阿奇霉素用于三联疗法根除活动性十二指肠溃疡中的幽门螺杆菌。

Azithromycin in a triple therapy for H.pylori eradication in active duodenal ulcer.

作者信息

Ivashkin Vladimir T, Lapina Tatiana L, Bondarenko Oksana Yu, Sklanskaya Olga A, Grigoriev Petr Ya, Vasiliev Yuri V, Yakovenko Emilia P, Gulyaev Pavel V, Fedchenko Valeri I

机构信息

V Vasilenko Clinic of internal diseases, gastroenterology and hepatology of the Moscow Sechenov Medical Academy, 119881 Pogodinskaya 5, Moscow, Russia.

出版信息

World J Gastroenterol. 2002 Oct;8(5):879-82. doi: 10.3748/wjg.v8.i5.879.

DOI:10.3748/wjg.v8.i5.879

PMID:12378634

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4656579/

Abstract

AIM

To assess and compare the efficacy and safety of two triple regimes: A) metronidazole, amoxicillin and omeprazole, which is still widely used in Russia, and B) azithromycin, amoxicillin and omeprazole in healing active duodenal ulcer and H.pylori eradication.

METHODS

100 patients with active duodenal ulcer were included in the open, multicentre, randomized study with comparative groups. Patients were randomly assigned to one of the following one-week triple regimes: A) metronidazole 500 mg bid, amoxicillin 1 g bid and omeprazole 20 mg bid (OAM, n=50) and B) azithromycin 1 g od for the first 3 days (total dose 3 g), amoxicillin 1 g bid and omeprazole 20 mg bid (OAA, n=50). Omeprazole 20 mg od was given after the eradication course as a monotherapy for three weeks. The control endoscopy was performed 8 weeks after the entry. H.pylori infection was determined in the entry of the study and four weeks after the cessation of treatment by means of histology and CLO-test.

RESULTS

97 patients completed the study according to the protocol (1 patient of the OAM group did not come to the control endoscopy, 2 patients of the OAA group stopped the treatment because of mild allergic urticaria). Duodenal ulcers were healed in 48 patients of the OAM group (96 %; CI 90.5-100 %) and in 46 patients of the OAA group (92 %; CI 89.5-94.5 %) (p=ns). H.pylori infection was eradicated in 15 out of 50 patients with OAM (30 %; CI 17-43 %) and in 36 out of 50 patients treated with OAA (72 %; CI 59-85 %) (P<0.001)- ITT analysis.

CONCLUSION

The triple therapy with omeprazole, amoxicillin and metronidazole failed to eradicate H.pylori in the majority of patients, which is an essential argument to withdraw this regimen out of the national recommendations. Macrolide with amoxicillin are preferable to achieve higher eradication rates. Azithromycin (1 g od for the first 3 days) can be considered as a successful component of the triple PPI-based regimen.

摘要

目的

评估并比较两种三联疗法的疗效和安全性：A）甲硝唑、阿莫西林和奥美拉唑，该疗法在俄罗斯仍被广泛使用；B）阿奇霉素、阿莫西林和奥美拉唑，用于治疗活动性十二指肠溃疡和根除幽门螺杆菌。

方法

100例活动性十二指肠溃疡患者被纳入这项开放、多中心、随机分组的对照研究。患者被随机分配至以下为期一周的三联疗法之一：A）甲硝唑500毫克，每日两次；阿莫西林1克，每日两次；奥美拉唑20毫克，每日两次（OAM组，n = 50）；B）阿奇霉素1克，首3天每日一次（总剂量3克），阿莫西林1克，每日两次，奥美拉唑20毫克，每日两次（OAA组，n = 50）。根除疗程结束后，给予奥美拉唑20毫克，每日一次，作为单一疗法持续3周。入组8周后进行对照内镜检查。在研究入组时以及治疗结束后4周，通过组织学和CLO检测确定幽门螺杆菌感染情况。

结果

97例患者按方案完成了研究（OAM组1例患者未进行对照内镜检查，OAA组2例患者因轻度过敏性荨麻疹停止治疗）。OAM组48例患者（96%；可信区间90.5 - 100%）的十二指肠溃疡愈合，OAA组46例患者（92%；可信区间89.5 - 94.5%）的十二指肠溃疡愈合（p = 无显著差异）。ITT分析显示，OAM组50例患者中有15例（30%；可信区间17 - 43%）的幽门螺杆菌感染被根除，OAA组50例接受治疗的患者中有36例（72%；可信区间59 - 85%）的幽门螺杆菌感染被根除（P < 0.001）。