De Abhishek, Godse Kiran, Dhoot Dhiraj, Sarda Aarti
Department of Dermatology, Calcutta National Medical College, Kolkata, West Bengal, Department of Dermatology, DY Patil, Navi, Department of Global Medical Affairs, Glenmark, Pharmaceuticals Limited, Mumbai, Maharashtra, Department of Dermatology, Wizderm, Kolkata, West Bengal, India.
Indian J Dermatol. 2021 Mar-Apr;66(2):159-164. doi: 10.4103/ijd.IJD_771_20.
Second-generation H1-antihistamines (SGAHs) are the mainstay of treatment of chronic spontaneous urticaria (CSU). Bilastine, newer non-sedating SGAHs, was recently introduced in India after the approval of the Drugs Controller General of India. There is a paucity of evidence about the long-term efficacy and safety of Bilastine in Indian patients. We undertook this study to find the long-term efficacy and tolerability of Bilastine in patients with CSU in India.
This retrospective chart analysis was conducted by analyzing electronic medical records from May 1, 2019, to March 20, 2020, to identify patients of CSU who were prescribed Bilastine. Adult patients, with CSU >6 months were included, who had an unsatisfactory response as per Urticaria Activity Score 7 (UAS7) to previous antihistamine therapies, and who continued treatment for at least 6 months were included. Treatment effectiveness was determined by retrospectively reviewing their UAS7 scores from their medical records and evaluating their scores at weeks 4, 8, 12, 16, 20, and 24. Also, DLQI was assessed and compared at baseline and week 24.
Forty-nine patients were found to fulfill the criteria and included in the study. At the end of 24 weeks, 51% of patients ( = 25) achieved complete treatment response (UAS = 0), whereas 49% of patients ( = 24) were labeled as well-controlled urticaria (UAS<6). At 24 weeks, the mean UAS7 score (1.35 ± 1.61) was statistically significant compared to the baseline score (20.2 ± 5.73). The mean score of DLQI was also reduced to 1.63 ± 1.18 at 24 weeks from 8.39 ± 2.49 at baseline (-value <0.001).
The study showed that in patients who had an inadequate response with commonly used antihistamines at a double dose or combined use, switching over to Bilastine resulted not only in relieving the symptoms of CSU but also improved the quality of life of the patients with CSU.
第二代H1抗组胺药(SGAHs)是慢性自发性荨麻疹(CSU)治疗的主要药物。比拉斯汀是一种新型非镇静性SGAHs,在获得印度药品总监批准后最近在印度上市。关于比拉斯汀在印度患者中的长期疗效和安全性的证据很少。我们进行这项研究以确定比拉斯汀在印度CSU患者中的长期疗效和耐受性。
通过分析2019年5月1日至2020年3月20日的电子病历进行这项回顾性图表分析,以确定开具比拉斯汀处方的CSU患者。纳入年龄大于6个月的成年CSU患者,这些患者根据荨麻疹活动评分7(UAS7)对先前的抗组胺治疗反应不佳,并且持续治疗至少6个月。通过回顾病历中的UAS7评分并评估第4、8、12、16、20和24周的评分来确定治疗效果。此外,在基线和第24周评估并比较皮肤病生活质量指数(DLQI)。
发现49名患者符合标准并纳入研究。在24周结束时,51%的患者(n = 25)实现了完全治疗反应(UAS = 0),而49%的患者(n = 24)被标记为荨麻疹得到良好控制(UAS<6)。在24周时,平均UAS7评分(1.35±1.61)与基线评分(20.2±5.73)相比具有统计学意义。DLQI的平均评分在基线时为8.39±2.49,在24周时也降至1.63±1.18(P值<0.001)。
该研究表明,对于双倍剂量或联合使用常用抗组胺药反应不足的患者,改用比拉斯汀不仅可以缓解CSU的症状,还可以改善CSU患者的生活质量。