Zhang Yan-Feng, Yang Lin-Dong
Department of Paediatrics, Yan'an People's Hospital, Yanan, China.
Medicine (Baltimore). 2019 Jan;98(2):e14046. doi: 10.1097/MD.0000000000014046.
This study investigated the effectiveness and safety of exercise training (ET) as an adjunctive therapy to montelukast for children with mild asthma (MA).
A total of 72 children, ages 4 to 12 years with MA were randomly assigned to a treatment group or a control group at a ratio of 1:1. The subjects in the treatment group received ET plus montelukast, while the participants in the control group received montelukast alone. The primary endpoint was lung function, as measured by forced expiratory volume in 1 second (FEV1) and ratio between FEV1 and forced vital capacity (FEV1/FVC). The secondary endpoints included the symptom improvements, as measured by clinical assessment score, and quality of life (QoL), as assessed with Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) scores. In addition, adverse events were also assessed during the period of this study. All outcomes were measured at baseline, at the end of 6-week treatment and 2-week follow-up after the treatment.
After 6-week treatment and 2-week follow-up, although ET plus montelukast did not show better effectiveness in improving lung function, as evaluated by the FEV1 (P > .05) and FEV1/FVC (P > .05) than montelukast alone, significant relief in clinical symptoms (P < .01), and improvement in QoL (P < .01) have achieved. Additionally, both groups had similar safety profile.
The results of this study showed that ET as an adjunctive therapy to montelukast may benefit for children with MA. Further studies are still needed to warrant the results of this study.
本研究调查了运动训练(ET)作为孟鲁司特辅助治疗手段对轻度哮喘(MA)儿童的有效性和安全性。
总共72名年龄在4至12岁的MA儿童以1:1的比例随机分为治疗组或对照组。治疗组的受试者接受ET加孟鲁司特治疗,而对照组的参与者仅接受孟鲁司特治疗。主要终点是肺功能,通过一秒用力呼气量(FEV1)以及FEV1与用力肺活量之比(FEV1/FVC)来衡量。次要终点包括通过临床评估评分衡量的症状改善情况,以及通过儿科过敏性疾病生活质量问卷(PADQLQ)评分评估的生活质量(QoL)。此外,在本研究期间还评估了不良事件。所有结果均在基线、6周治疗结束时以及治疗后2周随访时进行测量。
经过6周治疗和2周随访,尽管与单独使用孟鲁司特相比,ET加孟鲁司特在改善肺功能方面(通过FEV1(P>0.05)和FEV1/FVC(P>0.05)评估)未显示出更好的效果,但在临床症状方面取得了显著缓解(P<0.01),生活质量也得到了改善(P<0.01)。此外,两组的安全性相似。
本研究结果表明,ET作为孟鲁司特的辅助治疗手段可能对MA儿童有益。仍需进一步研究以证实本研究结果。