Karaulov Alexander V, Vylegzhanina Tamara, Ovchinnikov Andrey, Chernikova Mariia, Nenasheva Nataiya
Department of Clinical Immunology and Allergology of I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation,
National Research Center Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russian Federation.
Int Arch Allergy Immunol. 2019;179(2):142-151. doi: 10.1159/000497160. Epub 2019 Mar 15.
Intranasal sprays are recommended as targeted therapy for allergic rhinitis (AR). Triamcinolone acetonide is a nasal corticosteroid preparation indicated for the treatment of seasonal and perennial AR (PAR) in different countries worldwide.
In order to determine the efficacy of triamcinolone acetonide in the treatment of PAR, the non-inferiority of triamcinolone acetonide to fluticasone propionate was assessed in Russian adults.
In this randomized, double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial, a total of 260 patients with persistent PAR were randomized to receive either triamcinolone acetonide or fluticasone propionate nasal sprays for 4 weeks. The efficacy in symptom control was evaluated using the reflective total nasal symptom score (rTNSS) from baseline (day 0) to day 28. Safety was assessed through the reporting of adverse events.
The rTNSS mean values decreased from baseline to the end of study treatment (day 28) in both groups: -8.2 ± 3.0 in the triamcinolone acetonide arm versus -8.0 ± 2.8 in the fluticasone propionate arm. The mean difference between the groups (triamcinolone acetonide - fluticasone propionate) for rTNSS change from baseline was -0.2 (95% confidence interval -0.89 to 0.54), with an upper confidence limit of 0.54, which is lower than the non-inferiority margin of 0.8. Triamcinolone acetonide was well tolerated, with no difference in adverse event occurrence compared with fluticasone propionate.
Triamcinolone acetonide proved to be non-inferior to fluticasone propionate in adult patients with PAR; both treatments decreased rTNSS values and showed a good safety profile.
鼻内喷雾剂被推荐作为过敏性鼻炎（AR）的靶向治疗药物。曲安奈德是一种鼻用皮质类固醇制剂，在世界不同国家被用于治疗季节性和常年性变应性鼻炎（PAR）。
为了确定曲安奈德治疗PAR的疗效，在俄罗斯成年人中评估了曲安奈德相对于丙酸氟替卡松的非劣效性。
在这项随机、双盲、平行组、多中心、前瞻性、非劣效性III期临床试验中，共有260例持续性PAR患者被随机分为两组，分别接受曲安奈德或丙酸氟替卡松鼻喷雾剂治疗4周。使用从基线（第0天）到第28天的反射性总鼻症状评分（rTNSS）评估症状控制疗效。通过不良事件报告评估安全性。
两组从基线到研究治疗结束（第28天）rTNSS均值均下降：曲安奈德组为-8.2±3.0，丙酸氟替卡松组为-8.0±2.8。两组从基线开始的rTNSS变化均值差（曲安奈德-丙酸氟替卡松）为-0.2（95%置信区间-0.89至0.54），置信上限为0.54，低于非劣效性界值0.8。曲安奈德耐受性良好，与丙酸氟替卡松相比不良事件发生率无差异。
在成年PAR患者中，曲安奈德被证明不劣于丙酸氟替卡松；两种治疗均降低了rTNSS值且安全性良好。
