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三联疗法与阿莫西林加奥美拉唑治疗幽门螺杆菌感染的疗效及副作用的多中心、前瞻性、随机对照研究

Triple therapy vs. amoxicillin plus omeprazole for treatment of Helicobacter pylori infection: a multicenter, prospective, randomized, controlled study of efficacy and side effects.

作者信息

Thijs J C, van Zwet A A, Moolenaar W, Wolfhagen M J, ten Bokkel Huinink J

机构信息

Department of Internal Medicine, Bethesda Hospital, Hoeegeveen, The Netherlands.

出版信息

Am J Gastroenterol. 1996 Jan;91(1):93-7.

PMID:8561152
Abstract

OBJECTIVE

this study compares the efficacy and side effects of the two commonly used treatment regimens for Helicobacter pylori infection.

METHODS

118 patients with culture-proven H. pylori infection (61 with duodenal ulcer, 19 with gastric ulcer, three with both duodenal and gastric ulcer, and 35 with non-ulcer dyspepsia) were randomized to receive either triple therapy (tetracycline 250 mg, metronidazole 250 mg, colloidal bismuth subcitrate 120 mg, four times daily) for 14 days or amoxicillin 1000 mg and omeprazole 40 mg both twice daily for 14 days. The isolated H. pylori strain was metronidazole susceptible in 93%. Antral biopsy samples were taken for culture, urease testing, histology and, in most patients, for PCR at least 6 wk after treatment. A separate corpus sample was taken for culture. Eradication was defined as the absence of H. pylori in all specimens. In seven cases, when only histology was doubtfully positive, and all other tests including PCR were negative, a 13C-urea breath test was performed, the result of which was recorded by the patient on a semi-quantitative scale.

RESULTS

H. pylori was eradicated by triple therapy in 96.3% and by amoxicillin/omeprazole in 77.2% of the patients (p = 0.008). Side effects occurred more often with triple therapy (72.7% vs. 50.8%; p< 0.05) but were mild in most cases. Severe side effects occurred equally in both treatment groups.

CONCLUSIONS

When the prevalence of metronidazole resistance is low, triple therapy is more effective than amoxicillin/omeprazole. Side effects occur more often in triple therapy but are mild in most cases.

摘要

目的

本研究比较两种常用的幽门螺杆菌感染治疗方案的疗效和副作用。

方法

118例经培养证实的幽门螺杆菌感染患者(61例十二指肠溃疡患者、19例胃溃疡患者、3例同时患有十二指肠溃疡和胃溃疡的患者以及35例非溃疡性消化不良患者)被随机分为两组,一组接受三联疗法(四环素250毫克、甲硝唑250毫克、枸橼酸铋钾120毫克,每日4次),疗程14天;另一组接受阿莫西林1000毫克和奥美拉唑40毫克,均每日2次,疗程14天。分离出的幽门螺杆菌菌株对甲硝唑敏感的占93%。治疗后至少6周,采集胃窦活检样本进行培养、尿素酶检测、组织学检查,大多数患者还进行了聚合酶链反应(PCR)检测。另取一份胃体样本进行培养。根除定义为所有标本中均未检测到幽门螺杆菌。7例患者仅组织学检查结果可疑阳性,而包括PCR在内的所有其他检测均为阴性,对这些患者进行了13C尿素呼气试验,患者以半定量方式记录试验结果。

结果

三联疗法使96.3%的患者幽门螺杆菌得到根除,阿莫西林/奥美拉唑疗法使77.2%的患者幽门螺杆菌得到根除(p = 0.008)。三联疗法的副作用发生率更高(72.7%对50.8%;p < 0.05),但大多数情况下症状较轻。两个治疗组严重副作用的发生率相同。

结论

当甲硝唑耐药率较低时,三联疗法比阿莫西林/奥美拉唑更有效。三联疗法的副作用发生率更高,但大多数情况下症状较轻。

相似文献

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Omeprazole. A review of its use in Helicobacter pylori infection, gastro-oesophageal reflux disease and peptic ulcers induced by nonsteroidal anti-inflammatory drugs.奥美拉唑。关于其在幽门螺杆菌感染、胃食管反流病及非甾体抗炎药所致消化性溃疡中应用的综述。
Drugs. 1998 Sep;56(3):447-86. doi: 10.2165/00003495-199856030-00012.
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Mucoadhesive microspheres containing amoxicillin for clearance of Helicobacter pylori.
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J Gen Intern Med. 1996 Oct;11(10):613-21. doi: 10.1007/BF02599029.