每日 2 次服用铋剂四联疗法作为一线幽门螺杆菌根除治疗：一项关于 10 天、14 天和半剂量抗生素治疗的回顾性研究。

Twice-daily intake of bismuth-based quadruple therapy for first-line Helicobacter pylori eradication: A retrospective study on 10-day, 14-day, and half-dose antibiotic therapy.

机构信息

Department of Internal Medicine, Konkuk University School of Medicine, Seoul, South Korea.

出版信息

Helicobacter. 2023 Aug;28(4):e12998. doi: 10.1111/hel.12998. Epub 2023 Jun 9.

Abstract

BACKGROUND/AIMS: In areas with >15% clarithromycin resistance, bismuth-based quadruple therapy is recommended for first-line Helicobacter pylori eradication. This study aimed to determine the efficacy of the twice-daily intake of bismuth-based quadruple therapy among 10-day, 14-day, and half-dose antibiotic regimens.

METHODS

From May 2021 to March 2023, H. pylori-infected Korean adults were administered tetracycline (1 g), metronidazole (750 mg), bismuth potassium citrate (300 mg), and lansoprazole (30 mg) twice daily, after breakfast and dinner, for 10 days. The regimen was administered for 14 days if the body weight was ≥70 kg or if the patient had reinfection. Half doses of antibiotics were administered for 14 days if there was a risk of drug interactions or if the patient was aged ≥75 years. The C-urea breath test was performed after 6 weeks.

RESULTS

Among the 1258 infected Koreans, 85.1% (412/484) in the 10-day, 84.3% (498/591) in the 14-day, and 86.3% (158/183) in the half-dose antibiotic groups followed the instructions. In the per-protocol (PP) analysis, eradication rates were higher in the 10-day (90.5%, p = 0.019) and 14-day (90.2%, p = 0.023) groups than in the half-dose group (83.5%). In the intention-to-treat (ITT) analysis, eradication rates were higher in the 10-day group (80.6%) than in the half-dose group (73.2%, p = 0.039). In the half-dose group, the eradication rate was lower in patients aged ≥75 years (PP: 74.6%, ITT: 66.2%) than in those with a risk of drug interactions (PP: 89.7% [p = 0.017], ITT: 82.4% [p = 0.019]).

CONCLUSIONS

Twice-daily intake of bismuth-based quadruple therapy for 10-14 days showed an eradication rate of >90% in the PP analysis. A 10-day regimen could be administered to eradication-naive patients with a body weight below 70 kg. A half-dose antibiotic regimen might be recommended to patients with a risk of drug interactions but not to those aged ≥75 years simply due to old age.

摘要

背景/目的：在克拉霉素耐药率超过 15%的地区，建议使用含铋四联疗法作为幽门螺杆菌首次根除的一线治疗方案。本研究旨在确定在 10 天、14 天和半剂量抗生素方案中，每日两次服用含铋四联疗法的疗效。

方法

自 2021 年 5 月至 2023 年 3 月，韩国感染幽门螺杆菌的成年人在早餐和晚餐后每天服用两次四环素（1g）、甲硝唑（750mg）、枸橼酸铋钾（300mg）和兰索拉唑（30mg），共 10 天。如果体重≥70kg 或患者再次感染，则使用 14 天的方案。如果存在药物相互作用的风险或患者年龄≥75 岁，则使用抗生素半剂量方案 14 天。6 周后进行 C-尿素呼气试验。

结果

在 1258 名受感染的韩国人中，85.1%（412/484）在 10 天组、84.3%（498/591）在 14 天组和 86.3%（158/183）在半剂量抗生素组中按照指示服药。在符合方案（PP）分析中，10 天（90.5%，p=0.019）和 14 天（90.2%，p=0.023）组的根除率高于半剂量组（83.5%）。在意向治疗（ITT）分析中，10 天组的根除率（80.6%）高于半剂量组（73.2%，p=0.039）。在半剂量组中，≥75 岁患者的根除率（PP：74.6%，ITT：66.2%）低于有药物相互作用风险的患者（PP：89.7%[p=0.017]，ITT：82.4%[p=0.019]）。