非甾体消炎药与胃粘膜损伤-培训课件.pptVIP

* 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 plus aspirin), but was similar to the incidence in patients randomised to ibuprofen, 800 mg three-times daily (17.1%; p=0.62). The incidence in patients receiving both ibuprofen and aspirin was not determined, as the risks from this combination were felt to be ethically unacceptable in a study in which GI-supportive therapy was not allowed. The use of low-dose aspirin for cardioprotection is widespread and, as shown in this study, significantly increases the risk of peptic ulceration with COX-2 selective NSAIDs to the level seen with non-selective NSAIDs. * 42. H. pylori infection and NSAID use synergistically increase the risk of peptic ulcer disease Infection with H. pylori is known to be a major cause of peptic ulcer disease.78,79 The results of a meta-analysis showed an increase in ulcer occurrence and bleeding in patients with H. pylori infection who also used NSAIDs and indicated that there is synergy between H. pylori infection and the use of NSAIDs in