在中国临朐县进行的一项大型随机对照干预试验，通过根除幽门螺杆菌预防胃癌：基线结果和影响根除的因素。

A large randomised controlled intervention trial to prevent gastric cancer by eradication of Helicobacter pylori in Linqu County, China: baseline results and factors affecting the eradication.

机构信息

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.

Technische Universität München, Munich, Germany.

出版信息

Gut. 2016 Jan;65(1):9-18. doi: 10.1136/gutjnl-2015-309197. Epub 2015 May 18.

DOI:10.1136/gutjnl-2015-309197

PMID:25986943

Abstract

OBJECTIVE

To clarify the full range of benefits and adverse consequences of Helicobacter pylori eradication as a strategy for gastric cancer prevention, the community-based intervention trial was launched in Linqu County, China.

DESIGN

A total of 184,786 residents aged 25-54 years were enrolled in this trial and received (13)C-urea breath test. H. pylori positive participants were assigned into two groups, either receiving a 10-day quadruple anti-H. pylori treatment or lookalike placebos together with a single dosage of omeprazole and bismuth.

RESULTS

The prevalence of H. pylori in trial participants was 57.6%. A total of 94,101 subjects completed the treatment. The overall H. pylori eradication rate was 72.9% in the active group. Gender, body mass index, history of stomach disease, baseline delta over baseline-value of (13)C-urea breath test, missed medication doses, smoking and drinking were independent predictors of eradication failure. The missed doses and high baseline delta over baseline-value were important contributors in men and women (all Ptrend<0.001). However, a dose-response relationship between failure rate and smoking or drinking index was found in men (all Ptrend<0.001), while high body mass index (Ptrend<0.001) and history of stomach disease were significant predictors in women. The treatment failure rate increased up to 48.8% (OR 2.87, 95% CI 2.24 to 3.68) in men and 39.4% (OR 2.67, 95% CI 1.61 to 4.42) in women with multiple factors combined.

CONCLUSIONS

This large community-based intervention trial to eradicate H. pylori is feasible and acceptable. The findings of this trial lead to a distinct evaluation of factors influencing eradication that should be generally considered for future eradication therapies.

TRIAL REGISTRATION NUMBER

ChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.

摘要

目的

为阐明根除幽门螺杆菌作为胃癌预防策略的全部获益和不良后果，在中国临朐县开展了一项以社区为基础的干预试验。

设计

共有 184786 名年龄在 25-54 岁的居民参加了这项试验，并接受了（13）C-尿素呼气试验。幽门螺杆菌阳性的参与者被分为两组，一组接受为期 10 天的四联抗幽门螺杆菌治疗，另一组接受奥美拉唑和枸橼酸铋钾单剂量的安慰剂治疗。

结果

试验参与者中幽门螺杆菌的流行率为 57.6%。共有 94101 例受试者完成了治疗。在活性组中，总体幽门螺杆菌根除率为 72.9%。性别、体重指数、胃病史、基线（13）C-尿素呼气试验的 delta over baseline 值、漏服药物剂量、吸烟和饮酒是根除失败的独立预测因素。漏服药物剂量和高基线 delta over baseline 值是男女患者根除失败的重要因素（所有 Ptrend<0.001）。然而，在男性中，吸烟或饮酒指数与失败率之间存在剂量反应关系（所有 Ptrend<0.001），而在女性中，高体重指数（Ptrend<0.001）和胃病史是显著的预测因素。在男性中，治疗失败率增加到 48.8%（OR 2.87，95%CI 2.24 至 3.68），在女性中增加到 39.4%（OR 2.67，95%CI 1.61 至 4.42），这些因素在男性和女性中都有多种因素组合。