Oh Dong Hyun, Lee Dong Ho, Kang Kyu Keun, Park Young Soo, Shin Cheol Min, Kim Nayoung, Yoon Hyuk, Hwang Jin Hyeok, Jeoung Sook Hyang, Kim Jin Wook, Jang Eun Sun, Jung Hyun Chae
J Gastroenterol Hepatol. 2014 Jun;29(6):1171-6. doi: 10.1111/jgh.12518.
Recent prospective studies have shown that the sequential therapy has not achieved the target Helicobacter pylori eradication rate of > 80% in Korea. The aim of this study was to therefore assess the efficacy of the hybrid therapy as a first-line treatment for H. pylori eradication in a prospective trial.
From December 2012 to August 2013, 184 patients with confirmed H. pylori infections received either the 14-day hybrid therapy or the 14-day sequential therapy. Eradication outcomes were evaluated using a 13C-urea breath test at least 4 weeks after treatment cessation.
A total of 184 patients (90 receiving hybrid treatment and 94 receiving sequential treatment) completed the study. The eradication rates of the hybrid and sequential therapy groups were 81.1% (73/90; 95% confidence interval [CI] = 73.0-89.2%) and 79.8% (75/94; 95%CI = 71.7-87.9%), respectively, by intention-to-treat analysis (P = 0.821). By per protocol analysis, eradication rates were 85.9% (73/85; 95%CI = 78.5-93.3%) and 82.0% (73/89; 95%CI = 74.0-89.9%; P = 0.489), respectively. There were no significant intergroup differences in treatment compliance or discontinuation induced by severe side effects.
The hybrid therapy achieved acceptable eradication rate (85.9%), but not statistically significantly higher rates than the sequential therapy (82.0%). Further studies are therefore needed to identify first-line treatments with even better eradication rates in the Korean population.
近期的前瞻性研究表明，序贯疗法在韩国尚未达到幽门螺杆菌根除率>80%的目标。因此，本研究的目的是在一项前瞻性试验中评估混合疗法作为幽门螺杆菌根除一线治疗的疗效。
2012年12月至2013年8月，184例确诊幽门螺杆菌感染的患者接受了14天的混合疗法或14天的序贯疗法。在停止治疗至少4周后，使用13C尿素呼气试验评估根除结果。
共有184例患者（90例接受混合治疗，94例接受序贯治疗）完成了研究。意向性分析显示，混合疗法组和序贯疗法组的根除率分别为81.1%（73/90；95%置信区间[CI]=73.0-89.2%）和79.8%（75/94；95%CI=71.7-87.9%）（P=0.821）。按符合方案分析，根除率分别为85.9%（73/85；95%CI=78.5-93.3%）和82.0%（73/89；95%CI=74.0-89.9%；P=0.489）。在治疗依从性或严重副作用导致的停药方面，两组间无显著差异。
混合疗法达到了可接受的根除率（85.9%），但在统计学上并不显著高于序贯疗法（82.0%）。因此，需要进一步研究以确定在韩国人群中根除率更高的一线治疗方法。
