2026 年第 2 期 第 21 卷

含阿莫西林及克拉霉素的铋剂四联方案对合并非酒精性单纯性脂肪肝的幽门螺杆菌感染患者肝功能的影响

Effect of bismuth-containing quadruple therapy with amoxicillin and clarithromycin on liver function in patients with Helicobacter pylori infection complicated with non-alcoholic simple fatty liver disease

作者：张灵云1李慧敏2司小北1张月霞1乔蕾1蓝宇1

英文作者：Zhang Lingyun1 Li Huimin2 Si Xiaobei1 Zhang Yuexia1 Qiao Lei1 Lan Yu1

单位：1首都医科大学附属北京积水潭医院消化内科，北京100096；2北京大学首钢医院全科医学科，北京100144

英文单位：1Department of Gastroenterology Beijing Jishuitan Hospital Capital Medical University Beijing 100096 China; 2Department of General Practice Peking University Shougang Hospital Beijing 100144 China

关键词：幽门螺杆菌；非酒精性单纯性脂肪肝；铋剂四联疗法；阿莫西林；克拉霉素；肝功能

英文关键词：Helicobacterpylori;Non-alcoholicsimplefattyliver;Bismuth-containingquadrupletherapy; Amoxicillin;Clarithromycin;Liverfunction

• 摘要：

• 目的 探讨在合并非酒精性单纯性脂肪肝(NAFL)的幽门螺杆菌（Hp）感染患者中，含阿莫西林及克拉霉素的铋剂四联方案治疗后对肝功能的影响。方法 采用前瞻性的临床研究方式，选取2023年10月至2024年10月于首都医科大学附属北京积水潭医院就诊的Hp感染患者，根据是否合并NAFL分为NAFL组和无肝病组。所有患者均接受14 d的含阿莫西林及克拉霉素的铋剂四联方案根除Hp。比较2组患者的Hp根除率、治疗前后肝功能指标变化及不良反应发生率。结果 本研究共收集入组103例患者，其中3例患者分别因皮疹、合并肺部感染及外伤手术剔除出组，最终共纳入观察100例，NAFL组及无肝病组各50例。2组患者性别、年龄、Hp根除率差异均无统计学意义（均P＞0.05）。NAFL组的体重指数明显高于无肝病组［（26±3）kg/m2比（23±3）kg/m2］，差异有统计学意义（P＜0.001）。治疗前后2组肝功能指标均未超过正常值上限的3倍。2组患者治疗后丙氨酸转氨酶（ALT）、天冬氨酸转氨酶（AST）均高于治疗前，差异均有统计学意义（均P＜0.05），但治疗前后碱性磷酸酶、γ-谷氨酰转移酶（GGT）比较差异均无统计学意义（均P＞0.05）。2组患者Hp根除治疗前后肝功能指标变化幅度比较差异均无统计学意义（均P＞0.05）。NAFL组治疗后出现肝功能异常的比例为30.0%（15/50），无肝病组为10.0%（5/50），组间差异有统计学意义（P=0.012）。单因素分析结果显示，体重指数、治疗前ALT、AST、GGT是影响治疗后是否肝功能异常的因素（均P＜0.05）。多因素Logistic回归分析结果显示体重指数是唯一的影响因素（比值比=1.369，P＜0.05）。2组患者不良反应发生率比较差异无统计学意义（P＞0.05），以味觉异常、恶心、上腹不适和腹泻等消化系统不良反应为主，无严重不良反应发生。结论 无论有无肝病，含阿莫西林及克拉霉素的铋剂四联方案均可以引起以ALT、AST升高为主的肝脏损伤，且ALT、AST升高幅度在2组患者中无明显差异。NAFL患者治疗后出现肝功能异常的比例明显高于无肝病组，而体重指数升高是影响治疗后肝功能是否异常的重要因素。建议对于高体重指数的患者，在治疗期间及治疗后密切监测肝功能情况。

• Objective To investigate the effect of bismuth-containing quadruple therapy with amoxicillin and clarithromycin on liver function in patients with Helicobacter pylori (Hp) infection complicated with non-alcoholic simple fatty liver (NAFL). Methods A prospective clinical study was conducted. Patients with Hp infection who were admitted to Beijing Jishuitan Hospital, Capital Medical University from October 2023 to October 2024 were enrolled and divided into the NAFL group and the non-liver disease group according to the presence or absence of NAFL. All patients received 14 d bismuth-containing quadruple therapy with amoxicillin and clarithromycin for Hp eradication. The Hp eradication rate, changes in liver function indexes before and after treatment, and incidence of adverse reactions were compared between the two groups. Results A total of 103 patients were initially enrolled in the study, among whom 3 patients were excluded due to skin rash, complicated pulmonary infection and traumatic surgery respectively, with 100 patients finally included in the observation, 50 cases in each of the NAFL group and the non-liver disease group. There were no significant differences in gender, age and Hp eradication rate between the two groups (all P＞0.05). The body mass index (BMI) of the NAFL group was significantly higher than that of the non-liver disease group ［(26±3)kg/m2 vs (23±3)kg/m2］(P＜0.001). The liver function indexes of both groups did not exceed 3 times the upper limit of the normal value before and after treatment. After treatment, the levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in both groups were significantly higher than those before treatment (both P＜0.05), while there were no significant differences in alkaline phosphatase and gamma-glutamyl transferase (GGT) before and after treatment in both groups (all P＞0.05). There were no significant differences in the changes of liver function indexes before and after Hp eradication treatment between the two groups (all P＞0.05). The incidence of abnormal liver function after treatment in the NAFL group was significantly higher than that in the non-liver disease group ［30.0%(15/50) vs 10.0%(5/50)］(P=0.012). Univariate analysis showed that BMI, pre-treatment ALT, AST and GGT were influencing factors for abnormal liver function after treatment (all P＜0.05). Multivariate Logistic regression analysis showed that BMI was the only independent influencing factor (odds ratio=1.369, P＜0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P＞0.05), which were mainly digestive system reactions such as taste disturbance, nausea, epigastric discomfort and diarrhea, with no serious adverse reactions reported. Conclusion Bismuth-containing quadruple therapy with amoxicillin and clarithromycin can cause liver injury mainly characterized by elevated ALT and AST levels regardless of the presence or absence of liver disease, and there is no significant difference in the elevation ranges of ALT and AST between the two groups. The incidence of abnormal liver function after treatment in NAFL patients is significantly higher than that in non-liver disease patients, and increased BMI is an important influencing factor for abnormal liver function after treatment. It is recommended that close monitoring of liver function should be performed during and after treatment in patients with high BMI.