝硬化代偿期患者中医证型诊断提供参考价值。
- 肝硬化 /
- 乙型肝炎 /
- 中医证型 /
- 诊断
Abstract: Objective To investigate the association of five noninvasive diagnostic methods for liver cirrhosis, i.e., liver stiffness measurement (LSM) on FibroScan, aspartate aminotransferase-to-platelet ratio index (APRI), fibrosis-4 (FIB-4), gamma-glutamyl transpeptidase-to-platelet ratio (GPR), and red blood cell distribution width-to-platelet ratio (RPR), with traditional Chinese medicine (TCM) syndrome types in patients with compensated hepatitis B cirrhosis. Methods A retrospective analysis was performed for the clinical data of 327 patients who were diagnosed with compensated hepatitis B cirrhosis in The First Affiliated Hospital of Henan University of Chinese Medicine from January 2017 to January 2020, and based on their TCM syndrome type, they were divided into liver depression and spleen deficiency group with 160 patients, liver-gallbladder damp-heat syndrome group with 84 patients, liver-kidney Yin deficiency group with 13 patients, spleen-kidney Yang deficiency group with 5 patients, and blood stasis obstructing the collaterals group with 65 patients. Related data were collected, including clinical data, routine blood test results, liver function, LSM, and color Doppler ultrasound findings of liver, gallbladder, spleen, and pancreas. TCM syndrome differentiation was performed, and the models of APRI, FIB-4, GPR, and RPR were established. A one-way analysis of variance was used for comparison of normally distributed continuous data between multiple groups, and the least significant difference t-test was used for further comparison between two groups; the multiple independent samples Kruskal-Wallis H rank sum test was used for comparison of non-normally distributed continuous data between multiple groups, and the one- way Kruskal-Wallis ANOVA (k-sample) was used for multiple comparison; the binary logistic regression analysis was used to investigate the association between TCM syndrome types and non-invasive diagnosis of liver cirrhosis; the receiver operating characteristic (ROC) curve was used to evaluate the diagnostic capability of five noninvasive methods for predicting TCM syndrome type in compensated hepatitis B cirrhosis. Results The logistic regression analysis showed that in the liver-gallbladder damp-heat syndrome group, aspartate aminotransferase OR=1.981, 95%CI: 1.8225-2.139, P < 0.05), and LSM (OR=2.002, 95%CI: 1.840-2.160, P < 0.05) were influencing factors for compensated hepatitis B cirrhosis; in the liver depression and spleen deficiency group, portal vein width (OR=4.402, 95%CI: 4.050-4.754, P < 0.05), LSM (OR=3.901, 95%CI: 3.589-4.213, P < 0.05), APRI (OR=1.891, 95%CI: 1.740-2.042, P < 0.05), and FIB-4 (OR=1.845, 95%CI: 1.697-1.993, P < 0.05) were influencing factors for compensated hepatitis B cirrhosis; in the blood stasis obstructing the collaterals group, LSM (OR=2.465, 95%CI: 2.268-2.662, P < 0.05), APRI (OR=1.298, 95%CI: 1.194-1.402, P < 0.05), and FIB-4 (OR=1.849, 95%CI: 1.701-1.997, P < 0.05) were influencing factors for compensated hepatitis B cirrhosis. The ROC curve analysis showed that LSM and RPR had a significantly better diagnostic value than the other methods in evaluating liver-gallbladder damp-heat syndrome, and LSM and FIB-4 had a significantly better diagnostic value than the other methods in evaluating liver depression and spleen deficiency; all five noninvasive diagnostic methods had a good value in evaluating the syndrome of blood stasis obstructing the collaterals. Conclusion The five noninvasive diagnostic methods have their own advantages in evaluating different syndrome types, which provide a reference for the diagnosis of TCM syndrome types in patients with compensated hepatitis B cirrhosis.
- Liver Cirrhosis /
- Hepatitis B /
- TCM syndrome /
- Diagnosis

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图 1 肝郁脾虚证各无创诊断的ROC曲线

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图 2 肝胆湿热证各无创诊断的ROC曲线

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图 3 瘀血阻络证各无创诊断的ROC曲线

下载: 全尺寸图片幻灯片

表 1 中医证型分布情况

证型	例数	性别		年龄（岁）
证型	例数	男(例)	女(例)	年龄（岁）
肝郁脾虚证	160	120	40	42.96±10.74
肝胆湿热证	84	60	24	43.17±11.12
肝肾阴虚证	13	8	5	45.46±10.41
脾肾阳虚证	5	4	1	46.60±9.74
瘀血阻络证	65	46	19	47.80±10.92
统计值		χ²=1.569		F=2.451
P值		0.814		0.056

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表 2 代偿期乙型肝炎肝硬化患者主要中医证型基线资料比较

相关指标	肝郁脾虚证(n=160)	肝胆湿热证(n=84)	瘀血阻络证(n=65)	统计量	P值
PLT(×10⁹/L)	138.00(85.25~177.25)	110.50(92.25~142.75)	44.00(34.00~55.50)¹⁾²⁾	χ²=155.337	＜0.05
ALT(U/L)	34.00(21.95~43.63)	68.85(48.75~109.43)¹⁾	29.50(17.95~39.75)²⁾	χ²=123.210	＜0.05
AST(U/L)	28.95(23.60~39.63)	61.40(40.15~94.03)¹⁾	27.60(21.55~38.05)²⁾	χ²=86.659	＜0.05
Alb(g/L)	44.97±3.13	46.25±3.33¹⁾	31.41±2.46¹⁾²⁾	F=542.512	＜0.05
GLB(g/L)	29.04±4.46	28.76±4.71	29.09±4.62	F=0.128	0.88
GGT(U/L)	31.20(20.83~53.13)	39.10(27.33~65.15)¹⁾	27.70(21.70~44.05)²⁾	χ²=13.079	＜0.05
门静脉主干宽度(mm)	12.79±0.76	12.18±0.99¹⁾	13.40±0.58¹⁾²⁾	F=43.373	＜0.05
LSM值(kPa)	16.00(13.40~18.08)	18.65(16.63~25.00)¹⁾	24.40(22.30~26.50)¹⁾²⁾	χ²=131.312	＜0.05
APRI	1.10(0.62~1.35)	1.30(0.88~2.00)¹⁾	1.55(1.26~2.31)¹⁾	χ²=54.280	＜0.05
FIB-4	1.90(1.38~2.74)	2.66(1.99~3.54)¹⁾	6.19(4.66~8.37)¹⁾²⁾	χ²=129.893	＜0.05
GPR	0.67(0.27~1.18)	0.81(0.49~1.27)¹⁾	1.52(0.94~2.46)¹⁾²⁾	χ²=57.485	＜0.05
RPR	0.37±0.16	0.39±0.10	1.10±0.34¹⁾²⁾	F=351.219	＜0.05
注：与肝郁脾虚证相比，1)P＜0.05；与肝胆湿热证相比, 2)P＜0.05。

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表 3 各无创诊断评估肝郁脾虚证比较

无创诊断方法	AUC(95%CI)	cut-off值	敏感度(%)	特异度(%)	阳性预测值	阴性预测值	阳性似然比	阴性似然比
LSM值	0.982(0.955~0.995)	0.875	98.12	89.33	95.2	95.7	9.20	0.02
APRI	0.899(0.853~0.934)	0.629	86.87	76.00	88.5	73.1	3.62	0.17
FIB-4	0.950(0.913~0.974)	0.776	85.62	92.00	95.8	75.0	10.70	0.16
GPR	0.618(0.553~0.680)	0.303	55.63	74.67	82.4	44.1	2.20	0.59
RPR	0.752(0.692~0.806)	0.533	61.25	92.00	94.2	52.7	7.66	0.42

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表 4 各无创诊断评估肝胆湿热证比较

无创诊断方法	AUC(95%CI)	cut-off值	敏感度(%)	特异度(%)	阳性预测值	阴性预测值	阳性似然比	阴性似然比
LSM值	0.922(0.868~0.958)	0.806	95.24	85.33	87.9	94.1	6.49	0.06
APRI	0.834(0.767~0.888)	0.570	80.95	76.00	79.1	78.1	3.37	0.25
FIB-4	0.848(0.783~0.900)	0.536	86.90	66.67	74.5	82.0	2.61	2.61
GPR	0.844(0.778~0.896)	0.553	72.62	82.67	82.4	72.9	4.19	0.33
RPR	0.958(0.914~0.983)	0.777	85.71	92.00	92.3	85.2	10.71	0.16

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表 5 各无创诊断评估瘀血阻络证比较

无创诊断方法	AUC(95%CI)	cut-off值	敏感度(%)	特异度(%)	阳性预测值	阴性预测值	阳性似然比	阴性似然比
LSM值	0.969(0.925~0.991)	0.893	100.00	89.33	89.0	100.0	9.37	0.00
APRI	0.895(0.831~0.940)	0.731	98.46	74.67	77.1	98.2	3.89	0.02
FIB-4	0.949(0.899~0.979)	0.845	93.85	90.67	89.7	94.4	10.05	0.07
GPR	0.941(0.888~0.973)	0.765	93.85	82.67	82.4	93.9	5.41	0.07
RPR	0.935(0.880~0.969)	0.893	100.00	89.33	89.0	100.0	9.37	0.00

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