Hallas J, Lauritsen J, Villadsen H D, Gram L F
Dept. of Clinical Pharmacology, Odense University Medical School, Denmark.
Scand J Gastroenterol. 1995 May;30(5):438-44. doi: 10.3109/00365529509093304.
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.
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.
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 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. Short-term 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.
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.
非甾体抗炎药（NSAID）的使用与严重上消化道出血（UGB）之间的关系已得到确凿证实。关于风险因素的文献几乎都集中在患者亚组相对风险的比较上：男性与女性、老年人与年轻人等等。然而，从务实的临床角度来看，只有额外风险才能提供有意义、可靠的风险因素大小衡量标准。本研究的目的是确定患者亚组中的额外风险，并描述NSAIDs的使用模式。
在欧登塞的一个处方和诊断登记处进行了一项基于登记处的队列研究，该登记处覆盖了20.7万人，为期19个月。
总共确定了183例UGB患者（113例男性和70例女性），其中37例为NSAIDs当前使用者。未暴露者UGB的标准化发病率为每10万人年46例，暴露者人时的标准化发病率为每10万人年253例，额外风险为每10万人年207例（置信区间（CI），132 - 319），标准化发病率（SIR）为5.5（CI，3.9 - 7.9）。男性的额外风险高于女性（每10万人年277例对150例）。SIR随着暴露时间的延长而降低。75岁及以上人群（每10万人年1258例）和有消化性溃疡病史的患者（每10万人年879例）的额外风险特别高，分别比相应对照组高约10倍和5倍。NSAIDs的使用非常零散。我们发现31503名使用者，平均购买量为20限定日剂量。短期使用在所有年龄组中都非常普遍。女性、老年人和有溃疡病史的人使用NSAIDs的患病率高于其他人。
消化性溃疡病史与NSAID治疗的不良结局相关，应被视为相对禁忌证。高龄也显示出类似的强烈影响。男性性别和短期使用是次要风险因素。在不影响NSAIDs总体使用的情况下，NSAID相关UGB的发病率可能会降低。
