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泮托拉唑联合两种抗生素根除幽门螺杆菌:两种短期治疗方案的比较

Eradication of Helicobacter pylori with pantoprazole and two antibiotics: a comparison of two short-term regimens.

作者信息

Frevel M, Daake H, Janisch H D, Kellner H U, Krezdorn H G, Tanneberger D, Wack R

机构信息

Krankenhausstrasse, Bitburg, Germany; Taunusstrasse, Wiesbaden, Germany.

出版信息

Aliment Pharmacol Ther. 2000 Sep;14(9):1151-7. doi: 10.1046/j.1365-2036.2000.00827.x.

Abstract

BACKGROUND

High rates of Helicobacter pylori eradication can be achieved by combining proton pump inhibitors with two antibiotics. However, in the search for an optimal therapy a direct comparison of different regimens is necessary.

METHODS

For this open study, 331 patients with duodenal ulcer were screened and randomly allocated to either pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and metronidazole 500 mg b.d. (PCM) or pantoprazole 40 mg b.d., amoxycillin 1000 mg b.d., and clarithromycin 500 mg b.d. (PAC) for 7 days. Both combinations were followed by a 7-day therapy with pantoprazole 40 mg o.d. alone. Eradication of H. pylori was assessed by use of a 13C-urea breath test 4 weeks after the intake of the last medication.

RESULTS

Eradication rates were 90% in intention-to-treat patients from the PCM (132 out of 147; 95% CI: 84-94%) and the PAC group (135 out of 150; 95% CI: 84-94%). H. pylori was eradicated in 112 out of 117 per protocol patients of the PCM group (96%; 95% CI: 90-99%) and in 119 out of 126 patients of the PAC group (94%; 95% CI: 89-98%). Rapid relief from ulcer pain and a decrease in the mean intensity of other gastrointestinal symptoms was observed. Sixty-nine patients reported adverse events, none of which were related to the intake of pantoprazole. Four serious adverse events, none related to the trial medication, were observed.

CONCLUSIONS

Both pantoprazole-based short-term triple therapies are highly effective and well-tolerated treatment regimens in the eradication of H. pylori.

摘要

背景

质子泵抑制剂联合两种抗生素可实现较高的幽门螺杆菌根除率。然而,为了寻找最佳治疗方案,有必要对不同治疗方案进行直接比较。

方法

在这项开放性研究中,对331例十二指肠溃疡患者进行筛选,并随机分为两组,一组接受泮托拉唑40mg,每日两次,克拉霉素500mg,每日两次,甲硝唑500mg,每日两次(PCM组);另一组接受泮托拉唑40mg,每日两次,阿莫西林1000mg,每日两次,克拉霉素500mg,每日两次(PAC组),疗程均为7天。两组治疗方案结束后均给予泮托拉唑40mg,每日一次,单药治疗7天。在服用最后一剂药物4周后,采用13C-尿素呼气试验评估幽门螺杆菌的根除情况。

结果

在意向性分析中,PCM组(147例中132例,90%;95%可信区间:84%-94%)和PAC组(150例中135例,90%;95%可信区间:84%-94%)的幽门螺杆菌根除率均为90%。按方案分析,PCM组117例患者中有112例(96%;95%可信区间:90%-99%)的幽门螺杆菌被根除,PAC组126例患者中有119例(94%;95%可信区间:89%-98%)的幽门螺杆菌被根除。观察到溃疡疼痛迅速缓解,其他胃肠道症状的平均强度有所降低。69例患者报告了不良事件,均与服用泮托拉唑无关。观察到4例严重不良事件,均与试验药物无关。

结论

两种基于泮托拉唑的短期三联疗法在根除幽门螺杆菌方面都是高效且耐受性良好的治疗方案。

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