International immunopharmacology · 2025
Efficacy and safety of intranasal corticosteroids combined with mucoactive drugs for chronic rhinosinusitis.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Hu Li, Li Houyong, Yang Lu, Zhao Changqing, Tan Guolin, Li Haitong, Zheng Gang, Yu Shaoqing, Xie Lifeng, Liu Yuehui, Song Xicheng, Wang Quangui, Chang Wei, Zhang Jiqiao, Zhang Dan, Gu Yurong, Wang Dehui
Аннотация
BACKGROUND: Chronic rhinosinusitis (CRS) leads to a burden in life and economy. Better therapies need to be explored.
OBJECTIVE: This stage I study aims to explore the efficacy and safety of intranasal corticosteroids combined with mucoactive drugs for CRS.
METHODS: This randomized-controlled, double-blind study was conducted at 13 hospitals from 2021.01.31 to 2023.01.17. CRS patients were randomly assigned into the eucalyptol-limonene-pinene enteric capsules (ELP) group or placebo group, both using budesonide nasal spray (two doses of 64 μg into each nostril twice a day), and followed up at baseline, week 4, and week 8. The difference of Major Symptom Score (MSS) sum score from baseline to week 8 was defined as the primary endpoint.
RESULTS: The data of 291 patients (ELP group: 146 VS. placebo group: 145) were analyzed. The improved mean (SD) of MSS of the budesonide-ELP patients was 4.24 (2.59) at week 4 and 4.37(2.64) at week 8, higher than 3.51(2.27) (Pweek 4 = 0.012) and 3.85 (2.47) (Pweek 8 = 0.093) of budesonide-treated patients, respectively. While, the budesonide-ELP patients had a higher improvement percentage in nasal congestion, postnasal drip, rhinorrhea, and anosmia at week 8 (all P < 0.05). The current clinical control questionnaire in the ELP group significantly differed with placebo group patients at week 4 (P = 0.012), but not at week 8 (P = 0.681). Moreover, the change of Lund-Mackay (LM) and VAS between the two groups was not different at week 8, respectively. However, the CT score of budesonide-ELP-treated patients has significantly improved among smokers at week 8 (P = 0.022).
CONCLUSION: Intranasal corticosteroid combined with mucoactive drugs therapy (budesonide-256 μg/day combined with ELP enteric capsules-0.8 g/day) has the potential to improve subjective symptoms and promote physiological recovery for adult patients with CRS, especially for smokers.
OBJECTIVE: This stage I study aims to explore the efficacy and safety of intranasal corticosteroids combined with mucoactive drugs for CRS.
METHODS: This randomized-controlled, double-blind study was conducted at 13 hospitals from 2021.01.31 to 2023.01.17. CRS patients were randomly assigned into the eucalyptol-limonene-pinene enteric capsules (ELP) group or placebo group, both using budesonide nasal spray (two doses of 64 μg into each nostril twice a day), and followed up at baseline, week 4, and week 8. The difference of Major Symptom Score (MSS) sum score from baseline to week 8 was defined as the primary endpoint.
RESULTS: The data of 291 patients (ELP group: 146 VS. placebo group: 145) were analyzed. The improved mean (SD) of MSS of the budesonide-ELP patients was 4.24 (2.59) at week 4 and 4.37(2.64) at week 8, higher than 3.51(2.27) (Pweek 4 = 0.012) and 3.85 (2.47) (Pweek 8 = 0.093) of budesonide-treated patients, respectively. While, the budesonide-ELP patients had a higher improvement percentage in nasal congestion, postnasal drip, rhinorrhea, and anosmia at week 8 (all P < 0.05). The current clinical control questionnaire in the ELP group significantly differed with placebo group patients at week 4 (P = 0.012), but not at week 8 (P = 0.681). Moreover, the change of Lund-Mackay (LM) and VAS between the two groups was not different at week 8, respectively. However, the CT score of budesonide-ELP-treated patients has significantly improved among smokers at week 8 (P = 0.022).
CONCLUSION: Intranasal corticosteroid combined with mucoactive drugs therapy (budesonide-256 μg/day combined with ELP enteric capsules-0.8 g/day) has the potential to improve subjective symptoms and promote physiological recovery for adult patients with CRS, especially for smokers.