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[根据剂量和给药方案,采用奥美拉唑、阿莫西林和克拉霉素治疗根除幽门螺杆菌的有效性]

[Effectiveness of the eradication of Helicobacter pylori by treatment with omeprazol, amoxicillin, and clarithromycin according to dosage and administration schedule].

作者信息

Martín Mir M L, Val J, Fuentes J, García S, Yus C, Simón M A, Gomollón F

机构信息

Servicio de Aparato Digestivo, Hospital Miguel Servet, Zaragoza.

出版信息

Gastroenterol Hepatol. 1998 Nov;21(9):432-6.

PMID:9882932
Abstract

BACKGROUND

There are many reports that evaluate the efficacy of the combination of omeprazole, amoxicillin and clarithromycin in the eradication of Helicobacter pylori, but data about effectivity in clinical practice are sparse. The goal of our study is to evaluate the effectivity in the clinical setting of this combination with diverse durations and doses.

METHODS

This is a retrospective analysis of 187 patients (128 male and 59 female), with an endoscopic diagnosis of duodenal ulcer (156), gastric ulcer (25) and both (6) with Helicobacter pylori infection as defined by both: a positive ureasa test and histology. After diagnosis the patient were treated with one of three combinations: a) omeprazole: 20 mg/12 h + amoxicillin: 1 g/12 h + clarithromycin: 500 mg/12 h, during 6 days (n = 60); b) omeprazole: 20 mg/12 h + amoxicillin: 1 g/12 h + clarithromycin: 500 mg/12 h, during 7 days (n = 74), and c) omeprazole: 20 mg/12 h + amoxicillin: 1 g/8 h + clarithromycin: 500 mg/8 h, during 7 days (n = 53). After the 6 or 7 day treatment period the patients did not receive any further treatment until a follow-up control unit. Eradication was evaluated with one of two tests: endoscopy (with ureasa test and at least 4 histologic samples) (n = 90) or urea breath test according to european protocol (n = 97).

RESULTS

No patient dropped out because of side effects and compliance was above 80% in all cases. The global eradication rate was 87.2% (CI 95%: 82.4-92%). According to treatment the rate were respectively 80% (CI 95%: 67.7-89.2%) with scheme A; 89.2% (CI 95%: 79.8-95.2%) with scheme B, and 92.5% (CI 95%: 81.8-97.9%) with scheme C, with no statistically significant differences among groups. Difference between schemes and C, however, was almost reached (p = 0.053).

CONCLUSIONS

The combination of omeprazole, amoxicillin and clarithromycin at standard doses (scheme B) is effective in clinical practice. Higher dose of amoxicillin and clarithromycin does not improve the results, and shorter duration of therapy associated with lower, although not significant rate of eradication.

摘要

背景

有许多报告评估了奥美拉唑、阿莫西林和克拉霉素联合使用根除幽门螺杆菌的疗效,但关于其在临床实践中的有效性数据较少。我们研究的目的是评估这种联合用药在不同疗程和剂量的临床环境中的有效性。

方法

这是一项对187例患者(128例男性和59例女性)的回顾性分析,这些患者经内镜诊断为十二指肠溃疡(156例)、胃溃疡(25例)以及两者皆有(6例),且通过尿素酶试验阳性和组织学检查确诊为幽门螺杆菌感染。诊断后,患者接受以下三种联合用药方案之一治疗:a)奥美拉唑:20毫克/12小时 + 阿莫西林:1克/12小时 + 克拉霉素:500毫克/12小时,疗程6天(n = 60);b)奥美拉唑:20毫克/12小时 + 阿莫西林:1克/12小时 + 克拉霉素:500毫克/12小时,疗程7天(n = 74);c)奥美拉唑:20毫克/12小时 + 阿莫西林:1克/8小时 + 克拉霉素:500毫克/8小时,疗程7天(n = 53)。在6天或7天的治疗期后,患者在随访控制单元之前不再接受任何进一步治疗。采用以下两种检测方法之一评估根除情况:内镜检查(进行尿素酶试验并至少取4份组织学样本)(n = 90)或根据欧洲方案进行尿素呼气试验(n =97)。

结果

没有患者因副作用退出,所有病例的依从性均高于80%。总体根除率为87.2%(95%CI:82.4 - 92%)。根据治疗方案,A方案的根除率为80%(95%CI:67.7 - 89.2%);B方案为89.2%(95%CI:79.8 - 95.2%);C方案为92.5%(95%CI:81.8 - 97.9%),各组之间无统计学显著差异。然而,方案B和C之间的差异几乎达到显著水平(p = 0.053)。

结论

标准剂量的奥美拉唑、阿莫西林和克拉霉素联合用药(方案B)在临床实践中有效。阿莫西林和克拉霉素的高剂量并未改善治疗效果,疗程较短虽根除率较低但无显著差异。

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