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标准“马斯特里赫特三联疗法”失败后,幽门螺杆菌感染不同“二线”疗法的随机研究

Randomized study of different 'second-line' therapies for Helicobacter pylori infection after failure of the standard 'Maastricht triple therapy'.

作者信息

Perri F, Festa V, Merla A, Barberani F, Pilotto A, Andriulli A

机构信息

Division of Gastroenterology, Hospital, IRCCS, San Giovanni Rotondo, Italy.

出版信息

Aliment Pharmacol Ther. 2003 Oct 15;18(8):815-20. doi: 10.1046/j.1365-2036.2003.01755.x.

DOI:10.1046/j.1365-2036.2003.01755.x
PMID:14535875
Abstract

BACKGROUND

Triple therapy with proton pump inhibitor, clarithromycin and amoxicillin and, in the event of eradication failure, quadruple therapy with proton pump inhibitor, bismuth, tetracycline and metronidazole have been proposed in Maastricht as the optimal sequential treatment of Helicobacter pylori infection.

AIM

To compare two second-line regimens with quadruple therapy.

METHODS

One hundred and eighty patients with a previous failed course of standard therapy were randomly given one of the following 7-day treatments: ranitidine bismuth citrate 400 mg b.d. plus amoxicillin 1 g b.d. and tinidazole 500 mg b.d. (RBCAT), pantoprazole 40 mg b.d. plus amoxicillin 1 g b.d. and levofloxacin 500 mg/day (PAL) and pantoprazole 40 mg b.d., bismuth citrate 240 mg b.d., tetracycline 500 mg q.d.s. and metronidazole 500 mg b.d. (PBTM). The eradication rate was assessed by 13C-urea breath test. Side-effects and compliance were evaluated by a standardized questionnaire and by counting returned medication.

RESULTS

The RBCAT, PAL and PBTM groups achieved mean intention-to-treat eradication rates of 85%, 63% and 83%, respectively (P<0.05 for PAL vs. either RBCAT or PBTM). Compliance was optimal in all patients, although side-effects were more commonly observed in the PBTM group than in the other two patient groups (P<0.0001).

CONCLUSIONS

Both RBCAT and PBTM can be used as second-line therapies. Conversely, PAL did not achieve satisfactory eradication rates.

摘要

背景

在马斯特里赫特,已提出使用质子泵抑制剂、克拉霉素和阿莫西林进行三联疗法,若根除失败,则使用质子泵抑制剂、铋剂、四环素和甲硝唑进行四联疗法作为幽门螺杆菌感染的最佳序贯治疗方案。

目的

比较两种二线治疗方案与四联疗法。

方法

180例先前标准治疗疗程失败的患者被随机给予以下7天治疗方案之一:枸橼酸雷尼替丁铋400毫克,每日两次,加阿莫西林1克,每日两次,替硝唑500毫克,每日两次(RBCAT);泮托拉唑40毫克,每日两次,加阿莫西林1克,每日两次,左氧氟沙星500毫克/天(PAL);泮托拉唑40毫克,每日两次,枸橼酸铋240毫克,每日两次,四环素500毫克,每日四次,甲硝唑500毫克,每日两次(PBTM)。通过13C-尿素呼气试验评估根除率。通过标准化问卷和计算回收药物来评估副作用和依从性。

结果

RBCAT组、PAL组和PBTM组的平均意向性治疗根除率分别为85%、63%和83%(PAL组与RBCAT组或PBTM组相比,P<0.05)。所有患者的依从性都很好,尽管PBTM组比其他两组更常观察到副作用(P<0.0001)。

结论

RBCAT和PBTM均可作为二线治疗方法。相反,PAL未达到令人满意的根除率。

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