■比拉斯汀是一种新型的第二代抗组胺药。印度人群中很少有研究比较比拉斯汀与其他第二代抗组胺药如西替利嗪的安全性和有效性。因此,本研究是有计划的。
■这是一个随机的,对70例慢性自发性荨麻疹(CSU)患者进行了开放标签比较平行组研究。患者每天一次接受西替利嗪10mg或比拉斯汀20mg,持续6周。主要终点是找出基线和6周时平均总症状评分(MTSS)的差异。次要终点是找出风团数量的变化,瘙痒量表的变化,风浪大小的刻度,风团干扰睡眠的变化,镇静视觉模拟量表(VAS)的变化,红斑强度的规模变化,以及皮肤区域受累程度(SESI)量表的变化。
■比拉斯汀和西替利嗪可显著降低MTSS,平均风团数,基线至第1、3和6周的平均瘙痒量表。bilastine中MTSS的平均差异显着更大。与比拉斯汀相比,西替利嗪在镇静作用下的VAS评分显着增加。两种药物均具有良好的耐受性和安全性。像头痛这样的不良事件,胃刺激,口干,西替利嗪组的镇静作用较多。
■比拉斯汀在CSU患者中比西替利嗪更有效,并且在1周时观察到了疗效。在西替利嗪组中没有看到。
UNASSIGNED: Bilastine is a novel second-generation antihistaminic. Very few studies in Indian population have compared the safety and efficacy of bilastine with other second-generation antihistaminic like cetirizine. Hence, the present
study was planned.
UNASSIGNED: This was a randomized, open-label comparative parallel group
study conducted on 70 patients of chronic spontaneous urticaria (CSU). Patients either received
cetirizine 10 mg or bilastine 20 mg once daily for 6 weeks. The primary endpoint was to find out the difference in the mean total symptom score (MTSS) at baseline and 6 weeks. The secondary endpoint was to find out changes in the scale of the number of wheals, change in pruritus scale, scale for size of wheal, change for interference of wheals with sleep, change in visual analog scale (VAS) for sedation, change in scale for intensity of erythema, and change in Scale for Extent of Skin Area Involvement (SESI).
UNASSIGNED: Bilastine and cetirizine offer a significant reduction in MTSS, mean number of wheals, and mean pruritus scale at baseline to 1, 3, and 6 weeks. The mean difference in MTSS was significantly more in bilastine.
Cetirizine showed a significant increase in VAS score for sedation as compared to bilastine. Both the drugs were well tolerated and safe. Adverse events like headache, gastric irritation, dryness of mouth, and sedation were more reported in cetirizine group.
UNASSIGNED: Bilastine was more efficacious than cetirizine in patients of CSU and the efficacy was seen earlier at 1 week, which was not seen in the
cetirizine group.