PDF(Pubmed)
Abstract：
UNASSIGNED: The treatment options for chronic spontaneous urticaria (CSU) primarily include second generation non-sedative antihistamine (SGAHs). Bilastine is a newer, nonsedating SGAH approved for urticaria in February 2019 by the Drugs Controller General of India. Its major advantages are in terms of superior efficacy, lack of drug interactions and adverse effects, including sedation, compared to conventional SGAHs. The role of cytokines in the pathogenesis of CSU is well known. However, there is a shortage of data regarding the change in serum levels of proinflammatory cytokines following H1 antihistamines. We conducted this trial to evaluate the role of bilastine in cytokine modulation and autoimmunity, thereby explaining its role in modifying the disease process in CSU.
UNASSIGNED: This prospective study was conducted in a tertiary institute in Kolkata on patients aged 12 years and above with a CSU >6 months. These patients had an unsatisfactory response, as per the Urticaria Activity Score 7 (UAS7), to previous antihistamine therapies in standard doses. Treatment effectiveness was determined by comparing the UAS7 at baseline with that at weeks 4, 8 and 12. Also, baseline serum interleukin-6 (IL-6) and IL-17 were compared with those at the end of the study, that is, 12 weeks.
UNASSIGNED: Thirty patients who matched the inclusion criteria and signed informed consent were included in the study. At the end of 12 weeks, 10% of patients (n = 3) achieved a complete treatment response (UAS = 0), whereas 43.33% of patients (n = 13) were labelled as having well-controlled urticaria (UAS <6). At 12 weeks, the mean UAS7 score (6.47 ± 4.45) was statistically significant compared to the baseline score (25.47 ± 7.74). The mean values of serum IL-6 (pg/ml) and IL-17 (pg/ml) at baseline were 5.96 ± 5.24 pg/ml and 6.96 ± 5.97 pg/ml, respectively. At the end of treatment, that is, 3 months, the mean values were reduced to 4.61 ± 4.56 pg/ml and 5.08 ± 3.87 pg/ml. The reduction was statistically significant for both serum IL-6 (P < 0.001) and IL-17 (P < 0.0001).
UNASSIGNED: We conclude that bilastine at a once-daily continuous dose of 40 mg for 3 months is safe and effective in CSU patients who are refractory to treatment at the standard doses of SGAHs. Improved symptomatic control with bilastine was also associated with better control over the inflammatory process, as suggested by the lowering of mean cytokine levels in our study.
UNASSIGNED: This prospective study was conducted in a tertiary institute in Kolkata on patients aged 12 years and above with a CSU >6 months. These patients had an unsatisfactory response, as per the Urticaria Activity Score 7 (UAS7), to previous antihistamine therapies in standard doses. Treatment effectiveness was determined by comparing the UAS7 at baseline with that at weeks 4, 8 and 12. Also, baseline serum interleukin-6 (IL-6) and IL-17 were compared with those at the end of the study, that is, 12 weeks.
UNASSIGNED: Thirty patients who matched the inclusion criteria and signed informed consent were included in the study. At the end of 12 weeks, 10% of patients (n = 3) achieved a complete treatment response (UAS = 0), whereas 43.33% of patients (n = 13) were labelled as having well-controlled urticaria (UAS <6). At 12 weeks, the mean UAS7 score (6.47 ± 4.45) was statistically significant compared to the baseline score (25.47 ± 7.74). The mean values of serum IL-6 (pg/ml) and IL-17 (pg/ml) at baseline were 5.96 ± 5.24 pg/ml and 6.96 ± 5.97 pg/ml, respectively. At the end of treatment, that is, 3 months, the mean values were reduced to 4.61 ± 4.56 pg/ml and 5.08 ± 3.87 pg/ml. The reduction was statistically significant for both serum IL-6 (P < 0.001) and IL-17 (P < 0.0001).
UNASSIGNED: We conclude that bilastine at a once-daily continuous dose of 40 mg for 3 months is safe and effective in CSU patients who are refractory to treatment at the standard doses of SGAHs. Improved symptomatic control with bilastine was also associated with better control over the inflammatory process, as suggested by the lowering of mean cytokine levels in our study.
摘要：
■慢性自发性荨麻疹（CSU）的治疗选择主要包括第二代非镇静性抗组胺药（SGAHs）。比拉斯汀是一个较新的，非镇静SGAH于2019年2月被印度药物总监批准用于荨麻疹。它的主要优点是疗效优越，缺乏药物相互作用和不良反应，包括镇静,与传统的SGAH相比。细胞因子在CSU发病机理中的作用是众所周知的。然而,关于H1抗组胺药治疗后血清促炎细胞因子水平变化的数据不足.我们进行了这项试验，以评估比拉斯汀在细胞因子调节和自身免疫中的作用，从而解释了其在改变CSU疾病过程中的作用。
■这项前瞻性研究是在加尔各答的一所高等院校对12岁及以上CSU>6个月的患者进行的。这些患者的反应不令人满意，根据荨麻疹活动评分7（UAS7），以前标准剂量的抗组胺疗法。通过比较基线时的UAS7与第4、8和12周的UAS7来确定治疗有效性。此外，基线血清白细胞介素-6（IL-6）和IL-17与研究结束时的比较，也就是说,12周
■30名符合纳入标准并签署知情同意书的患者纳入本研究。在12周结束时，10％的患者（n=3）达到了完整的治疗反应（UAS=0），而43.33%的患者（n=13）被标记为控制良好的荨麻疹（UAS<6）。12周时,与基线评分(25.47±7.74)相比,平均UAS7评分(6.47±4.45)具有统计学意义.基线时血清IL-6(pg/ml)和IL-17(pg/ml)的平均值分别为5.96±5.24pg/ml和6.96±5.97pg/ml,分别。在治疗结束时,也就是说,3个月,平均值降至4.61±4.56pg/ml和5.08±3.87pg/ml.血清IL-6（P<0.001）和IL-17（P<0.0001）的降低具有统计学意义。
■我们得出的结论是，每天一次连续剂量为40mg，持续3个月的比拉斯汀对标准剂量SGAHs治疗无效的CSU患者是安全有效的。bilastine改善症状控制也与更好地控制炎症过程有关。正如我们研究中降低平均细胞因子水平所暗示的那样。
■这项前瞻性研究是在加尔各答的一所高等院校对12岁及以上CSU>6个月的患者进行的。这些患者的反应不令人满意，根据荨麻疹活动评分7（UAS7），以前标准剂量的抗组胺疗法。通过比较基线时的UAS7与第4、8和12周的UAS7来确定治疗有效性。此外，基线血清白细胞介素-6（IL-6）和IL-17与研究结束时的比较，也就是说,12周
■30名符合纳入标准并签署知情同意书的患者纳入本研究。在12周结束时，10％的患者（n=3）达到了完整的治疗反应（UAS=0），而43.33%的患者（n=13）被标记为控制良好的荨麻疹（UAS<6）。12周时,与基线评分(25.47±7.74)相比,平均UAS7评分(6.47±4.45)具有统计学意义.基线时血清IL-6(pg/ml)和IL-17(pg/ml)的平均值分别为5.96±5.24pg/ml和6.96±5.97pg/ml,分别。在治疗结束时,也就是说,3个月,平均值降至4.61±4.56pg/ml和5.08±3.87pg/ml.血清IL-6（P<0.001）和IL-17（P<0.0001）的降低具有统计学意义。
■我们得出的结论是，每天一次连续剂量为40mg，持续3个月的比拉斯汀对标准剂量SGAHs治疗无效的CSU患者是安全有效的。bilastine改善症状控制也与更好地控制炎症过程有关。正如我们研究中降低平均细胞因子水平所暗示的那样。
