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幽门螺杆菌根除:7 天与 14 天三联疗法的随机对照试验。

Helicobacter pylori eradication: A randomised comparative trial of 7-day versus 14-day triple therapy.

机构信息

Department of Medicine, Aga Khan University Hospital, Nairobi.

出版信息

S Afr Med J. 2012 May 8;102(6 Pt 2):368-71. doi: 10.7196/samj.5302.

DOI:10.7196/samj.5302
PMID:22668909
Abstract

Background. Helicobacter pylori is associated with several upper gastrointestinal conditions including chronic gastritis, peptic ulcer disease, and gastric malignancy. Proton pump inhibitor-based triple therapies are considered the standard regimens for H. pylori eradication, but the optimal duration of therapy is controversial. To prevent infection and complications, local studies should be undertaken to evaluate H. pylori eradication rates in a country. Objectives. We compared 7-day and 14-day regimens to determine the optimum duration of triple therapy for H. pylori eradication. Methods. We undertook a prospective randomised comparative trial of 7-day and 14-day triple therapy regimen for H. pylori eradication at the Aga Khan University Hospital, Nairobi; 120 patients with dyspepsia and H. pylori infection were randomised to receive esomeprazole, amoxicillin and clarithromycin for either 7 days (EAC 7) or 14 days (EAC 14). Compliance and side-effects were assessed 2 weeks after the start of therapy and H. pylori eradication was assessed by stool antigen tests 4 weeks after treatment. Results. Both the intention-to-treat (ITT; N=120) and per protocol (PP; N=97) analyses showed no significant differences between the eradication rates of EAC 7 (ITT 76.7%; PP 92%) and EAC 14 (ITT 73.3%; PP 93.6%) (ITT p=0.67; PP p=0.76). Poor compliance was reported in one patient in the EAC 14 group. The incidence of adverse events was comparable in the two groups. Conclusion. One-week and 2-week triple treatments for H. pylori eradication are similar in terms of efficacy, safety and patient compliance.

摘要

背景

幽门螺杆菌与多种上消化道疾病相关,包括慢性胃炎、消化性溃疡病和胃癌。质子泵抑制剂三联疗法被认为是幽门螺杆菌根除的标准方案,但治疗的最佳持续时间仍存在争议。为了预防感染和并发症,应在当地开展研究,评估一个国家的幽门螺杆菌根除率。目的:我们比较了 7 天和 14 天方案,以确定幽门螺杆菌根除的三联疗法最佳持续时间。方法:我们在肯尼亚内罗毕的 Aga Khan 大学医院进行了一项前瞻性随机对照试验,比较了 7 天和 14 天三联疗法方案对幽门螺杆菌的根除效果。120 例消化不良和幽门螺杆菌感染患者被随机分为两组,分别接受埃索美拉唑、阿莫西林和克拉霉素治疗 7 天(EAC7)或 14 天(EAC14)。在治疗开始后 2 周评估依从性和不良反应,在治疗结束后 4 周通过粪便抗原检测评估幽门螺杆菌的根除情况。结果:意向治疗(ITT;N=120)和按方案(PP;N=97)分析均显示,EAC7(ITT 根除率为 76.7%;PP 根除率为 92%)和 EAC14(ITT 根除率为 73.3%;PP 根除率为 93.6%)之间的根除率无显著差异(ITT p=0.67;PP p=0.76)。EAC14 组有 1 例患者报告依从性差。两组不良反应的发生率相似。结论:在疗效、安全性和患者依从性方面,1 周和 2 周的三联治疗方案用于幽门螺杆菌根除效果相似。

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