Mori Kazutaka, Fujisawa Tomoyuki, Inui Naoki, Hashimoto Dai, Enomoto Noriyuki, Nakamura Yutaro, Kuroishi Shigeki, Yokomura Koshi, Toyoshima Mikio, Imokawa Shiro, Yamada Takashi, Shirai Toshihiro, Masuda Masafumi, Hayakawa Hiroshi, Chida Kingo, Suda Takafumi
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
Respir Med. 2016 Oct;119:1-6. doi: 10.1016/j.rmed.2016.08.007. Epub 2016 Aug 15.
The stepping down of asthma treatment can be considered when asthma symptoms have been well controlled with inhaled corticosteroids (ICSs)/long-acting β2 adrenergic agonists (LABAs). However, few data are available comparing the efficacy between two step-down strategies, to reduce ICS/LABA dose or to withdraw LABA continuing ICS, in well-controlled asthmatics.
This was a prospective multicentre randomized, two-arm, controlled study. Ninety-one asthmatic patients controlled by budesonide/formoterol combination (BFC) 320/9 μg twice daily were assigned to 2 stepping-down treatments as follows: the BFC group; BUD/FM 160/4.5 μg twice daily, and the ICS group; ICS (budesonide 400 μg twice daily or equivalent dose of ICS) without LABA, and followed for 12 weeks. The primary outcome was the incidence of asthma exacerbations. Asthma control, pulmonary function tests, and fraction of exhaled nitric oxide (FeNO) were evaluated at the beginning and end of the period.
The incidence of exacerbations was 16.3% in the BFC groups and 12.5% in the ICS group, which were not different between the groups (p = 0.766). No significant differences were found in QOL score and FeNO between 0 week and 12 week in the both group. FEV1 and FEV1 percentage of the predicted value were lower at week 12 than at week 0 in the ICS group, but not in the BFC group.
The two step-down strategies for 12 weeks have equal acceptability in well-controlled asthmatics treated with medium-dose of BFC, however, withdrawal of LABA may have potential risk to deteriorate FEV1.
This study was registered to UMIN-CTR (http://www.umin.ac.jp/ctr/), UMIN000010333.
当哮喘症状通过吸入性糖皮质激素（ICS）/长效β2肾上腺素能激动剂（LABA）得到良好控制时，可以考虑逐步减少哮喘治疗药物。然而，在病情得到良好控制的哮喘患者中，比较两种逐步减量策略（减少ICS/LABA剂量或停用LABA并继续使用ICS）疗效的数据很少。
这是一项前瞻性多中心随机双臂对照研究。91例每日两次使用布地奈德/福莫特罗联合制剂（BFC）320/9μg控制病情的哮喘患者被分配到以下两种逐步减量治疗方案中：BFC组，每日两次使用BUD/FM 160/4.5μg；ICS组，使用不含LABA的ICS（每日两次使用布地奈德400μg或等效剂量的ICS），并随访12周。主要结局指标是哮喘急性发作的发生率。在研究开始和结束时评估哮喘控制情况、肺功能测试以及呼出一氧化氮分数（FeNO）。
BFC组的急性发作发生率为16.3%，ICS组为12.5%，两组之间无差异（p = 0.766）。两组在第0周和第12周的生活质量评分和FeNO方面均未发现显著差异。ICS组在第12周时的第一秒用力呼气容积（FEV1）和预测值的FEV1百分比低于第0周，但BFC组没有。
对于使用中剂量BFC治疗且病情得到良好控制的哮喘患者，两种为期12周的逐步减量策略具有相同的可接受性，然而，停用LABA可能存在使FEV1恶化的潜在风险。
本研究已在UMIN-CTR（http://www.umin.ac.jp/ctr/）注册，UMIN000010333。
