Nguyen My Tra Thi, Le My Huyen, Vu Minh Nguyet, Baumann Katrine, Skov Per Stahl, Le Doanh Huu
Hue University of Medicine and Pharmacy, Hue University, Vietnam.
Hanoi Medical University, Hanoi, Vietnam.
PLoS One. 2025 Aug 25;20(8):e0326445. doi: 10.1371/journal.pone.0326445. eCollection 2025.
This study aimed to evaluate the clinical effectiveness of bilastine in type IIb autoimmune CSU (type IIb aiCSU) patients over an 8-week period, as well as to identify factors predicting treatment response.
34 type IIb aiCSU patients with positive basophil histamine release assays (BHRA) and positive Autologous Serum Skin Test (ASST) tests, from the Vietnam National Dermatology and Venereology Hospital, were included. Patients began treatment with the standard dose of bilastine, with the dose increased every two weeks for those who did not achieve adequate response. The Urticaria Control Test (UCT), Weekly Urticaria Activity Score (UAS7), and the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) were used.
Significant improvements in all measures were observed, with 82.4% of patients achieving complete response by week 8. Of these, 47.1% responded to the standard dose, while 14.7% did not respond even at the maximum (x4) dose. UAS7 average scores decreased from a baseline mean of 28.9 to 2.9, indicating substantial reduction in disease activity. UCT scores improved from 47.1% of patients having poor disease control (UCT < 12) after week 2 to 85.3% achieving good control (UCT ≥ 12) by week 8. QoL also significantly improved, with CU-Q2oL scores dropping from 44.9 at baseline to 25.3 at week 8. Basopenia, high baseline UAS7 score and a history of autoimmune disease were associated with poorer treatment responses, while normal/high IgE levels were linked to better outcomes.
The findings suggest that bilastine is highly effective in controlling aiCSU symptoms and improving QoL.
本研究旨在评估比拉斯汀在8周内对IIb型自身免疫性慢性自发性荨麻疹（IIb型aiCSU）患者的临床疗效，并确定预测治疗反应的因素。
纳入了越南国家皮肤病与性病医院的34例嗜碱性粒细胞组胺释放试验（BHRA）和自体血清皮肤试验（ASST）呈阳性的IIb型aiCSU患者。患者开始使用标准剂量的比拉斯汀进行治疗，对于未达到充分反应的患者，每两周增加一次剂量。使用了荨麻疹控制试验（UCT）、每周荨麻疹活动评分（UAS7）和慢性荨麻疹生活质量问卷（CU-Q2oL）。
所有指标均有显著改善，82.4%的患者在第8周时达到完全缓解。其中，47.1%的患者对标准剂量有反应，而14.7%的患者即使在最大（x4）剂量下也无反应。UAS7平均评分从基线时的28.9降至2.9，表明疾病活动度大幅降低。UCT评分从第2周后47.1%的患者疾病控制不佳（UCT < 12）改善至第8周时85.3%的患者达到良好控制（UCT ≥ 12）。生活质量也显著改善，CU-Q2oL评分从基线时的44.9降至第8周时的25.3。嗜碱细胞减少、基线UAS7评分高和自身免疫性疾病史与较差的治疗反应相关，而正常/高IgE水平与较好的结局相关。
研究结果表明，比拉斯汀在控制aiCSU症状和改善生活质量方面非常有效。
