Spanish Centre for Pharmacoepidemiologic Research, Madrid, Spain; Department of Public Health and Maternal and Child Health, Faculty of Medicine, Complutense University of Madrid, Madrid, Spain.
Servicio de Aparato Digestivo, Hospital Clínico, University of Zaragoza, IIS Aragón, Zaragoza, Spain; CIBERehd, Instituto de Salud Carlos III, Madrid, Spain.
Clin Gastroenterol Hepatol. 2019 Apr;17(5):887-895.e6. doi: 10.1016/j.cgh.2018.05.061. Epub 2018 Jun 14.
BACKGROUND & AIMS: There are few data on the incidence of upper and lower gastrointestinal bleeding (UGIB and LGIB) from observational studies of low-dose aspirin users. We aimed to estimate incidence rates of UGIB and LGIB in a large cohort of new users of low-dose aspirin in the United Kingdom, with subanalyses of hospitalization status and fatalities.
We performed a population-based study of 199,079 new users of low-dose aspirin (median age, 64.0 years) identified from the Health Improvement Network primary care database (2000-2012). Individuals were followed for a median 5.4 years (maximum, 14 years) to identify new cases of UGIB and LGIB. Following multistep validation, we calculated overall and age- and sex-specific incidence rates; we performed subanalyses for health care use and death within 30 days of GIB. We also estimated rates within a matched (1:1) cohort of nonusers of low-dose aspirin at the start of the follow-up period.
The low-dose aspirin users had 1115 UGIB events and 1936 LGIB events; most subjects with UGIB events (58.9%) were hospitalized, whereas most subjects with LGIB events were referred to secondary care (72.8%). Crude incidence rates of GIB per 1000 person-years were 0.97 for subjects with UGIB (95% CI, 0.91-1.02) and 1.68 for subjects with LGIB (95% CI, 1.60-1.75). Incidence rates per 1000 person-years for patients hospitalized for GIB were 0.57 for UGIB (95% CI, 0.53-0.61) and 0.45 for LGIB (95% CI, 0.42-0.49); for referred (but not hospitalized) cases, these values were 0.39 for UGIB (95% CI, 0.36-0.43) and 1.22 for LGIB (1.16-1.29). Incidence rates per 1000 person-years were 0.06 for fatal UGIB (95% CI, 0.04-0.07), 0.01 for fatal LGIB (95% CI, 0.01-0.02), 0.91 for nonfatal UGIB (95% CI, 0.86-0.97), and 1.66 for nonfatal LGIB (95% CI, 1.59-1.74). Among nonusers of low-dose aspirin, incidence rates per 1000 person-years were 0.67 (95% CI, 0.63-0.75) for UGIB and 0.76 (95% CI, 0.72-0.82) for LGIB.
In a population-based study of low-dose aspirin users, the incidence of LGIB was higher than the incidence of UGIB. However, incidence rates of hospitalized GI bleeds and 30-day mortality rates were lower for LGIB than for UGIB. These estimates are valuable for benefit-risk assessments of low-dose aspirin for cardiovascular and colorectal cancer prevention.
关于低剂量阿司匹林使用者的上消化道出血（UGIB）和下消化道出血（LGIB）发生率，观察性研究的数据较少。我们旨在通过对英国大量低剂量阿司匹林新使用者进行队列研究，估计 UGIB 和 LGIB 的发生率，并对住院状况和死亡进行亚分析。
我们对来自健康改善网络初级保健数据库（2000-2012 年）的 199079 名低剂量阿司匹林新使用者（中位年龄 64.0 岁）进行了一项基于人群的研究。对参与者进行中位 5.4 年（最长 14 年）的随访，以确定新发生的 UGIB 和 LGIB 病例。在经过多步验证后，我们计算了总体和年龄、性别特异性的发病率；对 30 天内 GIB 相关的医疗保健使用和死亡进行了亚分析。我们还估计了在随访期开始时与低剂量阿司匹林非使用者匹配（1:1）队列中的发生率。
低剂量阿司匹林使用者有 1115 例 UGIB 事件和 1936 例 LGIB 事件；大多数 UGIB 事件（58.9%）的患者住院，而大多数 LGIB 事件的患者被转诊至二级保健机构（72.8%）。UGIB 患者每 1000 人年的 GIB 发生率为 0.97（95%CI，0.91-1.02），LGIB 患者为 1.68（95%CI，1.60-1.75）。因 GIB 住院的患者发生率为 UGIB 0.57（95%CI，0.53-0.61），LGIB 0.45（95%CI，0.42-0.49）；对于转诊（但未住院）病例，UGIB 和 LGIB 的发生率分别为 0.39（95%CI，0.36-0.43）和 1.22（95%CI，1.16-1.29）。UGIB 的致命率为 0.06（95%CI，0.04-0.07），LGIB 的致命率为 0.01（95%CI，0.01-0.02），非致命性 UGIB 的发生率为 0.91（95%CI，0.86-0.97），非致命性 LGIB 的发生率为 1.66（95%CI，1.59-1.74）。在低剂量阿司匹林非使用者中，UGIB 的发生率为每 1000 人年 0.67（95%CI，0.63-0.75），LGIB 的发生率为 0.76（95%CI，0.72-0.82）。
在低剂量阿司匹林使用者的基于人群的研究中，LGIB 的发生率高于 UGIB。然而，LGIB 的住院 GIB 发生率和 30 天死亡率低于 UGIB。这些估计值对于评估低剂量阿司匹林用于心血管疾病和结直肠癌预防的获益风险具有重要意义。
