Department of Pediatrics, University of Naples Federico II, Italy.
Adv Ther. 2010 Nov;27(11):870-8. doi: 10.1007/s12325-010-0076-8. Epub 2010 Oct 14.
Inhaled hypertonic saline improves lung function and decreases pulmonary exacerbations in people with cystic fibrosis. However, side effects such as cough, narrowing of airways and saltiness cause intolerance of the therapy in 8% of patients. The aim of our study was to compare the effect of an inhaled solution of hyaluronic acid and hypertonic saline with hypertonic solution alone on safety and tolerability.
A total of 20 patients with cystic fibrosis aged 6 years and over received a single treatment regimen of 7% hypertonic saline solution or hypertonic solution with 0.1% hyaluronate for 2 days nonconsecutively after a washout period in an open crossover study. Cough, throat irritation, and salty taste were evaluated by a modified ordinal score for assessing tolerability; "pleasantness" was evaluated by a five-level, Likert-type scale. Forced expiratory volume in 1 second was registered before and after the end of the saline inhalations.
All 20 patients (nine males, 11 females, mean age 13 years, range 8.9-17.7) completed the study. The inhaled solution of 0.1% hyaluronic acid and hypertonic saline significantly improved tolerability and pleasantness compared to hypertonic saline alone. No major adverse effects were observed. No difference was documented in pulmonary function tests between the two treatments.
Hyaluronic acid combined with hypertonic saline solution may contribute to improved adherence to hypertonic saline therapy. Further clinical trials are needed to confirm our findings. Considering the extraordinary versatility of hyaluronic acid in biological reactions, perspective studies could define its applicability to halting progression of lung disease in cystic fibrosis.
吸入高渗盐水可改善囊性纤维化患者的肺功能并减少肺部恶化。然而,8%的患者因咳嗽、气道狭窄和咸味等副作用而无法耐受该治疗。本研究旨在比较单独使用高渗盐水溶液与高渗盐水溶液和 0.1%透明质酸的吸入溶液对安全性和耐受性的影响。
在一项开放交叉研究中,20 名年龄在 6 岁及以上的囊性纤维化患者在洗脱期后连续两天非连续接受 7%高渗盐水溶液或高渗盐水溶液加 0.1%透明质酸钠单一治疗方案。通过改良的排序评分评估咳嗽、咽喉刺激和咸味的耐受性;通过五级李克特量表评估“愉悦感”。在盐水吸入前后记录用力呼气量。
所有 20 名患者(9 名男性,11 名女性,平均年龄 13 岁,范围 8.9-17.7)均完成了研究。与单独使用高渗盐水相比,0.1%透明质酸和高渗盐水的吸入溶液显著提高了耐受性和愉悦感。未观察到主要不良事件。两种治疗方法之间的肺功能测试无差异。
透明质酸与高渗盐水溶液联合使用可能有助于提高对高渗盐水治疗的依从性。需要进一步的临床试验来证实我们的发现。考虑到透明质酸在生物反应中的非凡多功能性,前瞻性研究可以确定其在阻止囊性纤维化中肺病进展的适用性。