Department of Dermatology and Allergy, Allergie Cenrtum Charité, Charité-Universitätsmedizin, Berlin, Germany.
Clin Exp Allergy. 2012 Oct;42(10):1423-9. doi: 10.1111/j.1365-2222.2012.03957.x.
Urticaria, and especially chronic spontaneous urticaria (CSU), is a difficult condition to treat. Consequently, clinicians need to use the best H(1)-antihistamines currently available and the pharmaceutical industries need to keep developing H(1)-antihistamines that are more effective than the ones we have today. To do this we need to be able to compare the clinical efficacy of both established and new drugs. Obviously, the ideal way to do this is to use head-to-head studies in CSU. However, such studies are extremely expensive and, in the case of novel molecules, have ethical and logistical problems. Consequently, we need to have predictive models. Although determination of Ki, an indicator of the in vitro potency of an H(1)-antihistamine, may help in the initial selection of candidate molecules, the large differences in volume of distribution and tissue accumulation in humans, precludes this from being a good predictor of clinical efficacy in CSU. From the data reviewed in this article, especially the direct comparative data of desloratadine and levocetirizine in weal and flare studies and CSU, weal and flare response would appear to be the best indicator we have of effectiveness of H(1)-antihistamines in clinical practice. However, it must be pointed out that the conclusion is, essentially, based on detailed comparisons of two drugs in studies sponsored by pharmaceutical companies. Consequently, to confirm the conclusions of this review, a multicentre study independent from the influence of pharmaceutical companies should be commissioned to compare the speed of onset and effectiveness of desloratadine, fexofenadine and levocetirizine in chronic spontaneous urticaria and against histamine-induced weal and flare responses in the same patients so that we have a clear understanding of the predictive value of our models.
荨麻疹，尤其是慢性自发性荨麻疹（CSU），是一种难以治疗的疾病。因此，临床医生需要使用目前最好的 H（1）抗组胺药，制药行业也需要不断开发比现有药物更有效的 H（1）抗组胺药。为此，我们需要能够比较现有和新药的临床疗效。显然，理想的方法是在 CSU 中进行头对头研究。然而，此类研究非常昂贵，并且对于新型分子，存在伦理和后勤问题。因此，我们需要有预测模型。尽管 Ki 的测定，即 H（1）抗组胺药体外效力的指标，可能有助于候选分子的初步选择，但人类分布容积和组织积累的巨大差异使其不能成为 CSU 临床疗效的良好预测指标。从本文综述的数据来看，特别是地氯雷他定和左西替利嗪在风团和红斑研究和 CSU 中的直接比较数据，风团和红斑反应似乎是我们在临床实践中评估 H（1）抗组胺药有效性的最佳指标。然而，必须指出的是，该结论基本上是基于制药公司赞助的两项药物的详细比较。因此，为了证实本综述的结论，应委托一项独立于制药公司影响的多中心研究，比较地氯雷他定、非索非那定和左西替利嗪在慢性自发性荨麻疹中的起效速度和疗效，以及在相同患者中组胺诱导的风团和红斑反应，以便我们清楚地了解我们模型的预测价值。
