Fock K M, Chelvam P, Lim S G
Division of Gastroenterology, Dept of Medicine, Changi General Hospital, Singapore.
Aliment Pharmacol Ther. 2000 Feb;14(2):225-31. doi: 10.1046/j.1365-2036.2000.00691.x.
The efficacy of proton pump inhibitor based triple therapy in patients from South-East Asia, where metronidazole resistance is reportedly high, has not been formally assessed in randomized, multicentre trials.
To compare the eradication rates of Helicobacter pylori, ulcer healing rates and side-effects of three regimens of omeprazole triple therapy in patients with duodenal ulcer from South-East Asia and to study the impact of metronidazole resistance.
A single blind, randomized parallel group, comparative multicentre study. A total of 246 patients from 15 centres in four South-East Asian countries were randomized to receive OAC (omeprazole 20 mg b.d., amoxycillin 1 g b. d., clarithromycin 500 mg b.d.), OAM (omeprazole 20 mg b.d., amoxycillin 1 g b.d., metronidazole 400 mg b.d.) or OMC (omeprazole 20 mg b.d., metronidazole 400 mg b.d., clarithromycin 500 mg b.d.) for 7 days. After triple therapy, the patients were further randomized to receive either omeprazole or placebo for 7 days. Upper gastrointestinal endoscopy was performed before treatment and 4 weeks after treatment. Biopsies for culture and for histopathological examination for H. pylori were taken from corpus and antrum before treatment and 4 weeks after treatment.
The eradication rates were intention-to-treat/per protocol (95% CI): OAC 87% (79-94%)/94% (89-100%); OAM 80% (70-89%)/91% (83-98%); OMC 85% (77-93%)/94% (88-100%). The difference in eradication rates between the three groups was not statistically significant (P=0.419). Pre-treatment metronidazole resistance, was found in 34% of isolates and was a significant prognostic factor in patients receiving OAM (odds ratio 5.26) but not in patients receiving OAC or OMC.
All three treatment regimens were safe, well tolerated and highly effective for eradication of H. pylori and ulcer healing. Pre-treatment metronidazole resistance reduced the efficacy of OAM but did not affect the efficacy of OMC.
在据报道甲硝唑耐药率较高的东南亚患者中，基于质子泵抑制剂的三联疗法的疗效尚未在随机、多中心试验中得到正式评估。
比较东南亚十二指肠溃疡患者中三种奥美拉唑三联疗法方案的幽门螺杆菌根除率、溃疡愈合率及副作用，并研究甲硝唑耐药性的影响。
一项单盲、随机平行组、比较性多中心研究。来自四个东南亚国家15个中心的246例患者被随机分为接受OAC（奥美拉唑20毫克，每日两次，阿莫西林1克，每日两次，克拉霉素500毫克，每日两次）、OAM（奥美拉唑20毫克，每日两次，阿莫西林1克，每日两次，甲硝唑400毫克，每日两次）或OMC（奥美拉唑20毫克，每日两次，甲硝唑400毫克，每日两次，克拉霉素500毫克，每日两次）治疗7天。三联疗法后，患者进一步随机分为接受奥美拉唑或安慰剂治疗7天。在治疗前和治疗后4周进行上消化道内镜检查。在治疗前和治疗后4周从胃体和胃窦取活检组织进行幽门螺杆菌培养和组织病理学检查。
意向性分析/符合方案分析的根除率（95%可信区间）：OAC为87%（79 - 94%）/94%（89 - 100%）；OAM为80%（70 - 89%）/91%（83 - 98%）；OMC为85%（77 - 93%）/94%（88 - 100%）。三组根除率的差异无统计学意义（P = 0.419）。在34%的分离株中发现治疗前甲硝唑耐药，并且是接受OAM患者的一个显著预后因素（比值比5.26），但在接受OAC或OMC的患者中并非如此。
所有三种治疗方案对根除幽门螺杆菌和溃疡愈合均安全、耐受性良好且高效。治疗前甲硝唑耐药降低了OAM的疗效，但不影响OMC的疗效。
