Cuadrado-Lavín Antonio, Salcines-Caviedes J Ramón, Diaz-Perez Ainhoa, Carrascosa Miguel F, Ochagavía María, Fernandez-Forcelledo José Luis, Cobo Marta, Fernández-Gil Pedro, Ayestarán Blanca, Sánchez Blanca, Campo Cristina, Llorca Javier, Lorenzo Silvia, Illaro Aitziber
Department of Gastroenterology, Hospital Universitario Marqués de Valdecilla-Instituto de Investigación Marqués de Valdecilla (IDIVAL), Avda de Valdecilla s/n, 39008, Santander, Cantabria, Spain.
Department of Gastroenterology, Hospital Comarcal de Laredo-IDIVAL, Avda Derechos Humanos s/n, 39770 Laredo, Cantabria, Spain.
J Antimicrob Chemother. 2015 Aug;70(8):2376-81. doi: 10.1093/jac/dkv089. Epub 2015 Apr 7.
Helicobacter pylori eradication remains a challenge. Non-bismuth-based quadruple regimens (NBQR) have shown high eradication rates (ER) elsewhere that need to be locally confirmed. The objective of this study was to compare the first-line ER of a hybrid therapy (20 mg of omeprazole twice daily and 1 g of amoxicillin twice daily for 10 days, adding 500 mg of clarithromycin twice daily and 500 mg of metronidazole every 8 h for the last 5 days; OA-OACM) with that of a 10 day concomitant regimen consisting of taking all four drugs twice daily every day (including 500 mg of metronidazole every 12 h; OACM). A 10 day arm with standard triple therapy (OAC; 20 mg of omeprazole/12 h, 1 g of amoxicillin/12 h and 500 mg of clarithromycin/12 h) was included.
Three hundred consecutive patients were randomized (1: 2: 2) into one of the three following regimens: (i) OAC (60); (ii) OA-OACM (120); and (iii) OACM (120). Eradication was generally confirmed by a [(13)C]urea breath test at least 4 weeks after the end of treatment. Adverse events and compliance were assessed. EudraCT: 2011-006258-99.
ITT cure rates were: OAC, 70.0% (42/60) (95% CI: 58.3-81.7); OA-OACM, 90.8% (109/120) (95% CI: 85.6-96.0); and OACM, 90.0% (107/119) (95% CI: 84.6-95.4). PP rates were: OAC, 72.4% (42/58) (95% CI: 60.8-84.1); OA-OACM, 93.9% (108/115) (95% CI: 89.5-98.3); and OACM, 90.3% (102/113) (95% CI: 84.8-95.8). Both NBQR significantly improved ER compared with OAC (P < 0.01), but no differences were seen between them. Mean compliance was elevated [98.0% (SD = 9.8)] with no differences between groups. There were more adverse events in the quadruple arms (OACM, 65.8%; OA-OACM, 68.6%; OAC, 46.6%; P < 0.05), but no significant differences between groups in terms of severity were seen.
Hybrid and concomitant regimens show good ER against H. pylori infection with an acceptable safety profile. They clearly displace OAC as first-line regimen in our area.
幽门螺杆菌根除仍然是一项挑战。非铋剂四联疗法（NBQR）在其他地区已显示出高根除率（ER），但需要在本地得到证实。本研究的目的是比较一种联合疗法（奥美拉唑20mg每日两次、阿莫西林1g每日两次，共10天，在最后5天添加克拉霉素500mg每日两次和甲硝唑500mg每8小时一次；OA - OACM）与一种为期10天的同时服用所有四种药物每日两次（包括甲硝唑500mg每12小时一次；OACM）的联合疗法的一线根除率。纳入了一个为期10天的标准三联疗法组（OAC；奥美拉唑20mg/12小时、阿莫西林1g/12小时和克拉霉素500mg/12小时）。
300例连续患者被随机分为（1∶2∶2）以下三种疗法之一：（i）OAC（60例）；（ii）OA - OACM（120例）；（iii）OACM（120例）。治疗结束后至少4周，一般通过[¹³C]尿素呼气试验确认根除情况。评估不良事件和依从性。欧洲临床试验数据库编号：2011 - 006258 - 99。
意向性分析治愈率为：OAC组70.0%（42/60）（95%置信区间：58.3 - 81.7）；OA - OACM组90.8%（109/120）（95%置信区间：85.6 - 96.0）；OACM组90.0%（107/119）（95%置信区间：84.6 - 95.4）。符合方案分析治愈率为：OAC组72.4%（42/58）（95%置信区间：60.8 - 84.1）；OA - OACM组93.9%（108/115）（95%置信区间：89.5 - 98.3）；OACM组90.3%（102/113）（95%置信区间：84.8 - 95.8）。与OAC组相比，两种NBQR疗法均显著提高了根除率（P < 0.01），但两者之间无差异。平均依从性较高[98.0%（标准差 = 9.8）]，组间无差异。四联疗法组不良事件更多（OACM组65.8%；OA - OACM组68.6%；OAC组46.6%；P < 0.05），但在严重程度方面组间无显著差异。
联合疗法和同时服用疗法对幽门螺杆菌感染显示出良好的根除率，安全性可接受。在我们地区，它们明显取代OAC成为一线疗法。
