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奥美拉唑(40毫克)在溃疡性反流性食管炎的短期治疗中优于雷尼替丁。

Omeprazole (40 mg) is superior to ranitidine in short-term treatment of ulcerative reflux esophagitis.

作者信息

Vantrappen G, Rutgeerts L, Schurmans P, Coenegrachts J L

机构信息

Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium.

出版信息

Dig Dis Sci. 1988 May;33(5):523-9. doi: 10.1007/BF01798351.

Abstract

The efficacy and safety of omeprazole, 40 mg once daily for four to eight weeks of treatment, were studied in 61 patients with ulcerative reflux esophagitis. A double-blind controlled study design was used, and the patients were randomly allocated to treatment with either omeprazole 40 mg once daily or ranitidine 150 mg twice daily. Endoscopy was performed prior to inclusion into the study, after four weeks and, if unhealed, again after eight weeks. Healing of esophagitis was defined as complete disappearance of all esophageal ulcerations. Symptoms were recorded before entry, after four weeks, and again after eight weeks in unhealed patients. Fifty-one patients were included in the per-protocol analysis at day 29, and 50 patients at day 57. The healing rate after four weeks of treatment was 22 of 26 patients (85%) treated with omeprazole and 10 of 25 patients (40%) treated with ranitidine (P less than 0.001). The corresponding figures after eight weeks were 24 of 25 (96%), and 13 of 25 (52%) (P less than 0.001). These results were confirmed in the intent-to-treat analysis. Patients treated with omeprazole showed a significantly faster and more profound relief in heartburn than patients treated with ranitidine: 85% had no heartburn after four weeks of treatment with omeprazole compared to 24% in patients treated with ranitidine (P = 0.00007). The percentage of patients who were free of all reflux symptoms was significantly greater in the omeprazole-treated group as compared to the ranitidine-treated group (62% and 12% respectively; P = 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

对61例溃疡性反流性食管炎患者进行了研究,探讨每日一次服用40毫克奥美拉唑、疗程为4至8周的疗效和安全性。采用双盲对照研究设计,患者被随机分配接受每日一次40毫克奥美拉唑治疗或每日两次150毫克雷尼替丁治疗。在纳入研究前、四周后以及(若未愈合)八周后进行内镜检查。食管炎愈合定义为所有食管溃疡完全消失。在未愈合患者中,于入组前、四周后及八周后记录症状。在第29天,51例患者纳入符合方案分析,第57天为50例。治疗四周后,接受奥美拉唑治疗的26例患者中有22例(85%)愈合,接受雷尼替丁治疗的25例患者中有10例(40%)愈合(P小于0.001)。八周后的相应数据分别为25例中的24例(96%)和25例中的13例(52%)(P小于0.001)。这些结果在意向性分析中得到证实。与接受雷尼替丁治疗的患者相比,接受奥美拉唑治疗的患者烧心缓解显著更快、更明显:奥美拉唑治疗四周后85%的患者无烧心症状,而雷尼替丁治疗患者为24%(P = 0.00007)。与雷尼替丁治疗组相比,奥美拉唑治疗组无所有反流症状的患者百分比显著更高(分别为62%和12%;P = 0.0001)。(摘要截短至250字)

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