Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group.
Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group.
复制标题
奥美拉唑与米索前列醇治疗与非甾体类抗炎药相关的溃疡的比较。
DOI：
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发表时间：
1999
影响因子：
158.5
通讯作者：
N. Yeomans
中科院分区：
文献类型：
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作者：
C. Hawkey;J. Karrasch;L. Szczepanski;D. G. Walker;A. Barkun;A. Swannell;N. Yeomans
背景
米索前列醇对使用非类固醇抗炎药(NSAIDs)引起的溃疡有效，但由于腹泻和腹痛，其耐受性通常较差。我们比较了奥美拉唑和米索前列醇在愈合和预防与非类固醇抗炎药相关的溃疡方面的疗效。
方法
在一项双盲研究中，我们随机分配了935名需要持续非甾体抗炎药治疗的患者，他们的胃或十二指肠有溃疡或超过10个溃疡(或两者都有)，每天早上口服奥美拉唑20毫克或40毫克或米索前列醇200微克，每天四次。患者接受了四周的治疗，或者在没有愈合的情况下，治疗了八周。治疗成功被定义为没有溃疡，每个部位存在少于5个糜烂，并且不超过轻度消化不良。然后，我们随机将732名治疗成功的患者重新分配到维持治疗，每天服用20毫克奥美拉唑，每天两次服用200微克米索前列醇，或服用安慰剂6个月。
结果
治疗8周后，服用20毫克奥美拉唑的患者有76%(308名患者中有233名)，服用40毫克奥美拉唑的患者有75%(315名患者中有237名)，服用米索前列醇的患者中有71%(298名患者中有212名)。服用20 mg奥美拉唑的患者胃溃疡愈合率显著高于服用米索前列醇的患者，但服用40 mg奥美拉唑的患者胃溃疡愈合率明显高于服用米索前列醇的患者。在十二指肠溃疡患者中，使用任何一种剂量的奥美拉唑的愈合率都高于使用米索前列醇，而单独服用米索前列醇的患者的愈合率更高。在维持治疗期间，使用奥美拉唑的患者(61%)比服用米索前列醇(48%，P=0.001)的患者更多的患者保持缓解状态，使用这两种药物的患者比服用安慰剂的患者(27%，P<；0.001)更多。在愈合期，米索前列醇组的不良事件比服用20毫克和40毫克奥美拉唑组更多(分别为59%、48%和46%)。
结论
两种剂量的奥美拉唑和米索前列醇对溃疡、糜烂和与非类固醇相关的症状的治疗成功率相似。与米索前列醇相比，使用奥美拉唑维持治疗的复发率较低。奥美拉唑的耐受性好于米索前列醇。
BACKGROUND
Misoprostol is effective for ulcers associated with the use of nonsteroidal antiinflammatory drugs (NSAIDs) but is often poorly tolerated because of diarrhea and abdominal pain. We compared the efficacy of omeprazole and misoprostol in healing and preventing ulcers associated with NSAIDs.
METHODS
In a double-blind study, we randomly assigned 935 patients who required continuous NSAID therapy and who had ulcers or more than 10 erosions in the stomach or duodenum (or both) to receive 20 mg or 40 mg of omeprazole orally in the morning or 200 microg of misoprostol orally four times daily. Patients were treated for four weeks or, in the absence of healing, eight weeks. Treatment success was defined as the absence of ulcers and the presence of fewer than five erosions at each site and not more than mild dyspepsia. We then randomly reassigned 732 patients in whom treatment was successful to maintenance therapy with 20 mg of omeprazole daily, 200 microg of misoprostol twice daily, or placebo for six months.
RESULTS
At eight weeks, treatment was successful in 76 percent of the patients given 20 mg of omeprazole (233 of 308), 75 percent of those given 40 mg of omeprazole (237 of 315), and 71 percent of those given misoprostol (212 of 298). The rates of gastric-ulcer healing were significantly higher with 20 mg of omeprazole (but not 40 mg of omeprazole) than with misoprostol. Healing rates among patients with duodenal ulcers were higher with either dose of omeprazole than with misoprostol, whereas healing rates among patients with erosions alone were higher with misoprostol. More patients remained in remission during maintenance treatment with omeprazole (61 percent) than with misoprostol (48 percent, P=0.001) and with either drug than with placebo (27 percent, P<0.001). There were more adverse events during the healing phase in the misoprostol group than in the groups given 20 mg and 40 mg of omeprazole (59 percent, 48 percent, and 46 percent, respectively).
CONCLUSIONS
The overall rates of successful treatment of ulcers, erosions, and symptoms associated with NSAIDs were similar for the two doses of omeprazole and misoprostol. Maintenance therapy with omeprazole was associated with a lower rate of relapse than misoprostol. Omeprazole was better tolerated than misoprostol.