Svoboda P, Kantorová I, Ochmann J, Doubek J, Kozumplík L, Marsová J
Research Center for Traumatology, Pharmaceutical University of Brno.
Hepatogastroenterology. 1997 May-Jun;44(15):886-90.
BACKGROUND/AIMS: The eradication of Helicobacter pylori (Hp) infection in duodenal ulcer and dyspepsia has been achieved using various therapy regimens. The efficacy of protein pump inhibitor pantoprazole as part of these regimens has not been widely studied.
During a prospective randomized trial, 250 Hp positive patients with either duodenal ulcer, erosive bulbitis, or gastritis and dyspepsia were treated using 14 days of therapy 1) pantoprazole 40 mg daily and clarithromycin 500 mg b.i.d. (PC), 2) pantoprazole 40 mg daily and clarithromycin 500 mg b.i.d. plus amoxicillin 1 g b.i.d. (PCA), or 3) bismuth subcitrate 120 mg t.i.d., roxithromycin 150 mg b.i.d., metronidazole 250 mg b.i.d. plus ranitidin 300 mg (BRMR). Hp status was assessed on 3 tests at the inclusion (2-specimen rapid urease test, 2-specimen histology, serology) and 2 tests (2-specimen rapid urease test, 2-specimen histology) 4 weeks after the end of the treatment.
The entry criteria was fulfilled in 250 patients, of whom 13 missed the control endoscopy. The treatment had to be discontinued for adverse effects in 8 (10%) BRMR patients, and 1 (1%) PCA patients. Compliance was 100% in the PC group. All ulcers were healed at the end of the study with one exception in the BRMR group. The best eradication rate of Hp was shown by the PCA group with 94.8% (n = 73/77) followed by the PC group with 82.5% (n = 66/80) and finally the BRMR with 67.6% (n = 48/71)-PCA:BRMR - p < 0.001; PC:BRMR-p < 0.001; PCA:PC-p < 0.05.
This study showed that triple therapy using PPI pantoprazole combined with antibiotics clarithromycin and amoxicillin was very effective in the eradication of Hp and treatment of duodenal ulcer with rare side effects. The dual pantoprazole and clarithromycin therapy had the highest rate of patient compliance, but is less effective than triple therapy. The combination of ranitidin with bismuth based triple therapy had the highest number of adverse events and the lowest rate of Hp eradication and therefore, should not be recommended.
背景/目的：采用多种治疗方案已实现十二指肠溃疡和消化不良患者幽门螺杆菌（Hp）感染的根除。作为这些治疗方案一部分的质子泵抑制剂泮托拉唑的疗效尚未得到广泛研究。
在一项前瞻性随机试验中，250例Hp阳性的十二指肠溃疡、糜烂性球炎或胃炎伴消化不良患者接受了为期14天的治疗：1）每日泮托拉唑40mg和克拉霉素500mg，每日两次（PC）；2）每日泮托拉唑40mg、克拉霉素500mg，每日两次加阿莫西林1g，每日两次（PCA）；或3）枸橼酸铋钾120mg，每日三次，罗红霉素150mg，每日两次，甲硝唑250mg，每日两次加拉尼替丁300mg（BRMR）。在纳入时通过3项检测（2份标本快速尿素酶试验、2份标本组织学检查、血清学检查）评估Hp状态，在治疗结束后4周通过2项检测（2份标本快速尿素酶试验、2份标本组织学检查）评估。
250例患者符合入选标准，其中13例未进行对照内镜检查。8例（10%）BRMR组患者和1例（1%）PCA组患者因不良反应不得不停止治疗。PC组的依从性为100%。研究结束时所有溃疡均愈合，BRMR组有1例除外。PCA组的Hp根除率最高，为94.8%（n = 73/77），其次是PC组，为82.5%（n = 66/80），最后是BRMR组，为67.6%（n = 48/71）——PCA与BRMR相比，p < 0.001；PC与BRMR相比，p < 0.001；PCA与PC相比，p < 0.05。
本研究表明，使用质子泵抑制剂泮托拉唑联合抗生素克拉霉素和阿莫西林的三联疗法在根除Hp和治疗十二指肠溃疡方面非常有效，且副作用罕见。泮托拉唑和克拉霉素的双联疗法患者依从率最高，但效果不如三联疗法。雷尼替丁与铋剂三联疗法联合使用时不良事件最多，Hp根除率最低，因此不建议使用。
