O'Neill Katherine, Moran Fidelma, Tunney Michael M, Elborn J Stuart, Bradbury Ian, Downey Damian G, Rendall Jackie, Bradley Judy M
Centre for Experimental Medicine, Queen's University Belfast , Belfast , UK.
School of Health Sciences, Ulster University , Jordanstown , UK.
BMJ Open Respir Res. 2017 Jan 12;4(1):e000168. doi: 10.1136/bmjresp-2016-000168. eCollection 2017.
Streamlining the timing of treatments in cystic fibrosis (CF) is important to optimise adherence while ensuring efficacy. The optimal timing of treatment with hypertonic saline (HTS) and airway clearance techniques (ACT) is unknown.
This study hypothesised that HTS before ACT would be more effective than HTS during ACT as measured by Lung Clearance Index (LCI).
Adults with CF providing written informed consent were randomised to a crossover trial of HTS before ACT or HTS during ACT on consecutive days. ACT treatment consisted of Acapella Duet. Patients completed LCI and spirometry at baseline and 90 min post treatment. Mean difference (MD) and 95% CIs were reported.
13 subjects completed the study (mean (SD) age 33 (12) years, forced expiratory volume in 1second % (FEV%) predicted 51% (22), LCI (no. turnovers) 14 (4)). Comparing the two treatments (HTS before ACT vs HTS during ACT), the change from baseline to 90 min post treatment in LCI (MD (95% CI) -0.02 (-0.63 to 0.59)) and FEV% predicted (MD (95% CI) -0.25 (-2.50 to 1.99)) was not significant. There was no difference in sputum weight (MD (95% CI) -3.0 (-14.9 to 8.9)), patient perceived ease of clearance (MD (95% CI) 0.4 (-0.6 to 1.3) or satisfaction (MD (95% CI) 0.4 (-0.6 to 1.5)). The time taken for HTS during ACT was significantly shorter (MD (95% CI) 14.7 (9.8 to 19.6)).
In this pilot study, HTS before ACT was no more effective than HTS during ACT as measured by LCI.
NCT01753869; Pre-results.
优化囊性纤维化(CF)治疗的时间安排对于提高依从性并确保疗效至关重要。高渗盐水(HTS)和气道廓清技术(ACT)的最佳治疗时间尚不清楚。
本研究假设,通过肺清除指数(LCI)测量,ACT前使用HTS比ACT期间使用HTS更有效。
成年CF患者提供书面知情同意书后,被随机分配到连续两天进行ACT前使用HTS或ACT期间使用HTS的交叉试验。ACT治疗采用Acapella Duet。患者在基线和治疗后90分钟完成LCI和肺功能测定。报告平均差异(MD)和95%置信区间(CI)。
13名受试者完成了研究(平均(标准差)年龄33(12)岁,1秒用力呼气容积百分比(FEV%)预测值为51%(22),LCI(周转次数)为14(4))。比较两种治疗方法(ACT前使用HTS与ACT期间使用HTS),治疗后90分钟LCI从基线的变化(MD(95%CI)-0.02(-0.63至0.59))和FEV%预测值(MD(95%CI)-0.25(-2.50至1.99))无显著差异。痰液重量(MD(95%CI)-3.0(-14.9至8.9))、患者感觉的清除难易程度(MD(95%CI)0.4(-0.6至1.3))或满意度(MD(95%CI)0.4(-0.6至1.5))均无差异。ACT期间使用HTS的时间明显更短(MD(95%CI)14.7(9.8至19.6))。
在这项初步研究中,通过LCI测量,ACT前使用HTS并不比ACT期间使用HTS更有效。
NCT01753869;预结果。