Druce H M, Thoden W R, Mure P, Furey S A, Lockhart E A, Xie T, Galant S, Prenner B M, Weinstein S, Ziering R, Brandon M L
Department of Clinical Research, Whitehall-Robins Healthcare, Madison, New Jersey 07940-0871, USA.
J Clin Pharmacol. 1998 Apr;38(4):382-9. doi: 10.1002/j.1552-4604.1998.tb04439.x.
A double-blind, randomized, placebo-controlled, parallel-group, multicenter study was conducted to compare the effectiveness of an extended-release formulation of a classical antihistamine, brompheniramine, and a second-generation compound, loratadine, in the treatment of allergic rhinitis. Subjects with symptoms of allergic rhinitis received brompheniramine 12 mg twice daily (n = 112), loratadine 10 mg once daily (n = 112), or placebo twice daily (n = 114) for 7 days. Study medications were blinded using a double-dummy technique. Subjects completed an overall evaluation of symptom relief on a daily basis and returned on treatment days 3 and 7, at which times the investigator assessed symptom severity. The investigator and subject each completed a global efficacy evaluation, and subjects were interviewed regarding adverse experiences. The primary efficacy variable was the physicians' global efficacy evaluation on day 3. Symptoms also were analyzed as summed severity scores for all symptoms and for the nasal symptom cluster of rhinorrhea, sneezing, and nasal blockage. At all post-baseline evaluations (days 3, 7, and averaged over the two days), brompheniramine was significantly better than loratadine and placebo for both sets of summed symptom scores and all three global assessments. Loratadine was significantly better than placebo for physician ratings of total symptom severity averaged over the two days and for the physician and subject ratings of the nasal cluster on day 3. Central nervous system-related symptoms were the most frequently reported adverse experiences; somnolence was reported most frequently by patients taking brompheniramine, and its occurrence was less frequent as treatment continued. A nonprescription, extended-release formulation of brompheniramine 12 mg twice daily provided significantly better relief of symptomatic allergic rhinitis than loratadine 10 mg once daily.
进行了一项双盲、随机、安慰剂对照、平行组、多中心研究，以比较经典抗组胺药溴苯那敏的缓释制剂与第二代化合物氯雷他定在治疗过敏性鼻炎方面的有效性。有过敏性鼻炎症状的受试者接受溴苯那敏12毫克每日两次（n = 112）、氯雷他定10毫克每日一次（n = 112）或安慰剂每日两次（n = 114），持续7天。使用双模拟技术使研究药物保持盲态。受试者每天完成症状缓解的总体评估，并在治疗第3天和第7天复诊，此时研究者评估症状严重程度。研究者和受试者各自完成总体疗效评估，并就不良经历对受试者进行访谈。主要疗效变量是第3天医生的总体疗效评估。症状还被分析为所有症状以及流涕、打喷嚏和鼻塞鼻症状群的总严重程度评分。在所有基线后评估（第3天、第7天以及两天的平均值）中，溴苯那敏在两组总症状评分和所有三项总体评估方面均显著优于氯雷他定和安慰剂。氯雷他定在两天的总症状严重程度医生评分以及第3天医生和受试者对鼻症状群的评分方面显著优于安慰剂。中枢神经系统相关症状是最常报告的不良经历；嗜睡在服用溴苯那敏的患者中报告最为频繁，且随着治疗的持续其发生率降低。每日两次服用12毫克非处方溴苯那敏缓释制剂在缓解症状性过敏性鼻炎方面显著优于每日一次服用10毫克氯雷他定。
