Concomitant and hybrid therapy for Helicobacter pylori infection: A randomized clinical trial
Concomitant and hybrid therapy for Helicobacter pylori infection: A randomized clinical trial
复制标题
DOI：
10.1111/jgh.12983
复制
发表时间：
2015-09-01
影响因子：
4.1
通讯作者：
Jang, Byung Ik
中科院分区：
文献类型：
--
作者：
Heo, Jun;Jeon, Seong Woo;Jang, Byung Ik
背景和目的本研究旨在验证在抗生素耐药性日益增加的时代，幽门螺杆菌感染的一线伴随治疗方案和混合治疗方案的等效性。这项研究的目的还在于评估方案compliance.MethodsH. pylori感染的患者从六家医院在韩国被随机分配到伴随或混合方案。伴随治疗方案包括20 mg埃索美拉唑、1 g阿莫西林、500 mg克拉霉素和500 mg甲硝唑，每日两次，持续10天。混合方案包括5天的双重治疗（20 mg埃索美拉唑和1 g阿莫西林，每日两次），随后进行5天四联治疗（埃索美拉唑20 mg，阿莫西林1 g，克拉霉素500 mg，甲硝唑500 mg，结果在意向治疗分析中，联合治疗和混合治疗的根除率分别为78.6%（187/238）和78.8%（190/241），符合方案分析的阳性率分别为89.8%（176/196）和89.6%（181/202）。对于两项分析，95%置信区间均在8%等效性界值范围内。混合组的依从性（95.0%）优于合并组（90.1%），差异具有边缘显著性（P=0.051）。合并组恶心（15.8%vs8.8%，P=0.028）和反流（17.6%vs10.7%，P=0.040）的不良事件发生率高于混合组。在抗生素耐药性高的地区，混合疗法可能是幽门螺杆菌的合理一线治疗选择。
Background and AimsThis 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.MethodsH.pylori-infected patients from six hospitals in Korea were randomly assigned to either concomitant or hybrid regimens. The concomitant regimen consisted of 20mg of esomeprazole, 1g of amoxicillin, 500mg of clarithromycin, and 500mg metronidazole, twice daily for 10 days. The hybrid regimen consisted of a 5-day dual therapy (20mg of esomeprazole and 1g of amoxicillin, twice daily) followed by a 5-day quadruple therapy (20mg of esomeprazole, 1g of amoxicillin, 500mg of clarithromycin, and 500mg of metronidazole, twice daily).ResultsEradication 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).ConclusionAs 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.