反流性食管炎五种维持疗法的比较。

A comparison of five maintenance therapies for reflux esophagitis.

作者信息

Vigneri S, Termini R, Leandro G, Badalamenti S, Pantalena M, Savarino V, Di Mario F, Battaglia G, Mela G S, Pilotto A

机构信息

Institute of Internal Medicine and Geriatrics, University of Palermo, Italy.

出版信息

N Engl J Med. 1995 Oct 26;333(17):1106-10. doi: 10.1056/NEJM199510263331703.

DOI:10.1056/NEJM199510263331703

PMID:7565948

Abstract

BACKGROUND

Patients with reflux esophagitis have a high rate of relapse within one year after therapy is discontinued.

METHODS

We enrolled 175 adults with endoscopy-confirmed reflux esophagitis in a prospective study comparing five maintenance therapies. All the patients were initially treated with omeprazole (40 mg orally once a day) for four to eight weeks, and healing was confirmed by endoscopy. Participants were then stratified according to their initial grade of esophagitis and randomly assigned to 12 months of treatment with one of the following: cisapride (10 mg three times a day), ranitidine (150 mg three times a day), omeprazole (20 mg per day), ranitidine plus cisapride (10 mg three times a day), or omeprazole plus cisapride. Endoscopy was repeated after 6 and 12 months of treatment; the endoscopists were blinded to the treatment assignments. Remission was defined as the absence of esophageal lesions on scheduled or unscheduled follow-up endoscopy.

RESULTS

In an intention-to-treat analysis, the numbers of patients in continued remission at 12 months were 19 of 35 (54 percent) in the cisapride group, 17 of 35 (49 percent) in the ranitidine group, 28 of 35 (80 percent) in the omeprazole group, 23 of 35 (66 percent) in the ranitidine-plus-cisapride group, and 31 of 35 (89 percent) in the omeprazole-plus-cisapride group. Omeprazole was significantly more effective than cisapride (P = 0.02) or ranitidine (P = 0.003), and combination therapy with omeprazole plus cisapride was significantly more effective than cisapride alone (P = 0.003), ranitidine alone (P < 0.001), or ranitidine plus cisapride (P = 0.03). Ranitidine plus cisapride was significantly better than ranitidine alone (P = 0.05).

CONCLUSIONS

For maintenance treatment of reflux esophagitis, omeprazole alone or in combination with cisapride is more effective than ranitidine alone or cisapride alone, and the combination of omeprazole and cisapride is more effective than ranitidine plus cisapride.

摘要

背景

反流性食管炎患者在停止治疗后的一年内复发率很高。

方法

我们纳入了175例经内镜确诊的反流性食管炎成年患者，进行一项比较五种维持治疗方法的前瞻性研究。所有患者最初均接受奥美拉唑（每日口服40毫克）治疗4至8周，并通过内镜检查确认愈合情况。然后根据患者最初的食管炎分级进行分层，并随机分配接受以下其中一种治疗12个月：西沙必利（每日3次，每次10毫克）、雷尼替丁（每日3次，每次150毫克）、奥美拉唑（每日20毫克）、雷尼替丁加西沙必利（每日3次，每次10毫克）或奥美拉唑加西沙必利。治疗6个月和12个月后重复进行内镜检查；内镜检查人员对治疗分配情况不知情。缓解定义为在计划或非计划的随访内镜检查中无食管病变。

结果

在意向性分析中，西沙必利组35例患者中有19例（54%）在12个月时持续缓解，雷尼替丁组35例中有17例（49%），奥美拉唑组35例中有28例（80%），雷尼替丁加西沙必利组35例中有23例（66%），奥美拉唑加西沙必利组35例中有31例（89%）。奥美拉唑比西沙必利（P = 0.02）或雷尼替丁（P = 0.003）显著更有效，奥美拉唑加西沙必利的联合治疗比单独使用西沙必利（P = 0.003）、单独使用雷尼替丁（P < 0.001）或雷尼替丁加西沙必利（P = 0.03）显著更有效。雷尼替丁加西沙必利比单独使用雷尼替丁显著更好（P = 0.05）。