Heo Jun, Jeon Seong Woo, Jung Jin Tae, Kwon Joong Goo, Lee Dong Wook, Kim Hyun Soo, Yang Chang Hun, Park Jeong Bae, Park Kyung Sik, Cho Kwang Bum, Lee Si Hyung, Jang Byung Ik
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
J Gastroenterol Hepatol. 2015 Sep;30(9):1361-6. doi: 10.1111/jgh.12983.
This study aimed to validate the equivalence of first-line concomitant and hybrid regimens for Helicobacter pylori infection in an era of increasing antibiotic resistance. The study also aimed to assess regimen compliance.
H. pylori-infected patients from six hospitals in Korea were randomly assigned to either concomitant or hybrid regimens. The concomitant regimen consisted of 20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg metronidazole, twice daily for 10 days. The hybrid regimen consisted of a 5-day dual therapy (20 mg of esomeprazole and 1 g of amoxicillin, twice daily) followed by a 5-day quadruple therapy (20 mg of esomeprazole, 1 g of amoxicillin, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily).
Eradication rates for concomitant and hybrid therapy were 78.6% (187/238) and 78.8% (190/241) in the intention-to-treat analysis, and 89.8% (176/196) and 89.6% (181/202) in the per protocol analysis. For both analyses, 95% confidence intervals fell within the ± 8% equivalence margin. Adherence was better in the hybrid group (95.0%) than in the concomitant group (90.1%), a difference that was borderline significant (P = 0.051). Adverse event rates were higher in the concomitant group than in the hybrid group for nausea (15.8% vs 8.8%; P = 0.028) and regurgitation (17.6% vs 10.7%; P = 0.040).
As compared with concomitant therapy, hybrid therapy offered similar efficacy, better compliance, and fewer adverse events. Hybrid therapy could be a reasonable first-line treatment option for H. pylori in areas with high antibiotics resistance.
本研究旨在验证在抗生素耐药性不断增加的时代，幽门螺杆菌感染一线联合疗法与序贯疗法的等效性。该研究还旨在评估治疗方案的依从性。
来自韩国六家医院的幽门螺杆菌感染患者被随机分配至联合疗法组或序贯疗法组。联合疗法组包括20毫克埃索美拉唑、1克阿莫西林、500毫克克拉霉素和500毫克甲硝唑，每日两次，共10天。序贯疗法组包括为期5天的双联疗法（20毫克埃索美拉唑和1克阿莫西林，每日两次），随后是为期5天的四联疗法（20毫克埃索美拉唑、1克阿莫西林、500毫克克拉霉素和500毫克甲硝唑，每日两次）。
在意向性分析中，联合疗法和序贯疗法的根除率分别为78.6%（187/238）和78.8%（190/241），在符合方案分析中分别为89.8%（176/196）和89.6%（181/202）。对于这两种分析，95%置信区间均落在±8%等效性界限内。序贯疗法组的依从性（95.0%）优于联合疗法组（90.1%），差异接近显著（P = 0.051）。联合疗法组恶心（15.8%对8.8%；P = 0.028）和反流（17.6%对10.7%；P = 0.040）的不良事件发生率高于序贯疗法组。
与联合疗法相比，序贯疗法疗效相似、依从性更好且不良事件更少。在抗生素耐药性高的地区，序贯疗法可能是幽门螺杆菌感染合理的一线治疗选择。
