Ratner P H, van Bavel J H, Martin B G, Hampel F C, Howland W C, Rogenes P R, Westlund R E, Bowers B W, Cook C K
Sylvana Research, San Antonio, Texas 78229, USA.
J Fam Pract. 1998 Aug;47(2):118-25.
Intranasal corticosteroids and oral antihistamines are both effective in the treatment of seasonal allergic rhinitis, although the therapeutic value of administering the two types of agents concurrently has rarely been evaluated. This study was designed to compared the efficacy, safety, and impact on quality of life of fluticasone propionate aqueous nasal spray (FP ANS), loratadine, FP ANS plus loratadine, and placebo (an aqueous nasal spray plus tablet) in the treatment of seasonal allergic rhinitis during the mountain cedar allergy season in south central Texas.
Six hundred patients with seasonal allergic rhinitis were treated for 2 weeks with either FP ANS 200 microgram once daily, loratadine 10 mg once daily, the FP ANS and loratadine regimens combined, or placebo in a multicenter, randomized, double-blind, double-dummy, parallel-group study.
Clinician- and patient-rated total and individual nasal symptom scores after 7 and 14 days of therapy and overall evaluations were significantly lower (P < .001) in the FP ANS and FP ANS plus loratadine groups compared with the loratadine only and placebo groups. Loratadine was not statistically different from placebo in clinician and patient symptom score ratings nor in overall clinician and patient evaluations. FP ANS plus loratadine and FP ANS monotherapy were comparable in efficacy in almost all evaluations; for some patient-rated symptoms the combination was found superior. Mean score changes in the Rhinoconjunctivitis Quality of Life Questionnaire from baseline to day 14 showed significantly greater improvement (P < .001) in quality of life in the FP ANS group than in the group of patients receiving loratadine only or placebo and no significant benefit was demonstrated in the FP ANS plus loratadine group over the FP ANS monotherapy group. No serious or unusual drug-related adverse events were reported. Combining loratadine with FP ANS did not alter the adverse events profile or frequency.
鼻内用皮质类固醇和口服抗组胺药在季节性变应性鼻炎的治疗中均有效，不过同时使用这两类药物的治疗价值很少得到评估。本研究旨在比较丙酸氟替卡松水鼻喷雾剂（FP ANS）、氯雷他定、FP ANS加氯雷他定以及安慰剂（水鼻喷雾剂加片剂）在德克萨斯州中南部山区雪松过敏季节治疗季节性变应性鼻炎时的疗效、安全性及对生活质量的影响。
在一项多中心、随机、双盲、双模拟、平行组研究中，600例季节性变应性鼻炎患者接受了为期2周的治疗，治疗方案为每日一次使用200微克FP ANS、每日一次使用10毫克氯雷他定、FP ANS与氯雷他定联合用药方案或安慰剂。
与单用氯雷他定组和安慰剂组相比，治疗7天和14天后，FP ANS组以及FP ANS加氯雷他定组的临床医生和患者评定的总鼻症状评分及各个鼻症状评分以及总体评估均显著更低（P <.001）。氯雷他定在临床医生和患者症状评分评定以及总体临床医生和患者评估方面与安慰剂无统计学差异。在几乎所有评估中，FP ANS加氯雷他定与FP ANS单药治疗的疗效相当；对于一些患者评定的症状，联合用药方案更优。从基线到第14天，变应性鼻炎生活质量问卷的平均评分变化显示，FP ANS组的生活质量改善显著大于单用氯雷他定组或安慰剂组患者，且FP ANS加氯雷他定组相对于FP ANS单药治疗组未显示出显著益处。未报告严重或异常的药物相关不良事件。氯雷他定与FP ANS联合使用未改变不良事件的类型或频率。
