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庆大霉素治疗感染性心内膜炎每日一次与每日两次给药的随机临床试验

Once versus twice daily gentamicin dosing for infective endocarditis: a randomized clinical trial.

作者信息

Buchholtz Kristine, Larsen Carsten Toftager, Schaadt Bente, Hassager Christian, Bruun Niels Eske

机构信息

Department of Cardiology, Gentofte University Hospital, Copenhagen, Denmark. krisbuch @ vip.cybercity.dk

出版信息

Cardiology. 2011;119(2):65-71. doi: 10.1159/000329842. Epub 2011 Aug 17.

DOI:10.1159/000329842
PMID:21846985
Abstract

OBJECTIVES

The aim of this randomized study was to investigate the effects of once versus twice daily gentamicin dosing on renal function and measures of infectious disease in a population with infective endocarditis (IE).

METHODS

Seventy-one IE patients needing gentamicin treatment according to guidelines were randomized to either once (n = 37) or twice daily (n = 34) doses of gentamicin. Kidney function (glomerular filtration rate, GFR) was measured with an isotope method ((51)Cr-EDTA) at the beginning of treatment and at discharge. Treatment efficacy was assessed by C-reactive protein (CRP) time to half-life, mean CRP and leukocytes.

RESULTS

Baseline GFR was similar in the two groups. Both groups displayed a significant fall in GFR from admission to discharge. The mean decrease in GFR was as follows: with once daily gentamicin, 17.0% (95% confidence interval 7.5-26.5), and with twice daily gentamicin, 20.4% (95% confidence interval 12.0-28.8). However, there was no significant difference in the GFR decrease between the once and twice daily regimens (p = 0.573). No difference in infection parameters was demonstrated between the two dosing regimens.

CONCLUSIONS

A twice daily gentamicin dosing regimen is neither less nephrotoxic nor more efficient than a once daily regimen in the treatment of IE patients. When indicated, gentamicin may therefore also be administered as a single-dose regimen in the treatment of IE patients.

摘要

目的

本随机研究旨在调查在感染性心内膜炎(IE)患者中,庆大霉素每日一次给药与每日两次给药对肾功能及传染病指标的影响。

方法

71例根据指南需要庆大霉素治疗的IE患者被随机分为每日一次(n = 37)或每日两次(n = 34)剂量的庆大霉素治疗组。在治疗开始时及出院时,采用同位素方法((51)Cr - EDTA)测量肾功能(肾小球滤过率,GFR)。通过C反应蛋白(CRP)半衰期、平均CRP和白细胞评估治疗效果。

结果

两组的基线GFR相似。两组从入院到出院时GFR均显著下降。GFR的平均下降情况如下:每日一次庆大霉素治疗组为17.0%(95%置信区间7.5 - 26.5),每日两次庆大霉素治疗组为20.4%(95%置信区间12.0 - 28.8)。然而,每日一次与每日两次给药方案之间的GFR下降无显著差异(p = 0.573)。两种给药方案在感染参数方面无差异。

结论

在治疗IE患者时,每日两次庆大霉素给药方案在肾毒性方面并不低于每日一次给药方案,在疗效方面也不高于每日一次给药方案。因此,在有指征时,庆大霉素也可采用单剂量方案用于IE患者的治疗。

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