Donnelly A, Casale T B
Department of Internal Medicine, University of Iowa College of Medicine, Iowa City.
J Allergy Clin Immunol. 1993 May;91(5):997-1004. doi: 10.1016/0091-6749(93)90212-x.
Nedocromil sodium has proven to be efficacious in prophylactic and long-term therapy for the treatment of seasonal allergic rhinitis. We examined the speed of onset of intranasal nedocromil sodium (1%) for relief of symptoms due to ragweed allergic rhinitis.
In a double-blind, placebo-controlled trial, 104 patients received either nedocromil sodium or placebo four times daily. Patients spent 10 hours per day for 2 consecutive days in Iowa City Park during the peak of ragweed season. Only patients who had significant symptoms during 3 hourly baseline assessments received drug. Symptom scores for stuffy nose, runny nose, itchy nose, and sneezing and global symptom summary scores were recorded at 19 hourly time points during the 2 days. In the evening patients recorded symptom scores for the postexposure period.
In comparison with placebo, nedocromil significantly improved rhinitis symptoms as evidenced by lower symptom summary scores within 2 hours (p = 0.016). Further, this reduction in rhinitis symptoms was maintained throughout the 2-day pollen exposure period. After patients left the study site, postexposure symptom summary scores were also significantly lower in patients treated with nedocromil compared with those treated with placebo (p < 0.007).
Nedocromil significantly relieved preexisting seasonal allergic rhinitis symptoms during peak pollen exposures within 2 hours of the first dose, and the therapeutic benefits were maintained on a dosing regimen of four times a day.
已证实奈多罗米钠在季节性变应性鼻炎的预防和长期治疗中有效。我们研究了鼻用奈多罗米钠(1%)缓解豚草变应性鼻炎症状的起效速度。
在一项双盲、安慰剂对照试验中,104例患者每日接受4次奈多罗米钠或安慰剂治疗。在豚草季节高峰期,患者连续2天每天在爱荷华市公园呆10小时。只有在3次每小时的基线评估中有明显症状的患者才接受药物治疗。在这2天内的19个每小时时间点记录鼻塞、流涕、鼻痒、打喷嚏的症状评分以及总体症状综合评分。晚上患者记录暴露后时间段的症状评分。
与安慰剂相比,奈多罗米显著改善鼻炎症状,2小时内症状综合评分较低即证明了这一点(p = 0.016)。此外,在整个2天的花粉暴露期内,鼻炎症状的这种减轻一直持续。患者离开研究地点后,与接受安慰剂治疗的患者相比,接受奈多罗米治疗的患者暴露后症状综合评分也显著较低(p < 0.007)。
奈多罗米在首剂用药后2小时内花粉暴露高峰期显著缓解已有的季节性变应性鼻炎症状,且每天4次的给药方案能维持治疗效果。