运动训练作为孟鲁司特治疗轻度哮喘的辅助治疗:一项随机对照试验
2019/03/21
摘要
背景：本研究探讨运动训练(ET)辅助治疗轻度哮喘(MA)的有效性和安全性。
方法：将72名4～12岁MA患儿随机分为治疗组和对照组，比例为1:1。治疗组接受ET +孟鲁司特治疗，对照组仅接受孟鲁司特治疗。主要终点是肺功能，通过1秒用力呼气容积(FEV1)和FEV1与用力肺活量(FEV1/FVC)的比值来测量。次要终点包括症状改善(以临床评估评分衡量)和生活质量(以儿科过敏性疾病生活质量问卷(PADQLQ)评分评估)。此外，在本研究期间评估不良事件。所有结果均在基线、6周治疗结束时和治疗后2周随访时进行测量。
结果：在六周的治疗和随访2周中,尽管ET + 孟鲁司特和单独孟鲁司特相比在改善肺功能方面并未显示更好的效果,评估的FEV1 (P > 0. 05)和FEV1 / FVC (P >0 . 05),但是可以明显缓解临床症状(P <0 . 01)，并改善生命质量(P < 0. 01)。此外，两组患者的安全状况相似。
结论：本研究结果表明，ET作为孟鲁司特的辅助治疗可能对MA患儿有益。为了证实这项研究的结果还需要进一步的研究。
Exercise training as an adjunctive therapy to montelukast in children with mild asthma: A randomized controlled trial.
Zhang YF, Yang LD.
Abstract
BACKGROUND: This study investigated the effectiveness and safety of exercise training (ET) as an adjunctive therapy to montelukast for children with mild asthma (MA).
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
背景：本研究探讨运动训练(ET)辅助治疗轻度哮喘(MA)的有效性和安全性。
方法：将72名4～12岁MA患儿随机分为治疗组和对照组，比例为1:1。治疗组接受ET +孟鲁司特治疗，对照组仅接受孟鲁司特治疗。主要终点是肺功能，通过1秒用力呼气容积(FEV1)和FEV1与用力肺活量(FEV1/FVC)的比值来测量。次要终点包括症状改善(以临床评估评分衡量)和生活质量(以儿科过敏性疾病生活质量问卷(PADQLQ)评分评估)。此外，在本研究期间评估不良事件。所有结果均在基线、6周治疗结束时和治疗后2周随访时进行测量。
结果：在六周的治疗和随访2周中,尽管ET + 孟鲁司特和单独孟鲁司特相比在改善肺功能方面并未显示更好的效果,评估的FEV1 (P > 0. 05)和FEV1 / FVC (P >0 . 05),但是可以明显缓解临床症状(P <0 . 01)，并改善生命质量(P < 0. 01)。此外，两组患者的安全状况相似。
结论：本研究结果表明，ET作为孟鲁司特的辅助治疗可能对MA患儿有益。为了证实这项研究的结果还需要进一步的研究。
(中日友好医院呼吸与危重症医学科 禹汶伯 摘译 林江涛 审校)
(Medicine (Baltimore). 2019 Jan;98(2).)
(Medicine (Baltimore). 2019 Jan;98(2).)
Exercise training as an adjunctive therapy to montelukast in children with mild asthma: A randomized controlled trial.
Zhang YF, Yang LD.
Abstract
BACKGROUND: This study investigated the effectiveness and safety of exercise training (ET) as an adjunctive therapy to montelukast for children with mild asthma (MA).
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
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