比较高剂量双联疗法与含铋四联疗法对海南岛幽门螺杆菌感染初次根除的疗效：一项随机、多中心临床试验。

Comparing high-dose dual therapy with bismuth-containing quadruple therapy for the initial eradication of Helicobacter pylori infection on Hainan Island: A randomized, multicenter clinical trial.

作者信息

Liu Dan-Ni, Wang Qiu-Yan, Li Pei-Yuan, Wu Dong-Han, Pan Jing, Chen Zheng-Yi, Li Yan-Qiang, Han Xiang-Yang, Lan Cheng, Tang Jing, Tan Yan, Mo Cui-Yi, Yang Wei-Zhong, Han Jun-Ling, Huang Xiao-Xi

机构信息

Department of Gastroenterology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China.

Department of Gastroenterology, Tongji Wenchang Hospital of Huazhong University of Science and Technology, Wenchang, China.

出版信息

Clin Res Hepatol Gastroenterol. 2023 May;47(5):102125. doi: 10.1016/j.clinre.2023.102125. Epub 2023 Apr 14.

DOI:10.1016/j.clinre.2023.102125

PMID:37062356

Abstract

BACKGROUND

Traditional bismuth-containing quadruple therapy, as a first-line eradication treatment for Helicobacter pylori (H. pylori), has several disadvantages, including drug side effects, low medication adherence, and high costs. Trials of high-dose dual treatment have demonstrated its advantages, which include good safety and adherence profiles. In this study, we investigated the efficacy, safety, and compliance of a high-dose dual therapy when compared with bismuth-based quadruple treatment for the initial eradication of H. pylori infection on Hainan Island, China.

METHODS

We randomized 846 H. pylori-infected patients into two groups. A bismuth-containing quadruple therapy group was administered the following: esomeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg twice daily, and colloidal bismuth pectin in suspension 150 mg three times/day for 2 weeks. A high-dose dual therapy group was administered the following: esomeprazole 20 mg four times/day and amoxicillin 1000 mg three times/day for 2 weeks. Patients were given a 13C urea breath test at 4 weeks at treatment end. Adverse effects and compliance were evaluated at follow-up visits.

RESULTS

Eradication rates in the high-dose dual therapy group were: 90.3% (381/422, 95% confidence interval [CI]: 87.1%-92.9%) in intention-to-treat (ITT) and 93.6% (381/407, 95% CI: 90.8%-95.8%) in per-protocol (PP) analyses. Eradication rates were 87.3% in ITT (370/424, 95% CI: 83.7%-90.3%) and 91.8% in PP analyses (370/403, 95% CI: 88.7%-94.3%) for quadruple therapy, with no statistical differences (P = 0.164 in ITT and P = 0.324 in PP analyses). Adverse effects were 13.5% (55/407) in the dual group and 17.4% (70/403) in the quadruple group (P = 0.129). Compliance was 92.4% (376/407) in the dual group and 86.6% (349/403) in the quadruple group (P = 0.007).

CONCLUSIONS

High-dose dual therapy had high eradication rates comparable with bismuth-based quadruple treatment, with no differences in adverse effects, however higher adherence rates were recorded.

摘要

背景

传统含铋四联疗法作为幽门螺杆菌（H. pylori）的一线根除治疗方法，存在多种缺点，包括药物副作用、用药依从性低和成本高。高剂量双联疗法试验已证明其优势，包括良好的安全性和依从性。在本研究中，我们在中国海南岛比较了高剂量双联疗法与基于铋剂的四联疗法对H. pylori感染进行初始根除治疗的疗效、安全性和依从性。

方法

我们将846例H. pylori感染患者随机分为两组。含铋四联疗法组给予以下药物：埃索美拉唑20毫克、阿莫西林1000毫克和克拉霉素500毫克，每日两次；胶体果胶铋混悬液150毫克，每日三次，共2周。高剂量双联疗法组给予以下药物：埃索美拉唑20毫克，每日四次；阿莫西林1000毫克，每日三次，共2周。治疗结束4周时对患者进行13C尿素呼气试验。在随访时评估不良反应和依从性。

结果

高剂量双联疗法组在意向性治疗（ITT）分析中的根除率为90.3%（381/422，95%置信区间[CI]：87.1%-92.9%），符合方案（PP）分析中的根除率为93.6%（381/407，95% CI：90.8%-95.8%）。四联疗法在ITT分析中的根除率为87.3%（370/424，95% CI：83.7%-90.3%），PP分析中的根除率为91.8%（370/403，95% CI：88.7%-94.3%），无统计学差异（ITT分析中P = 0.164，PP分析中P = 0.324）。双联组不良反应发生率为13.5%（55/407）；四联组为17.4%（70/403）（P = 0.129）。双联组依从率为92.4%（376/407），四联组为86.6%（349/403）（P = 0.007）。