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目的确认并量化螺内酯与上消化道出血和溃疡之间的联系。设计人群为基础的病例对照研究。背景环境荷兰的初级保健信息数据库。参加者数据库中从1996年1月1日至2003年9月30日,所有年龄大于等于18岁的人。排除曾有酒精中毒或消化道肿瘤病史的患者。每个胃十二指肠溃疡或上消化道出血的病例配比十个对照,按年龄(出生年)、性别和索引日期进行匹配。主要结果评价使用条件 Logistic 回归分析,根据潜在的混杂因子对上消化道事件(出血或穿孔)的发生做出校正。结果在源人群中的306645位患者中,确认523个胃十二指肠溃疡或上消化道出血病例,与5230个对照进行配比。正在应用螺内酯治疗与消化道事件风险胜增加2.7倍相关联(95%可信区间1.2～6.0)。结论胃十二指肠溃疡或上消化道出血发生风险在使用螺内酯的患者中明显增加。
Objective To identify and quantify the link between spironolactone and upper gastrointestinal bleeding and ulceration. Design-based case-control study. Background The Netherlands primary care information database. In the Participant Database, from January 1, 1996 to September 30, 2003, all people above the age of 18 are eligible. Exclude patients who had had a history of alcoholism or gastrointestinal cancer. Each stomach or duodenal ulcer or upper gastrointestinal bleeding cases were matched by ten controls, matched by age (year of birth), sex and index date. MAIN OUTCOME MEASUREMENTS Logistic regression analysis was used to correct for the occurrence of upper gastrointestinal events (bleeding or perforation) based on potential confounders. Results Of the 306,645 patients in the source population, 523 cases of gastroduodenal ulcer or upper gastrointestinal bleeding were identified, matching 5230 controls. Treatment with spironolactone is associated with an 2.7-fold increased risk of digestive events (95% confidence interval 1.2 to 6.0). Conclusions The risk of gastroduodenal ulcer or upper gastrointestinal bleeding is significantly increased in patients using spironolactone.