含兰索拉唑口崩片四联根除HP方案的临床对比研究

Clinical comparative study of standard quadruple therapy eradication of HP with lansoprazole oral disintegrating tablets

目的观察不同吸收途径的同类型质子泵抑制剂(PPI)为基础的相同方案根除幽门螺旋杆菌(HP)的效果。方法选择经13C尿素呼气试验、幽门螺旋杆菌抗体阳性确诊的178例体检无症状幽门螺旋杆菌感染者,随机分为对照组89例及观察组89例,对照组:兰索拉唑肠溶片(30mg,bid),观察组:兰索拉唑口崩片(30mg,bid),两组都采用标准四联疗法治疗10d,均服用阿莫西林胶囊(1000mg,bid)+呋喃唑酮片(100mg,bid)+枸橼酸铋钾胶囊(220mg,bid),根除幽门螺旋杆菌疗程结束4周及24周后复查13C尿素呼气试验,按照ITT分析和PP分析计算2组患者HP根除率及95%CI,并观察不良反应发生率及24周后复发率。结果按ITT分析,对照组及观察组的HP根除率分别是70.79%(95%CI 61.34%-80.24%)、83.15%(95%CI 75.37%-90.93%),差异有统计学意义(χ~2=3.384,P≤0.05);按照PP分析,对照组及观察组的HP根除率分别是79.75%(95%CI 71.19%-88.31%)、94.87%(95%CI 89.97%-99.77%),差异有显著统计学意义(χ~2=8.077,P<0.01),24周后对照组复发率为11.11%(7/63),观察组复发率为10.81%(8/74),两组比较差异无统计学意义(χ~2=0.003,P>0.05),不良反应发生率两组间比较差异无统计学意义(P>0.05)。结论以兰索拉唑口崩片为基础的根除幽门螺旋杆菌标准四联疗法具有极高的根除率,安全性高,不良反应少,可推荐为一线的根除幽门螺旋杆菌标准四联疗法选择用药。

Objective To observe the effect of the same type of proton pump inhibitors(PPI)with different absorption pathways on the eradication of Helicobacter pylori(HP).Methods 178 cases of asymptomatic Helicobacter pylori infection confirmed by 13C urea breath test and positive antibody to Helicobacter pylori were randomly divided into control group(89 cases)and observation group(89 cases).Control group:lansoprazole enteric-coated tablet 30 mg bid,observation group:lansoprazole oral disintegrating table 30 mg bid,both groups were treated with standard quadruple therapy for 10 days,both took amoxicillin capsule 1000 mg bid,furazolidone tablet 100mg bid and bismuth potassium citrate capsule 220mg bid.After 4 weeks and 24 weeks of eradication of Helicobacter pylori,13C urea breath test was reexamined.HP eradication rate and 95%CI were calculated according to ITT analysis and PP analysis.The incidence of adverse reactions and recurrence rate after 24 weeks were observed.Results According to ITT analysis,the eradication rate of HP in the control group and the observation group were 70.79%(95%CI 61.34%-80.24%),83.15%(95%CI 75.37%-90.93%),the difference was statistically significant(χ2=3.384,P≤0.05);According to PP analysis,HP eradication rates in the control group and the observation group were 79.75%(95%CI 71.19%-88.31%),94.87%(95%CI 89.97%-99.77%),the difference was statistically significant(χ2=8.077,P<0.01).The recurrence rate in the control group was 11.11%(7/63)after 24 weeks,the recurrence rate in the observation group was 10.81%(8/74),there was no significant difference between the two groups(χ2=0.003,P>0.05),and there was no significant difference in the incidence of adverse reactions between the two groups.Conclusion The standard quadruple therapy for eradication of Helicobacter pylori based on lansoprazole oral disintegrating table has a high eradication rate,high safety and few adverse reactions.It can be recommended as a first-line standard quadruple therapy for the eradication of Helicobacter pylori.