Bengbu Medical College Graduate Department, Bengbu, China.
Department of Otolaryngology, Affiliated Hospital of Jiaxing University, No. 1882 Zhonghuan South Road, Jiaxing, China.
Eur Arch Otorhinolaryngol. 2022 Apr;279(4):1691-1699. doi: 10.1007/s00405-021-07085-w. Epub 2021 Sep 30.
GSP301 is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid). This meta-analysis aims to evaluate the efficacy and safety of GSP301 in the treatment of allergic rhinitis.
A systematic review and meta-analysis were conducted. The data were collected from PubMed, Cochrane Central Register of Controlled Trials and Embase databases till June 2021. In patients with AR, short-term (2/6 weeks) and long-term (52 weeks) effects of GSP301 were assessed. Average morning and evening 12-h reflective total nasal symptom score (rTNSS), instantaneous total nasal symptom score (iTNSS), reflective total ocular symptom score (rTOSS), instantaneous total ocular symptom score(iTOSS), Physician-assessed nasal symptom score (PNSS), rhinoconjunctivitis quality of life (RQLQ), rhinitis control assessment test (RCAT) and adverse events (AEs) were measured.
Five randomized controlled trials were included. GSP301 showed greatly improvement in rTNSS (MD = - 0.99; [95% CI - 1.19 to - 0.79]; P < 0.01; I = 0), iTNSS (MD = - 1.05; [95% CI - 1.44 to - 0.67]; P < 0.01; I > 50%), rTOSS (MD = - 0.50; [95% CI - 0.72 to - 0.29]; P < 0.01; I = 0), iTOSS (MD = - 0.64; [95% CI - 1.02 to - 0.26]; P < 0.01; I > 50%), PNSS (MD = - 1.01; [95% CI - 1.32 to - 0.69]; P < 0.01; I = 22.13%), RQLQ (MD = - 0.43; [95% CI - 0.57 to - 0.30]; P < 0.01; I = 0%) and RCAT (MD = 1.94; [95% CI 1.43-2.45]; P < 0.01; I = 0%) in the short term. No statistical difference was observed in the outcome of long-term PNSS, RQLQ and RCAT.
GSP301 is a safe and well-tolerated medication. It showed short-term benefits for seasonal and perennial AR, but may not help to improve patients' quality of life and rhinitis control in the long run.
GSP301 是盐酸奥洛他定(抗组胺药)和糠酸莫米松(皮质类固醇)的固定剂量组合。本荟萃分析旨在评估 GSP301 在治疗过敏性鼻炎中的疗效和安全性。
进行了系统评价和荟萃分析。数据来自 PubMed、Cochrane 对照试验中心注册库和 Embase 数据库,截至 2021 年 6 月。在 AR 患者中,评估了 GSP301 的短期(2/6 周)和长期(52 周)疗效。测量了平均清晨和傍晚 12 小时反射性总鼻症状评分(rTNSS)、瞬时总鼻症状评分(iTNSS)、反射性总眼部症状评分(rTOSS)、瞬时总眼部症状评分(iTOSS)、医生评估的鼻症状评分(PNSS)、鼻炎生活质量问卷(RQLQ)、鼻炎控制评估测试(RCAT)和不良反应(AE)。
纳入了 5 项随机对照试验。GSP301 在 rTNSS(MD=-0.99;[95%CI-1.19 至-0.79];P<0.01;I=0)、iTNSS(MD=-1.05;[95%CI-1.44 至-0.67];P<0.01;I>50%)、rTOSS(MD=-0.50;[95%CI-0.72 至-0.29];P<0.01;I=0)、iTOSS(MD=-0.64;[95%CI-1.02 至-0.26];P<0.01;I>50%)、PNSS(MD=-1.01;[95%CI-1.32 至-0.69];P<0.01;I=22.13%)、RQLQ(MD=-0.43;[95%CI-0.57 至-0.30];P<0.01;I=0%)和 RCAT(MD=1.94;[95%CI 1.43-2.45];P<0.01;I=0%)方面具有短期疗效。在长期 PNSS、RQLQ 和 RCAT 方面,没有观察到统计学差异。
GSP301 是一种安全且耐受良好的药物。它在季节性和常年性 AR 中显示出短期益处,但可能无助于改善患者的生活质量和长期的鼻炎控制。