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克拉霉素单药治疗根除幽门螺杆菌:一项随机双盲试验。

Clarithromycin as monotherapy for eradication of Helicobacter pylori: a randomized, double-blind trial.

作者信息

Peterson W L, Graham D Y, Marshall B, Blaser M J, Genta R M, Klein P D, Stratton C W, Drnec J, Prokocimer P, Siepman N

机构信息

Medical Service, Dallas VA Medical Center, Texas.

出版信息

Am J Gastroenterol. 1993 Nov;88(11):1860-4.

PMID:8237933
Abstract

UNLABELLED

Current regimens to eradicate Helicobacter pylori usually consist of metronidazole plus a bismuth compound, as well as a third agent such as tetracycline. Such regimens are not ideal because organisms may be metronidazole-resistant, side-effects occur, and compliance is often poor. This randomized, double-blind study was designed to assess the ability of clarithromycin, a new macrolide antimicrobial, as monotherapy to eradicate H. pylori. Thirty-seven healthy volunteers who were H. pylori positive by 13C-urea breath test plus histology and/or culture completed 14 days of oral therapy with clarithromycin in one of three dosages. Eradication, defined as all three tests negative at 4-6 wk after the end of therapy, was achieved in 2/13 (15%) with clarithromycin 500 mg bid, 4/11 (36%) with 1000 mg bid, and 7/13 (54%) with 500 mg qid. Isolates of H. pylori were resistant to clarithromycin prior to therapy in 12% of subjects, and became resistant during therapy in 21% of subjects. Taste perversion, the most common side effect, resulted in one subject terminating therapy.

CONCLUSIONS

Whereas clarithromycin is a promising antimicrobial in the eradication of H. pylori, it is not sufficient to be used as monotherapy.

摘要

未标记

目前根除幽门螺杆菌的治疗方案通常包括甲硝唑加铋剂,以及第三种药物如四环素。这类方案并不理想,因为细菌可能对甲硝唑耐药,会出现副作用,且患者依从性往往较差。这项随机双盲研究旨在评估新型大环内酯类抗菌药物克拉霉素作为单一疗法根除幽门螺杆菌的能力。37名经13C尿素呼气试验及组织学和/或培养确诊为幽门螺杆菌阳性的健康志愿者,以三种剂量之一接受了为期14天的克拉霉素口服治疗。根除定义为治疗结束后4 - 6周所有三项检测均为阴性,接受克拉霉素500mg每日两次治疗的13名患者中有2名(15%)实现根除,接受1000mg每日两次治疗的11名患者中有4名(36%)实现根除,接受500mg每日四次治疗的13名患者中有7名(54%)实现根除。12%的受试者在治疗前幽门螺杆菌分离株对克拉霉素耐药,21%的受试者在治疗期间出现耐药。味觉异常是最常见的副作用,导致1名受试者终止治疗。

结论

虽然克拉霉素在根除幽门螺杆菌方面是一种有前景的抗菌药物,但作为单一疗法并不足够。

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