Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Pharmacotherapy. 2011 Mar;31(3):239-47. doi: 10.1592/phco.31.3.239.
To compare Helicobacter pylori eradication therapy with antisecretory therapy alone on the risk of hospitalization for a major ulcer event.
Retrospective, population-based cohort study.
The 2000-2006 National Health Insurance database in Taiwan.
A total of 838,176 patients diagnosed with a gastrointestinal ulcer and who filled at least one prescription for antiulcer therapy, either H. pylori eradication therapy (331,364 patients [39.53%]) or antisecretory therapy alone (506,812 patients [60.47%]), between January 1, 2001, and December 31, 2006.
The primary outcome was hospitalization for a major ulcer event, defined as a gastrointestinal ulcer with hemorrhage and/or perforation. Cox proportional hazards models, adjusted for demographic and clinical characteristics, were used to compare the risk of hospitalization for a major ulcer event between the group receiving H. pylori eradication therapy (triple or quadruple combination therapy that includes an antisecretory agent) and the group receiving antisecretory therapy alone (histamine₂-receptor blocker or proton pump inhibitor). The H. pylori eradication therapy group was divided into initial users (combination therapy received immediately after gastrointestinal ulcer diagnosis) and late users (combination therapy received after antisecretory therapy with time lag ≤ 180 days, 181-365 days, or > 365 days from ulcer diagnosis). A secondary analysis was conducted in the three late H. pylori eradication therapy subgroups to determine if risk of hospitalization for major ulcer events differed by timing of receipt of therapy. Compared with the antisecretory therapy alone group, the H. pylori therapy group (initial users) had a significantly decreased risk of hospitalization for major ulcer events (adjusted hazard ratio [AHR] 0.57, 95% confidence interval [CI] 0.54-0.59, p<0.001). However, later use of H. pylori therapy was associated with a higher risk of hospitalization for major ulcer events (time lag 181-365 days, AHR 1.68, 95% CI 1.51-1.86, p<0.001; > 365 days, AHR 1.74, 95% CI 1.67-1.80, p<0.001) compared with those who received H. pylori therapy within 6 months (≤ 180 days) after gastrointestinal ulcers were diagnosed.
Helicobacter pylori therapy given within 6 months of a diagnosis of gastrointestinal ulcer was associated with a reduced risk of hospitalization for major ulcer events. Our findings extend the evidence from clinical trials that report the value of H. pylori eradication therapy in reducing ulcer recurrence by documenting the real-world benefit of reducing the risk of hospitalization for major gastrointestinal ulcer events.
比较幽门螺杆菌根除疗法与单独抗分泌疗法在主要溃疡事件住院风险方面的差异。
回顾性、基于人群的队列研究。
台湾 2000-2006 年国家健康保险数据库。
2001 年 1 月 1 日至 2006 年 12 月 31 日期间，共有 838176 例被诊断为胃肠道溃疡且至少开具了一种抗溃疡治疗药物处方的患者，包括幽门螺杆菌根除治疗（331364 例[39.53%]）或单独抗分泌治疗（506812 例[60.47%]）。
主要结局为主要溃疡事件住院，定义为伴有出血和/或穿孔的胃肠道溃疡。采用 Cox 比例风险模型，调整人口统计学和临床特征后，比较幽门螺杆菌根除治疗组（三联或四联疗法，包括一种抗分泌药物）和单独抗分泌治疗组（组胺₂受体阻滞剂或质子泵抑制剂）的主要溃疡事件住院风险。幽门螺杆菌根除治疗组分为初始使用者（胃肠道溃疡诊断后立即接受联合治疗）和晚期使用者（抗分泌治疗后延迟 180 天、181-365 天或>365 天接受联合治疗）。在三个晚期幽门螺杆菌根除治疗亚组中进行了二次分析，以确定治疗时机是否会影响主要溃疡事件住院风险。与单独抗分泌治疗组相比，幽门螺杆菌治疗组（初始使用者）主要溃疡事件住院风险显著降低（校正风险比[HR]0.57，95%置信区间[CI]0.54-0.59，p<0.001）。然而，晚期使用幽门螺杆菌治疗与主要溃疡事件住院风险增加相关（延迟 181-365 天，HR 1.68，95%CI 1.51-1.86，p<0.001；>365 天，HR 1.74，95%CI 1.67-1.80，p<0.001），与胃肠道溃疡诊断后 6 个月内（≤180 天）接受幽门螺杆菌治疗的患者相比。
胃肠道溃疡诊断后 6 个月内给予幽门螺杆菌治疗与主要溃疡事件住院风险降低相关。我们的研究结果扩展了临床试验的证据，即证明了幽门螺杆菌根除治疗通过降低溃疡复发的风险而具有实际价值，同时也证明了通过降低主要胃肠道溃疡事件住院风险具有实际价值。
