囊性纤维化患者吸入谷胱甘肽与安慰剂对比的随机、单盲、对照试验
Randomized, single blind, controlled trial of inhaled glutathione vs placebo in patients with cystic fibrosis.
作者信息
Calabrese C, Tosco A, Abete P, Carnovale V, Basile C, Magliocca A, Quattrucci S, De Sanctis S, Alatri F, Mazzarella G, De Pietro L, Turino C, Melillo E, Buonpensiero P, Di Pasqua A, Raia V
机构信息
Department of Cardiothoracic and Respiratory Sciences, Second University of Naples, Italy.
Department of Translational Medical Sciences, Cystic Fibrosis Center, University "Federico II" of Naples, Italy.
出版信息
J Cyst Fibros. 2015 Mar;14(2):203-10. doi: 10.1016/j.jcf.2014.09.014. Epub 2014 Nov 4.
BACKGROUND
In cystic fibrosis (CF) the defective CF transmembrane conductance regulator protein may be responsible for the impaired transport of glutathione (GSH), the first line defense of the lung against oxidative stress. The aim of this single-blind, randomized, placebo-controlled trial was to evaluate the effect of inhaled GSH in patients with CF.
METHODS
54 adult and 51 pediatric patients were randomized to receive inhaled GSH or placebo twice daily for 12 months.
RESULTS
Twelve month treatment with inhaled GSH did not achieve our predetermined primary outcome measure of 15% improvement in FEV1%. Only in patients with moderate lung disease, 3, 6 and 9 months therapy with GSH resulted in a statistically significant increase of FEV1 values from the baseline. Moreover GSH therapy improved 6-minute walking test in pediatric population. GSH was well tolerated by all patients.
CONCLUSIONS
Inhaled GSH has slight positive effects in CF patients with moderate lung disease warranting further study.
TRIAL REGISTRY
ClinicalTrials.gov; No.: NCT01450267; URL: www.clinicaltrialsgov.
背景
在囊性纤维化（CF）中，有缺陷的CF跨膜传导调节蛋白可能是导致谷胱甘肽（GSH）转运受损的原因，而GSH是肺部抵御氧化应激的第一道防线。这项单盲、随机、安慰剂对照试验的目的是评估吸入GSH对CF患者的影响。
方法
54名成年患者和51名儿科患者被随机分组，每天两次吸入GSH或安慰剂，持续12个月。
结果
吸入GSH进行12个月的治疗未达到我们预定的主要结局指标，即第一秒用力呼气容积（FEV1%）改善15%。仅在中度肺部疾病患者中，使用GSH进行3、6和9个月的治疗后，FEV1值较基线有统计学显著增加。此外，GSH治疗改善了儿科患者的6分钟步行试验。所有患者对GSH耐受性良好。
结论
吸入GSH对中度肺部疾病的CF患者有轻微的积极作用，值得进一步研究。
试验注册
ClinicalTrials.gov；编号：NCT01450267；网址：www.clinicaltrialsgov 。
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