Ramanna Kalpana Mali, Sumanth Thota Sai, Konda Deepthi, Eerike Madhavi, Kalaiselvan Soundarya Priyadarsini, Elangovan Chandru, Konda Venu Goapala Rao, Janti Siddharam S
Department of Pharmacology, Neelima Institute of Medical Sciences, Hyderabad, Telangana, India.
Department of Pharmacology, All India Institute of Medical Sciences, Bibinagar, Hyderabad, Telangana, 508126, India.
Arch Dermatol Res. 2025 Mar 1;317(1):516. doi: 10.1007/s00403-025-04045-w.
Chronic Spontaneous Urticaria (CSU) significantly affects quality of life. This study evaluates the efficacy of histaglobulin combined with antihistamine (bilastine) versus antihistamine alone in CSU management. A single-center, open-label, randomized trial was conducted in the dermatology OPD of a tertiary care hospital from September 2023 to August 2024. Fifty-seven eligible participants aged > 18 years with symptoms persisting > 6 weeks were randomized into test -histaglobulin plus bilastine group(n = 27) or bilastine alone (n = 30) groups. The test group received weekly histaglobulin injections and daily bilastine (20 mg), while the bilastine alone group received bilastine 20 mg only. Baseline data, including demographics, CSU characteristics, and Urticaria Activity Score (UAS), were recorded. Investigations included blood counts, renal/liver/thyroid function tests, serum IgE, absolute eosinophil count (AEC), vitamin B12 levels, and Autologous Serum Skin Test (ASST). UAS7 scores were recorded weekly for 6 weeks. The primary outcome was the change in UAS, with secondary outcomes assessing symptom control, and adverse events. A total 57 participants were recruited, with 27 and 30 in the test and bilastine alone group respectively. The combination of Histaglobulin with bilastine demonstrated significantly greater efficacy compared to bilastine alone. By Week 6, the Histaglobulin group achieved an 89.9% reduction in UAS versus 59.4% in the bilastine alone group (p < 0.01), with faster symptom resolution observed from Week 2. Laboratory findings showed notable reductions in serum IgE and AEC in the Histaglobulin group, suggesting enhanced modulation of allergic responses. No adverse effects were reported, highlighting the therapy's safety. The addition of Histaglobulin to bilastine provides a superior and well-tolerated treatment option for CSU, delivering faster symptom relief and better disease control. These findings support its use as an effective adjunctive therapy, warranting further investigation in larger sample size studies.
慢性自发性荨麻疹（CSU）严重影响生活质量。本研究评估组胺球蛋白联合抗组胺药（比拉斯汀）与单用抗组胺药在CSU治疗中的疗效。2023年9月至2024年8月，在一家三级医院的皮肤科门诊进行了一项单中心、开放标签的随机试验。57名年龄>18岁、症状持续>6周的符合条件的参与者被随机分为试验组（组胺球蛋白加比拉斯汀组，n = 27）或单用比拉斯汀组（n = 30）。试验组每周注射组胺球蛋白并每日服用比拉斯汀（20毫克），而单用比拉斯汀组仅服用20毫克比拉斯汀。记录基线数据，包括人口统计学、CSU特征和荨麻疹活动评分（UAS）。检查包括血细胞计数、肾/肝/甲状腺功能测试、血清IgE、绝对嗜酸性粒细胞计数（AEC）、维生素B12水平和自体血清皮肤试验（ASST）。连续6周每周记录UAS7评分。主要结局是UAS的变化，次要结局评估症状控制和不良事件。共招募了57名参与者，试验组和单用比拉斯汀组分别为27名和30名。与单用比拉斯汀相比，组胺球蛋白与比拉斯汀联合使用显示出显著更高的疗效。到第6周时，组胺球蛋白组的UAS降低了89.9%，而单用比拉斯汀组为59.4%（p<0.01），从第2周开始观察到症状缓解更快。实验室检查结果显示，组胺球蛋白组的血清IgE和AEC显著降低，表明过敏反应的调节增强。未报告不良反应，突出了该疗法的安全性。在比拉斯汀中添加组胺球蛋白为CSU提供了一种更优且耐受性良好的治疗选择，能更快缓解症状并更好地控制疾病。这些发现支持将其用作有效的辅助治疗方法，值得在更大样本量的研究中进一步探究。
