Fayaz Syed H, Varadarajan Sathyanarayanan, Ansari Sanofer, James Jerin
Novo Nordisk India Pvt Ltd, Bengaluru, Karnataka, India.
Department of Pharmacology, SRM IST, Kattankulathur, Tamil Nadu, India.
Indian J Dermatol. 2021 Nov-Dec;66(6):704. doi: 10.4103/ijd.ijd_1042_20.
Chronic Idiopathic Urticaria (CIU) is a debilitating disease characterised by almost daily presence of urticarial symptoms like short-lived wheals, itching, and erythema for at least 6 weeks without an identifiable cause there by leading to impairment of quality of life of the patient.
To evaluate the efficacy and safety of loratadine and rupatadine in chronic idiopathic urticaria.
This is a prospective, randomized, single-blind, parallel arm study conducted to evaluate the efficacy and safety of loratadine and rupatadine in patients with CIU. The study was registered prospectively with Clinical Trial registry of India (CTRI/2017/05/008624). Institutional Ethics Committee clearance was obtained. Written informed consent was obtained from all the participants before enrolment into the trial. The study was conducted in the outpatient department of Dermatology, SRM Medical College, Kattankulathur, Tamil Nadu, India, during the period from June 2017 to August 2018. Patients with CIU enrolled into the study based on inclusion-exclusion criteria were given the intervention drugs; Loratadine 10 mg once daily or rupatadine10 mg once daily orally for 6 weeks.
Rupatadine is more efficacious than loratadine in the reduction of Total Leucocyte Count, Differential Count and Absolute Eosinophil Count, the key determinants of allergy. Rupatadine also produced better improvement in Total symptom Score, Dermatology Life Quality Index in patients with CIU.
Analysis of all the parameters of efficacy and safety establishes the probable superiority of rupatadine over loratadine for the treatment of urticaria.
慢性特发性荨麻疹(CIU)是一种使人衰弱的疾病,其特征是几乎每天都出现荨麻疹症状,如短暂性风团、瘙痒和红斑,持续至少6周且无明确病因,从而导致患者生活质量受损。
评估氯雷他定和卢帕他定治疗慢性特发性荨麻疹的疗效和安全性。
这是一项前瞻性、随机、单盲、平行组研究,旨在评估氯雷他定和卢帕他定对CIU患者的疗效和安全性。该研究已在印度临床试验注册中心(CTRI/2017/05/008624)进行前瞻性注册。获得了机构伦理委员会的批准。在所有参与者入选试验前均获得了书面知情同意书。该研究于2017年6月至2018年8月在印度泰米尔纳德邦卡坦库拉图尔SRM医学院皮肤科门诊进行。根据纳入-排除标准入选该研究的CIU患者接受干预药物治疗;氯雷他定10毫克每日一次或卢帕他定10毫克每日一次口服,持续6周。
在降低白细胞总数、分类计数和绝对嗜酸性粒细胞计数(过敏的关键决定因素)方面,卢帕他定比氯雷他定更有效。卢帕他定在CIU患者的总症状评分、皮肤病生活质量指数方面也有更好的改善。
对所有疗效和安全性参数的分析表明,在治疗荨麻疹方面,卢帕他定可能优于氯雷他定。