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双倍剂量兰索拉唑联合阿莫西林的双联疗法与双倍剂量兰索拉唑、阿莫西林及克拉霉素的三联疗法根除幽门螺杆菌感染的前瞻性随机开放研究结果

Dual therapy using a double dose of lansoprazole with amoxicillin versus triple therapy using a double dose of lansoprazole, amoxicillin, and clarithromycin to eradicate Helicobacter pylori infection: results of a prospective randomized open study.

作者信息

Lamouliatte H, Cayla R, Zerbib F, Forestier S, de Mascarel A, Joubert-Collin M, Mégraud F

机构信息

Service des maladies de l'appareil digestif, Hôpital Saint-André, Bordeaux, France.

出版信息

Am J Gastroenterol. 1998 Sep;93(9):1531-4. doi: 10.1111/j.1572-0241.1998.00280.x.

Abstract

OBJECTIVES

The eradication of Helicobacter pylori is recommended in duodenal ulcer disease. The aim of this randomized open trial was to evaluate and compare H. pylori eradication and safety after a dual therapy consisting of lansoprazole (30 mg b.i.d.) and amoxicillin (1 g b.i.d.) versus a triple therapy consisting of lansoprazole (30 mg b.i.d.), amoxicillin (1 g b.i.d.), and clarithromycin (500 mg b.i.d.) administered from day 1 to day 14.

METHODS

All patients with an ulcer received lansoprazole (30 mg) from day 15 to day 28. H. pylori status was determined from antral biopsies using histology, culture, and polymerase chain reaction (PCR) upon inclusion and 1-3 months after the end of the treatment.

RESULTS

Of the 50 patients included in the study, five did not adhere to the protocol. H. pylori eradication was obtained in 37.5% of the patients receiving lansoprazole-amoxicillin (n = 9/24) and in 95.2% of the patients receiving lansoprazole-amoxicillin-clarithromycin (n = 20/21, p < 0.0002). Minor side effects appeared in 8.3% of the cases during dual therapy (n = 2/24) and in 52% during triple therapy (n = 13/22, p < 0.001). These side effects consisted mainly of diarrhea and a metallic taste.

CONCLUSION

Concomitant administration of double doses of lansoprazole with amoxicillin and clarithromycin is very efficacious against H. pylori infection compared with dual therapy.

摘要

目的

十二指肠溃疡疾病推荐根除幽门螺杆菌。本随机开放试验的目的是评估和比较由兰索拉唑(30毫克,每日两次)和阿莫西林(1克,每日两次)组成的双联疗法与由兰索拉唑(30毫克,每日两次)、阿莫西林(1克,每日两次)和克拉霉素(500毫克,每日两次)组成的三联疗法从第1天至第14天给药后幽门螺杆菌的根除情况及安全性。

方法

所有溃疡患者从第15天至第28天接受兰索拉唑(30毫克)治疗。纳入时以及治疗结束后1 - 3个月,通过组织学、培养和聚合酶链反应(PCR)从胃窦活检确定幽门螺杆菌状态。

结果

纳入研究的50例患者中,5例未遵守方案。接受兰索拉唑 - 阿莫西林治疗的患者中37.5%实现幽门螺杆菌根除(n = 9/24),接受兰索拉唑 - 阿莫西林 - 克拉霉素治疗的患者中95.2%实现根除(n = 20/21,p < 0.0002)。双联疗法期间8.3%的病例出现轻微副作用(n = 2/24),三联疗法期间52%的病例出现轻微副作用(n = 13/22,p < 0.001)。这些副作用主要包括腹泻和金属味。

结论

与双联疗法相比,双倍剂量的兰索拉唑与阿莫西林和克拉霉素联合给药对幽门螺杆菌感染非常有效。

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