改良二联方案治疗幽门螺杆菌感染的疗效观察

Efficacy and safety of modified dual therapy for the eradication treatment of Helicobacter pylori infection

目的评价改良二联方案治疗幽门螺杆菌(Hp)感染的疗效及安全性。方法纳入2019年12月1日至2020年12月31日在该院确诊为Hp感染的240例患者,根据不同治疗方案将其分为4组:改良二联治疗组(A组,艾司奥美拉唑+阿莫西林);含阿莫西林+克拉霉素四联治疗组(B组,艾司奥美拉唑+胶体果胶铋+阿莫西林+克拉霉素);含阿莫西林+左氧氟沙星四联治疗组(C组,艾司奥美拉唑+胶体果胶铋+阿莫西林+左氧氟沙星);含克拉霉素+替硝唑四联治疗组(D组,艾司奥美拉唑+枸橼酸铋钾+克拉霉素+替硝唑),每组60例,疗程均为14 d,疗程结束4周后复查^(13)C呼气试验,观察各组疗效及不良反应。结果A组60例患者中,完成试验58例,其中1例因不能耐受皮疹退出,1例因拒绝复查退出。B组有3例因拒绝复查退出试验,剩余57例患者完成试验。C、D两组各60例患者全部完成试验。A、B、C、D组按意向治疗(ITT)分析的Hp根除率分别为88.33%、71.67%、68.33%、56.67%,不良反应率分别为8.33%、11.67%、13.33%、10.00%;按方案治疗(PP)分析的Hp根除率分别为91.38%、75.44%、68.33%、56.67%,不良反应率分别为6.90%、12.28%、13.33%、10.00%。ITT及PP分析根除率在各组间比较,差异均有统计学意义(P<0.05);而各组不良反应发生率的比较,差异无统计学意义(P>0.05)。结论改良二联方案根除率明显高于含阿莫西林+克拉霉素、含阿莫西林+左氧氟沙星及含克拉霉素+替硝唑的四联方案,且安全性与四联方案相当。

Objective To evaluate the efficacy and safety of the modified dual therapy in the eradication treatment of Helicobacter pylori(Hp)infection.Methods A total of 240 patients diagnosed with Hp infection at the hospital from December 1,2019 to December 31,2020 were included.The patients were divided into the A group(received esomeprazole 20 mg Qid+amoxicillin 0.75 g Qid),the B group(received esomeprazole 20 mg Bid+colloidal pectin bismuth 200 mg Bid+amoxicillin 1 g Bid+clarithromycin 0.5 g Bid),the C group(received esomeprazole 20 mg Bid+colloidal pectin bismuth 200 mg Bid+amoxicillin 1 g Bid+levofloxacin 0.5 g Qd)and the D group(received esomeprazole 20 mg Bid+bismuth potassium citrate 220 mg Bid+Clarithromycin 0.5 g Bid+Tinidazole 0.5 g Bid).A total of60 patients were allocated in each group and the treatment course lasted for 14 days.13 Curea breath test was rechecked four weeks after the treatment,and the efficacy and adverse events were evaluated.Results In the A group,58 patients completed the follow-up,but one patient with drawed due to the intolerance to drug-related rash and one patient refused to reexamine.In the B group,57 patients completed the follow-up but three patients with drawed.In the C and D groups,all patients completed the follow-up.According to the intention to treatment analysis(ITT),the eradication rates in the four groups were 88.33%,71.67%,68.33%and 56.67%,and the adverse event rates were 8.33%,11.67%,13.33%and 10.00%,respectively.According to the treatment plan(PP),the eradication rates were 91.38%,75.44%,68.33%and 56.67%,and the adverse event rates were 6.90%,12.28%,13.33%and 10.00%,respectively.ITT and PP analysis showed statistically significant differences in the eradication rate among all groups(P<0.05),and there was no statistical significance in the adverse event rates(P>0.05).Conclusion The eradication rate of the modified dual therapy is superior to the quadruple therapy containing amoxicillin and clarithromycin,amoxicillin and levofloxacin,or clarithromycin and tinidazole.The safety of the modified dual therapy is not inferior to these quadruple therapy.