幽门螺杆菌治疗失败后的七天“挽救”疗法：奥美拉唑、铋剂、四环素和甲硝唑与枸橼酸铋雷尼替丁、四环素和甲硝唑的对比

Seven-day 'rescue' therapy after Helicobacter pylori treatment failure: omeprazole, bismuth, tetracycline and metronidazole vs. ranitidine bismuth citrate, tetracycline and metronidazole.

作者信息

Gisbert J P, Gisbert J L, Marcos S, Grávalos R G, Carpio D, Pajares J M

机构信息

Department of Gastroenterology, University Hospital of 'La Princesa', Madrid, Spain.

出版信息

Aliment Pharmacol Ther. 1999 Oct;13(10):1311-6. doi: 10.1046/j.1365-2036.1999.00615.x.

DOI:10.1046/j.1365-2036.1999.00615.x

PMID:10540045

Abstract

BACKGROUND

Eradication therapy with omeprazole (O), amoxycillin (A) and clarithromycin (C) is used extensively, although it often fails. A 'rescue' therapy with a quadruple combination of O, bismuth (B), tetracycline (T) and metronidazole (M) has been recommended.

AIM

: To assess ranitidine bismuth citrate (Rbc) instead of O and B for treatment failure.

METHODS

Sixty consecutive patients (13 duodenal ulcer, 47 non-ulcer dyspepsia) in whom a previous eradication trial with O, A and C had failed were randomized to receive one of two regimens for 7 days: O (20 mg b.d.), B (120 mg q. d.s.), T (500 mg q.d.s.) and M (250 mg q.d.s.) (group OBTM, n=30); or Rbc (400 mg b.d.), T (500 mg q.d.s.) and M (250 mg q.d.s.) (group RbcTM, n=30). Eradication was defined as a negative 13C-urea breath test 1 month after completing therapy.

RESULTS

Mean age +/- s.d. was 45 +/- 12 years, 47% were males. Distribution of studied variables (age, sex, smoking, duodenal ulcer/non-ulcer dyspepsia) was similar in both therapeutic groups. Per protocol eradication was achieved in 17 out of 29 patients (59%) in group OBTM and in 25 out of 29 patients (86%) in group RbcTM (P < 0.05). Intention-to-treat eradication was achieved, respectively, in 17 out of 30 (57%) and in 25 out of 30 (83%) (P < 0.05). In the multivariate analysis the variables which influenced on H. pylori eradication were the type of therapy (odds ratio, OR=3.9; 95%CI: 1.02-15; P < 0.05) and diagnosis (duodenal ulcer/non-ulcer dyspepsia) (OR=0.1; CI: 0.02-0.4). Adverse effects were infrequent and mild with both regimens.

CONCLUSION

Therapy with RbcTM is a promising option after H. pylori eradication failure with OCA, achieving a higher efficacy than quadruple therapy with OBTM.

摘要

背景

尽管奥美拉唑（O）、阿莫西林（A）和克拉霉素（C）的根除疗法经常失败，但仍被广泛使用。有人推荐使用由O、铋剂（B）、四环素（T）和甲硝唑（M）组成的四联“补救”疗法。

目的

评估用雷尼替丁枸橼酸铋（Rbc）替代O和B治疗失败的情况。

方法

连续纳入60例患者（13例十二指肠溃疡，47例非溃疡性消化不良），这些患者之前使用O、A和C进行根除治疗失败，将其随机分为两组，接受两种治疗方案之一，为期7天：O（20毫克，每日2次）、B（120毫克，每日4次）、T（500毫克，每日4次）和M（250毫克，每日4次）（OBTM组，n = 30）；或Rbc（400毫克，每日2次）、T（500毫克，每日4次）和M（250毫克，每日4次）（RbcTM组，n = 30）。根除定义为治疗完成后1个月13C - 尿素呼气试验结果为阴性。

结果

平均年龄±标准差为45±12岁，47%为男性。两个治疗组中研究变量（年龄、性别、吸烟、十二指肠溃疡/非溃疡性消化不良）的分布相似。按照方案分析，OBTM组29例患者中有17例（59%）实现根除，RbcTM组29例患者中有25例（86%）实现根除（P < 0.05）。意向性分析分别在30例中的17例（57%）和30例中的25例（83%）实现根除（P < 0.05）。多因素分析中，影响幽门螺杆菌根除的变量是治疗类型（比值比，OR = 3.9；95%置信区间：1.02 - 15；P < 0.05）和诊断（十二指肠溃疡/非溃疡性消化不良）（OR = 0.1；置信区间：0.02 - 0.4）。两种治疗方案的不良反应均不常见且轻微。