NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND UPPER GASTROINTESTINAL-BLEEDING, IDENTIFYING HIGH-RISK GROUPS BY EXCESS RISK ESTIMATES
NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND UPPER GASTROINTESTINAL-BLEEDING, IDENTIFYING HIGH-RISK GROUPS BY EXCESS RISK ESTIMATES
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DOI：
10.3109/00365529509093304
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发表时间：
1995-05-01
影响因子：
1.9
通讯作者：
GRAM, LF
中科院分区：
文献类型：
--
作者：
HALLAS, J;LAURITSEN, J;GRAM, LF
背景：使用非甾体类抗炎药（NSAID）与严重上消化道出血（UGB）之间的关系已无可置疑。关于风险因素的文献几乎完全集中在患者亚组的相对风险比较上：男性与女性，老年人与年轻人等等。然而，从实用的、临床的角度来看，只有过度风险提供了一个有意义的、可靠的衡量风险因素大小的方法。该研究的目的是确定亚组患者的过度风险，并确定非甾体抗炎药的使用模式。方法：在欧登塞的处方和诊断登记处进行了一项基于登记的队列研究，该研究涵盖了207,000人，为期19个月。结果：共发现183例UGB患者（113例男性，70例女性），其中37例目前正在使用非甾体抗炎药。未暴露者UGB的标准化发病率为每10万人年46例，暴露者为每10万人年253例，产生的超额风险为每10万人年207例（置信区间（CI）， 132-319），标准化发病率比（SIR）为5.5 （CI, 3.9-7.9）。男性比女性有更高的额外风险（每10万人年277人比150人）。SIR随暴露时间的增加而降低。75岁及以上的人群（每10万人年1258人）和有消化性溃疡史的患者（每10万人年879人）的额外风险尤其高，大约是互补组的10倍和5倍。非甾体抗炎药的使用非常分散。我们发现有31503名用户，平均每日购买20剂。短期用药在所有年龄组中都非常普遍。女性、老年人和有溃疡史的人使用非甾体抗炎药的比例高于其他人。结论：消化性溃疡病史与非甾体抗炎药治疗的不良后果相关，应视为相对禁忌症。研究还显示，高龄也有类似的强烈影响。男性和短期使用是次要的风险因素。非甾体抗炎药相关UGB的发生率可以在不影响非甾体抗炎药总体使用的情况下降低。
Background: The relationship between use of nonsteroidal anti-inflammatory drugs (NSAID) and severe upper gastrointestinal bleeding (UGB) has been established beyond reasonable doubt. The literature on risk factors has almost exclusively focused on comparisons of relative risks in subgroups of patients: men versus women, old versus young and so forth. However, from a pragmatic, clinical viewpoint, only the excess risk provides a meaningful, robust measure of the magnitude of risk factors. The purpose of the study was to determine the excess risks in subgroups of patients and to characterize the utilization pattern of NSAIDs. Methods: A registry-based cohort study was conducted in a prescription and diagnosis registry in Odense, which covered a population of 207,000 persons for a period of 19 months. Results: In total, 183 (113 men and 70 women) UGB patients were identified, of whom 37 were current users of NSAIDs. The standardized incidence rate of UGB was 46 per 100,000 person-years for nonexposed and 253 per 100,000 person-years for exposed person-time, yielding an excess risk of 207 per 100,000 person-years (confidence interval (CI), 132-319) and a standardized incidence ratio (SIR) of 5.5 (CI, 3.9-7.9). Men had a higher excess risk than women (277 versus 150 per 100,000 person-years). The SIR decreased with increasing duration of exposure. The excess risk was particularly high in persons aged 75 years or more (1258 per 100,000 person-years) and in patients with a history of peptic ulcer (879 per 100,000 person-years), being about 10- and 5-fold higher than in the complementary groups. NSAID utilization was remarkably sporadic. We found 31,503 users and a median purchase of 20 defined daily doses. Shortterm use was highly prevalent in all age groups. Women, the elderly, and persons with a history of ulcer had a higher prevalence of NSAID use than others. Conclusions: A history of peptic ulcer is associated with adverse outcome of NSAID therapy and should be regarded as a relative contraindication. A similarly strong effect of high age was shown. Male sex and short-term use are minor risk factors. The incidence of NSAID-related UGB can probably be reduced without affecting the overall utilization of NSAIDs.