bilastine与非索非那定联合用药治疗慢性自发性荨麻疹的疗效观察

B. Shah, A. Choudhary, Deval Mistry, N. Jangid, Shikha R. Shah, Shruti Kamat, G. Deshmukh, D. Dhoot, Hanmant Barkate
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摘要

在对标准剂量的第二代抗组胺药(SGAHs)无反应的患者中,建议将剂量增加4倍。尽管SGAHs是安全的,但对其加药后的安全性的担忧仍然存在,并且缺乏直接比较不同SGAHs加药的研究,从而使药物的选择变得困难。80例慢性自发性荨麻疹(CSU)患者随机接受bilastine或非索非那定治疗(每组40例)。患者开始使用常规剂量的药物(bilastine 20mg或非索非那定180mg)治疗前2周。2周后仍有症状(UAS≥7)的患者分别给予双剂量bilastine (20mg BD)或非索非那定(180mg BD),再持续2周。采用UAS评分法评价荨麻疹的控制情况。采用CU-Q2oL问卷评估患者的生活质量。通过分析患者报告的不良事件(ae)来评估安全性。74名患者完成了这项研究。41例患者(bilastine - 23和非索非那定- 18)在第2周获得了充分的荨麻疹控制(UAS≤6)。在给予高剂量bilastine或非索非那定的33例患者中,17例患者(bilastine - 9和非索非那定- 8)在第4周获得了充分的荨麻疹控制。比拉斯汀与非索非那定相比,显著改善患者的生活质量(32.38±5.83 vs 38.71±5.92);P < 0.005)。13例患者(bilastine组6例,非索非那定组7例)报告了一个或多个不良反应,镇静是最常见的副作用。增加bilastine的剂量可以缓解荨麻疹症状,改善大多数患者的生活质量,而不影响嗜睡或安全性。与非索非那定相比,比拉斯汀与改善的生活质量和更少的镇静有关。
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The effectiveness of bilastine and fexofenadine updosing in the management of chronic spontaneous urticaria
In patients not responding to standard dosages of second-generation antihistamines (SGAHs), updosing up to 4-fold is recommended. Even though SGAHs are safe, the concerns regarding their safety after updosing still remain and the studies directly comparing the updosing of different SGAHs are lacking thus making the choice of drug difficult. Eighty patients with chronic spontaneous urticaria (CSU) were randomized to receive either bilastine or fexofenadine (40 in each group). Patients were started on conventional dose of either drug (bilastine 20 mg or fexofenadine 180 mg) for the first 2 weeks. Those patients who remained symptomatic after 2 weeks (UAS ≥ 7) were given double dose of bilastine (20 mg BD) or fexofenadine (180 mg BD), respectively, for another 2 weeks. Control of urticaria was assessed by evaluating UAS score. Patients’ quality of life was assessed by CU-Q2oL questionnaire. Safety was evaluated by analyzing the adverse events (AEs) reported by the patients. Seventy-four patients completed the study. Forty-one patients (bilastine – 23 and fexofenadine – 18) achieved adequate control of urticaria (UAS ≤ 6) at week 2. Out of 33 patients who were given high dose of bilastine or fexofenadine, 17 patients (bilastine – 9 and fexofenadine – 8) achieved adequate control of urticaria at week 4. Bilastine was associated with significant improvement in quality of life of patients compared to fexofenadine (32.38 ± 5.83 vs. 38.71 ± 5.92.; P < 0.005). Thirteen patients (six in bilastine group and seven in fexofenadine group) reported one or more AEs with sedation being the most common side effect. Updosing of bilastine provided relief from urticaria symptoms, improved quality of life in the majority of the patients without compromising somnolence or safety. Bilastine was associated with improved quality of life and less sedation compared to fexofenadine.
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