幽门螺杆菌感染被认为是胃癌发病机制中最重要的危险因素。本研究旨在评估根除幽门螺杆菌治疗对高危人群胃癌发病率和死亡率的长期影响。

一项前瞻性、随机、安慰剂对照试验于1994年7月在中国南方的一个高危地区进行。总共1630名无症状的幽门螺杆菌感染个体被随机分配接受根除幽门螺杆菌的标准三联疗法(n = 817)或安慰剂(n = 813)，并随访至2020年12月。主要结果是胃癌的发生率。总死亡率和特定原因死亡率是次要结果。

在 26.5 年的随访中，治疗组的 21 名参与者 (2.57%) 和安慰剂组的 35 名参与者 (4.31%) 被诊断出患有胃癌。与安慰剂组相比，接受幽门螺杆菌治疗的参与者胃癌发病率较低（风险比 [HR]，0.57；95% CI，0.33-0.98）。在没有胃部癌前病变的患者（HR，0.37；95% CI，0.15-0.95）和基线时没有消化不良症状的患者（HR，0.44；95% CI，0.21-0.94）中观察到更明显的风险降低。此外，与安慰剂组 527 名持续性幽门螺杆菌感染参与者中观察到的 32 例胃癌相比，治疗组中成功根除幽门螺杆菌的 625 名受试者中仅发现 16 例（HR，0.46；95% CI，0.26-0.83） .然而，两组之间的任何死亡率终点均无统计学差异。根除幽门螺杆菌可能对高危人群的胃癌提供长期保护，特别是对于基线时没有胃部癌前病变的感染者。

Abstract

Background & aims: Helicobacter pylori infection is considered as the most important risk factor in the pathogenesis of gastric cancer. This study aims to evaluate the long-term effects of H pylori eradication treatment on the incidence and mortality of gastric cancer among a high-risk population.

Methods: This prospective, randomized, placebo-controlled trial was conducted in a high-risk area in southern China in July 1994. A total of 1630 asymptomatic, H pylori-infected individuals were randomly assigned to receive standard triple therapy for H pylori eradication (n = 817) or placebo (n = 813), and were followed up until December 2020. The primary outcome was incidence of gastric cancer. Total and cause-specific mortalities were the secondary outcomes.

Results: During 26.5 years of follow-up, 21 participants (2.57%) in the treatment arm and 35 (4.31%) in the placebo arm were diagnosed with gastric cancer. Participants receiving H pylori treatment had a lower incidence of gastric cancer compared with their placebo counterparts (hazard ratio [HR], 0.57; 95% CI, 0.33-0.98). More obvious risk reduction was observed among those without premalignant gastric lesions (HR, 0.37; 95% CI, 0.15-0.95) and those without dyspepsia symptoms at baseline (HR, 0.44; 95% CI, 0.21-0.94). Furthermore, compared with 32 cases of gastric cancer observed among 527 participants with persistent H pylori infection in the placebo group, only 16 were identified in 625 subjects with successful eradication in the treatment group (HR, 0.46; 95% CI, 0.26-0.83). However, there were no statistically significant differences for any mortality end points between the 2 groups.

Conclusions: Eradication of H pylori might confer a long-term protection against gastric cancer in high-risk populations, especially for infected individuals without precancerous gastric lesions at baseline.

原文链接：

https://www.gastrojournal.org/article/S0016-5085(22)00338-9/fulltext?referrer=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F#relatedArticles

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