一项非劣效性研究:包含更高剂量雷贝拉唑的改良双重疗法在根除幽门螺杆菌方面与标准四联疗法同样成功。

A Non-Inferiority Study: Modified Dual Therapy Consisting Higher Doses of Rabeprazole Is as Successful as Standard Quadruple Therapy in Eradication of Helicobacter pylori.

作者信息

Sapmaz Ferdane, Kalkan Ismail H, Atasoy Pinar, Basyigit Sebahat, Guliter Sefa

机构信息

1Department of Gastroenterology, Keçiören Education and Training Hospital, Keçiören, Ankara, Turkey; and 2Department of Gastroenterology, Faculty of Medicine, Kırıkkale University, Kırıkkale, Turkey; and 3Department of Pathology, Faculty of Medicine, Kırıkkale University, Kırıkkale, Turkey.

出版信息

Am J Ther. 2017 Jul/Aug;24(4):e393-e398. doi: 10.1097/MJT.0000000000000316.

Abstract

The aim is to compare high-dose rabeprazole and amoxicillin containing modified dual therapy (MDT) with bismuth subcitrate containing standard quadruple therapy (SQT) as the first-line Helicobacter pylori eradication treatment in terms of efficacy, safety, and adherence to treatment. A total of 200 consecutive patients diagnosed endoscopically with nonulcer dyspepsia with H. pylori infection were randomly assigned into 2 groups, 1 treated with amoxicillin 750 mg thrice daily plus rabeprazole 20 mg thrice daily (MDT group) or rabeprazole 20 mg b.i.d., bismuth subcitrate 120 mg q.i.d., tetracycline 500 mg q.i.d., metronidazole 500 mg t.i.d. (SQT group). Overall, 196 patients (98 in the MDT group and 98 in the SQT group) completed the study. H. pylori eradication was achieved in 84.7% of patients in the MDT group by intention to treat analysis and 84.9% by per-protocol analysis, which were comparable with SQT group (87.8% and 88.8%, respectively). Adverse events including nausea (P = 0.03), dysgeusia (P < 0.001), diarrhea (P = 0.001), black colored stool (P < 0.001), headache (P = 0.01), and abdominal pain (P = 0.05) were significantly higher in SQT group. The MDT is an efficient and safe treatment choice that could be recommended in the first-line eradication treatment of H. pylori.

摘要

目的是比较含高剂量雷贝拉唑和阿莫西林的改良双联疗法(MDT)与含枸橼酸铋钾的标准四联疗法(SQT)作为一线幽门螺杆菌根除治疗在疗效、安全性和治疗依从性方面的差异。共有200例经内镜诊断为幽门螺杆菌感染的非溃疡性消化不良患者被随机分为两组,一组接受阿莫西林750毫克每日三次加雷贝拉唑20毫克每日三次治疗(MDT组),另一组接受雷贝拉唑20毫克每日两次、枸橼酸铋钾120毫克每日四次、四环素500毫克每日四次、甲硝唑500毫克每日三次治疗(SQT组)。总体而言,196例患者(MDT组98例,SQT组98例)完成了研究。意向性分析显示MDT组84.7%的患者实现了幽门螺杆菌根除,符合方案分析为84.9%,与SQT组(分别为87.8%和88.8%)相当。SQT组恶心(P = 0.03)、味觉障碍(P < 0.001)、腹泻(P = 0.001)、黑便(P < 0.001)、头痛(P = 0.01)和腹痛(P = 0.05)等不良事件显著更高。MDT是一种有效且安全的治疗选择,可推荐用于幽门螺杆菌的一线根除治疗。

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