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利福昔明治疗甲硝唑治疗无效的艰难梭菌感染:一项前瞻性试点试验。

Rifaximin therapy for metronidazole-unresponsive Clostridium difficile infection: a prospective pilot trial.

机构信息

Gastroenterology, Hepatology and Liver Transplant, Columbia University College of Physicians and Surgeons, New York, NY, USA.

出版信息

Therap Adv Gastroenterol. 2010 Jul;3(4):221-5. doi: 10.1177/1756283X10372985.

Abstract

BACKGROUND

Clostridium difficile infection (CDI) is a recent epidemic in the United States, particularly in the hospital setting. Oral metronidazole is standard therapy for C. difficile infection, but resistance to metronidazole is becoming a clinical challenge.

METHODS

We evaluated the efficacy of the nonsystemic oral antibiotic rifaximin for the treatment of metronidazole-resistant C. difficile infection. Twenty-five patients with C. difficile infection were enrolled in the study. All had mild-to-moderate C. difficile infection (5-10 bowel movements a day without sepsis) unresponsive to metronidazole (i.e. stools positive for toxins A and B after oral metronidazole 500 mg three times daily [t.i.d.] for 5 days). After discontinuation of metronidazole, rifaximin 400 mg t.i.d. for 14 days was prescribed. Patients were followed for 56 days and stool was tested for C. difficile using polymerase chain reaction (PCR) to assess the effect of treatment. A negative PCR test result was interpreted as a favorable response to rifaximin.

RESULTS

Sixteen of 22 patients (73%) were eligible for study inclusion and completed rifaximin therapy experienced eradication of infection (stool negative for C. difficile) immediately after rifaximin therapy and 56 days post-treatment. Three patients (12%) discontinued therapy because of abdominal distention. Rifaximin was generally well tolerated.

CONCLUSIONS

In conclusion, rifaximin may be considered for treatment of mild-to-moderate C. difficile infection that is resistant to metronidazole. Larger randomized trials are needed to confirm these positive findings.

摘要

背景

艰难梭菌感染(CDI)是美国最近的一种流行病,特别是在医院环境中。口服甲硝唑是治疗艰难梭菌感染的标准疗法,但甲硝唑耐药性正成为临床挑战。

方法

我们评估了非系统性口服抗生素利福昔明治疗甲硝唑耐药性艰难梭菌感染的疗效。研究纳入了 25 例艰难梭菌感染患者。所有患者均患有轻度至中度艰难梭菌感染(每天 5-10 次排便,无败血症),对甲硝唑(即口服甲硝唑 500mg,每日 3 次,连用 5 天,粪便毒素 A 和 B 阳性)无反应。甲硝唑停药后,给予利福昔明 400mg,每日 3 次,连用 14 天。患者随访 56 天,用聚合酶链反应(PCR)检测粪便艰难梭菌,以评估治疗效果。PCR 检测结果阴性表示利福昔明治疗有效。

结果

22 例患者中有 16 例(73%)符合研究纳入标准,并完成了利福昔明治疗。16 例患者立即在利福昔明治疗后和治疗后 56 天清除了感染(粪便艰难梭菌阴性)。3 例(12%)患者因腹胀而停止治疗。利福昔明总体耐受性良好。

结论

总之,对于甲硝唑耐药的轻度至中度艰难梭菌感染,可考虑使用利福昔明治疗。需要更大规模的随机试验来证实这些阳性发现。

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