Choi I J, Jung H C, Choi K W, Kim J H, Ahn D S, Yang U S, Rew J S, Lee S I, Rhee J C, Chung I S, Chung J M, Hong W-S
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Clinical Research Institute, Seoul National University Hospital, Seoul, South Korea.
Aliment Pharmacol Ther. 2002 Jan;16(1):145-51. doi: 10.1046/j.1365-2036.2002.01130.x.
Proton pump inhibitor-based triple therapies are recommended as the first-line treatment for Helicobacter pylori eradication.
To evaluate the efficacies of low-dose clarithromycin triple therapy and tinidazole-containing triple therapy in a metronidazole resistance prevalent area and to compare the efficacies with standard triple therapy.
In a randomized, multicentre, prospective study, a total of 352 patients with duodenal ulcer or non-ulcer dyspepsia were randomly divided into three groups according to the administered regimen: OAC250 group (omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 250 mg), OAC500 group (omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg) and OTC group (omeprazole, 20 mg, tinidazole, 500 mg, and clarithromycin, 500 mg). The three groups received each regimen twice daily for 7 days. Upper gastrointestinal endoscopy was performed before and 4 weeks after treatment. H. pylori status was determined by rapid urease test and 13C urea breath test.
The eradication rates in the OAC250, OAC500 and OTC groups were 76.2%, 65.7% and 64.8% (95% confidence interval: 67.9-84.4%, 56.7-74.8% and 55.7-73.9%), respectively, by intention-to-treat analysis (P=0.149) and 92.8%, 87.2% and 84.1% (95% confidence interval: 84.4-97.3%, 77.9-93.8% and 73.9-91.2%), respectively, by per protocol analysis (P=0.088). All regimens were well tolerated and compliance was excellent.
Both low-dose clarithromycin triple therapy and tinidazole-containing triple therapy are effective and safe regimens for H. pylori eradication.
基于质子泵抑制剂的三联疗法被推荐为根除幽门螺杆菌的一线治疗方案。
评估在甲硝唑耐药普遍存在地区低剂量克拉霉素三联疗法和含替硝唑三联疗法的疗效，并与标准三联疗法的疗效进行比较。
在一项随机、多中心、前瞻性研究中，根据给药方案将总共352例十二指肠溃疡或非溃疡性消化不良患者随机分为三组：OAC250组（奥美拉唑20毫克、阿莫西林1000毫克和克拉霉素250毫克）、OAC500组（奥美拉唑20毫克、阿莫西林1000毫克和克拉霉素500毫克）和OTC组（奥美拉唑20毫克、替硝唑500毫克和克拉霉素500毫克）。三组均每日服用各方案两次，共7天。治疗前和治疗后4周进行上消化道内镜检查。通过快速尿素酶试验和13C尿素呼气试验确定幽门螺杆菌状态。
意向性分析显示，OAC250组、OAC500组和OTC组的根除率分别为76.2%、65.7%和64.8%（95%置信区间：67.9 - 84.4%、56.7 - 74.8%和55.7 - 73.9%）（P = 0.149）；符合方案分析显示，根除率分别为92.8%、87.2%和84.1%（95%置信区间：84.4 - 97.3%、77.9 - 93.8%和73.9 - 91.2%）（P = 0.088）。所有方案耐受性良好，依从性极佳。
低剂量克拉霉素三联疗法和含替硝唑三联疗法都是根除幽门螺杆菌的有效且安全的方案。
