Department of Epidemiology and Health Statistics, School of Public Health, Fujian Medical University, Fuzhou, China; Key Laboratory of Ministry of Education for Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China.
Changle Institute for Cancer Research, Fuzhou, China; Changle Center for Disease Prevention and Control, Fuzhou, China.
Gastroenterology. 2022 Jul;163(1):154-162.e3. doi: 10.1053/j.gastro.2022.03.039. Epub 2022 Mar 29.
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.
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.
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.
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.
幽门螺杆菌感染被认为是胃癌发病的最重要危险因素。本研究旨在评估高风险人群中幽门螺杆菌根除治疗对胃癌发病率和死亡率的长期影响。
这项前瞻性、随机、安慰剂对照试验于 1994 年 7 月在中国南方的一个高风险地区进行。共有 1630 名无症状、幽门螺杆菌感染的个体被随机分配接受标准三联疗法根除幽门螺杆菌（n=817）或安慰剂（n=813）治疗，并随访至 2020 年 12 月。主要结局是胃癌的发病率。总死亡率和死因特异性死亡率为次要结局。
在 26.5 年的随访期间，治疗组有 21 名（2.57%）参与者和安慰剂组有 35 名（4.31%）参与者被诊断为胃癌。接受幽门螺杆菌治疗的参与者胃癌发病率低于安慰剂组（风险比[HR]，0.57；95%置信区间，0.33-0.98）。在无癌前胃病变（HR，0.37；95%置信区间，0.15-0.95）和基线时无消化不良症状（HR，0.44；95%置信区间，0.21-0.94）的参与者中，风险降低更为明显。此外，与安慰剂组中持续幽门螺杆菌感染的 527 名参与者中的 32 例胃癌相比，治疗组中成功根除的 625 名参与者中仅发现 16 例（HR，0.46；95%置信区间，0.26-0.83）。然而，两组在任何死亡率终点均无统计学差异。
根除幽门螺杆菌可能为高危人群提供长期的胃癌保护，特别是对于基线时无癌前胃病变的感染者。
