Background and purpose

The purpose of this study was to investigate that on the basis of ICS-LABA treatment, whether or not adding on short course of oral corticosteroid could increase the rate of asthma control.

Methodology

This was a double blind, randomized controlled study. Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic. All patients included in the study received ICS-LABA as initial treatment. Two weeks oral corticosteroid or placebo were added on at the beginning of treatment. All the subjects were followed-up by daily measurement of PEF and asthma diary for 12 week and spirometry at 4 weeks and 12 weeks.

Results

13 cases were randomized to Corticosteroid group (M/F: 9/4, age: 45.0 ± 5.0 yrs), 11 to Placebo group (M/F: 4/7, age: 35.7 ± 9.6yrs). After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05). However, there were no significant difference between two groups in the improvement of ACT、ACQ、AQLQ、FEV1、FEV1% (all P > 0.05). After 4 weeks of treatment, total control was achieved in 3 (30.8%) in corticosteroid group and 2 (18.2%) in placebo group; Partial control was achieved in 7 (61.5%)in corticosteroid group and in 7 (63.6%) in placebo group. There was no significant difference in control rates between two groups (X² = 0.919, P = 0.632). Similar findings were observed after 12 weeks of treatment.

Conclusion

In maintenance treatment naïve moderate to severe persistent asthma, ICS-LABA therapy was adequate initial treatment for achieving asthma control in majority of the patients. Add on short course of oral corticosteroid provided no significant clinical benefit.

中文翻译：

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短期口服皮质类固醇激素用于中度至重度持续性哮喘的初始治疗：一项双盲，随机，安慰剂对照试验。

背景和目的

这项研究的目的是调查在ICS-LABA治疗的基础上，短期口服皮质类固醇激素能否增加哮喘的控制率。

方法

这是一项双盲，随机对照研究。从未接受过维持治疗的中度至重度持续性哮喘患者从门诊招募。纳入研究的所有患者均接受ICS-LABA作为初始治疗。在治疗开始时添加了两周的口服皮质类固醇或安慰剂。所有受试者均接受每日PEF和哮喘日记的测量，随访12周，并在4周和12周时进行肺活量测定。

结果

13例被随机分为皮质类固醇组（男/女：9/4岁，年龄：45.0±5.0岁），11例被随机分为安慰剂组（男/女：4/7岁，年龄：35.7±9.6岁）。治疗后，两组的ACT，ACQ，AQLQ，FEV1，FEV1％均较基线水平有明显改善（均P <0.05）。但是，两组的ACT，ACQ，AQLQ，FEV1，FEV1％的改善无明显差异（均P> 0.05）。治疗4周后，皮质类固醇组3例（30.8％）和安慰剂组2例（18.2％）达到了完全控制；皮质类固醇组7例（61.5％）和安慰剂组7例（63.6％）达到部分控制。两组之间的控制率无显着差异（X ²  = 0.919，P  = 0.632）。治疗12周后观察到相似的发现。

结论

在中度至重度持续哮喘的维持治疗中，ICS-LABA治疗是大多数患者实现哮喘控制的适当初始治疗。加上短期口服皮质类固醇激素并没有提供明显的临床益处。