Waitzinger J, Lenders H, Pabst G, Reh C, Ulbrich E
L.A.B. GmbH, Neu-Ulm, Germany.
Int J Clin Pharmacol Ther. 1995 Jul;33(7):373-83.
The efficacy of a multiple oral dose treatment with mebhydroline (Omeril coated tablets, 100 mg t.i.d.) was examined in 3 studies which were performed in a randomized, double-blind and placebo-controlled 2-way cross-over design. A second target was to investigate the suitability of different pharmacodynamic models for testing the efficacy of antihistamines. Study A involved a nasal provocation with a specific allergen in 11 symptom-free patients suffering from seasonal allergic rhinitis. In study B, a nasal provocation with histamine was investigated in 11 healthy volunteers. Study C involved a cutaneous provocation with a specific allergen in 12 symptom-free patients suffering from seasonal allergic rhinitis/atopy. The mebhydroline treatment's superiority over placebo was shown statistically at the 95% confidence level for the symptoms itchy nose in study A and for nasal congestion in study B. In study C, allergen-induced weals (planimetric measurement) and itching (visual analog scale) were significantly changed by mebhydroline. A qualitative evaluation revealed a reaction intensity that differed between the 2 treatments to a clinically relevant degree, however, without reaching significance. On the basis of the data it is expected that the clinical efficacy of mebhydroline may be further substantiated in confirmatory clinical trials which should include placebo and positive controls. The test methods used differed in their suitability for measuring the pharmacodynamic effects of antihistamines. Overall, the most clear-cut results were seen in hay fever patients using a specific allergen for provocation. The planimetric assessment of weal response should be preferred as a cutaneous model. Both AR and AARM have their clinical relevance. Based on highly significant results of a subgroup analysis there are indications in favor to AR, but momentary there is no definite conclusion in favor of or against either of the 2 methods.
在三项采用随机、双盲和安慰剂对照的双向交叉设计的研究中，考察了多剂量口服美比拉敏（奥美立糖衣片，100mg，每日三次）的疗效。第二个目标是研究不同药效学模型用于测试抗组胺药疗效的适用性。研究A对11名患有季节性变应性鼻炎且无症状的患者进行了特定变应原的鼻激发试验。研究B对11名健康志愿者进行了组胺鼻激发试验。研究C对12名患有季节性变应性鼻炎/特应性且无症状的患者进行了特定变应原的皮肤激发试验。在研究A中，对于鼻痒症状，以及在研究B中对于鼻充血症状，美比拉敏治疗优于安慰剂在95%置信水平上具有统计学意义。在研究C中，美比拉敏使变应原诱导的风团（平面测量）和瘙痒（视觉模拟量表）有显著变化。定性评估显示两种治疗之间的反应强度在临床相关程度上有所不同，但未达到显著性。根据这些数据，预计在应包括安慰剂和阳性对照的验证性临床试验中，美比拉敏的临床疗效可能会得到进一步证实。所使用的测试方法在测量抗组胺药药效学效应的适用性方面存在差异。总体而言，在使用特定变应原进行激发试验的花粉症患者中观察到了最明确的结果。风团反应的平面评估作为皮肤模型应更受青睐。变应性鼻炎（AR）和变应性皮肤病（AARM）都具有临床相关性。基于亚组分析的高度显著结果，有迹象支持AR，但目前对于这两种方法中的任何一种都没有明确支持或反对的结论。
