Yagami Akiko, Furue Masutaka, Togawa Michinori, Saito Akihiro, Hide Michihiro
Department of Dermatology, School of Medicine, Fujita Health University, Aichi, Japan.
Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
J Dermatol. 2017 Apr;44(4):375-385. doi: 10.1111/1346-8138.13644. Epub 2016 Nov 14.
A number of second-generation non-sedating antihistamines are used in clinical practices over the world. However, long-term safety and efficacy have not been proved high level evidence based medicine. We have performed an open-label, multicenter, phase III study to evaluate the long-term safety and efficacy of bilastine, a novel non-sedating H -antihistamine for patients with chronic spontaneous urticaria (CSU) or pruritus associated with skin diseases (trial registration no. JapicCTI-142528). Patients aged 18-74 years were treated with bilastine 20 mg once daily for up to 52 weeks. Safety and tolerability were assessed on the basis of adverse events (AE), bilastine-related AE, laboratory tests and vital signs. Efficacy was assessed based on rash score, itch score, overall improvement and quality of life. One hundred and ninety-eight patients enrolled, 122 of whom (61.6%) completed the 52-week treatment period. AE were reported in 64.5% and bilastine-related AE in 2.5% of patients throughout the 52-week treatment period. All AE were mild to moderate in severity. AE associated with the nervous system occurred in 10 patients (5.1%) including seven patients (3.6%) with headache. Somnolence reported in two of these patients (1.0%) was related to bilastine. All efficacy variables improved during treatment with bilastine. In conclusion, long-term treatment with bilastine 20 mg once daily for 52 weeks is safe and well tolerated in Japanese patients with CSU or pruritus associated with skin diseases. Bilastine improved disease symptoms of both conditions early in treatment, and the efficacy was maintained throughout the treatment.
多种第二代非镇静抗组胺药在全球临床实践中被使用。然而，长期安全性和有效性尚未得到基于高水平证据的医学验证。我们开展了一项开放标签、多中心、III期研究，以评估新型非镇静H-抗组胺药比拉斯汀对慢性自发性荨麻疹（CSU）或与皮肤疾病相关瘙痒症患者的长期安全性和有效性（试验注册号：JapicCTI-142528）。年龄在18 - 74岁的患者接受比拉斯汀20mg每日一次治疗，最长治疗52周。基于不良事件（AE）、比拉斯汀相关AE、实验室检查和生命体征评估安全性和耐受性。基于皮疹评分、瘙痒评分、总体改善情况和生活质量评估疗效。198例患者入组，其中122例（61.6%）完成了52周的治疗期。在整个52周治疗期内，64.5%的患者报告了AE，2.5%的患者报告了比拉斯汀相关AE。所有AE的严重程度均为轻至中度。10例患者（5.1%）出现与神经系统相关的AE，其中7例患者（3.6%）出现头痛。这些患者中有2例（1.0%）报告的嗜睡与比拉斯汀有关。在比拉斯汀治疗期间，所有疗效变量均有所改善。总之，日本CSU或与皮肤疾病相关瘙痒症患者每日一次服用20mg比拉斯汀进行52周的长期治疗是安全且耐受性良好的。比拉斯汀在治疗早期改善了两种疾病的症状，且疗效在整个治疗过程中得以维持。
