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
Institute of Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
Helicobacter. 2006 Oct;11(5):418-24. doi: 10.1111/j.1523-5378.2006.00432.x.
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.
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.
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).
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.
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。
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。
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）。
采用人群中耐药率低的药物并结合检测、治疗、复查及必要时再治疗的策略的综合方案，可使人群中幽门螺杆菌几乎被根除。这为规划全国或地区范围的根除计划提供了一个模式。
