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目的评价含四环素不同剂量和疗程的四联方案治疗幽门螺杆菌(Hp)的疗效和安全性。方法符合入选条件的Hp感染患者随机分为3组,治疗方案选用雷贝拉唑(10mg,bid)+胶体果胶铋(150mg,qid)+克拉霉素(500mg,bid),加四环素的四联疗法。A组四环素500mg,bid,疗程7d;B组四环素500mg,bid,疗程14d;C组四环素750mg,bid,疗程14d。观察疗效和不良反应。结果112例患者入选,106例完成整个研究过程。3组ITT分析Hp根除率分别为76.92%、84.21%、91.43%,各组间无统计学差异(χ2=2.991,P=0.224);PP分析根除率分别为81.08%、91.43%、94.18%,各组间亦无统计学差异(χ2=3.290,P=0.193)。3组不良反应发生率ITT分析分别为7.69%、15.79%、25.71%,PP分析分别为8.11%、17.14%、26.47%,A组与C组间有统计学差异(ITT:χ2=4.543,P=0.033;PP:χ2=4.391,P=0.036)。结论含四环素的四联方案根除Hp疗效理想,不良反应轻微,耐受性好,是一种可供选择的一线治疗方案。
Objective To evaluate the efficacy and safety of quadruple regimens containing different doses and courses of tetracycline in the treatment of Helicobacter pylori (Hp). Methods Patients with Hp infection who met the selection criteria were randomly divided into three groups. The treatment regimen consisted of rabeprazole (10 mg bid), colloidal bismuth pectin (150 mg qid), clarithromycin 500 mg bid, Combination therapy. A group of tetracycline 500mg, bid, treatment 7d; B tetracycline 500mg, bid, treatment 14d; C tetracycline 750mg, bid, treatment 14d. To observe the efficacy and adverse reactions. Results 112 patients were enrolled and 106 completed the entire study. The eradication rates of Hp in three groups were 76.92%, 84.21% and 91.43%, respectively (χ2 = 2.991, P = 0.224); the eradication rates of PP were 81.08%, 91.43% and 94.18% There was no significant difference between groups (χ2 = 3.290, P = 0.193). The incidences of adverse reactions in the three groups were 7.69%, 15.79% and 25.71%, respectively. The PP analysis was 8.11%, 17.14% and 26.47% respectively. There was a significant difference between group A and group C (ITT: χ2 = 4.543, P = 0.033; PP: χ2 = 4.391, P = 0.036). Conclusions Tetracycline-containing quadruple regimen is effective in eradicating Hp, with mild adverse reactions and good tolerability. It is an alternative first-line treatment option.