奥美拉唑与雷尼替丁治疗非甾体抗炎药相关性溃疡的比较。抑酸试验：雷尼替丁与奥美拉唑治疗非甾体抗炎药相关性溃疡的研究（ASTRONAUT）研究组。

A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-associated Ulcer Treatment (ASTRONAUT) Study Group.

作者信息

Yeomans N D, Tulassay Z, Juhász L, Rácz I, Howard J M, van Rensburg C J, Swannell A J, Hawkey C J

机构信息

Department of Medicine, University of Melbourne, Western Hospital, Footscray, Victoria, Australia.

出版信息

N Engl J Med. 1998 Mar 12;338(11):719-26. doi: 10.1056/NEJM199803123381104.

DOI:10.1056/NEJM199803123381104

PMID:9494148

Abstract

BACKGROUND

Suppressing acid secretion is thought o reduce the risk of ulcers associated with regular use of nonsteroidal antiinflammatory drugs (NSAIDs), but the best means of accomplishing this is uncertain.

METHODS

We studied 541 patients who required continuous treatment with NSAIDs and who had ulcers or more than 10 erosions in either the stomach or duodenum. Patients were randomly assigned to double-blind treatment with omeprazole, 20 mg or 40 mg orally per day, or ranitidine, 150 mg orally twice a day, for four or eight weeks, depending on when treatment was successful (defined as the resolution of ulcer and the presence of fewer than five erosions in the stomach, and fewer than five erosions in the duodenum, and not more than mild dyspepsia). We randomly assigned 432 patients in whom treatment was successful to maintenance treatment with either 20 mg of omeprazole per day or 150 mg of ranitidine twice a day for six months.

RESULTS

At eight weeks, treatment was successful in 80 percent (140 of 174) of the patients in the group given 20 mg of omeprazole per day, 79 percent (148 of 187) of those given 40 mg of omeprazole per day, and 63 percent (110 of 174) of those given ranitidine (P<0.001 for the comparison with 20 mg of omeprazole and P=0.001 for the comparison with 40 mg of omeprazole). The rates of healing of all types of lesions were higher with omeprazole than with ranitidine. During maintenance therapy, the estimated proportion of patients in remission at the end of six months was 72 percent in the omeprazole group and 59 percent in the ranitidine group. The rates of adverse events were similar between groups during both phases. Both medications were well tolerated.

CONCLUSIONS

In patients with regular use of NSAIDs, omeprazole healed and prevented ulcers more effectively than did ranitidine.

摘要

背景

抑制胃酸分泌被认为可降低与长期使用非甾体抗炎药（NSAIDs）相关的溃疡风险，但实现这一目标的最佳方法尚不确定。

方法

我们研究了541例需要持续使用NSAIDs治疗且胃或十二指肠有溃疡或10处以上糜烂的患者。根据治疗成功的时间（定义为溃疡愈合、胃内糜烂少于5处、十二指肠内糜烂少于5处且消化不良不超过轻度），患者被随机分配接受双盲治疗，分别口服奥美拉唑20毫克或40毫克每日一次，或雷尼替丁150毫克每日两次，治疗4周或8周。我们将432例治疗成功的患者随机分配接受维持治疗，分别口服奥美拉唑20毫克每日一次或雷尼替丁150毫克每日两次，为期6个月。

结果

8周时，每日服用20毫克奥美拉唑组的患者中80%（174例中的140例）治疗成功，每日服用40毫克奥美拉唑组的患者中79%（187例中的148例）治疗成功，服用雷尼替丁组的患者中63%（174例中的110例）治疗成功（与20毫克奥美拉唑组相比，P<0.001；与40毫克奥美拉唑组相比，P=0.001）。奥美拉唑治疗各类病变的愈合率均高于雷尼替丁。在维持治疗期间，奥美拉唑组6个月末缓解患者的估计比例为72%，雷尼替丁组为59%。两个阶段两组的不良事件发生率相似。两种药物耐受性均良好。