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铋剂四联疗法作为一线治疗方案根除幽门螺杆菌在土耳其人群中的疗效。

Efficacy of a modified sequential therapy including bismuth subcitrate as first-line therapy to eradicate Helicobacter pylori in a Turkish population.

机构信息

Department of Gastroenterology, Gulhane Military Medical Academy, School of Medicine, GATA Tıp Fakultesi, General Doktor Tevfik Sağlam Caddesi Etlik, Ankara, Turkey.

出版信息

Helicobacter. 2012 Dec;17(6):486-90. doi: 10.1111/j.1523-5378.2012.00989.x. Epub 2012 Aug 26.

DOI:10.1111/j.1523-5378.2012.00989.x
PMID:23067136
Abstract

BACKGROUND

Eradication rates of Helicobacter pylori with standard triple therapy are not satisfactory. Sequential therapy is an alternative method to overcome this problem.

OBJECTIVES

The aim of this study was to assess efficacy of a modified sequential therapy with the addition of a bismuth preparation, as first-line treatment in the eradication of H. pylori infection.

MATERIALS AND METHODS

One hundred and forty-two H. pylori-positive patients were included in the study. Patients were given a 14-day sequential therapy program consisting of pantoprazole, 40 mg (b.i.d. for 14 days); colloidal bismuth subcitrate, 300 mg 4 (two tablets before breakfast and dinner, for 14 days); amoxicillin, 1 g (b.i.d.for the first 7 days); tetracycline, 500 mg (q.i.d. for the second 7 days); and metronidazole, 500 mg (t.i.d. for the second 7 days). Eradication was tested by urea breath test (UBT) 6 weeks after completion of treatment.

RESULTS

Of the 142 patients included, 131 completed the study. "Per-protocol" and "intention-to-treat" analyses revealed high eradication rates in this group (92.0-95% CI, 87.2-96.8%, and 81.0-95% CI, 74.5-87.4%, respectively). There was no relation to sex and age with this modified sequential therapy. Compliance was satisfactory (11 patients - four women and seven men were unavailable for follow-up), and side effects were minimal (six patients had to stop treatment - metronidazole-related facial swelling and numbness on the face and hands in two patients; tetracycline-related fever and epigastric pain and nausea and vomiting in two patients; and amoxicillin-related diarrhea and vaginal discharge in two patients). These side effects were reversible and resolved after the cessation of the related medication.

CONCLUSIONS

This 14-day modified sequential treatment, including bismuth, achieves a significantly high eradication rates in patients with H. pylori infection, with five satisfactory patient compliance and minor side effects.

摘要

背景

标准三联疗法根除幽门螺杆菌的效果并不令人满意。序贯疗法是克服这一问题的一种替代方法。

目的

本研究旨在评估添加铋制剂的改良序贯疗法作为幽门螺杆菌感染根除的一线治疗方法的疗效。

材料和方法

将 142 例幽门螺杆菌阳性患者纳入本研究。患者接受 14 天的序贯治疗方案,包括泮托拉唑 40mg(每日两次,共 14 天);胶体次枸橼酸铋 300mg 4(每日两次,早餐和晚餐前各 2 片,共 14 天);阿莫西林 1g(每日两次,共 7 天);四环素 500mg(每日 4 次,共 7 天);甲硝唑 500mg(每日 3 次,共 7 天)。治疗结束后 6 周通过尿素呼气试验(UBT)检测根除情况。

结果

在纳入的 142 例患者中,有 131 例完成了研究。“按方案”和“意向治疗”分析显示,该组的根除率较高(92.0%-95%CI,87.2%-96.8%和 81.0%-95%CI,74.5%-87.4%)。这种改良的序贯疗法与性别和年龄无关。依从性令人满意(11 例患者——4 名女性和 7 名男性无法进行随访),副作用最小(6 例患者需要停止治疗——2 例因甲硝唑相关面部肿胀和面部及手部麻木;2 例因四环素相关发热、上腹痛、恶心和呕吐;2 例因阿莫西林相关腹泻和阴道分泌物)。这些副作用是可逆的,在停止相关药物治疗后得到解决。

结论

这种包含铋制剂的 14 天改良序贯治疗方案在幽门螺杆菌感染患者中取得了显著的高根除率,患者依从性良好,副作用轻微。

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