Farup Per G
Enhet for anvendt klinisk forskning, Det medisinske fakultet, Norges teknisk-naturvitenskapelige universitet, Trondheim.
Tidsskr Nor Laegeforen. 2003 Nov 20;123(22):3214-7.
Indications for H. pylori treatment as well as treatment regimens vary.
This trial compares three regimens with ranitidine bismuth citrate (RBC) or omeprazole as first line therapy, evaluates the effect of one regimen for retreatment, compares practice at Norwegian centres, and evaluates the utility of internet-based collaboration. Consecutive H. pylori positive outpatients at 14 centres were randomised to open treatment with one of the regimens. Patients in whom the first treatment was unsuccessful were offered an "enhanced" regimen with RBC. All participating centres submitted their data to a shared database via the internet.
The RBC 400 mg, clarithromycin 250 mg and metronidazole 500 mg regimen, all drugs given twice daily for 7 days, was significantly more effective than the other regimens; infections in 141 out of 146 patients (97%) were successfully eradicated. An enhanced regimen with RBC, clarithromycin and metronidazole was less suitable for retreatment after failure. There were significant differences in patient age and indication for treatment between the centres. The data were of high quality.
The regimen RBC, clarithromycin and metronidazole was the most effective and seems suitable as first-line treatment. The internet collaboration yielded data of high quality that disclosed that patients were not uniformly managed. Our collaborative approach seems to be a suitable method for quality assurance and the organisation of simple clinical multicentre trials.
幽门螺杆菌治疗的适应症以及治疗方案各不相同。
本试验比较了三种以枸橼酸铋雷尼替丁（RBC）或奥美拉唑作为一线治疗的方案，评估了一种再治疗方案的效果，比较了挪威各中心的治疗实践，并评估了基于互联网协作的效用。14个中心连续的幽门螺杆菌阳性门诊患者被随机分配接受其中一种方案的开放治疗。首次治疗未成功的患者接受含RBC的“强化”方案。所有参与中心通过互联网将其数据提交至一个共享数据库。
RBC 400毫克、克拉霉素250毫克和甲硝唑500毫克的方案，所有药物均每日服用两次，持续7天，其疗效显著优于其他方案；146例患者中有141例（97%）的感染被成功根除。含RBC、克拉霉素和甲硝唑的强化方案不太适合失败后的再治疗。各中心之间患者年龄和治疗适应症存在显著差异。数据质量很高。
RBC、克拉霉素和甲硝唑方案是最有效的，似乎适合作为一线治疗。互联网协作产生了高质量的数据，揭示了患者的治疗管理并不统一。我们的协作方法似乎是质量保证和简单临床多中心试验组织的合适方法。
