Henauer S A, Glück U
Merrell Dow, Medical Direction Europe, Zurich, Switzerland.
Eur J Clin Pharmacol. 1988;34(1):35-40. doi: 10.1007/BF01061414.
We have assessed the effects of terfenadine on rhinitis symptoms associated with the common cold in 91 patients in a double-blind placebo-controlled study. The patients received three doses of either terfenadine 60 mg (n = 44) or placebo (n = 47) at about 12-h intervals, starting in most patients within 48 h from the onset of symptoms. Because of deviations from the protocol, 28 cases were classified as not eligible for efficacy evaluation, but were nevertheless analysed. Excellent/good or moderate efficacy was reported by 63% of eligible and 59% of all patients who received terfenadine (placebo 40% and 51% respectively, p = 0.049 and 0.113 respectively). 68% of eligible and 52% of all patients indicated that they would take terfenadine again (placebo 23%, for both p = 0.002). Two h after tablet intake mean nasal airflow was increased by 11 l.min-1, SD 8 (placebo -1 l.min-1, SD 6, p = 0.005). Symptoms were improved and rhinoscopy showed reduced swelling and redness of the mucosa and reduced nasal secretion and obstruction (basically unchanged in the placebo group). Therefore, terfenadine seems to act favourably on the acute rhinitis symptoms associated with the common cold. Since terfenadine is devoid of anticholinergic activity, nose symptoms during the initial stage of the common cold may be mediated to an important degree by histamine.
我们在一项双盲安慰剂对照研究中，评估了特非那定对91例普通感冒相关鼻炎症状的影响。患者每隔约12小时接受三剂60毫克特非那定（n = 44）或安慰剂（n = 47），大多数患者在症状出现后48小时内开始用药。由于偏离方案，28例被归类为不符合疗效评估标准，但仍进行了分析。接受特非那定的合格患者中有63%、所有患者中有59%报告疗效为优/良或中等（安慰剂组分别为40%和51%，p分别为0.049和0.113）。68%的合格患者和52%的所有患者表示他们会再次服用特非那定（安慰剂组为23%，两者p均为0.002）。服药后两小时，平均鼻气流增加了11升/分钟，标准差为8（安慰剂组为-1升/分钟，标准差为6，p = 0.005）。症状有所改善，鼻镜检查显示黏膜肿胀和发红减轻，鼻分泌物和鼻塞减少（安慰剂组基本无变化）。因此，特非那定似乎对普通感冒相关的急性鼻炎症状有有利作用。由于特非那定没有抗胆碱能活性，普通感冒初期的鼻部症状可能在很大程度上由组胺介导。
