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目的评估含阿莫西林奥硝唑和含克拉霉素甲硝唑的两种四联疗法根除幽门螺杆菌(Hp)感染的疗效和安全性。方法 2014年1月至9月纳入接受胃镜检查诊断为慢性胃炎(包括萎缩性和非萎缩性胃炎)、组织切片染色法检测Hp阳性且既往未接受过Hp根除治疗的患者240例,随机分为试验组(n=118)与对照组(n=122)。试验组治疗方案:雷贝拉唑20 mg bid+枸橼酸铋钾0.22 g bid+阿莫西林1.0 g bid+奥硝唑0.5 g bid)×10 d。对照组治疗方案:雷贝拉唑20 mg bid+枸橼酸铋钾0.22 g bid+克拉霉素0.5g bid+甲硝唑0.4 g bid)×10 d。疗程结束4周后复查13C-尿素呼气试验(13C-UBT),评估Hp根除疗效,同时观察治疗期间及治疗结束后四周内的不良反应发生情况。结果按意向治疗(ITT)和按方案(PP)分析,试验组根除率分别为86.4%和91.9%,对照组分别为73.0%和80.9%,试验组ITT和PP根除率均显著高于对照组(P均<0.05)。试验组的不良反应发生率显著低于对照组(5.9%vs 22.1%,P<0.05),所有不良反应均在停药或适当处理后消失。结论对于非青霉素过敏的初治患者,含阿莫西林奥硝唑四联方案的疗效满意、安全性高,其疗效和安全性均显著高于含克拉霉素甲硝唑四联方案,可能更适用于临床。
Objective To evaluate the efficacy and safety of two quadruple therapies including ornithine ornidazole and metronidazole containing clarithromycin in the eradication of Helicobacter pylori (Hp) infection. Methods From January 2014 to September 2014, 240 patients diagnosed as chronic gastritis (including atrophic and non-atrophic gastritis) by gastroscopy, Hp positive by histological section staining and without Hp eradication were randomly divided into The experimental group (n = 118) and the control group (n = 122). The experimental group treatment options: rabeprazole 20 mg bid + bismuth potassium citrate 0.22 g bid + amoxicillin 1.0 g bid + ornidazole 0.5 g bid) × 10 d. Control group treatment options: rabeprazole 20 mg bid + bismuth potassium citrate 0.22 g bid + clarithromycin 0.5 g bid + metronidazole 0.4 g bid) × 10 d. The 13C-urea breath test (13C-UBT) was reviewed 4 weeks after the end of the course of treatment to evaluate the efficacy of Hp eradication and to observe the adverse reactions during and after treatment. Results According to ITT and PP analysis, the eradication rates were 86.4% and 91.9% in the test group and 73.0% and 80.9% in the control group respectively. The ITT and PP eradication rates in the experimental group were significantly higher than those in the control group (P <0.05). The incidence of adverse reactions in the experimental group was significantly lower than that in the control group (5.9% vs 22.1%, P <0.05). All the adverse reactions disappeared after withdrawal or appropriate treatment. Conclusion For non-penicillin-naive patients, the efficacy of amoxicillin ornidazole quadruple regimen is satisfactory and safe, and its efficacy and safety are significantly higher than those with metronidazole containing clarithromycin, which may be more Suitable for clinical use.