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幽门螺杆菌治疗两种管理策略的比较:临床研究与成本效益分析。

Comparison of two management strategies for Helicobacter pylori treatment: clinical study and cost-effectiveness analysis.

作者信息

Marko Dritana, Calvet Xavier, Ducons Julio, Guardiola Jordi, Tito Llucia, Bory Felipe

机构信息

Centre de Recerca d'Economia del Benestar, Parc Científic de Barcelona, Universitat de Barcelona, Barcelona, Spain.

出版信息

Helicobacter. 2005 Feb;10(1):22-32. doi: 10.1111/j.1523-5378.2005.00288.x.

Abstract

BACKGROUND

First-line proton pump inhibitor-based triple and quadruple therapies for Helicobacter pylori eradication present similar levels of efficacy. Cross-over treatment (quadruple following triple failure, and triple following quadruple failure) seems the most sensible approach to treatment failures, but the two strategies -'quadruple first' versus 'triple first'- have not been previously compared. The aims of our study were to assess the usefulness and the cost-effectiveness of the two treatment strategies.

MATERIAL AND METHODS

Forty-nine out of 344 patients included in a previous study comparing triple therapy - 7 days of omeprazole, amoxicillin and clarithromycin twice a day - with quadruple therapy - 7 days of omeprazole twice a day, plus tetracycline, metronidazole and bismuth subcitrate three times a day - failed initial treatment and were assigned to cross-over therapy. Cure was determined by urea breath test. A decision analysis was performed to compare the two eradication strategies.

RESULTS

Intention to treat cure rates were 46% (10/22 patients; 95% CI 24-68%) for second-line triple therapy and 63% (17/27 patients; 95% CI 42-81%) for second-line quadruple therapy. Per protocol cure rates were 71% and 85%, respectively. Intention to treat cure rates were 87% (95% CI 81-92%) for the 'triple first' versus 86% (95% CI 80-91%) for the 'quadruple first' strategy (p = .87). The 'quadruple first' strategy was more cost-effective. The incremental cost of 'triple first' strategy per person was 19 in the low-cost area and 65 US dollars in the high-cost area.

CONCLUSIONS

The effectiveness of 'triple first' and 'quadruple first' strategies is similar, although the latter seems slightly more cost-effective.

摘要

背景

基于一线质子泵抑制剂的三联和四联疗法用于根除幽门螺杆菌的疗效相似。交叉治疗(三联疗法失败后采用四联疗法,四联疗法失败后采用三联疗法)似乎是处理治疗失败情况最合理的方法,但此前尚未比较过“先四联”与“先三联”这两种策略。我们研究的目的是评估这两种治疗策略的实用性和成本效益。

材料与方法

在之前一项比较三联疗法(奥美拉唑、阿莫西林和克拉霉素,每日两次,共7天)与四联疗法(奥美拉唑每日两次,共7天,加四环素、甲硝唑和枸橼酸铋钾,每日三次)的研究中纳入的344例患者中,有49例初始治疗失败,被分配接受交叉治疗。通过尿素呼气试验确定治愈情况。进行决策分析以比较两种根除策略。

结果

二线三联疗法的意向性治疗治愈率为46%(22例患者中的10例;95%置信区间24 - 68%),二线四联疗法为63%(27例患者中的17例;95%置信区间42 - 81%)。符合方案分析的治愈率分别为71%和85%。“先三联”策略的意向性治疗治愈率为87%(95%置信区间81 - 92%),“先四联”策略为86%(95%置信区间80 - 91%)(p = 0.87)。“先四联”策略更具成本效益。“先三联”策略在低成本地区每人的增量成本为19美元,在高成本地区为65美元。

结论

“先三联”和“先四联”策略的有效性相似,尽管后者似乎在成本效益上略胜一筹。

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