Van Cauwenberge P, Juniper E F
Department of Otorhinolaryngology, University Hospital, Ghent, Belgium.
Clin Exp Allergy. 2000 Jun;30(6):891-9. doi: 10.1046/j.1365-2222.2000.00914.x.
As there have been no previously published studies, this multinational, double-blind, randomized, placebo-controlled, parallel group study compared the efficacy, safety and impact on quality of life (QoL) in seasonal allergic rhinitis patients (SAR) of fexofenadine and loratadine (with placebo), when administered once daily.
Six hundred and eighty-eight SAR patients were randomized to receive fexofenadine HCl 120 mg, loratadine 10 mg or placebo, once daily for 2 weeks. The key parameters were the change from baseline in: mean 24-h reflective total symptom scores (TSS); sum of four individual symptom scores, excluding nasal congestion; instantaneous TSS; individual symptom scores including nasal congestion; and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Adverse events were recorded.
Mean 24-h reflective and instantaneous TSS were significantly reduced by both fexofenadine HCl (both P </= 0.0001) and loratadine (P </= 0.001 and P </= 0.005, respectively) compared with placebo (n = 639). Among individual symptom scores, fexofenadine HCl was significantly better than loratadine in improving 24-h reflective itchy, watery, red eyes, as well as relieving nasal congestion (P </= 0.05 for both). Fexofenadine HCl was also significantly better than loratadine (P </= 0.03) and placebo (P </= 0.005) in improving QoL, and the differences were of a magnitude considered to be clinically relevant. Loratadine had no statistically significant effect on QoL compared with placebo. The incidence of adverse events was low and similar across all treatment groups.
Fexofenadine HCl and loratadine administered once daily are effective and well tolerated in SAR. In this study, fexofenadine HCl was significantly more effective than loratadine in relieving eye symptoms and nasal congestion. Furthermore, fexofenadine was significantly better than loratadine in improving QoL.
由于此前尚无已发表的研究，这项多中心、双盲、随机、安慰剂对照、平行组研究比较了非索非那定和氯雷他定（与安慰剂相比）在季节性变应性鼻炎（SAR）患者中每日给药一次时的疗效、安全性及对生活质量（QoL）的影响。
688例SAR患者被随机分为三组，分别接受每日一次120mg盐酸非索非那定、10mg氯雷他定或安慰剂治疗，疗程2周。关键参数包括自基线的变化：24小时平均反射性总症状评分（TSS）；四个单项症状评分之和（不包括鼻充血）；即时TSS；包括鼻充血在内的单项症状评分；以及变应性鼻炎生活质量问卷（RQLQ）。记录不良事件。
与安慰剂组（n = 639）相比，盐酸非索非那定（均P≤0.0001）和氯雷他定（分别为P≤0.001和P≤0.005）均使24小时平均反射性和即时TSS显著降低。在单项症状评分中，盐酸非索非那定在改善24小时反射性眼痒、流泪、眼红以及缓解鼻充血方面显著优于氯雷他定（两者均P≤0.05）。盐酸非索非那定在改善生活质量方面也显著优于氯雷他定（P≤0.03）和安慰剂（P≤0.005），且差异被认为具有临床相关性。氯雷他定与安慰剂相比，对生活质量无统计学显著影响。所有治疗组不良事件发生率均较低且相似。
每日一次服用盐酸非索非那定和氯雷他定在SAR治疗中有效且耐受性良好。在本研究中盐酸非索非那定在缓解眼部症状和鼻充血方面显著优于氯雷他定。此外，在改善生活质量方面，非索非那定显著优于氯雷他定。
