Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.
Gut Liver. 2013 Jul;7(4):406-10. doi: 10.5009/gnl.2013.7.4.406. Epub 2013 Jun 11.
BACKGROUND/AIMS: Several rescue therapies have been recommended to eradicate Helicobacter pylori infection in patients with a failure of first-line eradication therapy, but they still fail in more than 20% of cases. The aim of this study was to evaluate the efficacy and safety of levofloxacin, metronidazole, and lansoprazole (LML) triple therapy relative to quadruple therapy as a second-line treatment.
In total, 113 patients who failed first-line triple therapy for H. pylori infection were randomly assigned to two groups: LML for 7 days and tetracycline, bismuth subcitrate, metronidazole and lansoprazole (quadruple) for 7 days.
According to intention-to-treat analysis, the infection was eradicated in 38 of 56 patients (67.9%) in the LML group and 48 of 57 (84.2%) in the quadruple group (p=0.042). Per-protocol analysis showed successful eradication in 38 of 52 patients (73.1%) from the LML group and 48 of 52 (92.3%) from the quadruple group (p=0.010). There were no significant differences in the adverse effects in either treatment group.
LML therapy is less effective than quadruple therapy as a second-line treatment for H. pylori infection. Therefore, quadruple therapy should be considered as the primary second-line strategy for patients experiencing a failure of first-line H. pylori therapy in Korea.
背景/目的:已有多种补救疗法被推荐用于根除一线治疗失败的幽门螺杆菌感染,但仍有 20%以上的病例失败。本研究旨在评估左氧氟沙星、甲硝唑和兰索拉唑(LML)三联疗法相对于四联疗法作为二线治疗的疗效和安全性。
共有 113 例因幽门螺杆菌感染一线三联治疗失败的患者被随机分为两组:LML 组(7 天)和四环素、枸橼酸铋钾、甲硝唑和兰索拉唑(四联)组(7 天)。
根据意向治疗分析,LML 组 56 例患者中有 38 例(67.9%)感染根除,四联组 57 例患者中有 48 例(84.2%)感染根除(p=0.042)。按方案分析显示,LML 组 52 例患者中有 38 例(73.1%)感染根除,四联组 52 例患者中有 48 例(92.3%)感染根除(p=0.010)。两组的不良反应无显著差异。
LML 疗法作为二线治疗幽门螺杆菌感染的效果不如四联疗法。因此,在韩国,对于一线幽门螺杆菌治疗失败的患者,四联疗法应被视为主要的二线策略。