含左氧氟沙星三联疗法一线治疗幽门螺杆菌感染:多中心随机对照临床研究

Abstract

目的 观察含左氧氟沙星的三联疗法对幽门螺杆菌(Hp)根除效果及其患者依从性,比较传统的三联疗法与含左氧氟沙星的三联疗法对Hp的根除率.方法 为全国多中心随机平行对照临床研究,研究对象为既往未接受过根除治疗的Hp感染患者,将所有入选患者按照分层随机分为兰索拉唑+阿莫丙林+左氧氟沙星治疗组(LAL组)和兰索拉唑+阿莫西林+克拉霉素治疗组(LAC组),其中兰索拉唑30 mg 2次/d,阿莫西林1000 mg 2次/d,左氧氟沙星500 mg 1次/d,克拉霉素500mg 2次/d,均服药7 d.疗程结束4周后,采用尿素呼气试验判断根除效果,结果阴性者判断为Hp根除.共有300例Hp检测阳性的患者纳入研究,每组150例,平均年龄48.1岁,其中男153例;胃溃疡18例,十二指肠溃疡56例,慢性胃炎226例.结果 按符合方案(PP)分析Hp根除率,LAL组83.0%(122/147),LAC组78.2%(111/142),差异无统计学意义(P＞0.05);按意向治疗(ITT)分析,LAL组82.4%(122/148),LAC组74.5%(111/149),差异亦无统计学意义(P＞0.05).结论 含左氧氟沙星、阿莫西林的三联疗法作为一线根除Hp的治疗方案,可以获得较好的根除率,该方案患者依从性好,不良反应发牛率低,可以被推荐用于一线治疗Hp感染分案.

Objective To compare efficacy and tolerability of 7-day standard triple therapy versus 7-day levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori ( H. pylori) infection.Methods Three hundred consecutive H. pylori positive patients were randomized to receive: clarithromycin,amoxicillin, lansoprazole (Group A: n = 150) ; or amoxicillin, levofloxacin, lansoprazole (Group B: n =150). H. pylori status was rechecked by ~(13)C-urea breath test 4 weeks after the end of therapy. Results The eradication rates in intention to treat (ITT) and per protocol (PP) analyses were: Group A, 74. 5% ( 111/149) and 78. 2% (111/142) ; and Group B, 82.4% (122/148) and 83.0% (122/147). Although the eradication rate achieved with levofloxacin-based triple therapy was higher than that with standard therapies in either ITT or PP analysis, but no significantly difference was found between the two triple therapies. The incidence of side effects was similar among groups. Conclusions A 7-day levofloxacin-based triple therapy can achieve higher H. pylori eradication rate than standard regimen. The levofloxacin-based regimen can be one effective therapy for the first-line anti-H, pylori treatment.