论文部分内容阅读
目的比较含铋剂的10 d方案初次根治幽门螺杆菌(Hp)失败后由雷贝拉唑、阿莫西林组成的两联方案和含雷贝拉唑、阿莫西林的标准四联方案补救治疗Hp感染的有效性和安全性,并进行成本-效果分析。方法收集从2014年1月至12月在上海中冶医院门诊以含铋剂的四联10 d方案初次根除Hp失败的患者113例,按随机数字表法分为两组。RA方案组57例:雷贝拉唑10 mg+阿莫西林0.5 g,每天4次,疗程14 d;RBAO方案组56例:雷贝拉唑20 mg+枸橼酸铋钾0.22 g+阿莫西林1.0 g+奥硝唑0.5 g,每天2次,疗程14 d。治疗结束至少4周后行~(13)C呼气试验检查,评价Hp根除情况。对Hp的根除率分别进行意向性分析(intention-to-test,ITT)和符合方案分析(per-protocol,PP)。对不良反应和依从性进行随访,以PP根除率进行成本-效果分析。结果 Hp根除率(ITT)在RA组(61.4%)低于RBAO组(75.0%),但差异无统计学意义(P=0.121);Hp根除率(PP)在RA组(64.8%)低于RBAO组(82.4%),差异有统计学意义(P=0.042)。不良反应发生率RA组(3.5%)低于RBAO组(16.1%),差异有统计学意义(P=0.024)。两组临床试验的完成率分别为94.7%和91.1%,依从性差异无统计学意义(P=0.490)。成本-效果分析显示,每获得一个单位效果,RA组成本(5.75元)略低于RBAO组(5.88元)。结论含雷贝拉唑、阿莫西林的标准四联方案补救根除Hp的疗效优于由雷贝拉唑、阿莫西林组成的两联方案,但是从安全性及药物经济学角度评价,两联方案略优于标准四联方案。
OBJECTIVE To compare the two-regimen program consisting of rabeprazole and amoxicillin after the first radical cure of Helicobacter pylori (Hp) and the standard quadruple salvage therapy with rabeprazole and amoxicillin Hp infection effectiveness and safety, and cost-effectiveness analysis. Methods From January 2014 to December 2014, 113 patients with failed Hp eradication for the first time in the Zhongye Hospital of Shanghai Metallurgical Corporation for 4 days and 10 days with bismuth were collected and divided into two groups according to the random number table. RA group 57 cases: rabeprazole 10 mg + amoxicillin 0.5 g, 4 times a day for 14 days; 56 cases of RBAO regimen: rabeprazole 20 mg + bismuth potassium citrate 0.22 g + amoxicillin 1.0 g + Ornidazole 0.5 g, 2 times a day, treatment 14 d. At least 4 weeks after the end of treatment line ~ (13) C breath test to assess the situation of Hp eradication. The eradication rates of Hp were analyzed by intention-to-test (ITT) and per-protocol (PP) respectively. Adverse reactions and follow-up were followed up for cost-effectiveness analysis with PP eradication rate. Results The Hp eradication rate (ITT) in RA group (61.4%) was lower than that in RBAO group (75.0%), but the difference was not statistically significant (P = 0.121) RBAO group (82.4%), the difference was statistically significant (P = 0.042). The incidence of adverse reactions in RA group (3.5%) was lower than that in RBAO group (16.1%), the difference was statistically significant (P = 0.024). The completion rates of the two groups of clinical trials were 94.7% and 91.1%, respectively, with no significant difference in compliance (P = 0.490). The cost-effectiveness analysis showed that for each unit effect obtained, the RA group cost (5.75 yuan) was slightly lower than the RBAO group (5.88 yuan). Conclusions The standard quadruple protocol containing rabeprazole and amoxicillin is superior to the two-drug regimen consisting of rabeprazole and amoxicillin in the eradication of Hp. However, in terms of safety and pharmacoeconomics, Slightly better than the standard program quadruple program.