Department of Pediatrics, Jikei University Daisan Hospital, Tokyo, Japan.
Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.
Allergol Int. 2016 Jul;65(3):306-11. doi: 10.1016/j.alit.2016.02.010. Epub 2016 May 4.
Several guidelines, including the Japanese Pediatric Guideline for the Treatment and Management of Asthma (JPGL), recommend salmeterol/fluticasone combination therapy (SFC) as step 3 to 4 treatment for moderate to severe asthma. However, the optimal step-down approach to SFC remains unclear. In the current study, we examined step-down approaches in asthmatic children whose symptoms had been stabilized by SFC 100/200 μg/day.
This randomized, multicenter, open-label, parallel-group study was conducted over 12 weeks. For step-down therapy, subjects aged 5-15 years were randomly assigned to an SFC group (25/50 μg b.i.d.) or an FP group (100 μg b.i.d.), and treated for 12 weeks. Childhood Asthma Control Test (C-ACT) scores, lung function, and exhaled nitric oxide (FeNO) levels were monitored.
Of 131 enrolled subjects, 128 completed the study and were included in the analysis. Decreases in % peak expiratory flow rate and % forced expiratory flow at 50% of vital capacity (V50) were observed in the FP group at each time point. There was a significant difference between the two groups for the change in %V50 from its previous value at each time point. There were no significant changes in FeNO levels (range 15-20 ppb) or C-ACT scores (∼26 points) within or between groups.
A high level of asthma control was maintained with both approaches. The use of SFC step-down resulted in somewhat better respiratory function, with no worsening of airway inflammation. However, halving the dose of SFC and switching to FP alone are both optimal step-down approaches.
包括日本儿科哮喘治疗和管理指南（JPGL）在内的几项指南建议沙美特罗/氟替卡松联合疗法（SFC）作为中重度哮喘的第 3 至第 4 步治疗。然而，SFC 的最佳降级方法仍不清楚。在本研究中，我们检查了通过 SFC 100/200μg/天稳定症状的哮喘儿童的降级方法。
这是一项为期 12 周的随机、多中心、开放标签、平行组研究。对于降级治疗，年龄为 5-15 岁的受试者被随机分配到 SFC 组（25/50μg，每日 2 次）或 FP 组（100μg，每日 2 次），并治疗 12 周。监测儿童哮喘控制测试（C-ACT）评分、肺功能和呼出气一氧化氮（FeNO）水平。
在 131 名入组的受试者中，有 128 名完成了研究并被纳入分析。FP 组在每个时间点的呼气峰流速百分比和用力呼气 50%肺活量时的流速百分比（V50）均下降。两组之间每个时间点的 V50 相对于前值的变化存在显著差异。FeNO 水平（范围为 15-20ppb）或 C-ACT 评分（约 26 分）在组内或组间均无显著变化。
两种方法都能维持较高的哮喘控制水平。使用 SFC 降级会导致呼吸功能略有改善，而不会加重气道炎症。然而，将 SFC 的剂量减半并单独转换为 FP 是两种最佳的降级方法。
