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基于左氧氟沙星的三联疗法用于一线幽门螺杆菌根除治疗:一项多中心、随机、对照临床研究

[Levofloxacin-based triple therapy for first-line Helicobacter pylori eradication treatment: a multi-central, randomized, controlled clinical study].

作者信息

Cheng Hong, Hu Fu-lian, Zhang Guo-xin, Shi Rui-hua, Du Yi-qi, Li Zhao-shen, Han Wei, Li Yan-qing, Wu Qin-dong, Qian Ke-da

机构信息

Department of Gastroenterology, First Hospital, Peking University, Beijing 100034, China.

出版信息

Zhonghua Yi Xue Za Zhi. 2010 Jan 12;90(2):79-82.

PMID:20356486
Abstract

OBJECTIVE

To compare efficacy and tolerability of 7-day standard triple therapy versus 7-day levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori (H. pylori) infection.

METHODS

Three hundred consecutive H.pylori positive patients were randomized to receive: clarithromycin, amoxicillin, lansoprazole (Group A: n = 150); or amoxicillin, levofloxacin, lansoprazole (Group B: n = 150). H. pylori status was rechecked by (13)C-urea breath test 4 weeks after the end of therapy.

RESULTS

The eradication rates in intention to treat (ITT) and per protocol (PP) analyses were: Group A, 74.5% (111/149) and 78.2% (111/142); and Group B, 82.4% (122/148) and 83.0%(122/147). Although the eradication rate achieved with levofloxacin-based triple therapy was higher than that with standard therapies in either ITT or PP analysis, but no significantly difference was found between the two triple therapies. The incidence of side effects was similar among groups.

CONCLUSIONS

A 7-day levofloxacin-based triple therapy can achieve higher H.pylori eradication rate than standard regimen. The levofloxacin-based regimen can be one effective therapy for the first-line anti-H.pylori treatment.

摘要

目的

比较7天标准三联疗法与7天左氧氟沙星三联疗法对幽门螺杆菌(H. pylori)感染一线治疗的疗效和耐受性。

方法

连续纳入300例H. pylori阳性患者,随机分为两组:克拉霉素、阿莫西林、兰索拉唑组(A组:n = 150);阿莫西林、左氧氟沙星、兰索拉唑组(B组:n = 150)。治疗结束4周后通过(13)C-尿素呼气试验复查H. pylori感染情况。

结果

意向性分析(ITT)和符合方案分析(PP)的根除率分别为:A组,74.5%(111/149)和78.2%(111/142);B组,82.4%(122/148)和83.0%(122/147)。虽然在ITT或PP分析中,左氧氟沙星三联疗法的根除率高于标准疗法,但两种三联疗法之间差异无统计学意义。两组副作用发生率相似。

结论

7天左氧氟沙星三联疗法比标准方案可获得更高的H. pylori根除率。基于左氧氟沙星的方案可作为一线抗H. pylori治疗的有效方案之一。

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