Family History of Gastric Cancer and Helicobacter pylori Treatment
Family History of Gastric Cancer and Helicobacter pylori Treatment
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DOI：
10.1056/nejmoa1909666
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发表时间：
2020-01-30
影响因子：
158.5
通讯作者：
Joo, Jungnam
中科院分区：
文献类型：
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作者：
Choi, Ii Ju;Kim, Chan Gyoo;Joo, Jungnam
背景幽门螺杆菌感染和胃癌家族史是胃癌的主要危险因素。治疗是否能根除H.幽门螺杆菌可以降低胃癌的风险，在一级亲属胃癌家族史的人是未知的。方法采用单中心、双盲、安慰剂对照试验，对3100例胃癌患者一级亲属进行筛查。我们随机分配了1838名H。幽门螺杆菌感染，接受根除治疗（兰索拉唑[30 mg]、阿莫西林[1000 mg]和克拉霉素[500 mg]，每日两次，共7天）或安慰剂。主要结局是胃癌的发展。根据H.随访期间评估的幽门螺杆菌根除状态。结果共有1676名参与者被纳入改良的意向治疗人群，用于分析主要结局（治疗组832名，安慰剂组844名）。在中位随访9.2年期间，治疗组有10名参与者（1.2%）发生胃癌，安慰剂组有23名参与者（2.7%）发生胃癌（风险比，0.45; 95%置信区间[CI]，0.21至0.94;对数秩检验P=0.03）。在治疗组发生胃癌的10名参与者中，5名（50.0%）患有持续性H。幽门感染胃癌发生率为0.8%（5/608），其中H。幽门螺杆菌感染被根除，2.9%的参与者（28/979）持续感染（风险比，0.27; 95%CI，0.10至0.70）。不良事件轻微，治疗组比安慰剂组更常见（53.0%比19.1%; P
Background Helicobacter pylori infection and a family history of gastric cancer are the main risk factors for gastric cancer. Whether treatment to eradicate H. pylori can reduce the risk of gastric cancer in persons with a family history of gastric cancer in first-degree relatives is unknown. Methods In this single-center, double-blind, placebo-controlled trial, we screened 3100 first-degree relatives of patients with gastric cancer. We randomly assigned 1838 participants with H. pylori infection to receive either eradication therapy (lansoprazole [30 mg], amoxicillin [1000 mg], and clarithromycin [500 mg], each taken twice daily for 7 days) or placebo. The primary outcome was development of gastric cancer. A prespecified secondary outcome was development of gastric cancer according to H. pylori eradication status, assessed during the follow-up period. Results A total of 1676 participants were included in the modified intention-to-treat population for the analysis of the primary outcome (832 in the treatment group and 844 in the placebo group). During a median follow-up of 9.2 years, gastric cancer developed in 10 participants (1.2%) in the treatment group and in 23 (2.7%) in the placebo group (hazard ratio, 0.45; 95% confidence interval [CI], 0.21 to 0.94; P=0.03 by log-rank test). Among the 10 participants in the treatment group in whom gastric cancer developed, 5 (50.0%) had persistent H. pylori infection. Gastric cancer developed in 0.8% of participants (5 of 608) in whom H. pylori infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70). Adverse events were mild and were more common in the treatment group than in the placebo group (53.0% vs. 19.1%; P