Department of Clinical Immunology and Allergology, I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
Department of Immunology and Allergology, Russian Medical Academy for Continued Professional Education, Moscow, Russian Federation.
Int Arch Allergy Immunol. 2022;183(2):160-167. doi: 10.1159/000518753. Epub 2021 Sep 6.
Allergic rhinitis (AR) is a disease that affects ≤24% of people in Russia, significantly impairing quality of life (QoL). Intranasal corticosteroids, such as triamcinolone acetonide (TAA), are considered effective drugs for treatment. A post hoc analysis of data (phase III NASANIF trial) examined weekly QoL changes in patients receiving TAA for the treatment of perennial AR (PAR).
NASANIF (NCT03317015) was a double-blind, parallel group, multicenter, prospective, noninferiority, phase III clinical trial. Patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) for 4 weeks. Here, a post hoc analysis measures QoL using a shortened Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ). Differences in miniRQLQ score were evaluated using a mixed linear model and descriptive statistics. A subgroup analysis was performed in patients with a previous diagnosis of allergic conjunctivitis.
Of 260 patients eligible for randomization, 128 each completed treatment with TAA or FP. Overall and individual domain scores progressively improved and were significantly different versus baseline at week 4 in both treatment groups: LS mean difference TAA: -30.92 (95% CI [-33.01 to -28.83]), p < 0.001, and FP: -31.13 (-33.23 to -29.04), p < 0.001. In both arms of the subgroup, there was a significant reduction in eye symptoms. There was no significant difference between the TAA and FP treatment groups in any analyses.
TAA is effective in improving overall and individual domains of QoL in patients with PAR, over 4 weeks. Patients with a previous diagnosis of allergic conjunctivitis experienced significant improvements in QoL related to the resolution of these symptoms.
变应性鼻炎(AR)是一种影响≤24%俄罗斯人群的疾病,显著降低生活质量(QoL)。曲安奈德(TAA)等鼻内皮质类固醇被认为是治疗该病的有效药物。对数据的事后分析(NASANIF 三期试验)考察了接受 TAA 治疗常年性变应性鼻炎(PAR)患者每周 QoL 的变化。
NASANIF(NCT03317015)是一项双盲、平行组、多中心、前瞻性、非劣效性 III 期临床试验。PAR 患者按 1:1 随机分为 TAA 或丙酸氟替卡松(FP)组,接受治疗 4 周。本研究通过简化鼻结膜炎生活质量问卷(miniRQLQ)评估 QoL。采用混合线性模型和描述性统计分析评估 miniRQLQ 评分的差异。对既往有过敏性结膜炎诊断的患者进行了亚组分析。
260 例符合随机分组条件的患者中,128 例分别完成 TAA 或 FP 治疗。两组患者总体和各领域评分均逐渐改善,与基线相比,治疗 4 周后均有显著差异:TAA 的 LS 均值差为-30.92(95%CI [-33.01 至-28.83]),p<0.001,FP 为-31.13(-33.23 至-29.04),p<0.001。在亚组的两个治疗臂中,眼部症状均显著减轻。TAA 和 FP 治疗组之间的任何分析均无显著差异。
TAA 可有效改善 PAR 患者的整体和各领域 QoL,治疗持续 4 周。既往有过敏性结膜炎诊断的患者,随着这些症状的缓解,QoL 显著改善。