埃索美拉唑三联疗法对胃溃疡患者幽门螺杆菌根除率、胃溃疡愈合及复发预防的影响。

Effect of esomeprazole triple therapy on eradication rates of Helicobacter pylori, gastric ulcer healing and prevention of relapse in gastric ulcer patients.

作者信息

Tulassay Zsolt, Stolte Manfred, Sjölund Maria, Engstrand Lars, Butruk Eugeniusz, Malfertheiner Peter, Dite Petr, Tchernev Konstantin, Wong Benjamin C Y, Gottlow Mattis, Eklund Stefan, Wrangstadh Michael, Nagy Péter

机构信息

2nd Medical Clinic, Semmelweis University, Budapest, Hungary.

出版信息

Eur J Gastroenterol Hepatol. 2008 Jun;20(6):526-36. doi: 10.1097/MEG.0b013e3282f427ac.

DOI:10.1097/MEG.0b013e3282f427ac

PMID:18467912

Abstract

OBJECTIVES

To compare esomeprazole-based triple therapy with esomeprazole alone for the eradication of Helicobacter pylori (H. pylori), healing of ulcer and prevention of relapse in H. pylori-related gastric ulcer (GU) diseases.

METHODS

In this double-blind study, 401 H. pylori-positive patients with more than or equal to two GUs were randomized to: esomeprazole (20 mg) twice daily (bid) and amoxicillin (1000 mg) bid and clarithromycin (500 mg) bid (EAC) for 1 week, followed by placebo for 3 weeks (EAC and placebo); EAC for 1 week, followed by esomeprazole (20 mg) once daily (E20) for 3 weeks (EAC and E20); or esomeprazole (20 mg) bid and placebo antimicrobials for 1 week, followed by E20 for 3 weeks (E20 bid and E20). Patients with unhealed GUs at 4 weeks received E20 for an additional 4 weeks. Healed patients were followed up for 12 months.

RESULTS

Eradication rates at 4 weeks or 8 weeks were 82% for EAC and E20, 77% for EAC and placebo and 9.5% for E20 bid and E20 (intention-to-treat analysis). Significantly more patients receiving EAC than those receiving esomeprazole alone remained free of GUs during follow-up [EAC and E20, 90%; EAC and placebo, 87%; P=0.0005 for combined group vs. esomeprazole alone [E20 bid and E20 (74%)]. All treatments were well tolerated.

CONCLUSION

Esomeprazole-based triple therapy is effective for the eradication of H. pylori, healing of GU and prevention of relapse. Esomeprazole monotherapy for 3 weeks after triple therapy may be beneficial in terms of healing.

摘要

目的

比较以埃索美拉唑为基础的三联疗法与单用埃索美拉唑在根除幽门螺杆菌（H. pylori）、治愈溃疡以及预防幽门螺杆菌相关胃溃疡（GU）疾病复发方面的效果。

方法

在这项双盲研究中，401例幽门螺杆菌阳性且患有两个或两个以上胃溃疡的患者被随机分为：埃索美拉唑（20毫克）每日两次（bid）、阿莫西林（1000毫克）bid以及克拉霉素（500毫克）bid（EAC），疗程1周，随后服用安慰剂3周（EAC和安慰剂组）；EAC治疗1周，随后埃索美拉唑（20毫克）每日一次（E20），疗程3周（EAC和E20组）；或者埃索美拉唑（20毫克）bid加用安慰剂抗菌药物，疗程1周，随后E20治疗3周（E20 bid和E20组）。4周时溃疡未愈合的患者再接受4周的E20治疗。治愈的患者随访12个月。

结果

4周或8周时，EAC和E20组的根除率为82%，EAC和安慰剂组为77%，E20 bid和E20组为9.5%（意向性分析）。在随访期间，接受EAC治疗的患者中无胃溃疡的人数显著多于单用埃索美拉唑的患者[EAC和E20组为90%；EAC和安慰剂组为87%；联合组与单用埃索美拉唑组（E20 bid和E20组为74%）相比，P = 0.0005]。所有治疗耐受性良好。