Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China -: A randomized controlled trial
Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China -: A randomized controlled trial
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DOI：
10.1001/jama.291.2.187
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发表时间：
2004-01-14
影响因子：
120.7
通讯作者：
Chen, JS
中科院分区：
文献类型：
--
作者：
Wong, BCY;Lam, SK;Chen, JS
背景：虽然慢性幽门螺杆菌感染与胃癌有关，但幽门螺杆菌治疗对预防慢性携带者胃癌发生的作用尚不清楚。目的为确定幽门螺杆菌治疗是否能降低胃癌的发病率。设计、设置和研究对象1994年7月从福建省招募的1630名健康幽门螺杆菌携带者中国进行前瞻性、随机、安慰剂对照、基于人群的一级预防研究。共有988名研究对象没有癌前病变(胃萎缩、肠上皮化生或胃不典型增生)。干预患者被随机分配到接受幽门螺杆菌根除治疗：奥美拉唑20 mg，阿莫西林和克拉维酸钾的组合，750 mg，甲硝唑400 mg，每天两次(n=817)；或安慰剂(n=813)。主要结果衡量指标是随访期间的胃癌发生率，与根除幽门螺杆菌组和安慰剂组相比。结果在18例新发生的胃癌患者中，接受根除幽门螺杆菌治疗的患者(n=7)与未接受根除幽门螺杆菌治疗的患者(n=11)相比，总体上没有观察到下降(P=.33)。在一组没有出现癌前病变的患者中，与接受安慰剂治疗的患者相比，在根除幽门螺杆菌治疗后7.5年的随访期间，没有患者发生胃癌(0比6；P=0.02)。吸烟(危险比[HR]，6.2；95%可信区间[CI]2.3-16.5；P
Context Although chronic Helicobacter pylori infection is associated with gastric cancer, the effect of H pylori treatment on prevention of gastric cancer development in chronic carriers is unknown.Objective To determine whether treatment of H pylori infection reduces the incidence of gastric cancer.Design, Setting, and Participants Prospective, randomized, placebo-controlled, population-based primary prevention study of 1630 healthy carriers of H pylori infection from Fujian Province, China, recruited in July 1994 and followed up until January 2002. A total of 988 participants did not have precancerous lesions (gastric atrophy, intestinal metaplasia, or gastric dysplasia) on study entry.Intervention Patients were randomly assigned to receive H pylori eradication treatment: a 2-week course of omeprazole, 20 mg, a combination product of amoxicillin and clavulanate potassium, 750 mg, and metronidazole, 400 mg, all twice daily (n=817); or placebo (n=813).Main Outcome Measures The primary outcome measure was incidence of gastric cancer during follow-up, compared between H pylori eradication and placebo groups. The secondary outcome measure was incidence of gastric cancer in patients with or without precancerous lesions, compared between the 2 groups.Results Among the 18 new cases of gastric cancers that developed, no overall reduction was observed in participants who received H pylori eradication treatment (n=7) compared with those who did not (n=11) (P=.33). In a subgroup of patients with no precancerous lesions on presentation, no patient developed gastric cancer during a follow-up of 7.5 years after H pylori eradication treatment compared with those who received placebo (0 vs 6; P=.02). Smoking (hazard ratio [HR], 6.2; 95% confidence interval [CI] 2.3-16.5; P