García Rodríguez L A, Jick H
Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Lexington, MA 02173.
Lancet. 1994 Mar 26;343(8900):769-72. doi: 10.1016/s0140-6736(94)91843-0.
Exposure to non-steroidal anti-inflammatory drugs (NSAIDs) is known to increase substantially the risk of upper gastrointestinal bleeding and perforation (UGIB). We have carried out a population-based retrospective case-control study to assess the variation in risk associated with various individual NSAIDs, with adjustment for features of use and other independent risk factors. The study sample comprised 1457 cases of UGIB and 10,000 control subjects identified from general practitioners' computerised records in the UK. The adjusted estimate of relative risk of UGIB associated with current NSAID use was 4.7 (95% CI 3.8-5.7). Previous UGIB was the single most important predictor of UGIB (relative risk 13.5 [10.3-17.7]). For all NSAIDs together, the risk was greater for high doses than for low doses (7.0 [5.2-9.6] vs 2.6 [1.8-3.8]). The estimates of risk associated with the individual NSAIDs varied widely. Users of azapropazone (23.4 [6.9-79.5]) and piroxicam (18.0 [8.2-39.6]) had the highest risk of UGIB among the NSAIDs studied. All the other NSAIDs with sufficient data for individual analysis (ibuprofen, naproxen, diclofenac, ketoprofen, and indomethacin) had relative risks similar to that for overall NSAID use. NSAIDS should be used cautiously in patients who have other risk factors for UGIB; these include advanced age, smoking, history of peptic ulcer, and use of oral corticosteroids or anticoagulants.
已知使用非甾体抗炎药（NSAIDs）会大幅增加上消化道出血和穿孔（UGIB）的风险。我们开展了一项基于人群的回顾性病例对照研究，以评估与各种NSAIDs相关的风险差异，并对使用特征和其他独立风险因素进行了调整。研究样本包括从英国全科医生的计算机记录中识别出的1457例UGIB病例和10000名对照受试者。当前使用NSAIDs与UGIB相关的相对风险调整估计值为4.7（95%可信区间3.8 - 5.7）。既往UGIB是UGIB的单一最重要预测因素（相对风险13.5 [10.3 - 17.7]）。对于所有NSAIDs而言，高剂量的风险高于低剂量（7.0 [5.2 - 9.6] 对比 2.6 [1.8 - 3.8]）。与各NSAIDs相关的风险估计差异很大。在所研究的NSAIDs中，阿扎丙宗使用者（23.4 [6.9 - 79.5]）和吡罗昔康使用者（18.0 [8.2 - 39.6]）发生UGIB的风险最高。所有其他有足够数据进行个体分析的NSAIDs（布洛芬、萘普生、双氯芬酸、酮洛芬和吲哚美辛）的相对风险与总体NSAIDs使用的风险相似。对于有UGIB其他风险因素的患者，应谨慎使用NSAIDs；这些因素包括高龄、吸烟、消化性溃疡病史以及使用口服糖皮质激素或抗凝剂。
