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中国一项使用四种为期1周的三联疗法根除幽门螺杆菌的多中心研究。

A multicentre study on eradication of Helicobacter pylori using four 1-week triple therapies in China.

作者信息

Xiao S D, Liu W Z, Hu P J, Ouyang Q, Wang J L, Zhou L Y, Cheng N N

机构信息

Shanghai Institute of Digestive Disease, Shanghai Second Medical University Renji Hospital, Shanghai, China.

出版信息

Aliment Pharmacol Ther. 2001 Jan;15(1):81-6. doi: 10.1046/j.1365-2036.2001.00895.x.

Abstract

BACKGROUND

Short-term proton pump inhibitor-based triple therapies for the eradication of Helicobacter pylori are used widely. The eradication rates vary greatly from country to country and from region to region.

AIM

To assess the efficacy at eradicating H. pylori of 1-week regimens containing three medications: omeprazole (O) or colloidal bismuth subcitrate (B), furazolidone (F) or metronidazole (M), and amoxicillin (A) or clarithromycin (C).

METHODS

A multicentre study involving 20 hospitals in different regions of China. A total of 892 patients with H. pylori-positive non-ulcer dyspepsia or healed duodenal ulcer confirmed by endoscopy were recruited to receive, randomly, one of four regimens: OMC, OFC, OFA, and BFC, b.d. for 7 days. 13C-urea breath test was performed 4-8 weeks after completion of treatment.

RESULTS

The eradication rates with per protocol/intention-to-treat analyses were: OMC (n=217/219) 66%/65%; OFC (n=227/229) 69%/69%; OFA (n=223/225) 87%/86%; and BFC (n=214/219) 80%/78%. The eradication rate (per protocol analysis) in duodenal ulcer (79%) was higher than that in non-ulcer dyspepsia (73%, P=0.033). Patient compliance was good. The adverse events of the four regimens were mild, and mainly gastrointestinal.

CONCLUSIONS

The omeprazole, furazolidine and amoxicillin regimen achieves a high H. pylori eradication rate in different geographical regions of China.

摘要

背景

基于质子泵抑制剂的短期三联疗法广泛用于根除幽门螺杆菌。不同国家和地区的根除率差异很大。

目的

评估含三种药物的1周治疗方案根除幽门螺杆菌的疗效,这三种药物分别为奥美拉唑(O)或枸橼酸铋钾(B)、呋喃唑酮(F)或甲硝唑(M)以及阿莫西林(A)或克拉霉素(C)。

方法

一项多中心研究,涉及中国不同地区的20家医院。共招募了892例经内镜检查确诊为幽门螺杆菌阳性的非溃疡性消化不良或已愈合十二指肠溃疡患者,随机接受四种治疗方案之一:OMC、OFC、OFA和BFC,每日2次,共7天。治疗结束后4 - 8周进行¹³C - 尿素呼气试验。

结果

符合方案分析/意向性分析的根除率分别为:OMC(n = 217/219)66%/65%;OFC(n = 227/229)69%/69%;OFA(n = 223/225)87%/86%;BFC(n = 214/219)80%/78%。十二指肠溃疡患者的根除率(符合方案分析)为79%,高于非溃疡性消化不良患者(73%,P = 0.033)。患者依从性良好。四种治疗方案的不良事件均较轻微,主要为胃肠道反应。

结论

奥美拉唑、呋喃唑酮和阿莫西林治疗方案在中国不同地理区域均能实现较高的幽门螺杆菌根除率。

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