在我国胃癌高发区通过根除Hp预防胃癌发生:一项RCT研究

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Helibobacter pylori
eradication to prevent gastric cancer in a high-risk region of China:A Randomized Controlled Trial
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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.
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RESULTS

ቤተ መጻሕፍቲ ባይዱ
Smoking (hazard ratio [HR], 6.2; 95% confidence interval [CI], 2.3-16.5; P<.001) and older age (HR, 1.10; 95% CI, 1.05-1.15; P<.001) were independent risk factors for the development of gastric cancer in this cohort.
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RESEULTS


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).
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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).
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Wong BC, Lam SK, Wong WM, Chen JS, Zheng TT, Feng RE, Lai KC, Hu WH, Yuen ST, Leung SY, Fong DY, Ho J, Ching CK, Chen JS; China Gastric Cancer Study Group. Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: a randomized controlled trial. JAMA 2004. 291(2):187-94. 目录
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结论
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我们发现,在中国的一个高胃癌高发区,在为 期7.5年的随访期间,在接受Hp根除治疗的 受试者和那些接受安慰剂的受试者中,胃癌 的发病率在人口学水平上是相似。 在没有癌前病变的Hp感染者中,根除Hp可以 显著降低胃癌的发生。 进一步的研究探讨,在已经出现了癌前病变 的受试者中根除Hp的作用是必要的。
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CONCLUSIONS

We found that the incidence of gastric cancer development at the population level was similar between participants receiving H pylori eradication treatment and those receiving placebo during a period of 7.5 years in a highrisk region of China.
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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.
在我国胃癌高发区通过根除Hp预防胃 癌的发生:一项RCT研究
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研究背景

虽然幽门螺杆菌慢性感染与胃癌有关,在Hp 慢性感染的携带者中进行除菌治疗对防治 胃癌的发展中所起的作用仍是未知的。
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研究目的

确定根除Hp治疗是否会降低胃癌的发 病率。
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试验设计

该项前瞻性、随机、安慰剂对照,以人群为 基础的初级预防研究共招募了1630名Hp感 染的健康携带者,他们均来自中国福建省 。研究时间从1994年7月持续到2002年1月 。共有988名没有癌前病变(胃萎缩、肠上 皮化生或胃不典型增生)的参与者被纳入了 本项研究。
Parsonnet J, Forman D. Helicobacter pylori infection and gastric cancer--for want of more outcomes. JAMA 2004. 291(2):244-5. 目录
Peek RM Jr. Eradication of Helicobacter pylori as a means towards eliminating gastric adenocarcinoma. Gastroenterology 2004. 127(1):344-6. 目录
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干预措施

这些受试者被随机分为Hp根除治疗组(n = 817) 和安慰剂对照组(n = 813)。Hp根除治疗组的受 试者接受为期2周的除菌治疗:奥美拉唑,20毫克, 阿莫西林和克拉霉素钾的组合产品,750毫克,和 甲硝唑,400毫克,均为每天两次口服。
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观察指标


主要观察指标是比较Hp根除治疗组和安 慰剂组在随访期间胃癌的发病率; 次要观察指标是比较有或无癌前病变的2 组受试者胃癌的发病率。
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OBJECTIVE

To determine whether treatment of H pylori infection reduces the incidence of gastric cancer.
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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.
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研究结果
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在18个新发现的胃癌患者中,那些接受了Hp根除 治疗的受试者(n=7)与那些没有接受除菌治疗的 受试者相比(n=11),胃癌的发病率没有观察到 整体上的减少。 在没有癌前病变的患者中,在Hp根除治疗后7.5 年的随访时间里没有任何受试者患上胃癌,与 接受安慰剂治疗的受试者相比(0比6)。 在这个队列中,吸烟和老年是胃癌发生的独立 危险因素。
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CONCLUSIONS


In the subgroup of H pylori carriers without precancerous lesions, eradication of H pylori significantly decreased the development of gastric cancer. Further studies to investigate the role of H pylori eradication in participants with precancerous lesions are warranted.
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