Kjellman N I, Andersson B
Clin Allergy. 1986 Sep;16(5):441-9. doi: 10.1111/j.1365-2222.1986.tb01979.x.
Terfenadine suspension, 30 mg b.i.d., was compared with placebo in a randomized, double-blind cross-over study in twenty-five children, 6-12 years of age, with grass pollen induced allergic rhinoconjunctivitis. The patients were treated during two 7-day periods separated by a 4-day wash-out period. Efficacy was assessed during a period without provoking pollen in the air. At the end of each treatment period, skin-prick tests were carried out in quadruplicate with three concentrations of grass pollen extracts (identical batches of Pharmalgen) and histamine HCl, 1 and 10 mg/ml, as were conjunctival provocations with the same grass pollen. The mean size of weals caused by allergen and histamine was significantly smaller after terfenadine than after placebo; in fact, terfenadine increased the tolerance to the allergen by a factor of ten. Similarly, the tolerance to conjunctival provocation was significantly increased during terfenadine treatment as compared with placebo. There was no significant difference between the treatments in scores for alertness and salivation. Seasonal symptoms were mild when the children were allowed to use terfenadine in an open follow-up study. Thus, terfenadine reduced specific as well as non-specific reactivity in grass pollen allergic children and caused few side effects.
在一项针对25名6至12岁因草花粉诱发变应性鼻结膜炎的儿童进行的随机、双盲交叉研究中,将特非那定混悬液(每日两次,每次30毫克)与安慰剂进行了比较。患者在两个7天疗程中接受治疗,疗程之间间隔4天的洗脱期。在空气中没有诱发花粉的时期评估疗效。在每个治疗期结束时,用三种浓度的草花粉提取物(相同批次的Pharmalgen)和1毫克/毫升及10毫克/毫升的盐酸组胺进行四重皮肤点刺试验,并用相同的草花粉进行结膜激发试验。特非那定治疗后,变应原和组胺引起的风团平均大小明显小于安慰剂治疗后;事实上,特非那定使对变应原的耐受性提高了10倍。同样,与安慰剂相比,特非那定治疗期间结膜激发试验的耐受性也显著提高。两种治疗在警觉性和唾液分泌评分方面没有显著差异。在一项开放的随访研究中,当允许儿童使用特非那定时,季节性症状较轻。因此,特非那定降低了草花粉过敏儿童的特异性和非特异性反应性,且副作用较少。