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[米诺环素四联疗法与个体化疗法用于幽门螺杆菌感染再治疗的比较]

[Minocycline quadruple versus tailored therapy in retreatment of Helicobacter pylori infection].

作者信息

Zhang Lingyun, Zhou Liya, Song Zhiqiang, Ding Yu, Bai Peng

机构信息

Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China.

Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China; Email:

出版信息

Zhonghua Nei Ke Za Zhi. 2015 Dec;54(12):1013-7.

Abstract

OBJECTIVE

To compare eradication rates, safety and compliance of minocycline quadruple and tailored therapies in patients retreated for Helicobacter pylori (H.pylori) infection.

METHODS

Between January 2014 and June 2014, 135 patients with dyspepsia (18-70 years) and H. pylori infection after at least one previous eradication treatment at a tertiary hospital were randomly assigned to a 10-day treatment with minocycline quadruple therapy versus tailored triple regimen of PPI, amoxicillin and a third antibiotic. In the group of tailored therapy, medications were adjusted based on clarithromycin sensitivity and cytochrome P450 isoenzyme 2C19 genotype. Eradication status was assessed 4-12 weeks after treatment.

RESULTS

Although H. pylori eradication rates were higher in the minocycline therapy group than that in the tailored therapy group in intention-to-treat [84.1% (95%CI 75.0%-93.2%) vs 75.8%(95%CI 65.1%-86.5%), P=0.245] and per-protocol [88.3% (95%CI 80.3%-96.3%) vs 79.7%(95%CI 69.7%-89.7%), P=0.197] analyses, the differences between the two groups were not statistically significant.The incidence of adverse effects and compliance between the two groups were also comparable.

CONCLUSIONS

The tailored therapy in this study had a poor eradication efficacy in the retreated patients with H. pylori infection.Minocycline quadruple therapy achieved a relatively satisfactory eradication efficacy and may be an alternative choice for the retreatment of H. pylori infection.

CLINICAL TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR-TRC-13003975.

摘要

目的

比较米诺环素四联疗法与个体化疗法对幽门螺杆菌(H.pylori)感染再治疗患者的根除率、安全性及依从性。

方法

2014年1月至2014年6月,选取一家三级医院中135例年龄在18 - 70岁、有消化不良症状且至少接受过一次H.pylori根除治疗的患者,将其随机分为两组,一组接受为期10天的米诺环素四联疗法,另一组接受基于质子泵抑制剂(PPI)、阿莫西林和第三种抗生素的个体化三联疗法。在个体化治疗组中,根据克拉霉素敏感性和细胞色素P450同工酶2C19基因型调整用药。治疗后4 - 12周评估根除情况。

结果

在意向性分析[84.1%(95%CI 75.0% - 93.2%)vs 75.8%(95%CI 65.1% - 86.5%),P = 0.245]和符合方案分析[88.3%(95%CI 80.3% - 96.3%)vs 79.7%(95%CI 69.7% - 89.7%),P = 0.197]中,虽然米诺环素治疗组的H.pylori根除率高于个体化治疗组,但两组之间的差异无统计学意义。两组的不良反应发生率和依从性也相当。

结论

本研究中的个体化疗法对H.pylori感染再治疗患者的根除疗效较差。米诺环素四联疗法取得了相对满意的根除疗效,可能是H.pylori感染再治疗的一种替代选择。

临床试验注册号

中国临床试验注册中心,ChiCTR - TRC - 13003975。

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