Gayathri Elango, Sowmya Parvathareddy, Punnagai Kumaravelu, Mahalakshmi Veeraraghavan
Department of Pharmacology, Dhanalakshmi Srinivasan Medical College, Perambalur, Tamil Nadu, India.
Department of Pharmacology, Sri Ramachandra Medical College & Research Institute, Chennai, Tamil Nadu, India.
Indian J Dermatol Venereol Leprol. 2023 Sep-Oct;89(5):672-679. doi: 10.25259/IJDVL_333_2021.
Background Urticaria is a common skin disease which often causes impairment in the quality of life. The ideal drug for chronic urticaria would have antihistaminic and anti-inflammatory actions. Bepotastine besilate is a recently approved novel anti-allergic agent with multiple mechanisms of action; levocetirizine is a potent and selective second-generation H1 receptor antagonist used in the treatment of urticaria. Aim To compare the efficacy and safety of bepotastine besilate versus levocetirizine in patients with chronic spontaneous urticaria. Methods The study design is a randomised, open-label, parallel-group, prospective interventional study. The study subjects were randomly assigned to either of the two groups a and b, each group had 50 patients with chronic urticaria. Statistical analyses were performed using (SPSS, version 18) for all the variables. Chi-square test was used for comparison between categorical variables. An unpaired student's t-test was done for quantitative variables. Results There was a significant decrease in mean urticaria activity score (P < 0.001), chronic urticaria quality of life (P < 0.001) and clinical global improvement (P < 0.001) in both the treatment groups but this improvement was higher in the bepotastine than in the levocetirizine group. There was no significant difference in the mean of absolute eosinophil count, C-reactive protein, aspartate transaminase, alanine transaminase from baseline to 4th week between the two study groups. Visual analogue scale showed statistically significant improvement from baseline to 4th week (P < 0.001) of follow-up but this increase was higher in levocetirizine group (0.64-4.24) than in bepotastine group (0.56-2.56) Limitations Blinding was not done. To assess the efficacy and safety of bepotastine, a larger study can be planned. Conclusion This study found that bepotastine is superior to levocetirizine and showed a statistically significant reduction in mean urticaria activity score 7, improved quality of life and clinical global improvement in patients with urticaria.
荨麻疹是一种常见的皮肤病，常导致生活质量下降。治疗慢性荨麻疹的理想药物应具有抗组胺和抗炎作用。贝波司他丁是一种最近获批的具有多种作用机制的新型抗过敏药物；左西替利嗪是一种强效且选择性的第二代H1受体拮抗剂，用于治疗荨麻疹。目的：比较贝波司他丁与左西替利嗪治疗慢性自发性荨麻疹患者的疗效和安全性。方法：本研究设计为随机、开放标签、平行组、前瞻性干预研究。研究对象被随机分为a组和b组，每组各有50例慢性荨麻疹患者。对所有变量使用（SPSS，版本18）进行统计分析。分类变量采用卡方检验进行比较。定量变量采用非配对学生t检验。结果：两个治疗组的平均荨麻疹活动评分（P < 0.001）、慢性荨麻疹生活质量（P < 0.001）和临床总体改善情况（P < 0.001）均有显著下降，但贝波司他丁组的改善程度高于左西替利嗪组。两个研究组从基线到第4周的绝对嗜酸性粒细胞计数、C反应蛋白、天冬氨酸转氨酶、丙氨酸转氨酶的平均值无显著差异。视觉模拟量表显示，随访从基线到第4周有统计学意义的改善（P < 0.001），但左西替利嗪组（0.64 - 4.24）的改善幅度高于贝波司他丁组（0.56 - 2.56）局限性：未进行盲法研究。为评估贝波司他丁的疗效和安全性，可计划进行更大规模的研究。结论：本研究发现贝波司他丁优于左西替利嗪，且在荨麻疹患者中平均荨麻疹活动评分7有统计学意义的显著降低，生活质量得到改善，临床总体情况也有所改善。
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