Efficacy of desloratadine, 5 mg, compared with fexofenadine, 180 mg, in patients with symptomatic seasonal allergic rhinitis.
Efficacy of desloratadine, 5 mg, compared with fexofenadine, 180 mg, in patients with symptomatic seasonal allergic rhinitis.
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地氯雷他定 5 mg 与非索非那定 180 mg 相比，对于有症状的季节性过敏性鼻炎患者的疗效。
DOI：
10.2500/aap.2006.27.2851
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发表时间：
2006
影响因子：
2.8
通讯作者：
D. Pearlman
中科院分区：
文献类型：
--
作者：
W. Berger;W. Lumry;E. Meltzer;D. Pearlman
这是美国第一个-比较地氯雷他定与非索非那定治疗有症状的季节性变应性鼻炎（SAR）患者的疗效和安全性。在这项双盲研究中，受试者随机接受地氯雷他定5 mg（n = 290）、非索非那定180 mg（n = 288）或安慰剂（n = 144），每日一次，持续15天。主要终点是从基线到研究结束的早晨即时总症状评分（AM NOW TSS）（不包括充血）的平均变化。次要指标包括早晨/晚上反射性TSS（AM/PM PRIOR TSS）（不包括充血）、AM NOW个体症状评分（AM NOW ISS）（包括充血）和AM/PM PRIOR ISS（包括充血）较基线的变化。受试者自我评估他们的症状的五点量表。与安慰剂组相比，地氯雷他定组（p = 0.006）和非索非那定组（p = 0.024）第15天的平均AM NOW TSS较基线显著降低。地氯雷他定和非索非那定无统计学差异（p = 0.491）;地氯雷他定与非索非那定的95%CI上限（0.259）在预先规定的非劣效性界值0.7 U内。地氯雷他定和非索非那定之间除充血外的平均AM/PM PRIOR TSS的降低程度相当（p = 0.405; CI = 0.221），但两种活性药物治疗组均显著高于安慰剂组（地氯雷他定，p < 0.001;非索非那定，p = 0.003）。与安慰剂相比，地氯雷他定和非索非那定使AM NOW ISS和AM/PM PRIOR ISS（均包括充血）降低幅度更大;两种活性治疗的降低幅度相当。所有治疗均耐受良好。5 mg地氯雷他定和180 mg非索非那定在治疗SAR方面的疗效和耐受性相当。两种治疗方法都比安慰剂有效。
This is the first U.S.-based study to compare efficacy and safety of desloratadine with fexofenadine in subjects with symptomatic seasonal allergic rhinitis (SAR). In this double-blind study, subjects were randomized to desloratadine, 5 mg (n = 290),fexofenadine, 180 mg (n = 288), or placebo (n = 144) once daily for 15 days. Primary end point was mean change from baseline to study end in morning instantaneous total symptom score (AM NOW TSS) excluding congestion. Secondary measures included change from baseline in the morning/evening reflective TSS (AM/PM PRIOR TSS) excluding congestion, AM NOW individual symptom score (AM NOW ISS) including congestion, and the AM/PM PRIOR ISS including congestion. Subjects self-evaluated their symptoms on a five-point scale. Mean AM NOW TSSs were significantly reduced from baseline at day 15 with desloratadine (p = 0.006) and fexofenadine (p = 0.024) versus placebo. Desloratadine and fexofenadine were not statistically different (p = 0.491); the upper limit of the 95% CI for desloratadine to fexofenadine (0.259) was within the prespecified noninferiority margin of 0.7 U. Decrease in mean AM/PM PRIOR TSS excluding congestion was comparable between desloratadine and fexofenadine (p = 0.405; CI = 0.221) but was significantly greater with both active treatments versus placebo (desloratadine, p < 0.001;fexofenadine, p = 0.003). Desloratadine and fexofenadine provided greater reduction in the AM NOW ISS and AM/PM PRIOR ISS (both including congestion) versus placebo; reductions were comparable between active treatments. All treatments were well tolerated. Desloratadine, 5 mg, and fexofenadine, 180 mg, provide comparable efficacy and tolerability in the treatment of SAR. Both treatments are significantly more effective than placebo.