高剂量二联疗法用于根除幽门螺杆菌的疗效观察

The efficacy and safety of high-dose dual therapy for the primary eradication of of Helicobacter pylori

目的评估高剂量二联疗法用于根除幽门螺杆菌(Hp)的疗效及安全性。方法收集幽门螺杆菌感染且初次治疗的577例患者资料,分为高剂量二联组和含铋剂四联组,其中高剂量二联组277例,含铋剂四联组300例,疗程均为14 d,治疗结束后观察各组根除率及不良反应发生率。结果高剂量二联组中有258例患者完成试验,19例退出试验。含铋剂四联组中有282例患者完成试验,18例退出试验。高剂量二联组及含铋剂四联组按意向治疗(ITT)分析的Hp根除率分别是86.2%和88.0%,按方案治疗(PP)分析的Hp根除率分别是92.6%和93.6%。根除率在2组之间的差异无统计学意义(χ^(2)=0.43、0.24,P>0.05)。高剂量二联组的不良反应发生率为5.0%,含铋剂四联组的不良反应发生率为14.9%,其差异存在统计学意义(χ^(2)=14.30,P<0.05)。结论高剂量二联疗法对幽门螺杆菌的根除率与含铋剂四联疗法的根除率相当,且不良反应发生率低,安全性更高。

Objective To evaluate the efficacy and safety of high-dose dual therapy for the eradication of Helicobacter pylori(Hp).Method A total of 577 patients with Helicobacter pylori infection initially treated were randomly divided into two groups:the high-dose dual therapy group(277 cases)and the bismuth-containing quadruple therapy group(300 cases),the course of treatment was 14 days.After treatment,the eradication rates and drug-related adverse events were compared between the two groups.Result In the high-dose dual therapy group,258 patients completed the trial,and 19 patients withdrew from the trial.In the bismuth-containing quadruple group,282 patients completed the trial,and 18 patients withdrew from the trial.The eradication rates of HP by intention to treat(ITT)analysis were 86.2% and 88.0%,respectively.The eradication rates of HP by protocol treatment(PP)analysis were 92.6% and 93.6%,respectively.There was no significant difference in the eradication rate between the two groups(χ^(2)=0.43、0.24,P>0.05).The incidence of adverse reaction in the high-dose dual therapy group was 5.0%,and the incidence of adverse reaction in the bismuth-containing quadruple group was 14.9%.There was significant differences between the two groups(χ^(2)=14.30,P<0.05).Conclusion The eradication rates of high-dose dual therapy for HP is comparable to that of bismuth-containing quadruple therapy,with a lower incidence of adverse reaction and higher safety.