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雷贝拉唑、氧氟沙星和阿莫西林治疗幽门螺杆菌根除的开放、随机多中心对照试验:7天与14天治疗对比

Open, randomized multicenter comparative trial of rabeprazole, ofloxacin and amoxicillin therapy for Helicobacter pylori eradication: 7 vs. 14 day treatment.

作者信息

Bosques-Padilla Francisco J, Garza-González Elvira, Calderón-Lozano Irma E, Reed-SanRoman Gerardo, de Ariño Suárez Mauricio, Valdovinos-Díaz Miguel A, Orozco-Gámiz Antonio, Blancas-Valencia Juan M, Tamayo-de la Cuesta José L

机构信息

Servicio de Gastroenterología, Hospital Universitario Dr José Eleuterio González Universidad Autónoma de Nuevo León, Mexico.

出版信息

Helicobacter. 2004 Oct;9(5):417-21. doi: 10.1111/j.1083-4389.2004.00265.x.

Abstract

BACKGROUND

Because of the increasing resistance to clarithromycin and metronidazole, two of the antibiotics used for the eradication of Helicobacter pylori, new therapeutic alternatives are needed. The aim of this study was to determine the efficacy of a randomized, comparative trial of 7 vs. 14-day triple treatment with rabeprazole, ofloxacin and amoxicillin for H. pylori eradication.

MATERIAL AND METHODS

The present authors studied 76 dyspeptic patients infected with H. pylori diagnosed by both histology and a rapid urease test. Patients were randomized to receive rabeprazole (20 mg b.i.d.), plus ofloxacin (400 mg b.i.d.) and amoxicillin (1000 mg b.i.d.) for 7 days (group 1) vs. 14 days (group 2) and were followed by 6 weeks. Eradication was assessed 4 weeks after completing the course of study treatment by the (14)C-urea breath test. Per protocol and intention-to-treat eradication rates were determined.

RESULTS

For the intention to treat analysis, the eradication rate was 62.2% for group 1 and 92.3% for group 2 (p =.004). For the per protocol analysis, eradication rate for group 1 was 63.9% and for group 2 was 97.3% (p =.001).

CONCLUSIONS

Triple therapy with rabeprazole, amoxicillin and ofloxacin by 14 days was efficient for H. pylori eradication and therefore deserves further study. The same regimen prescribed for 7 days had a significantly lower and unacceptable cure rate and should not be used.

摘要

背景

由于用于根除幽门螺杆菌的两种抗生素——克拉霉素和甲硝唑的耐药性不断增加,需要新的治疗方案。本研究的目的是确定雷贝拉唑、氧氟沙星和阿莫西林三联疗法7天与14天治疗幽门螺杆菌根除效果的随机对照试验结果。

材料与方法

本研究纳入76例经组织学和快速尿素酶试验确诊感染幽门螺杆菌的消化不良患者。患者被随机分为两组,一组接受雷贝拉唑(20mg,每日两次)加氧氟沙星(400mg,每日两次)和阿莫西林(1000mg,每日两次)治疗7天(第1组),另一组治疗14天(第2组),并随访6周。在完成研究治疗疗程4周后,通过¹⁴C尿素呼气试验评估根除情况。确定符合方案分析和意向性分析的根除率。

结果

意向性分析中,第1组根除率为62.2%,第2组为92.3%(p = 0.004)。符合方案分析中,第1组根除率为63.9%,第2组为97.3%(p = 0.001)。

结论

雷贝拉唑、阿莫西林和氧氟沙星三联疗法治疗14天对幽门螺杆菌根除有效,值得进一步研究。同样的方案治疗7天治愈率显著较低且不可接受,不应使用。

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