Louw J A, Van Rensburg C J, Moola S, Kotze D, Marks I N
Gastrointestinal Clinic and Department of Medicine, Groote Schuur Hospital and The University of Cape Town, South Africa.
Aliment Pharmacol Ther. 1998 Sep;12(9):881-5. doi: 10.1046/j.1365-2036.1998.00382.x.
Proton pump inhibitor based combination therapy is one standard strategy for Helicobacter pylori eradication.
To compare the eradication and duodenal ulcer healing efficacy of two 2-week, single dose, lansoprazole based combination therapies.
Healthy adult patients with endoscopically confirmed, H. pylori associated duodenal ulcer disease (3 mm > ulcer < 20 mm) were eligible for the study. All patients received a 14 day course of lansoprazole 30 mg o.m., and were randomized to receive either 7 or 14 days of amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. Patients were endoscoped at entry and 14-17 days later. Symptomatic, unhealed patients received a further 14 days of therapy with lansoprazole 30 mg o.m. Eradication was confirmed a minimum of 28 days after cessation of all therapy by urease reaction and histological assessment of gastric body and antral biopsies (three biopsies each site).
Sixty-two patients were randomized to a treatment arm, of which 58 could be included in an intention-to-treat and key-point-available analysis. H. pylori eradication rates were identical, at 93% (95% CI: 73-98% (1 week), 78-99% (2 week)). In the combined group, all but 13 ulcers were healed at 2 weeks; six required further therapy because of symptoms, while six of the seven asymptomatic patients went on to heal.
An eradication regimen, based on a 2-week course of single dose lansoprazole with 1 week of antibiotic co-therapy, is effective in eradicating H. pylori, while the 2 weeks of acid suppression is usually effective in duodenal ulcer healing.
基于质子泵抑制剂的联合疗法是根除幽门螺杆菌的一种标准策略。
比较两种基于兰索拉唑的2周单剂量联合疗法在根除幽门螺杆菌及治愈十二指肠溃疡方面的疗效。
经内镜确诊为幽门螺杆菌相关性十二指肠溃疡疾病（溃疡大小3毫米＞溃疡＜20毫米）的健康成年患者符合本研究条件。所有患者接受为期14天的口服30毫克兰索拉唑治疗，并随机分为两组，分别接受为期7天或14天的阿莫西林每日2次每次1克及克拉霉素每日2次每次500毫克治疗。患者在入组时及14 - 17天后接受内镜检查。有症状且溃疡未愈合的患者再接受为期14天的口服30毫克兰索拉唑治疗。在所有治疗停止至少28天后，通过尿素酶反应及胃体和胃窦活检组织学评估（每个部位取三块活检组织）确认幽门螺杆菌是否被根除。
62例患者被随机分配至各治疗组，其中58例可纳入意向性治疗及关键数据可用分析。幽门螺杆菌根除率相同，均为93%（95%置信区间：1周时为73 - 98%，2周时为78 - 99%）。在联合治疗组中，2周时除13例溃疡外其余均愈合；6例因症状需进一步治疗，而7例无症状患者中有6例随后愈合。
基于2周单剂量兰索拉唑联合1周抗生素治疗的根除方案对根除幽门螺杆菌有效，同时2周的抑酸治疗通常对十二指肠溃疡愈合有效。
