Respiratory Medicine, University of Ferrara, Ferrara, Italy
A. Papi and D.S. Ferreira contributed equally to this work.
Eur Respir J. 2023 Oct 12;62(4). doi: 10.1183/13993003.00047-2023. Print 2023 Oct.
Recent clinical trials of as-needed fixed-dose combination of inhaled corticosteroid (ICS)/formoterol have provided new evidence that may warrant a reconsideration of current practice. A Task Force was set up by the European Respiratory Society to provide evidence-based recommendations on the use of as-needed ICS/formoterol as treatment for mild asthma. The Task Force defined two questions that were assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach. The Task Force utilised the outcomes to develop recommendations for a pragmatic guideline for everyday clinical practice. The Task Force suggests that adults with mild asthma use as-needed ICS/formoterol instead of regular ICS maintenance treatment plus as-needed short-acting β-antagonist (SABA) and that adolescents with mild asthma use either as-needed ICS/formoterol or ICS maintenance treatment plus as-needed SABA (conditional recommendation; low certainty of evidence). The recommendation for adults places a relatively higher value on the reduction of systemic corticosteroid use and the outcomes related to exacerbations, and a relatively lower value on the small differences in asthma control. Either treatment option is suggested for adolescent patients as the balance is very close and data more limited. The Task Force recommends that adult and adolescent patients with mild asthma use as-needed ICS/formoterol instead of as-needed SABA (strong recommendation; low certainty of evidence). This recommendation is based on the benefit of as-needed ICS/formoterol in mild asthma on several outcomes and the risks related to as-needed SABA in the absence of anti-inflammatory treatment. The implementation of this recommendation is hampered in countries (including European Union countries) where as-needed ICS/formoterol is not approved for mild asthma.
最近按需使用固定剂量吸入皮质激素（ICS）/福莫特罗的临床试验提供了新的证据，可能需要重新考虑当前的治疗实践。欧洲呼吸学会成立了一个专门小组，就按需使用 ICS/福莫特罗治疗轻度哮喘提供基于证据的建议。该专门小组使用 GRADE（推荐分级、评估、发展与评价）方法评估了两个问题。该专门小组利用这些结果为日常临床实践制定了实用指南建议。该专门小组建议，轻度哮喘的成年患者使用按需 ICS/福莫特罗，而不是常规 ICS 维持治疗加按需使用短效 β-受体激动剂（SABA）；轻度哮喘的青少年患者可以选择按需使用 ICS/福莫特罗或 ICS 维持治疗加按需使用 SABA（有条件推荐；证据确定性低）。对于成年患者，建议将相对较高的价值放在减少全身皮质激素的使用和与加重相关的结果上，而将相对较低的价值放在哮喘控制方面的微小差异上。对于青少年患者，建议选择两种治疗方案，因为平衡非常接近，数据更为有限。该专门小组建议，轻度哮喘的成年和青少年患者使用按需 ICS/福莫特罗，而不是按需 SABA（强烈推荐；证据确定性低）。这一建议是基于在几个结果方面，按需使用 ICS/福莫特罗在轻度哮喘中有益，以及在没有抗炎治疗的情况下，按需使用 SABA 存在风险。在包括欧盟国家在内的一些国家，按需 ICS/福莫特罗未获准用于轻度哮喘，这一建议的实施受到了阻碍。
