Glaser J, Hein J, Daikeler R, Weithofer G, Vieth M, Schmidt M, Stolte M
Medizinische Klinik, Herz-Jesu-Krankenhaus Fulda.
Med Klin (Munich). 1998 Feb 15;93(2):65-9. doi: 10.1007/BF03043279.
The present study was conducted to investigate the efficacy and tolerability of a 7-day treatment with pantoprazole, amoxicillin and metronidazole for the eradication of Helicobacter pylori (H. pylori) infection.
Fifty patients (26 male, 24 female, age 18 to 86, mean 54 years) with an active duodenal (n = 25) or gastric ulcer (n = 25) were recruited into the study, 48 patients being H. pylori positive at the study start. Patients were treated with pantoprazole (40 mg bid), amoxicillin (1 g bid) and metronidazole (500 mg bid) for 7 days and for another 21 days with pantoprazole (40 mg/od). Four weeks after the end of study medications the patients were re-examined endoscopically and their H. pylori status was re-assessed using urease test, histology and 13C-urea-breath test.
In 39 of 48 intention to treat patients, H. pylori infection was cured, according to 81% (95%-CI = 67 to 91%). In the per protocol population in 35 of 41 patients H. pylori was eradicated, which results in an eradication rate of 85% (95%-CI = 71 to 94%). Ulcer healing was endoscopically confirmed in 45 of 48 patients (94%; 95%-CI = 83 to 99%) after 8 weeks. Six of 50 patients (12%) reported mild to moderate probable side-effects of the study medication. Cure of the infection was associated with a distinct reduction of the gastritis grade and activity.
A 7-day triple therapy using pantoprazole, amoxicillin and metronidazole is an effective and cost-effective alternative to regimens including clarithromycin for the treatment of H. pylori infection.
本研究旨在调查泮托拉唑、阿莫西林和甲硝唑7天疗法根除幽门螺杆菌(H. pylori)感染的疗效和耐受性。
招募50例患者(男性26例,女性24例,年龄18至86岁,平均54岁),其中活动性十二指肠溃疡患者25例,胃溃疡患者25例,48例患者在研究开始时幽门螺杆菌呈阳性。患者接受泮托拉唑(40毫克,每日两次)、阿莫西林(1克,每日两次)和甲硝唑(500毫克,每日两次)治疗7天,之后再接受泮托拉唑(40毫克,每日一次)治疗21天。研究药物结束四周后,对患者进行内镜复查,并使用尿素酶试验、组织学检查和13C尿素呼气试验重新评估其幽门螺杆菌感染状况。
在意向性治疗的48例患者中,39例患者的幽门螺杆菌感染得到治愈,治愈率为81%(95%置信区间 = 67%至91%)。在符合方案人群中,41例患者中的35例幽门螺杆菌被根除,根除率为85%(95%置信区间 = 71%至94%)。8周后,48例患者中的45例(94%;95%置信区间 = 83%至99%)经内镜检查证实溃疡愈合。50例患者中有6例(12%)报告了研究药物轻度至中度的可能副作用。感染治愈与胃炎分级和活动度的明显降低相关。
使用泮托拉唑、阿莫西林和甲硝唑的7天三联疗法是一种有效且具有成本效益的替代方案,可替代包括克拉霉素的治疗方案用于治疗幽门螺杆菌感染。