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治疗幽门螺杆菌对于预防异时性胃癌的效果 | Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2018-03-22 00:00:00 , DOI: 10.1056/nejmoa1708423
Il Ju Choi 1 , Myeong-Cherl Kook 1 , Young-Il Kim 1 , Soo-Jeong Cho 1 , Jong Yeul Lee 1 , Chan Gyoo Kim 1 , Boram Park 1 , Byung-Ho Nam 1
Affiliation  

背景:受限于胃黏膜或黏膜下层的早期胃癌患者通常有黏膜腺组织的晚期丧失(腺体萎缩),并且后续(异时性)新胃癌的发生风险较高。幽门螺杆菌根除治疗对组织学改善和异时性胃癌预防的长期影响仍不清楚。


方法:在这项前瞻性、双盲、安慰剂对照、随机试验中,我们分配了470例接受早期胃癌或高级别腺瘤内镜切除术的患者,分别接受幽门螺杆菌抗生素根除治疗或安慰剂。两个主要结局是在1年随访时或随后的内镜检查中检测到的异时性胃癌发生率,以及3年随访时胃体小弯侧腺体萎缩分级相对于基线的改善。


结果:改良意向治疗分析人群共纳入396例患者(治疗组194例,安慰剂组202例)。在5.9年的中位随访期间,治疗组14例患者(7.2%)和安慰剂组27例患者(13.4%)发生异时性胃癌(治疗组风险比,0.50;95%置信区间,0.26~0.94;P= 0.03)。在进行组织学分析的亚组的327例患者中,在治疗组48.4%的患者和安慰剂组15.0%的患者中观察到了胃体小弯侧萎缩分级相对于基线改善(P<0.001)。没有严重不良事件;治疗组中轻度不良事件较常见(42.0%vs.10.2%,P<0.001)。


结论:与接受安慰剂治疗的患者相比,接受幽门螺杆菌治疗的早期胃癌患者的异时性胃癌发生率较低,胃体萎缩分级相对于基线改善较多。(由韩国国立癌症中心[National Cancer Center, South Korea]资助;在ClinicalTrials.gov注册号为NCT02407119。)


Background

Patients with early gastric cancers that are limited to gastric mucosa or submucosa usually have an advanced loss of mucosal glandular tissue (glandular atrophy) and are at high risk for subsequent (metachronous) development of new gastric cancer. The long-term effects of treatment to eradicate Helicobacter pylori on histologic improvement and the prevention of metachronous gastric cancer remain unclear.

Methods

In this prospective, double-blind, placebo-controlled, randomized trial, we assigned 470 patients who had undergone endoscopic resection of early gastric cancer or high-grade adenoma to receive either H. pylori eradication therapy with antibiotics or placebo. Two primary outcomes were the incidence of metachronous gastric cancer detected on endoscopy performed at the 1-year follow-up or later and improvement from baseline in the grade of glandular atrophy in the gastric corpus lesser curvature at the 3-year follow-up.

Results

A total of 396 patients were included in the modified intention-to-treat analysis population (194 in the treatment group and 202 in placebo group). During a median follow-up of 5.9 years, metachronous gastric cancer developed in 14 patients (7.2%) in the treatment group and in 27 patients (13.4%) in the placebo group (hazard ratio in the treatment group, 0.50; 95% confidence interval, 0.26 to 0.94; P=0.03). Among the 327 patients in the subgroup that underwent histologic analysis, improvement from baseline in the atrophy grade at the gastric corpus lesser curvature was observed in 48.4% of the patients in the treatment group and in 15.0% of those in the placebo group (P<0.001). There were no serious adverse events; mild adverse events were more common in the treatment group (42.0% vs. 10.2%, P<0.001).

Conclusions

Patients with early gastric cancer who received H. pylori treatment had lower rates of metachronous gastric cancer and more improvement from baseline in the grade of gastric corpus atrophy than patients who received placebo. (Funded by the National Cancer Center, South Korea; ClinicalTrials.gov number, NCT02407119.)

更新日期:2018-03-21
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