哮喘联盟

   摘要
   目的：对于哮喘各种二线治疗用药的比较，尚缺乏主观和客观地评估。本研究旨在比较孟鲁司特、多索茶碱、噻托溴铵联合低剂量布地奈德治疗轻中度持续性哮喘的疗效和安全性。
   方法：所有患者都使用吸入性布地奈德（400µg），同时分别使用福莫特罗（12µg）、孟鲁司特（10 mg）、多索茶碱（400 mg）或者噻托溴铵（18µg）治疗6个月。结果包括1秒用力呼气量(FEV1)、圣乔治呼吸问卷(SGRQ)评分、哮喘症状评分（白天和夜间）、耐受性的评估和急救药物的使用。
   结果：总共297例患者完成这项研究。在所有4个组中，测量结果均显著改善。相对于其他3组二线控制药物，福莫特罗联合布地奈德具有更大和更早的改善。在这些二线治疗用药中，孟鲁司特从第45日开始提高FEV1 (P < 0.01)，从第30日开始提高SGRQ评分(P< 0.0001)，从第30日开始提高白天哮喘症状评分(P < 0.05)，从第30日开始提高夜间哮喘症状评分(P < 0.0001)，从第15日开始使用急救药物(P < 0.0001)，且急救药物起效快于多索茶碱、噻托溴铵组。试验中没有患者因不良反应而终止治疗。
   意义：在本试验涉及到的二线治疗方案中，布地奈德/孟鲁司特联合用药的结果优于布地奈德/多索茶碱联合用药或布地奈德/噻托溴铵联合用药，且不对患者的耐受性产生不利影响。采取盲法设计的进一步临床研究很可能会有用。
 

（苏楠 审校）
ClinTher.2015Jan7.pii:S0149-2918(14)00828-5.doi:10.1016/j.clinthera.2014.12.008. [Epub ahead of print]


 

Assessment of Montelukast, Doxofylline, and Tiotropium With Budesonide for the Treatment of Asthma: Which Is the Best Among the Second-Line Treatment? A Randomized Trial.
 

Rajanandh MG1, Nageswari AD2, Ilango K3.
 

Abstract
PURPOSE: Data comparing various second-line treatments for asthma with subjective and objective assessment are lacking. This study aimed to compare the efficacy and safety of montelukast, doxofylline, and tiotropium with a low-dose budesonide in patients with mild to moderate persistent asthma.
METHODS: Patients, all of whom were concurrently using inhaled budesonide (400 µg), were treated for 6 months with formoterol (12 µg), montelukast (10 mg), doxofylline (400 mg), or tiotropium (18 µg). Outcomes included forced expiratory volume in 1 second (FEV1), Saint George Respiratory Questionnaire (SGRQ) scores, asthma symptom scores (daytime and nighttime), and assessment of tolerability and rescue medication use.
FINDINGS: A total of 297 patients completed the study. In all 4 groups, significant improvements were observed in all the outcome measures, with formoterol treatment having greater and earlier improvements than the other 3 second-line controller medications with budesonide. Among the second-line treatments, montelukast improved the FEV1 from day 45 (P < 0.01), SGRQ scores from day 30 (P < 0.0001), daytime scores from day 30 (P < 0.05), nighttime scores from day 30 (P < 0.0001), and rescue medication use from day 15 (P < .0001) at a faster rate than doxofylline or tiotropium with budesonide. No patients discontinued the treatment because of adverse reactions.
IMPLICATIONS:Among the tested second-line treatment regimens, the budesonide/montelukast combination was found to be superior to either the budesonide/doxofylline or budesonide/tiotropium combination in all the outcome measures without adversely affecting the tolerability of the patients. Further clinical studies with blinding techniques are likely to be useful.
 

ClinTher.2015Jan7.pii:S0149-2918(14)00828-5.doi:10.1016/j.clinthera.2014.12.008. [Epub ahead of print]