不同疗程伴同疗法与含铋剂四联疗法根除幽门螺杆菌的疗效

Efficacy of different courses of concomitant therapy and bismuth containing quadruple therapy for eradication of Helicobacter pylori

目的:观察不同疗程的伴同疗法与含铋剂四联疗法根除幽门螺杆菌(Helicobacter pylori,H.pylori)的疗效和安全性.方法:随机选取2014-07-01/2015-07-01郑州大学第一附属医院消化内科门诊就诊,行胃镜检查明确胃部疾病(慢性糜烂性胃炎或消化性溃疡)并行13C呼气试验检测阳性的282例患者,按照就诊顺序,分别采用4组治疗方案:A组:埃索美拉唑镁肠溶片20 mg bid+克拉霉素片500 mg bid+阿莫西林胶囊1000 mg bid+甲硝唑片400 mg bid,7 d;B组:埃索美拉唑镁肠溶片20 mg bid+克拉霉素片500 mg bid+阿莫西林胶囊1000 mg bid+枸橼酸铋钾胶囊220 mg bid,7 d;C组:埃索美拉唑镁肠溶片20 mg bid+克拉霉素片500 mg bid+阿莫西林胶囊1000 mg bid+甲硝唑片400 mg bid,14 d;D组:埃索美拉唑镁肠溶片20 mg bid+克拉霉素片500 mg bid+阿莫西林胶囊1000mg bid+枸橼酸铋钾胶囊220 mg bid,14 d.根除治疗结束后4 wk复查13C呼气试验.结果:本研究共纳入患者282例,按符合方案(per-protocol,PP)分析A组H.pylori根除率为84.06%,B组为83.33%,C组为94.12%,D组为97.91%;按意向性(intention to treat,ITT)分析A组为80.56%,B组为78.57%,C组为92.96%,D组为91.55%,其中A组与B组、C组与D组的H.pylori根除率,经PP分析及ITT分析差异均无统计学意义;A组与C组、B组与D组的H.pylori根除率,经PP分析及ITT分析差异均有统计学意义(P<0.05);各组不良反应发生率及症状缓解率差异均无统计学意义.结论:伴同疗法和含铋剂四联疗法2 wk方案H.pylori根除率高、安全性良好且症状缓解率高,可推荐为临床根除H.pylori的一线治疗方案.

AIM：To compare the efficacy and safety of different protocols for eradication of Helicobacter pylori（H.pylori）.METHODS：We enrolled 282 consecutive patients with erosive gastritis or peptic ulcer who tested positive in the ^（13）C breath assay at the First Affiliated Hospital of Zhengzhou University between July 1,2014 and July 1,2015.All patients were randomly allocated to receive either esomeprazole enteric capsule20 mg,clarithromycin 500 mg,amoxicillin1000 mg and metronidazole 400 mg twice daily for 7 d（Group A）,or esomeprazole enteric capsule 20 mg,clarithromycin 500 mg,amoxicillin 1000 mg and Bismuth potassium citrate capsules 220 mg twice daily for 7 d（Group B）,or esomeprazole enteric capsules 20 mg,clarithromycin 500 mg,amoxicillin 1000 mg and metronidazole 400 mg twice daily for 14 d（Group C）,or esomeprazole enteric capsules20 mg,clarithromycin 500 mg,amoxicillin 1000 mg and bismuth potassium citrate capsules220 mg twice daily for 14 d（Group D）.The^（13）C breath assay was reassessed at four weeks after the cessation of therapy.RESULTS：Of 282 patients recruited in the study,the per protocol eradication rate was84.06%in group A,83.33%in group B,94.12%in group C,and 97.91%in group D;the intentionto-treat eradication rate was 80.56%in group A,78.57%in group B,92.96%in group C,and91.55%in group D.No significant differences in both per protocol and intention-to-treat eradication rates were found between groups A and B,or between groups C and D（P〈0.05 for all）,but significant differences in both per protocol and intention-to-treat eradication rates were found between groups A and C,and between groups B and D（P〈0.05 for all）.All groups did not differ statistically in terms of the incidence of adverse events and the rate of symptom amelioration（P〈0.05 for both）.CONCLUSION：Both 14-day concomitant therapy and bismuth containing quadruple therapy achieved higher eradication rates of H.pylori and higher safety and should be recommended as the first-line protocol for eradication of H.pylori.