The Alfred Hospital, Physiotherapy Department, Melbourne, Australia.
Respir Med. 2012 May;106(5):661-7. doi: 10.1016/j.rmed.2011.12.021. Epub 2012 Feb 19.
Inhalation of hypertonic saline (HTS) has short term positive effects on airways clearance in non-cystic fibrosis (CF) bronchiectasis, however its long term effects are unknown. The aim of this study was to determine the effect of HTS 6% on exacerbations, quality of life (QOL) and respiratory function over 12 months in non-CF bronchiectasis.
Forty patients were randomised to inhale isotonic saline (IS) 0.9% or HTS 6% daily for 12 months. Participants recorded their symptoms in a daily diary. Quality of life and respiratory function were measured after three, six and 12 months. Number of exacerbations and changes in sputum colonisation were recorded at 12 months. Participants, assessors and clinicians were blinded to group allocation.
The exacerbation rate at 12 months was similar in the two groups and similar clinically significant improvements in QOL were seen in both groups. The FEV(1) increased in both groups after six months (mean 90 ml, 95% confidence interval 11-169 ml) with no difference between groups (p = 0.394). The FEF(25-75%) significantly improved at all time points (mean increase at 12 months 187 ml, 69-304 ml) with no difference between groups (p = 0.705). There was a reduction in sputum colonisation in both groups (p = 0.046).
Inhalation of HTS or IS has similar effects on exacerbations, QOL, sputum colonisation and respiratory function over 12 months in non-CF bronchiectasis. The trial was registered with both Clinical Trials.gov - NCT00484263 and Australian New Zealand Clinical Trials Registry - ACTRN12607000367448.
吸入高渗盐水(HTS)对非囊性纤维化(CF)支气管扩张症的气道清除有短期的积极作用,但长期效果尚不清楚。本研究的目的是确定 HTS 6%在 12 个月内对非 CF 支气管扩张症的加重、生活质量(QOL)和呼吸功能的影响。
40 名患者被随机分为吸入等渗盐水(IS)0.9%或 HTS 6%组,每天吸入 12 个月。参与者在每日日记中记录他们的症状。在 3、6 和 12 个月后测量生活质量和呼吸功能。在 12 个月时记录加重次数和痰定植的变化。参与者、评估者和临床医生对分组情况均不知情。
两组在 12 个月时的加重率相似,两组的 QOL 均有相似的临床显著改善。两组的 FEV1 在 6 个月后均增加(平均增加 90ml,95%置信区间 11-169ml),两组之间无差异(p=0.394)。FEF(25-75%)在所有时间点均显著改善(平均增加 12 个月 187ml,69-304ml),两组之间无差异(p=0.705)。两组痰定植均减少(p=0.046)。
在非 CF 支气管扩张症中,吸入 HTS 或 IS 在 12 个月内对加重、生活质量、痰定植和呼吸功能的影响相似。该试验在 ClinicalTrials.gov 注册 - NCT00484263 和澳大利亚新西兰临床试验注册处 - ACTRN12607000367448。