Abstract：
Non-sedating H1 -antihistamines (nsAH) are the most commonly used treatment for chronic spontaneous urticaria (CSU). Many patients use them as on-demand (OD) therapy rather than a maintenance treatment. Here, we compared OD versus daily maintenance treatment with the nsAH rupatadine, assessed the efficacy of rupatadine updosing, and investigated potential long-term disease-modifying effects.
This multicenter, randomized study consisted of 2 weeks of screening, 8 weeks of double-blind treatment, and 6 weeks of treatment-free follow-up (OD allowed). Adult patients were randomized to 10 mg rupatadine OD or 10 mg rupatadine daily. At Week 4, if patients did not have a complete response, they switched from 10 to 20 mg rupatadine daily or underwent sham updosing (patients on 10 mg rupatadine OD). The primary aim was to compare CSU disease activity at the end of follow-up between daily versus OD. Additionally, we assessed the efficacy of rupatadine updosing. Major outcomes were disease activity, CSU-related quality of life (QoL), and disease control.
At Week 4, disease activity and QoL significantly improved in daily versus OD-treated patients. Updosing of rupatadine did not improve the mean disease activity, but the number of complete responders increased during updosing from 5% to 22%. At the end of follow-up, the disease activity of patients treated OD versus daily was not significantly different.
Daily rupatadine treatment significantly improved CSU disease activity and QoL during treatment versus OD treatment but not after discontinuation of rupatadine, indicating the benefits of a daily maintenance nsAH schedule.
This multicenter, randomized study consisted of 2 weeks of screening, 8 weeks of double-blind treatment, and 6 weeks of treatment-free follow-up (OD allowed). Adult patients were randomized to 10 mg rupatadine OD or 10 mg rupatadine daily. At Week 4, if patients did not have a complete response, they switched from 10 to 20 mg rupatadine daily or underwent sham updosing (patients on 10 mg rupatadine OD). The primary aim was to compare CSU disease activity at the end of follow-up between daily versus OD. Additionally, we assessed the efficacy of rupatadine updosing. Major outcomes were disease activity, CSU-related quality of life (QoL), and disease control.
At Week 4, disease activity and QoL significantly improved in daily versus OD-treated patients. Updosing of rupatadine did not improve the mean disease activity, but the number of complete responders increased during updosing from 5% to 22%. At the end of follow-up, the disease activity of patients treated OD versus daily was not significantly different.
Daily rupatadine treatment significantly improved CSU disease activity and QoL during treatment versus OD treatment but not after discontinuation of rupatadine, indicating the benefits of a daily maintenance nsAH schedule.
摘要：
背景：非镇静H1-抗组胺药（nsAH）是慢性自发性荨麻疹（CSU）最常用的治疗方法。许多患者将它们用作按需（OD）治疗，而不是维持治疗。这里,我们比较了使用nsAHrupatadine的OD与日常维持治疗，评估卢帕他定加药的疗效，并研究了潜在的长期疾病改善作用。
方法：这个多中心，随机研究包括2周的筛选，8周的双盲治疗，和6周的无治疗随访（OD允许）。成年患者随机接受10mg卢帕他定OD或10mg卢帕他定每日治疗。在第4周，如果患者没有完全反应，他们从每日10mg卢帕他定转为20mg卢帕他定或接受了假剂量(服用10mg卢帕他定OD的患者).主要目的是比较每日与OD之间在随访结束时的CSU疾病活动。此外,我们评估了卢帕他定加药的疗效.主要结果是疾病活动，CSU相关生活质量（QoL），和疾病控制。
结果：在第4周，与接受OD治疗的患者相比，每天的疾病活动和QoL显着改善。卢帕他定的剂量增加并没有改善平均疾病活动，但在给药过程中，完全缓解者的数量从5%增加到22%。在后续行动结束时，接受OD治疗的患者与每日治疗的患者的疾病活动无显著差异.
结论：与OD治疗相比，每日卢帕他定治疗可显著改善CSU疾病活动度和QoL，但停药卢帕他定后无改善，说明日常维护nsAH计划的好处。
方法：这个多中心，随机研究包括2周的筛选，8周的双盲治疗，和6周的无治疗随访（OD允许）。成年患者随机接受10mg卢帕他定OD或10mg卢帕他定每日治疗。在第4周，如果患者没有完全反应，他们从每日10mg卢帕他定转为20mg卢帕他定或接受了假剂量(服用10mg卢帕他定OD的患者).主要目的是比较每日与OD之间在随访结束时的CSU疾病活动。此外,我们评估了卢帕他定加药的疗效.主要结果是疾病活动，CSU相关生活质量（QoL），和疾病控制。
结果：在第4周，与接受OD治疗的患者相比，每天的疾病活动和QoL显着改善。卢帕他定的剂量增加并没有改善平均疾病活动，但在给药过程中，完全缓解者的数量从5%增加到22%。在后续行动结束时，接受OD治疗的患者与每日治疗的患者的疾病活动无显著差异.
结论：与OD治疗相比，每日卢帕他定治疗可显著改善CSU疾病活动度和QoL，但停药卢帕他定后无改善，说明日常维护nsAH计划的好处。
