Bruttmann G, Pedrali P
J Int Med Res. 1987 Mar-Apr;15(2):63-70. doi: 10.1177/030006058701500201.
Seventy patients received loratadine 40 mg once daily, terfenadine 60 mg twice daily, or placebo in a 14-day, double-blind, randomized study. Four nasal and four non-nasal symptoms associated with allergic rhinitis were evaluated. At the endpoint (the last evaluable visit), the mean total scores of combined nasal and non-nasal symptoms decreased (improved) from the baseline by 51.8% and 55.7% with loratadine and terfenadine, respectively, but increased (worsened) by 6.1% with placebo. There was a significant difference between both the loratadine and terfenadine treatment groups and the placebo group (P = 0.001) but not between the active medication groups (P = 0.608). Overall therapeutic response was good or excellent in 14 of the 23 patients given loratadine, in 18 of the 24 given terfenadine and in none of the 23 given placebo. The difference between each active medication group and the placebo group was significant (P less than or equal to 0.01) but there was no significant difference between the two active treatment groups (P greater than 0.35). No loratadine patient had any adverse side-effects. Sedating effects occurred in one terfenadine patient, headache in one placebo patient and two terfenadine patients (one terfenadine patient with severe headache discontinued treatment), and dyspepsia in two placebo patients. No anti-cholinergic effects occurred in this study. Loratadine 40 mg once daily was effective and safe in the relief of symptoms of allergic rhinitis.
在一项为期14天的双盲随机研究中,70名患者每日一次服用40毫克氯雷他定、每日两次服用60毫克特非那定或服用安慰剂。对与过敏性鼻炎相关的4种鼻部症状和4种非鼻部症状进行了评估。在研究终点(最后一次可评估访视)时,服用氯雷他定和特非那定的患者,其鼻部和非鼻部症状综合平均总分较基线分别下降(改善)了51.8%和55.7%,而服用安慰剂的患者该总分上升(恶化)了6.1%。氯雷他定治疗组和特非那定治疗组与安慰剂组之间存在显著差异(P = 0.001),但活性药物治疗组之间无显著差异(P = 0.608)。在服用氯雷他定的23名患者中,14名患者的总体治疗反应为良好或优秀;在服用特非那定的24名患者中,18名患者的总体治疗反应为良好或优秀;而在服用安慰剂的23名患者中,无一例总体治疗反应为良好或优秀。各活性药物治疗组与安慰剂组之间的差异具有统计学意义(P≤0.01),但两个活性治疗组之间无显著差异(P>0.35)。服用氯雷他定的患者均未出现任何不良反应。1名服用特非那定的患者出现镇静作用,1名服用安慰剂的患者和2名服用特非那定的患者(1名患有严重头痛的服用特非那定患者停止治疗)出现头痛,2名服用安慰剂的患者出现消化不良。本研究中未出现抗胆碱能效应。每日一次服用40毫克氯雷他定在缓解过敏性鼻炎症状方面有效且安全。