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澳大利亚对基于左氧氟沙星的三联疗法治疗难治性幽门螺杆菌感染的前瞻性评估。

A prospective evaluation of levofloxacin-based triple therapy for refractory Helicobacter pylori infection in Australia.

作者信息

Katelaris Peter H, Katelaris Anthea L

机构信息

Gastroenterology Department, Concord Hospital, University of Sydney, Sydney, New South Wales, Australia.

London School of Hygiene and Tropical Medicine, London, UK.

出版信息

Intern Med J. 2017 Jul;47(7):761-766. doi: 10.1111/imj.13432.

DOI:10.1111/imj.13432
PMID:28345276
Abstract

BACKGROUND

First-line Helicobacter pylori eradication failure is a common and challenging problem.

AIM

To assess the efficacy of salvage levofloxacin-based triple therapy in Australia.

METHODS

Prospective patients referred after prior treatment failure(s) were prescribed esomeprazole 40 mg, amoxicillin 1 g and levofloxacin 500 mg each twice daily for 10 days. All patients received detailed written and verbal adherence support. Outcome assessment was by C-urea breath test and/or histology and urease test.

RESULTS

In 150 consecutive, evaluable patients (66% female, mean age 54 ± 14 years; six smokers), the main indications for treatment were peptic ulcer disease (17%), increased gastric cancer risk (20%), symptoms (35%) and other risk reduction (28%). The median number of previous treatments was 2 (range 1-7). Eradication of H. pylori was achieved in 90% (intention to treat (ITT)) and 91% (per-protocol (PP)) of patients. The eradication rate did not differ according to the type or number of prior treatments: 93% when ≤2 (n = 107) compared with 84% after three or more prior treatments (n = 43; P = 0.13) or with age, ethnicity or indication for treatment but it was higher in females (ITT 94 vs 82%, P = 0.04). Adherence was excellent (95%). No serious adverse effects were observed; mild adverse effects were reported in 11%. No primary levofloxacin resistance was observed in 20 concurrent cases.

CONCLUSION

The efficacy and safety of this levofloxacin-based triple therapy suggests it should be used as a salvage regimen in this region. Randomised comparative trials are unlikely to be done but these data compare favourably with local data for other salvage therapies.

摘要

背景

一线根除幽门螺杆菌失败是一个常见且具有挑战性的问题。

目的

评估在澳大利亚采用含左氧氟沙星的挽救三联疗法的疗效。

方法

对先前治疗失败后转诊的前瞻性患者,给予埃索美拉唑40毫克、阿莫西林1克和左氧氟沙星500毫克,均每日两次,共10天。所有患者均获得详细的书面和口头依从性支持。通过碳-尿素呼气试验和/或组织学及尿素酶试验进行结果评估。

结果

在150例连续可评估患者中(66%为女性,平均年龄54±14岁;6例吸烟者),治疗的主要指征为消化性溃疡病(17%)、胃癌风险增加(20%)、症状(35%)和其他风险降低(28%)。既往治疗的中位数为2次(范围1 - 7次)。90%(意向性治疗(ITT))和91%(符合方案(PP))的患者实现了幽门螺杆菌根除。根除率不因既往治疗的类型或次数而有所不同:≤2次既往治疗时为93%(n = 107),三次或更多次既往治疗后为84%(n = 43;P = 0.13),也不因年龄、种族或治疗指征而不同,但女性的根除率更高(ITT 94%对82%,P = 0.04)。依从性良好(95%)。未观察到严重不良反应;11%的患者报告有轻微不良反应。20例同期病例中未观察到原发性左氧氟沙星耐药。

结论

这种含左氧氟沙星的三联疗法的疗效和安全性表明,它应作为该地区的挽救方案使用。不太可能进行随机对照试验,但这些数据与其他挽救疗法的当地数据相比具有优势。

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