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一项随机对照临床试验:吸入 L-精氨酸治疗囊性纤维化患者。

A randomized controlled trial of inhaled L-arginine in patients with cystic fibrosis.

机构信息

Division of Respiratory Medicine, Department of Pediatrics, the Hospital for Sick Children, University of Toronto, Toronto, Canada.

出版信息

J Cyst Fibros. 2013 Sep;12(5):468-74. doi: 10.1016/j.jcf.2012.12.008. Epub 2013 Jan 14.

DOI:10.1016/j.jcf.2012.12.008
PMID:23333044
Abstract

BACKGROUND

Cystic fibrosis (CF) airways are nitric oxide (NO) deficient. We studied safety and efficacy of repeated inhalations of nebulized L-arginine, the substrate for NO synthase (NOS), in patients with CF.

METHODS

Double-blind, randomized, placebo-controlled crossover treatment trial of twice daily inhalation of 500 mg L-arginine for two weeks compared to inhalation of saline in 19 CF patients (ClinicalTrials.gov Identifier: NCT00405665).

RESULTS

L-arginine inhalation was well tolerated and resulted in a significant increase in exhaled NO. FEV1 increased by an average of 56 ml compared to -8 ml after saline solution; but this difference did not reach statistical significance. Sputum concentrations of L-ornithine, the product of arginase activity, increased significantly while the L-ornithine derived polyamines did not. There was no change in inflammatory markers in sputum.

CONCLUSION

Repeated inhalation of L-arginine in CF patients was safe and well tolerated. Inhaled L-arginine increased NO production without evidence for changes in airway inflammation.

摘要

背景

囊性纤维化 (CF) 气道中一氧化氮 (NO) 含量不足。我们研究了 CF 患者重复吸入雾化 L-精氨酸(NO 合酶 (NOS) 的底物)的安全性和疗效。

方法

对 19 例 CF 患者进行了为期两周的每日两次吸入 500mg L-精氨酸与吸入生理盐水的双盲、随机、安慰剂对照交叉治疗试验(ClinicalTrials.gov 标识符:NCT00405665)。

结果

L-精氨酸吸入耐受良好,可显著增加呼气中 NO 的含量。与吸入生理盐水后增加 8ml 相比,FEV1 平均增加了 56ml;但这一差异无统计学意义。精氨酸酶活性产物 L-鸟氨酸的痰液浓度显著增加,但 L-鸟氨酸衍生的多胺没有变化。痰液中的炎症标志物没有变化。

结论

在 CF 患者中重复吸入 L-精氨酸是安全且耐受良好的。吸入 L-精氨酸可增加 NO 的产生,而气道炎症无变化。

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