The MACH2 study:: Role of omeprazole in eradication of Helicobacter pylori with 1-week triple therapies
The MACH2 study:: Role of omeprazole in eradication of Helicobacter pylori with 1-week triple therapies
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DOI：
10.1016/s0016-5085(99)70119-8
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发表时间：
1999-02-01
期刊：
影响因子：
29.4
通讯作者：
Cederberg, C
中科院分区：
文献类型：
--
作者：
Lind, T;Mégraud, F;Cederberg, C
背景与目的：奥美拉唑在三联疗法中的作用以及幽门螺杆菌耐药对治疗结果的影响尚未确定。本研究探讨了奥美拉唑的作用以及幽门螺杆菌原发耐药对根除和继发耐药的影响。方法：将539例有十二指肠溃疡病史且幽门螺杆菌筛选试验阳性的患者随机分为4组。OAC组给予奥美拉唑20 mg、阿莫西林1000 mg、克拉霉素500 mg，OMC组给予奥美拉唑20 mg、甲硝唑400 mg、克拉霉素250 mg，AC(阿莫西林1000 mg、克拉霉素500 mg)、MC(甲硝唑400 mg、克拉霉素250 mg)不给予奥美拉唑。所有剂量每天给药两次，持续一周。用C-13-尿素呼气试验评价治疗前后幽门螺杆菌感染情况。在入院时和治疗后持续感染的患者中进行药敏试验。结果：根治率OAC为94%/95%，AC为26%/25%(P<；0.001)，OMC为87%/91%，MC为69%/72%(P<；0.001)。对甲硝唑、克拉霉素和阿莫西林的耐药率分别为27%、3%和0%。甲硝唑敏感/耐药株的根治率OMC为95%/76%，MC为86%/43%。12名患者出现继发性甲硝唑和克拉霉素耐药：8名接受奥美拉唑治疗，16名未接受奥美拉唑治疗。结论：与仅含两种抗生素的方案相比，加入奥美拉唑可获得较高的根治率，减少原发耐药的影响，并可降低继发耐药的风险。
Background & Aims: The role of omeprazole in triple therapy and the impact of Helicobacter pylori resistance on treatment outcome are not established. This study investigated the role of omeprazole and influence of primary H. pylori resistance on eradication and development of secondary resistance. Methods: Patients (n = 539) with a history of duodenal ulcer and a positive H. pylori screening test result were randomized into 4 groups. OAC group received 20 mg omeprazole, 1000 mg amoxicillin, and 500 mg clarithromycin; OMC group received 20 mg omeprazole, 400 mg metronidazole, and 250 mg clarithromycin; and AC (amoxicillin, 1000 mg and clarithromycin, 500 mg) and MC (metronidazole, 400 mg, and clarithromycin, 250 mg) groups received no omeprazole. All doses were administered twice daily for 1 week. H. pylori status was assessed before and after therapy by C-13-urea breath test. Susceptibility testing was performed at entry and in patients with persistent infection after therapy. Results: Eradication (intention to treat [n = 514]/per protocol [n = 449]) was 94%/95% for OAC, 26%/25% for AC (P < 0.001), 87%/91% for OMC, and 69%/72% for MC (P < 0.001). Primary resistance was 27% for metronidazole, 3% for clarithromycin, and 0% for amoxicillin. Eradication in primary metronidazole-susceptible/-resistant strains was 95%/76% for OMC and 86%/43% for MC. Secondary metronidazole and clarithromycin resistance each developed in 12 patients: 8 treated with omeprazole and 16 without omeprazole. Conclusions: Addition of omeprazole achieves high eradication rates, reduces the impact of primary resistance, and may decrease the risk of secondary resistance compared with regimens containing only two antibiotics.