14 天三联疗法为基础的含铋四联疗法对初始幽门螺杆菌根除的高疗效。

High efficacy of 14-day triple therapy-based, bismuth-containing quadruple therapy for initial Helicobacter pylori eradication.

机构信息

Department of Gastroenterology, Shanghai Renji Hospital, Shanghai Institute of Digestive Disease, Shanghai Jiaotong University School of Medicine, China.

出版信息

Helicobacter. 2010 Jun;15(3):233-8. doi: 10.1111/j.1523-5378.2010.00758.x.

DOI:10.1111/j.1523-5378.2010.00758.x

PMID:20557366

Abstract

BACKGROUND

The success rate of currently recommended 7-day triple therapy with a PPI plus amoxicillin and clarithromycin has fallen into the unacceptable range. It is urgent to look for a new strategy to treat the infection of Helicobacter pylori.

AIMS

To observe the efficacy of triple therapy-based, bismuth-containing quadruple therapy for H. pylori treatment.

METHODS

A total of 160 patients with functional dyspepsia who were Hp+ were randomly assigned into two groups. Regimen: Omeprazole 20 mg, Amoxicillin 1.0 g, Clarithromycin 500 mg and Bismuth Potassium Citrate 220 mg, twice a day. Eighty patients received 7-day quadruple therapy and 80 patients received the same therapy for 14 days. Six weeks after treatment, H. pylori eradication was assessed by (13)C-urea breath test. Minimal inhibitory concentrations of metronidazole, clarithromycin and amoxicillin of clinical isolates were determined by the twofold agar dilution method.

RESULTS

Fourteen-day therapy led to a significant increase of H. pylori eradication success when compared to 7-day therapy in the intention-to-treat analysis (93.7 vs 80.0%; p = .01), and the per-protocol analysis (97.4 vs 82.0%; p = .0016). The H. pylori resistance rates to metronidazole, clarithromycin and amoxicillin were 42.1, 18.0 and 0%. Fourteen-day therapy was significantly more effective in patients with clarithromycin-resistant strains. Incidences of adverse events were comparable.

CONCLUSIONS

Addition bismuth and prolonging treatment duration can overcome H. pylori resistance to clarithromycin and decrease the bacterial load. Fourteen-day triple therapy-based, bismuth-containing quadruple therapy achieved ITT success rate 93% and could be recommended as the first line eradication regimen.

摘要

背景

目前推荐的质子泵抑制剂加阿莫西林和克拉霉素 7 天三联疗法的成功率已经下降到不可接受的范围。急需寻找一种新的策略来治疗幽门螺杆菌感染。

目的

观察基于三联疗法的含铋四联疗法治疗幽门螺杆菌的疗效。

方法

将 160 例功能性消化不良且 Hp+患者随机分为两组。方案：奥美拉唑 20mg，阿莫西林 1.0g，克拉霉素 500mg，枸橼酸铋钾 220mg，每日 2 次。80 例患者接受 7 天四联疗法，80 例患者接受相同疗法 14 天。治疗 6 周后，通过（13）C-尿素呼气试验评估 H. pylori 根除情况。采用二倍琼脂稀释法测定临床分离株甲硝唑、克拉霉素和阿莫西林的最低抑菌浓度。

结果

意向治疗分析中，14 天治疗组 H. pylori 根除成功率显著高于 7 天治疗组（93.7% vs 80.0%；p =.01），且符合方案分析（97.4% vs 82.0%；p =.0016）。甲硝唑、克拉霉素和阿莫西林对 H. pylori 的耐药率分别为 42.1%、18.0%和 0%。14 天治疗组对克拉霉素耐药菌株的疗效明显更好。不良反应发生率相当。