Randomised clinical trial comparing concomitant and hybrid therapy for eradication of Helicobacter pylori infection.
Randomised clinical trial comparing concomitant and hybrid therapy for eradication of Helicobacter pylori infection.
复制标题
DOI：
10.1371/journal.pone.0244500
复制
发表时间：
2020
期刊：
影响因子：
3.7
通讯作者：
Tonkic A
中科院分区：
文献类型：
--
作者：
Mestrovic A;Perkovic N;Bozic J;Pavicic Ivelja M;Vukovic J;Kardum G;Puljiz Z;Tonkic A
本研究的主要目的是在克罗地亚分裂-达尔马蒂亚县（克拉霉素耐药率超过20%）比较幽门螺杆菌感染一线根除治疗中的合并治疗和混合治疗。研究的次要目的是确定和比较这些治疗方案之间的依从性和不良事件发生率。在一项开放标签、随机临床试验中，共有140例H。pylori感染的患者随机分为联合治疗组（埃索美拉唑40 mg，阿莫西林1 g，甲硝唑500 mg，克拉霉素500 mg，每日2次，共14 d）或混合治疗组（埃索美拉唑40 mg，阿莫西林1 g，每日2次，共14 d，最后7 d加用甲硝唑500 mg，克拉霉素500 mg，每日2次）。意向治疗分析中合并治疗组和混合治疗组的根除率分别为84.1%（58/69）和83.1%（59/71），符合方案分析中为96.7%（58/60）和95.2%（59/62）。两组间无显著差异（ITT分析：P = 0.878; PP分析：P = 0.675）。伴随治疗组的不良事件发生率更高（33.3% vs 18.3%，P = 0.043）。各组之间的依从率没有差异。混合疗法的根除率与合并疗法相似，但不良事件发生率较低。在耐药性日益严重的今天，少用抗生素的根除方案，作为混合疗法，应是合理的一线治疗选择。幽门感染临床试验，政府：NCT 03572777。
The primary objective of this study was to compare concomitant and hybrid therapy in the first line eradication treatment of Helicobacter pylori infection in Split-Dalmatia County, Croatia, in which clarithromycin resistance is above 20%. The secondary objective of the study was to determine and compare compliance and adverse events rate between these therapeutic protocols. In an open-label, randomised clinical trial 140 patients total with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 g, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or hybrid (esomeprazole 40 mg and amoxicillin 1 g twice daily during 14 days with adding metronidazole 500 mg and clarithromycin 500 mg twice daily, in the last 7 days,) treatment group. Eradication rates for concomitant group and hybrid therapy group were 84.1% (58/69) and 83.1% (59/71) respectively in the intention-to-treat analysis and 96.7% (58/60) and 95.2% (59/62) in per-protocol analysis. There was no significant difference between the groups (ITT analysis: P = 0.878; PP analysis: P = 0.675). Adverse events were more frequent in the concomitant group (33.3% vs 18.3%, P = 0.043). There was no difference among groups regarding compliance rate. Hybrid therapy has similar eradication rate as concomitant therapy, with lower adverse events rate. In the era of increasing antibiotic resistance, eradication regime with less antibiotic’s usage, as hybrid therapy, should be reasonable first line treatment choice for H. pylori infection. Clinical Trials, gov: NCT03572777.
登录
查看更多内容
影响因子：
29.4
作者：
Savoldi A;Carrara E;Graham DY;Conti M;Tacconelli E
通讯作者：
Tacconelli E
DOI：
10.4166/kjg.2018.71.1.31
发表时间：
2018-01-25
影响因子：
--
作者：
Bae, Hyun Jin;Kim, Joon Sung;Nam, Yun Jung
通讯作者：
Nam, Yun Jung
影响因子：
4.1
作者：
Heo, Jun;Jeon, Seong Woo;Jang, Byung Ik
通讯作者：
Jang, Byung Ik
影响因子：
4.3
作者：
Chen, Kuan-Yang;Lin, Tsung-Jung;Wu, Deng-Chyang
通讯作者：
Wu, Deng-Chyang
影响因子：
24.5
作者：
Malfertheiner, P.;Megraud, F.;El-Omar, E. M.
通讯作者：
El-Omar, E. M.