Georgopoulos Sotirios D, Xirouchakis Elias, Liatsos Christos, Apostolopoulos Pericles, Kasapidis Panagiotis, Martinez-Gonzalez Beatriz, Laoudi Fotini, Stoupaki Maria, Axiaris Georgios, Sgouras Dionysios, Mentis Andreas, Michopoulos Spyridon
GI and Hepatology Department, Athens Medical, Paleo Faliron Hospital, 17562 Athens, Greece.
Gastroenterology Department, 401 General Military Hospital of Athens, 17562 Athens, Greece.
Antibiotics (Basel). 2024 Mar 20;13(3):280. doi: 10.3390/antibiotics13030280.
: We conducted an equivalence trial of quadruple non-bismuth "concomitant" and "hybrid" regimens for eradication in a high clarithromycin resistance area. : There were 321 treatment-naïve -positive individuals in this multicenter clinical trial randomized to either the hybrid (esomeprazole 40 mg/bid, amoxicillin 1 g/bid for 7 days, then 7 days esomeprazole 40 mg/bid, amoxicillin 1 g/bid, clarithromycin 500 mg/bid, and metronidazole 500 mg/bid) or the concomitant regimen (all medications given concurrently bid for 10 days). Eradication was tested using histology and/or a 13C-urea breath test. : The concomitant regimen had 161 patients (90F/71M, mean 54.5 years, 26.7% smokers, 30.4% ulcer) and the hybrid regimen had 160 (80F/80M, mean 52.8 years, 35.6% smokers, 31.2% ulcer). The regimens were equivalent, by intention to treat 85% and 81.8%, ( = 0.5), and per protocol analysis 91.8% and 87.8%, ( = 0.3), respectively. The eradication rate by resistance, between concomitant and hybrid regimens, was in susceptible strains (97% and 97%, = 0.6), clarithromycin single-resistant strains (86% and 90%, = 0.9), metronidazole single-resistant strains (96% and 81%, = 0.1), and dual-resistant strains (70% and 53%, = 0.5). The side effects were comparable, except for diarrhea being more frequent in the concomitant regimen. : A 14-day hybrid regimen is equivalent to a 10-day concomitant regimen currently used in high clarithromycin and metronidazole resistance areas. Both regimens are well tolerated and safe.
我们在一个克拉霉素高耐药地区进行了一项四重非铋剂“序贯”和“联合”方案根除幽门螺杆菌的等效性试验。在这项多中心临床试验中，有321例初治幽门螺杆菌阳性个体被随机分为序贯组（埃索美拉唑40毫克/每日两次，阿莫西林1克/每日两次，共7天，然后7天埃索美拉唑40毫克/每日两次，阿莫西林1克/每日两次，克拉霉素500毫克/每日两次，甲硝唑500毫克/每日两次）或联合组（所有药物每日两次同时服用10天）。使用组织学和/或13C尿素呼气试验检测根除情况。联合组有161例患者（90名女性/71名男性，平均54.5岁，26.7%吸烟者，30.4%有溃疡），序贯组有160例（80名女性/80名男性，平均52.8岁，35.6%吸烟者，31.2%有溃疡）。在意向性分析中，两种方案等效，分别为85%和81.8%（P = 0.5），按方案分析分别为91.8%和87.8%（P = 0.3）。在敏感菌株中，联合组和序贯组的根除率分别为97%和97%（P = 0.6）；克拉霉素单耐药菌株中分别为86%和90%（P = 0.9）；甲硝唑单耐药菌株中分别为96%和81%（P = 0.1）；双重耐药菌株中分别为70%和53%（P = 0.5）。除联合组腹泻更常见外，两组副作用相当。14天序贯方案与目前在克拉霉素和甲硝唑高耐药地区使用的10天联合方案等效。两种方案耐受性良好且安全。
