一项基于社区的幽门螺杆菌治疗研究，采用检测、治疗、复查和对初始治疗失败进行再治疗的策略。

A community-based study of Helicobacter pylori therapy using the strategy of test, treat, retest, and re-treat initial treatment failures.

作者信息

Lee Yi-Chia, Wu Hui-Min, Chen Tony Hsiu-Hsi, Liu Tzeng-Ying, Chiu Han-Mo, Chang Chun-Chao, Wang Hsiu-Po, Wu Ming-Shiang, Chiang Hung, Wu Meng-Chen, Lin Jaw-Town

机构信息

Institute of Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.

出版信息

Helicobacter. 2006 Oct;11(5):418-24. doi: 10.1111/j.1523-5378.2006.00432.x.

DOI:10.1111/j.1523-5378.2006.00432.x

PMID:16961802

Abstract

BACKGROUND

Although eradication of Helicobacter pylori infection can decrease the risk of gastric cancer, the optimal regimen for treating the general population remains unclear. We report the eradication rate (intention-to-treat and per protocol) of a community-based H. pylori therapy using the strategy of test, treat, retest, and re-treat initial treatment failures.

MATERIALS AND METHODS

In 2004, a total of 2658 residents were recruited for 13C-urea breath testing. Participants with positive results for infection received a standard 7-day triple therapy (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily), and a 10-day re-treatment (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and levofloxacin 500 mg once daily) if the follow-up tests remained positive. Both H. pylori status and side-effects were assessed 6 weeks after treatment.

RESULTS

Among 886 valid reporters, eradication rates with initial therapy were 86.9% (95% confidence interval [CI]: 84.7-89.1%) and 88.7% (95%CI: 86.5-90.9%) by intention-to-treat and per protocol analysis, respectively. Re-treatment eradicated infection in 91.4% (95%CI: 86-96.8%) of 105 nonresponders. Adequate compliance was achieved in 798 (90.1%) of 886 subjects receiving the initial treatment and in all 105 re-treated subjects. Mild side-effects occurred in 24% of subjects. Overall intention-to-treat and per protocol eradication rates were 97.7% (95%CI: 96.7-98.7%) and 98.8% (95%CI: 98.5-99.3%), respectively, which were only affected by poor compliance (odds ratio, 3.3; 95%CI, 1.99-5.48; p < .0001).

CONCLUSIONS

A comprehensive plan using drugs in which the resistance rate is low in a population combined with the strategy of test, treat, retest, and re-treat of needed can result in virtual eradication of H. pylori from a population. This provides a model for planning country- or region-wide eradication programs.

摘要

背景

尽管根除幽门螺杆菌感染可降低胃癌风险，但针对普通人群的最佳治疗方案仍不明确。我们报告了一项基于社区的幽门螺杆菌治疗方案的根除率（意向性分析和符合方案分析），该方案采用检测、治疗、复查及对初始治疗失败病例进行再治疗的策略。

材料与方法

2004年，共招募了2658名居民进行¹³C尿素呼气试验。感染检测结果呈阳性的参与者接受标准的7天三联疗法（埃索美拉唑40毫克，每日一次；阿莫西林1克，每日两次；克拉霉素500毫克，每日两次），如果随访检测仍为阳性，则进行为期10天的再治疗（埃索美拉唑40毫克，每日一次；阿莫西林1克，每日两次；左氧氟沙星500毫克，每日一次）。在治疗6周后评估幽门螺杆菌状态及副作用。

结果

在886名有效报告者中，意向性分析和符合方案分析得出的初始治疗根除率分别为86.9%（95%置信区间[CI]：84.7 - 89.1%）和88.7%（95%CI：86.5 - 90.9%）。在105名无反应者中，再治疗使91.4%（95%CI：86 - 96.8%）的患者根除了感染。886名接受初始治疗的受试者中有798名（90.1%）以及所有105名接受再治疗的受试者实现了充分的依从性。24%的受试者出现轻微副作用。总体意向性分析和符合方案分析的根除率分别为97.7%（95%CI：96.7 - 98.7%）和98.8%（95%CI：98.5 - 99.3%），仅受依从性差的影响（优势比，3.3；95%CI，1.99 - 5.48；p <.0001）。