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静脉注射氨基糖苷类药物每日一次与多次给药治疗囊性纤维化的比较。

Once-daily versus multiple-daily dosing with intravenous aminoglycosides for cystic fibrosis.

作者信息

Smyth Alan R, Bhatt Jayesh

机构信息

Division of Child Health, Obstetrics & Gynaecology (COG), School of Medicine, University of Nottingham, Queens Medical Centre, Derby Road, Nottingham, UK, NG7 2UH.

出版信息

Cochrane Database Syst Rev. 2014 Feb 4(2):CD002009. doi: 10.1002/14651858.CD002009.pub5.

DOI:10.1002/14651858.CD002009.pub5
PMID:24497229
Abstract

BACKGROUND

People with cystic fibrosis, who are chronically colonised with the organism Pseudomonas aeruginosa, often require multiple courses of intravenous aminoglycoside antibiotics for the management of pulmonary exacerbations. The properties of aminoglycosides suggest that they could be given in higher doses less often.

OBJECTIVES

To assess the effectiveness and safety of once-daily versus multiple-daily dosing of intravenous aminoglycoside antibiotics for the management of pulmonary exacerbations in cystic fibrosis.

SEARCH METHODS

We searched the Cystic Fibrosis Specialist Register held at the Cochrane Cystic Fibrosis and Genetic Disorders Group's editorial base, comprising references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings.Date of the most recent search: 25 November 2013.

SELECTION CRITERIA

All randomised controlled trials, whether published or unpublished, in which once-daily dosing of aminoglycosides has been compared with multiple-daily dosing in terms of efficacy or toxicity or both, in people with cystic fibrosis.

DATA COLLECTION AND ANALYSIS

The two authors independently selected the studies to be included in the review and assessed the risk of bias of each study. Data were independently extracted by each author. Authors of the included studies were contacted for further information. As yet unpublished data were obtained for one of the included studies.

MAIN RESULTS

Fifteen studies were identified for possible inclusion in the review. Four studies reporting results from a total of 328 participants were included in this review. All studies compared once-daily dosing with thrice-daily dosing. One study had a low risk of bias for all criteria assessed; the remaining three included studies had a high risk of bias from blinding, but for other criteria were judged to have either an unclear or a low risk of bias.There was no significant difference between treatment groups in: forced expiratory volume at one second, mean difference 0.33 (95% confidence interval -2.81 to 3.48); forced vital capacity, mean difference 0.29 (95% confidence interval -6.58 to 7.16); % weight for height, mean difference -0.82 (95% confidence interval -3.77 to 2.13); body mass index, mean difference 0.00 (95% confidence interval -0.42 to 0.42); or in the incidence of ototoxicity, relative risk 0.56 (95% confidence interval 0.04 to 7.96). The percentage change in creatinine significantly favoured once-daily treatment in children, mean difference -8.20 (95% confidence interval -15.32 to -1.08), but showed no difference in adults, mean difference 3.25 (95% confidence interval -1.82 to 8.33).

AUTHORS' CONCLUSIONS: Once- and three-times daily aminoglycoside antibiotics appear to be equally effective in the treatment of pulmonary exacerbations of cystic fibrosis. There is evidence of less nephrotoxicity in children.

摘要

背景

患有囊性纤维化的患者长期被铜绿假单胞菌定植,在治疗肺部病情加重时常常需要多次静脉注射氨基糖苷类抗生素。氨基糖苷类药物的特性表明,可以减少给药频率并提高剂量。

目的

评估静脉注射氨基糖苷类抗生素每日一次给药与每日多次给药治疗囊性纤维化肺部病情加重的有效性和安全性。

检索方法

我们检索了 Cochrane 囊性纤维化和遗传疾病小组编辑基地保存的囊性纤维化专科注册库,其中包括通过全面电子数据库检索、手工检索相关期刊以及手工检索会议论文摘要集确定的参考文献。最新检索日期:2013 年 11 月 25 日。

入选标准

所有随机对照试验,无论是否发表,只要是将囊性纤维化患者中氨基糖苷类药物每日一次给药与每日多次给药在疗效或毒性或两者方面进行比较的试验。

数据收集与分析

两位作者独立选择纳入综述的研究,并评估每项研究的偏倚风险。每位作者独立提取数据。与纳入研究的作者联系以获取更多信息。其中一项纳入研究获得了尚未发表的数据。

主要结果

确定了 15 项可能纳入综述的研究。本综述纳入了 4 项研究,共报告了 328 名参与者的结果。所有研究均比较了每日一次给药与每日三次给药。一项研究在所有评估标准方面偏倚风险较低;其余三项纳入研究在盲法方面存在较高偏倚风险,但在其他标准方面被判定为偏倚风险不明确或较低。治疗组之间在以下方面无显著差异:一秒用力呼气量,平均差值 0.33(95%置信区间 -2.81 至 3.48);用力肺活量,平均差值 0.29(95%置信区间 -6.58 至 7.16);身高体重百分比,平均差值 -0.82(95%置信区间 -3.77 至 2.13);体重指数,平均差值 0.00(95%置信区间 -0.42 至 0.42);或耳毒性发生率,相对风险 0.56(95%置信区间 0.04 至 7.96)。肌酐百分比变化在儿童中明显有利于每日一次治疗,平均差值 -8.20(95%置信区间 -15.32 至 -1.08),但在成人中无差异,平均差值 3.25(95%置信区间 -1.82 至 8.33)。

作者结论

每日一次和每日三次的氨基糖苷类抗生素在治疗囊性纤维化肺部病情加重方面似乎同样有效。有证据表明儿童中的肾毒性较小。

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