Zheng Qing, Pan Yan, Zhang Lin, Xiao Shu Dong
Shanghai Institute of Digestive Disease, Shanghai Second Medical University, Renji Hospital, Shanghai, China.
Chin J Dig Dis. 2005;6(4):202-5. doi: 10.1111/j.1443-9573.2005.00233.x.
The proton pump inhibitor (PPI)-based 7-day triple therapy is the regimen with the highest cure rates for eradication of Helicobacter pylori infection and has been recommended as the first-line regimen in the world. It had been reported that a 1-day quadruple therapy could also successfully cure 95% of the H. pylori infected patients.
To observe the efficacy of 1-day high-dose quadruple therapy versus 7-day triple therapy for treatment of H. pylori infection, and to observe side-effects of the two different regimens.
This randomized, open, parallel-controlled study was conducted at Renji Hospital between November 2004 to March 2005. A total of 80 consecutive patients with non-ulcer dyspepsia, who were H. pylori positive proven by both rapid urease test and histology were included and randomly assigned to 1-day quadruple therapy or 7-day triple therapy. Thirty-nine patients were administered with 1-day high-dose quadruple therapy including esomeprazole 40 mg b.i.d., colloidal bismuth subcitrate 440 mg q.i.d., amoxicillin 2 g q.i.d. and metronidazole (400 mg q.i.d.) for 1 day. Forty-one patients received a standard 7-day triple therapy consisting of esomeprazole 20 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1 g b.i.d. for 7 days. The eradication rates were evaluated by the (13)C-urea breath test at least 4 weeks after completion of a course treatment.
Seventy-seven patients completed the trial and three patients dropped out. The eradication rates in the 1-day therapeutic group and the 7-day therapeutic group were 39.5% (15/38) and 84.6% (33/39), respectively. There was a statistically significant difference between the two groups (P < 0.0001). Short-lasting and self-limiting side effects including thirst, a metallic taste, diarrhea and abdominal pain were reported in three patients (7.9%) in the 1-day group and seven patients (18%) in the 7-day group (P = 0.31).
A 1-day high-dose quadruple therapy with amoxicillin, metronidazole, bismuth salt, and esomeprazole is not effective for eradication of H. pylori compared with the standard 7-day triple therapy.
基于质子泵抑制剂（PPI）的7天三联疗法是根除幽门螺杆菌感染治愈率最高的方案，已被推荐为全球一线治疗方案。据报道，1天四联疗法也能成功治愈95%的幽门螺杆菌感染患者。
观察1天高剂量四联疗法与7天三联疗法治疗幽门螺杆菌感染的疗效，并观察两种不同治疗方案的副作用。
本随机、开放、平行对照研究于2004年11月至2005年3月在仁济医院进行。共纳入80例经快速尿素酶试验和组织学检查证实为幽门螺杆菌阳性的非溃疡性消化不良患者，随机分为1天四联疗法组或7天三联疗法组。39例患者接受1天高剂量四联疗法，包括埃索美拉唑40 mg，每日2次；枸橼酸铋钾440 mg，每日4次；阿莫西林2 g，每日4次；甲硝唑（400 mg，每日4次），疗程1天。41例患者接受标准7天三联疗法，包括埃索美拉唑20 mg，每日2次；克拉霉素500 mg，每日2次；阿莫西林1 g，每日2次，疗程7天。在完成一个疗程治疗后至少4周，通过（13）C尿素呼气试验评估根除率。
77例患者完成试验，3例患者退出。1天治疗组和7天治疗组的根除率分别为39.5%（15/38）和84.6%（33/39）。两组之间存在统计学显著差异（P<0.0001）。1天治疗组有3例患者（7.9%）报告出现短暂的、自限性副作用，包括口渴、金属味、腹泻和腹痛；7天治疗组有7例患者（18%）出现上述副作用（P=0.31）。
与标准7天三联疗法相比，阿莫西林、甲硝唑、铋盐和埃索美拉唑的1天高剂量四联疗法根除幽门螺杆菌无效。
