Department of Allergy, Basurto Hospital. Bilbao, Spain.
J Investig Allergol Clin Immunol. 2011;21 Suppl 3:16-23.
The evaluation of quality of life (QoL) and its modification through therapeutic interventions has become a prioritary concern in recent years and a requirement on the part of regulatory agencies for the authorization of new drugs. In clinical studies of allergic disorders, particularly allergic rhinitis and urticaria, different types of generic questionnaires have been used - especially disease specific instruments such as the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) or skin disease specific tools such as the Dermatology Life Quality Index (DLQI). Throughout its clinical development, bilastine has been shown to be more effective than placebo and at least as effective as cetirizine, levocetirizine, fexofenadine or desloratadine in controlling the symptoms of seasonal allergic rhinitis and chronic urticaria. QoL has been studied as a secondary objective in three allergic rhinitis clinical trials, using the RQLQ, in a total of 2335 patients. Likewise, in chronic urticaria, QoL has been evaluated using the DLQI in a total of 525 patients, versus levocetirizine and placebo. The improvement in the QoL parameters in these studies (RQLQ or DLQI domains) at all times proved proportional to the symptoms improvement. In general, the data obtained relating to changes in QoL are concordant with the mean global visual analog scale (VAS in mm) values and their changes, from the beginning until the end of the treatment period, for all of the trials, for bilastine and all its comparators.
近年来,生活质量(QoL)的评估及其通过治疗干预的改善已成为优先关注的问题,也是监管机构批准新药的要求。在过敏疾病的临床研究中,特别是过敏性鼻炎和荨麻疹,使用了不同类型的通用问卷-特别是疾病特异性仪器,如鼻结膜炎生活质量问卷(RQLQ)或皮肤病特异性工具,如皮肤病生活质量指数(DLQI)。在其临床开发过程中,比拉斯汀已被证明比安慰剂更有效,并且在控制季节性过敏性鼻炎和慢性荨麻疹的症状方面与西替利嗪、左西替利嗪、非索非那定或地氯雷他定至少同样有效。在三项过敏性鼻炎临床试验中,作为次要目标,使用 RQLQ 对 2335 名患者进行了生活质量研究。同样,在慢性荨麻疹中,使用 DLQI 对总共 525 名患者进行了生活质量评估,与左西替利嗪和安慰剂进行了比较。这些研究中(RQLQ 或 DLQI 领域)的生活质量参数的改善始终证明与症状改善成正比。一般来说,与治疗期开始到结束之间的所有试验中,比拉斯汀及其所有对照药物的平均全球视觉模拟量表(VAS 以毫米为单位)值及其变化相关的 QoL 变化数据是一致的。