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囊性纤维化患者每日与每周使用阿奇霉素的比较。

Daily versus weekly azithromycin in cystic fibrosis patients.

作者信息

McCormack J, Bell S, Senini S, Walmsley K, Patel K, Wainwright C, Serisier D, Harris M, Bowler S

机构信息

Department of Medicine and Infectious Diseases, University of Queensland, Mater Adult Hospital, South Brisbane, 4101 Queensland, Australia.

出版信息

Eur Respir J. 2007 Sep;30(3):487-95. doi: 10.1183/09031936.00163306. Epub 2007 May 30.

Abstract

Four randomised, placebo-controlled trials have previously documented the clinical benefits of azithromycin (AZM) in cystic fibrosis (CF) patients. The present study examined whether the beneficial effect of AZM is equivalent when administered daily or weekly. A double-blind, randomised study was carried out in 208 CF patients aged 6-58 yrs who were assigned to AZM either 250 mg daily (n = 103) or 1,200 mg weekly (n = 105) for 6 months, with assessments at baseline and at 1, 3, 6 and 7 months. Patients were taken from five adult and children CF centres in South-east Queensland, Australia. Equivalence was demonstrated between the two groups (daily versus weekly) with respect to improvements in lung function (forced expiratory volume in one second and forced vital capacity), C-reactive protein, days spent in hospital, admission rates and nutrition (body mass index, z-scores) using 95% confidence intervals with a tolerance interval of +/-10%. In patients aged <18 yrs the daily group had significantly better improvements in z-scores for height and weight after 6 months. In children, a nutritional advantage for daily administration was found. Gastro-intestinal adverse effects were more common with weekly therapy. Apart from these findings, daily and weekly administered azithromycin demonstrated similar outcomes for cystic fibrosis patients.

摘要

此前已有四项随机、安慰剂对照试验记录了阿奇霉素(AZM)对囊性纤维化(CF)患者的临床益处。本研究探讨了每日给药与每周给药时AZM的有益效果是否相当。对208名年龄在6至58岁的CF患者进行了一项双盲随机研究,这些患者被分配接受每日250毫克AZM(n = 103)或每周1200毫克AZM(n = 105)治疗,为期6个月,并在基线、第1、3、6和7个月进行评估。患者来自澳大利亚昆士兰州东南部的五个成人和儿童CF中心。使用95%置信区间和±10%的耐受区间,两组(每日给药组与每周给药组)在肺功能改善(一秒用力呼气量和用力肺活量)、C反应蛋白、住院天数、入院率和营养状况(体重指数、z评分)方面表现出等效性。在年龄小于18岁的患者中,每日给药组在6个月后身高和体重的z评分改善明显更好。在儿童中,发现每日给药具有营养优势。每周治疗的胃肠道不良反应更为常见。除这些发现外,每日和每周给药的阿奇霉素对囊性纤维化患者显示出相似的结果。

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