泮托拉唑三联疗法治疗十二指肠溃疡的临床试验

Clinical Trial of Efficacy of Triple Therapy of Pantoprazo le in Treatment of Duodenal Ulcer

目的观察以泮托拉唑为基础的三联疗法治疗十二指肠溃疡的疗效.方法选择符合诊断标准的十二指肠溃疡(Helicobacter pylori, Hp)阳性患者78例,采用随机数字表产生随机顺序,未执行分配隐藏,非盲法.将患者分为泮托拉唑 (PAC)组39例 (泮托拉唑 40 mg+阿莫西林 1.0 g +克拉霉素 0.5 g,bid)和奥美拉唑(OAC)组39例(奥美拉唑 20 mg + 阿莫西林1.0 g+克拉霉素0.5 g, bid).两组疗程均为7天,随访时间4～6周.以Hp根除率、症状缓解率、不良反应等指标进行疗效和安全性评估.结果本研究纳入78例,完成75例,失访3例.其PAC组失访1例,OAC组失访2例.意向治疗分析和符合方案分析结果显示,两组Hp根除率分别为87.2%/89.5%和87.2%/91.9%;临床疗效有效率分别为79.4%/81.6%和82.0%/86.5%,两组疗效差异无统计学意义(P＞0.05);PAC组不良反应发生率为10.6%,OAC组为8.1%,两组差异也无统计学意义(P＞0.05).结论以泮托拉唑为基础的三联疗法治疗Hp阳性的十二指肠溃疡,其疗效与奥美拉唑相当,且不良反应少,患者耐受性好.

Objective To investigate the efficacy of pantoprazole and omeprazole as p art of triple therapy in treatment of duodenal ulcer. Methods Seventy-eight patients with duodenal ulcer and HP-p ositive were randomized to two groups. A random number table was used to generat e random sequence. The sequence was not concealed. No blinding was used. Thirty -nine patients received pantoprazole 40 mg + amoxicillin 1.0 g + clarithromyci n 0.5 g (PAC group) and 39 patients received omeprazole 20 mg + amoxicillin 1. 0 g + clarithromycin 0.5 g (OAC group), twice daily with duration of 7 days. Th e follow-up time was 4 to 6 weeks. Results At the end of the treatment, 38 patients completed the study, and 1 patient lost t o follow-up in the PAC group; thirty-seven patients completed the study, two pa tients lost to follow-up in the OAC group. The results of intention-to-treat analysis and per-protocol analysis showed that the HP eradication rates were 8 7.2%/89.5% in the PAC group and 87.2%/91.9% in the OAC group (P >0.05); the clinical improvement rates were 79.4%/81.6% in the PAC group and 82.0%/86.5% in the OAC group (P>0.05). The side effect r ates were 10.6% in the PAC group and 8.1% in the OAC group (P >0.05). No significant difference was found between the two groups (P >0.05). Conclusions The PAC group is therapeutically effective for eradication of HP and improves symptoms and has an equivalent effect to OAC group for patients with HP-positive duodenal ulcer . Both drugs are well tolerated.