抗肝纤维化中药治疗对肝硬化并发肠系膜上静脉栓塞患者预后的影响

冯颖; 时克; 张晓华; 杨莉; 王宪波

doi:10.3969/j.issn.1001-5256.2022.07.015

抗肝纤维化中药治疗对肝硬化并发肠系膜上静脉栓塞患者预后的影响

DOI: 10.3969/j.issn.1001-5256.2022.07.015

首都医科大学附属北京地坛医院中西医结合中心，北京 100015

基金项目:

国家自然科学基金 (82004153);

北京市科学技术委员会项目 (Z191100006619033)

伦理学声明：本研究方案于2021年3月经由首都医科大学附属北京地坛医院伦理委员会审批，批号：DTZZLX-202103。所纳入患者均签署知情同意书。

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：冯颖负责分析数据、撰写论文；时克负责实施研究并参与修改论文；张晓华、杨莉负责收集病例、患者随访工作、参考文献整理与图表修改；王宪波负责研究设计及审阅、修改论文。

详细信息

通信作者:
王宪波，wangxianbo638@163.com

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出版历程
- 收稿日期: 2022-03-28
- 录用日期: 2022-05-02
- 出版日期: 2022-07-20

Effect of anti-liver fibrosis traditional Chinese medicine therapy on the prognosis of patients with liver cirrhosis and superior mesenteric venous thrombosis

Center of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China

Research funding:

National Natural Science Foundation of China (82004153);

Beijing Science and Technology Project (Z191100006619033)

More Information

Corresponding author: WANG Xianbo, wangxianbo638@163.com (ORCID: 0000-0002-3593-5741)

摘要

摘要: 目的通过抗肝纤维化中药治疗，分析对肝硬化并发肠系膜上静脉栓塞(SMVT)患者生存情况的影响。方法回顾性分析2017年1月—2020年6月在首都医科大学附属北京地坛医院住院治疗的231例肝硬化合并SMVT的患者临床资料，分为中药组(114例)和对照组(117例)。所有患者在针对原发病的常规治疗方案基础上，充分评估抗血栓指征，有必要者均应用标准抗血栓治疗；中药组在此基础上服用抗肝纤维化中药≥6个月。正态分布的计量资料两组间比较采用独立样本t检验；非正态分布的计量资料两组间比较采用Mann-Whitney U检验。计数资料组间比较采用χ²检验。采用Cox回归模型分析影响患者预后的独立性因素；观察患者发生终点事件(死亡)的情况，采用Kaplan-Meier法描绘生存曲线，用log-rank法进行比较检验；根据Child评分分层分析抗肝纤维化中药对不同级别肝功能患者预后的影响，以及不同种类抗肝纤维化中药对患者预后的影响。结果多因素分析显示年龄[风险比(HR)=1.039，95%CI：1.001~1.078，P=0.041]、CRP(HR=1.025，95%CI：1.009~1.041，P=0.003)是患者死亡的独立危险因素，而口服抗肝纤维化中药是保护性因素(HR=0.148，95%CI：0.051~0.429，P=0.001)。生存曲线分析显示中药组生存率高于对照组(95.6% vs 81.2%，χ²=17.032，P＜0.000 1)；进一步分析显示，Child-Pugh A级患者的生存率中药组高于对照组(100% vs 66.7%，χ²=4.003，P=0.045); Child-Pugh B级患者的生存率中药组亦高于对照组(96.7% vs 85.1%，χ²=10.788，P=0.002)。3种抗肝纤维化中药对患者预后影响差异无统计学意义(P＞0.05)。结论年龄、CRP是影响肝硬化并发SMVT患者预后的独立危险因素；抗肝纤维化中药治疗能降低患者的病死率，特别是在Child-Pugh A级及B级患者中疗效更明显。
- 肝硬化 /
- 肠系膜静脉 /
- 静脉血栓栓塞 /
- 中草药
Abstract: Objective To investigate the effect of anti-liver fibrosis traditional Chinese medicine (TCM) therapy on the prognosis of patients with liver cirrhosis and superior mesenteric venous thrombosis (SMVT). Methods A retrospective analysis was performed for the clinical data of 231 patients with liver cirrhosis and SMVT who were hospitalized and treated in Beijing Ditan Hospital, Capital Medical University, from January 2017 to June 2020, and the patients were divided into TCM group with 114 patients and control group with 117 patients. In addition to the conventional treatment regimen for primary diseases, antithrombotic indications were fully evaluated, and standard antithrombotic treatment was applied if necessary; the patients in the TCM group were given anti-liver fibrosis TCM therapy for ≥6 months. The independent samples t-test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U 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 two groups. The Cox regression model was used to analyze the independent influencing factors for prognosis; outcome events (death) were observed, the Kaplan-Meier method was used to plot survival curves, and the log-rank test was used for comparison; a stratified analysis based on Child score was performed to investigate the effect of anti-liver fibrosis TCM therapy on the prognosis of patients with different liver function grades and the effect of different anti-liver fibrosis TCM drugs on the prognosis of patients. Results The multivariate analysis showed that age (hazard ratio [HR]=1.039, 95% confidence interval [CI]: 1.001-1.078, P=0.041) and C-reactive protein (CRP) (HR=1.025, 95%CI: 1.009-1.041, P=0.003) were independent risk factors for death, while oral administration of anti-liver fibrosis TCM drugs was a protective factor (HR=0.148, 95%CI: 0.051-0.429, P=0.001). The survival curve analysis showed that the TCM group had a significantly higher survival rate than the control group (95.6% vs 81.2%, χ²=17.032, P < 0.0001), and further analysis showed that compared with the control group, the TCM group had significantly higher survival rates of the patients with Child-Pugh grade A/B liver function (Child-Pugh grade A: 100% vs 66.7%, χ²=4.003, P=0.045; Child-Pugh grade B: 96.7% vs 85.1%, χ²=10.788, P=0.002). There was no significant difference in the effect on the prognosis of patients between the three anti-liver fibrosis TCM drugs (P > 0.05). Conclusion Age and CRP are independent influencing factors for the prognosis of patients with liver cirrhosis and SMVT, and anti-liver fibrosis TCM therapy can reduce the mortality rate of patients, especially in the patients with Child-Pugh grade A/B liver function.
- Liver Cirrhosis /
- Mesenteric Veins /
- Venous Thromboembolism /
- Drugs, Chinese Herbal

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图 1 中药组和对照组患者的总生存期及根据肝功能分层、中药亚组分析生存情况

注：a，中药组和对照组总生存期情况；b~d，按照肝功分层分析中药组和对照组患者生存情况(b: Child-Pugh A级；c：Child-Pugh B级；d：Child-Pugh C级)；e，按照不同种类中药进行亚组分析患者生存情况。

Figure 1. The overall survival time was analyzed according to liver function or TCM subgroups

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表 1 231例入组患者的基线情况

Table 1. Baseline characteristics of 231 patients

项目	总体(n=231)	对照组(n=117)	中药组(n=114)	统计值	P值
男/女(例)	173/58	92/25	81/33	χ²=1.76	0.18
年龄(岁)	57.59±11.42	59.10±11.58	56.04±11.08	t=2.05	0.06
酗酒[例(%)]	87(37.66)	45(38.46)	42(36.84)	χ²=0.06	0.80
乙型肝炎[例(%)]	130(56.28)	64(54.70)	66(57.89)	χ²=0.24	0.63
丙型肝炎[例(%)]	21(9.09)	12(10.26)	9(7.89)	χ²=0.39	0.53
酒精性肝病[例(%)]	34(14.72)	20(17.09)	14(12.28)	χ²=1.07	0.30
其他肝病[例(%)]	46(19.91)	21(17.95)	25(21.93)	χ²=0.57	0.45
腹部症状[例(%)]	96(41.56)	52(44.44)	44(38.60)	χ²=0.81	0.37
腹水[例(%)]	185(80.09)	97(82.91)	88(77.19)	χ²=1.18	0.28
消化道出血[例(%)]	104(45.02)	53(45.30)	51(44.74)	χ²=0.01	0.93
肝性脑病[例(%)]	23(9.96)	14(11.97)	9(7.89)	χ²=1.07	0.30
基础疾病[例(%)]	109(47.19)	58(49.57)	51(44.74)	χ²=0.54	0.46
脾切除[例(%)]	55(23.81)	25(21.37)	30(26.32)	χ²=0.78	0.38
门静脉栓塞[例(%)]	177(76.62)	89(76.07)	88(77.19)	χ²=0.04	0.84
WBC(×10⁹/L)	3.65(2.33~5.49)	3.71(2.28~5.30)	3.63(2.35~5.94)	Z=0.21	0.83
Hb(g/L)	89.00(71.20~120.30)	88.00(70.55~122.00)	89.00(72.40~119.63)	Z=0.00	1.00
PLT(×10⁹/L)	83.40(54.00~142.00)	82.40(55.50~141.10)	87.00(52.85~142.30)	Z=0.65	0.52
INR	1.30(1.19~1.43)	1.31(1.19~1.43)	1.30(1.19~1.44)	Z=0.21	0.83
ALT(U/L)	21.60(14.99~35.20)	22.40(14.35~37.90)	21.30(15.83~33.93)	Z=0.03	0.98
AST(U/L)	27.10(18.90~37.50)	26.60(18.25~38.90)	27.25(19.55~35.98)	Z=0.13	0.89
TBil(μmol/L)	17.50(12.80~26.20)	17.80(12.75~27.60)	17.05(12.80~24.70)	Z=1.00	0.32
Alb(g/L)	32.67±5.02	32.12±4.98	33.23±5.01	t=1.68	0.10
BUN(mmol/L)	5.56(4.30~7.55)	5.88(4.34~8.04)	5.15(4.22~7.26)	Z=1.77	0.08
Cr(μmol/L)	66.30(57.75~80.20)	68.65(59.93~81.90)	64.90(53.50~75.60)	Z=2.00	0.06
CRP(mg/L)	3.90(1.20~15.30)	4.90(1.50~20.00)	3.40(1.00~10.89)	Z=1.26	0.21
Child-Pugh分级	7(6~8)	7(6~9)	7(6~8)	Z=1.80	0.07
MELD评分	6.54(3.72~9.35)	7.14(3.93~9.95)	5.92(3.00~8.93)	Z=1.37	0.17
注：BUN, 尿素氮；Cr，血肌酐。

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表 2 影响肝硬化合并SMVT患者预后的单因素及多因素Cox回归分析

Table 2. Univariate and multivariate Cox regression analyses for overall survival of patients with liver cirrhosis complicated with SMVT

变量	单因素分析			多因素分析
变量	β值	HR (95%CI)	P值	β值	HR (95%CI)	P值
性别	-0.180	0.835(0.336~2.075)	0.698
年龄	0.067	1.069(1.034~1.105)	0.001	0.038	1.039(1.001~1.078)	0.041
酗酒	-0.168	0.845(0.38~1.882)	0.680
乙型肝炎	0		0.884
丙型肝炎	0.159	1.172(0.434~3.165)	0.755
酒精性肝病	-0.138	0.871(0.169~4.496)	0.869
其他肝病	-0.384	0.681(0.132~3.518)	0.647
腹水	0.585	1.794(0.617~5.216)	0.283
肝性脑病	0.337	1.401(0.42~4.674)	0.583
腹部症状	0.618	1.856(0.871~3.955)	0.109
消化道出血	-0.079	0.924(0.432~1.975)	0.838
脾切除	0.792	2.207(0.763~6.388)	0.144
基础疾病	0.029	1.029(0.481~2.202)	0.941
门静脉栓塞	0.010	1.010(0.427~2.391)	0.982
中药	-1.802	0.165(0.062~0.437)	0.001	-1.913	0.148(0.051~0.429)	0.001
WBC	0.101	1.106(1.016~1.205)	0.021	0.085	1.089(0.980~1.211)	0.114
Hb	0.002	1.002(0.989~1.015)	0.790
PLT	-0.001	0.999(0.996~1.003)	0.778
INR	1.609	4.997(0.974~25.646)	0.054
ALT	0.005	1.005(0.996~1.014)	0.277
AST	0.009	1.009(1.003~1.015)	0.006	0.001	1.001(0.993~1.008)	0.855
TBil	0.029	1.029(1.011~1.048)	0.001	0.012	1.013(0.983~1.043)	0.407
Alb	-0.030	0.97(0.898~1.049)	0.447
BUN	0.089	1.093(0.989~1.208)	0.083
Cr	0.011	1.011(0.992~1.030)	0.251
CRP	0.032	1.032(1.020~1.044)	0.001	0.025	1.025(1.009~1.041)	0.003
Child-Pugh分级	0.325	1.384(1.101~1.739)	0.005	0.090	1.095(0.820~1.462)	0.540
MELD评分	0.155	1.168(1.051~1.298)	0.004	0.123	1.131(0.988~1.295)	0.075

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