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埃索美拉唑、阿莫西林和甲硝唑四联疗法治疗首次治疗失败后的幽门螺杆菌感染有效(KDOG0201 研究)。

Quadruple therapy with ecabet sodium, omeprazole, amoxicillin and metronidazole is effective for eradication of Helicobacter pylori after failure of first-line therapy (KDOG0201 Study).

机构信息

Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara-shi, Japan.

出版信息

J Clin Pharm Ther. 2010 Jun;35(3):303-7. doi: 10.1111/j.1365-2710.2009.01092.x.

Abstract

BACKGROUND AND OBJECT

An antiulcer agent, ecabet sodium, is active against Helicobacter pylori. The aim of the present study was to clinically examine whether eradication therapy, which includes ecabet sodium, is effective in eradication of H. pylori after failure of first-line therapy.

METHODS

Patients with peptic ulcer who failed with first-line triple eradication therapy containing clarithromycin received quadruple therapy with omeprazole (20 mg, twice daily), amoxicillin (750 mg, twice daily), metronidazole (500 mg, twice daily) and ecabet sodium (1000 mg, twice daily) for 14 days. Eradication of H. pylori was judged by 13C-urea breath test 8 weeks later.

RESULTS

Fifty-two patients (36 men and 16 women) were included. Their mean age was 51.4 years (range 28-73). One patient dropped out because of diarrhoea. The eradication rate was 98.0% (50/51) according to the per-protocol analysis and 96.2% (50/52) according to the intention-to-treat analysis. Side effects occurred in seven patients, but none were serious.

CONCLUSIONS

Quadruple therapy including ecabet sodium is useful as second-line eradication treatment for H. pylori.

摘要

背景和目的

一种抗溃疡剂,硫糖铝钠,对幽门螺杆菌有活性。本研究的目的是临床检查在一线治疗失败后,包含硫糖铝钠的根除疗法是否对幽门螺杆菌的根除有效。

方法

接受包含克拉霉素的一线三联根除疗法失败的消化性溃疡患者接受奥美拉唑(20mg,每日两次)、阿莫西林(750mg,每日两次)、甲硝唑(500mg,每日两次)和硫糖铝钠(1000mg,每日两次)四联疗法,持续 14 天。8 周后通过 13C-尿素呼气试验判断幽门螺杆菌的根除情况。

结果

52 例患者(36 名男性和 16 名女性)纳入研究。他们的平均年龄为 51.4 岁(范围 28-73 岁)。1 名患者因腹泻而退出。根据方案分析,根除率为 98.0%(50/51),根据意向治疗分析,根除率为 96.2%(50/52)。7 名患者出现副作用,但均不严重。

结论

包含硫糖铝钠的四联疗法是治疗幽门螺杆菌的二线有效根除疗法。

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