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* 28. Aspirin, alone or with another NSAID, increases the risk of upper GI complications A systematic review of epidemiological studies has shown that patients taking thromboprophylactic doses of aspirin, 75 mg daily, present a twofold increased risk of upper GI complications compared with those not taking aspirin, and the risk is further increased with the use of analgesic/anti-inflammatory doses of 150–300 mg daily.63 Adding aspirin to another non-selective NSAID results in an eightfold increase in risk compared with not adding aspirin. Furthermore, the relative risk associated with aspirin is not reduced by buffered and enteric-coated formulations. In recognition of this risk, the use of GI supportive therapy is recommended for patients with other risk factors who need to take aspirin, including those taking low-dose aspirin as a prophylactic therapy for the prevention of cardiovascular disease (see Slide 51). * 荟萃分析的综述胃肠内外给药均可导致 双氯芬酸-扶他林 美洛西康-莫可比,斯来美 * FDA在公告中指出,综合现有的研究数据,非甾体抗炎药基本上都有潜在的心血管和消化道出血风险。其公告主要分为三个层次:第一是要求辉瑞主动从市场上撤回“风险/效益比较不理想”的Bextra,同时在西乐葆说明书中加入黑框警告;第二是要求所有非甾体抗炎类处方药的制造商修改说明书,加上同样的黑框警告;第三是要求所有非甾体抗炎类非处方药(OTC)的制造商修改产品说明书,增加更详细的警示信息(包括处方药中已标明的和安全用药信息。 * 25. Risk of peptic ulceration is similar between non-selective and COX-2 selective NSAIDs with concomitant low-dose aspirin Although COX-2 selective NSAIDs are associated with a lower risk of peptic ulceration than non-selective NSAIDs, their concomitant use with low-dose aspirin increases the risk to a level similar to that seen with non-selective NSAIDs. This was demonstrated recently in a double-blind trial with 1615 patients whose osteoarthritis required NSAID therapy but who were free from ulcers at baseline.43 The cumulative incidence of ulcers in patients randomised to rofecoxib, 25 mg daily, plus low-dose enteric-coated aspirin, 81 mg daily, was significantly greater than with aspirin alone, 81 mg daily, or placebo (16.1%, 7.3% and 5.8%, respectively; p0.001 for both comparisons with rofecoxib
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