内镜结扎联合中医辨证论治对肝硬化食管静脉曲张破裂出血的二级预防效果

陈冲; 吕莹; 陈茜蕾; 刘成海; 刘平; 慕永平

doi:10.3969/j.issn.1001-5256.2022.05.019

内镜结扎联合中医辨证论治对肝硬化食管静脉曲张破裂出血的二级预防效果

DOI: 10.3969/j.issn.1001-5256.2022.05.019

上海中医药大学附属曙光医院，上海市中医药研究院肝病研究所，肝肾疾病病证教育部重点实验室，上海市中医临床重点实验室，上海 201203

基金项目:

国家自然科学基金 (81874390);

上海市科学技术委员会科技创新项目 (15411950500);

上海市临床重点专科建设项目 (shslczdzk01201)

伦理学声明：本研究方案于2019年3月30日经由上海中医药大学附属曙光医院医学伦理委员会批准，批号：2016-464-15-01。所有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：刘平、慕永平、刘成海负责课题设计，经费支持，指导论文撰写及修订；陈冲负责信息采集，数据分析，论文撰写；吕莹、陈茜蕾负责信息采集。

详细信息

通信作者:
刘平, liuliver@vip.sina.com

慕永平, ypmu8888@126.com

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出版历程
- 收稿日期: 2021-09-27
- 录用日期: 2021-10-29
- 出版日期: 2022-05-20

Effect of endoscopic ligation combined with traditional Chinese medicine syndrome differentiation-based treatment in the secondary prevention of esophageal variceal bleeding in patients with liver cirrhosis

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine; Institute of Liver Diseases, Shanghai Institute of Traditional Chinese Medicine; Key Laboratory of Liver and Kidney Diseases, Ministry of Education; Shanghai Key Laboratory of Traditional Chinese Clinical Medicine, Shanghai 201203, China

Research funding:

National Natural Science Foundation of China (81874390);

Scientific and Technological Innovation Project of Shanghai Municipal Commission of Science and Technology (15411950500);

Shanghai Key Specialty of Traditional Chinese Clinical Medicine (shslczdzk01201)

More Information

Corresponding author: LIU Ping, liuliver@vip.sina.com(ORCID: 0000-0002-6808-8243); MU Yongping, ypmu8888@126.com(ORCID: 0000-0002-6152-4508)

摘要

摘要: 目的观察内镜下结扎联合中医辨证论治防治肝硬化食管静脉曲张破裂出血(EVB)二级预防的疗效。方法选取2015年4月—2021年2月上海中医药大学附属曙光医院肝硬化科收治的行内镜下结扎治疗的EVB患者108例，对同时服用中药治疗的患者定义为中西医组(n=59)，对未服用中药治疗的患者定义西医组(n=49)。比较两组患者的再出血发生率、病死率以及门静脉高压性胃病的改善率等。计量资料符合正态分布者采用t检验；不符合正态分布者采用Mann-Whitney U秩和检验；计数资料2组间对比采用χ²检验或Fisher确切概率法；并采用Cox回归分析评估影响再出血的危险因素。结果中西医组内镜结扎后13~24个月的再出血率显著低于西医组(2% vs 12%, P=0.045)；中西医组再出血病死率显著低于西医组(2% vs 12%, P=0.045)，且门静脉高压性胃病的总有效率显著高于西医组(90% vs 77%, P=0.04)。基础疾病(主要包括糖尿病、高血压、心脏病)及肝功能Child-Pugh分级是影响再出血的显著危险因素(P值均＜0.05)。结论内镜结扎联合中医辨证论治可显著降低EVB的迟发性再出血发生率和病死率，改善门静脉高压性胃病的程度，为结扎联合中医药提高EVB二级预防的综合疗效提供了新策略。
- 肝硬化 /
- 食管和胃静脉曲张 /
- 内窥镜检查 /
- 医学, 中国传统
Abstract: Objective To investigate the efficacy of endoscopic ligation combined with traditional Chinese medicine (TCM) syndrome differentiation-based treatment in the secondary prevention of esophageal variceal bleeding (EVB) in patients with liver cirrhosis. Methods A total of 108 EVB patients who were admitted to Department of Liver Cirrhosis, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from April 2015 to February 2021 and underwent endoscopic ligation were enrolled, among whom 59 patients with TCM treatment were enrolled as Chinese and Western medicine group, and 49 patients without TCM treatment were enrolled as Western medicine group. The two groups were compared in terms of the incidence rate of rebleeding, mortality rate, and the improvement rate of portal hypertensive gastropathy. The t-test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U rank sum test was used for comparison of non-normally distributed continuous data between groups; the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups; a Cox regression analysis was used to evaluate the risk factors for rebleeding. Results Compared with the Western medicine group, the Chinese and Western medicine group had a significantly lower rebleeding rate within 13-24 months after ligation (2% vs 12%, P=0.045), a significantly lower mortality rate of rebleeding (2% vs 12%, P=0.045), and a significantly higher overall response rate of portal hypertensive gastropathy (90% vs 77%, P=0.04). Underlying diseases (mainly including diabetes, hypertension, and heart disease) and Child-Pugh class for liver function were significant risk factors for rebleeding (all P < 0.05). Conclusion Ligation combined with TCM treatment can significantly reduce the incidence rate of delayed rebleeding and the mortality rate of EVB and improve the degree of portal hypertensive gastropathy, which provides a new strategy for ligation combined with TCM treatment to improve the overall response of EVB secondary prevention.
- Liver Cirrhosis /
- Esophageal and Gastric Varices /
- Endoscopy /
- Medicine, Chinese Traditional

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表 1 两组基线资料比较

Table 1. Comparison of baselines between the two groups

项目	西医组(n=49)	中西医组(n=59)	统计值	P值
性别[例(%)]			χ²=0.02	0.889
男	25(51)	32(54)
女	24(49)	27(46)
年龄(岁)	61.00(50.0~68.0)	57.00(47.0~65.5)	Z=1664.5	0.177
病程(年)	4.00(1.00~8.00)	3.00(1.0~9.0)	Z=1479	0.838
肝硬化原因[例(%)]				0.882
AIH	1(2)	2(3)
PBC	6(12)	6(10)
丙型肝炎肝硬化	1(2)	1(2)
不明原因肝硬化	6(12)	11(19)
混合型肝硬化	6(12)	6(10)
酒精性肝硬化	6(12)	3(5)
血吸虫性肝硬化	3(6)	6(10)
乙型肝炎肝硬化	20(41)	23(39)
重叠综合征(AIH+PBC)	0(0)	1(2)
肝功能指标
TBil(μmol/L)	20.74(11.29~34.50)	20.40(8.80~31.35)	Z=1624.5	0.271
ALT(U/L)	31.00(21.00~39.00)	35.00(22.50~53.50)	Z=1172	0.092
AST(U/L)	38.00(30.00~45.00)	40.00(30.00~56.50)	Z=1248.5	0.224
Alb(g/L)	34.80(30.40~38.41)	35.60(32.15~38.65)	Z=1242.5	0.211
Child-Pugh分级[例(%)]				0.304
A级	18(37)	22(37)
B级	20(41)	30(51)
C级	11(22)	7(12)
食管静脉曲张程度[例(%)]				1.000
中度	5(10)	6(10)
重度	44(90)	53(90)
PHG[例(%)]			χ²=2.935	0.231
无	23(47)	19(32)
轻度	16(33)	28(47)
重度	10(20)	12(20)
高血压病[例(%)]			χ²=0.417	0.518
无	40(82)	44(75)
有	9(18)	15(25)
糖尿病[例(%)]			χ²=0.123	0.725
无	35(71)	45(76)
有	14(29)	14(24)
心脏病[例(%)]				1.000
无	48(98)	57(97)
有	1(2)	2(3)
饮酒史[例(%)]			χ²=0.101	0.750
无	36(73)	46(78)
有	13(27)	13(22)
吸烟史[例(%)]				1.000
无	41(84)	50(85)
有	8(16)	9(15)

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表 2 再出血的发生率

Table 2. Incidence of rebleeding

再出血时间	西医组 (n=49)	中西医组 (n=59)	P值
早期再出血[例(%)]
6周内	1(2)	1(2)	1.0
迟发性再出血[例(%)]
6周~6个月	3(6)	4(7)	1.0
7~12个月	2(4)	2(3)	1.0
13~24个月	6(12)	1(2)	0.045
25个月以后	0	1(2)	1.0

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表 3 Cox回归分析

Table 3. Cox regression analysis

变量	B值	SE	Wald	Exp(B)	P值
组别	-0.037	0.554	0.004	0.964	0.947
性别	0.900	0.826	1.187	2.459	0.276
年龄	0.008	0.030	0.068	1.008	0.795
内镜治疗次数	-0.630	0.372	2.871	0.533	0.090
入组时食管静脉曲张分级	0.738	1.191	0.384	2.091	0.536
是否合并胃底静脉曲张	-1.198	0.898	1.779	0.302	0.182
是否合并PHG			0.367		0.832
轻度	0.184	0.738	0.062	1.202	0.803
重度	0.426	0.707	0.363	1.532	0.547
病程	0.093	0.081	1.343	1.098	0.247
基础疾病	1.546	0.655	5.572	4.693	0.018
饮酒史	0.892	0.847	1.109	2.440	0.292
吸烟史	0.977	0.805	1.475	2.657	0.225
肝硬化原因	0.674	0.700	0.926	1.962	0.336
肝功能Child-Pugh分级	1.550	0.539	8.260	4.713	0.004

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