瑞巴派特四联疗法根除幽门螺旋杆菌的临床研究

Clinical Research of Rebamipide -based Quadruple Therapy for Helicobacter Pylori Eradication

目的观察和比较含瑞巴派特和铋剂的两种方案根除幽门螺旋杆菌（Hp）药物成本与效果的关系。方法124例患者随机分为试验组和对照组。试验组65例，给予兰索拉唑30mg、阿莫西林1．0g、呋喃唑酮0．1g，每天2次，及瑞巴派特0．1g每天3次；对照组59例给予兰索拉唑30mg、阿莫西林1．0g、呋喃唑酮0．1g和胶体酒石酸铋220mg，每天2次。2组疗程均10天。治疗第38天以14C尿素呼气试验结果判断Hp根除情况，分析疗效及药物经济学，记录和分析出现的不良反应。结果两种方案的根除率分别为72．3％（47／65）和81．4％（48／59），差异无统计学意义（P〉0．05）；而药物成本分别为164．95元和250．1元，试验组成本-效果分析优于对照组，差异有统计学意义（P〈0．05）。试验组和对照组的不良反应发生率分别为12．31％（8／65）和15．26％（9／59），差异无统计学意义（P〉0．05），两组均未见严重不良反应。结论含瑞巴派特四联方案与含铋剂四联方案相比疗效和安全性接近，但前者价格合理，适于临床应用。

Objective To observe and compare the efficacy and cost - effective of rebamipide - based quadruple therapy versus bismuth - based quadruple therapy. Methods 124 patients were randomly assigned to treatment group and control group. Lansoprazole 30 mg, amoxicillin 1000 mg,furazolidone 100 mg twice a day and rebamipide 100 mg three times a day were administrated to 65 patients in treatment group. Lansoprazole 30 mg, amoxicillin 1000 mg, furazolidone 100 mg and Bismuth 220 mg twice a day were administrated to 59 patients in control group. Courses of treatment were both 10 days. Hp eradication was estimated by 14C urea breath test at the 38th day after treatment. Cost - effectiveness was analyzed;adverse effects were recorded and analyzed. Data were analyzed by chi square test. Results The eradication rates of treatment group and control group were 72.3% （47/65） and 81.4% （48/59） respectively. There was no significant difference （ P 〉 0.05 ） between these two groups. The cost in treatment group and control group were 164.95 and 250.1 yuan. Cost - effectiveness in treatment group was significantly better than that in control group （P 〈 0.05）. Rates of side effects in treatment group and control group were 12.31% （8/65）and 15.26% （9/59）re- spectively. There was no significant difference between the two groups （P 〉 0.05 ）. No serious adverse effect was observed in two groups. Conclusion Effectiveness and safety are ahnost the same between the two groups. However, Rebamipide - based quadruple therapy has better cost - effectiveness, which is suitable for clinical application.