Schuller D E, Selcow J E, Joos T H, Hannaway P J, Hirsch S R, Schwartz H J, Filley W V, Fink J N
Department of Pediatric Allergy, Immunology and Pulmonary Medicine, Geisinger Medical Center, Danville, PA 17822.
J Allergy Clin Immunol. 1990 Oct;86(4 Pt 1):554-61. doi: 10.1016/s0091-6749(05)80212-x.
This study was a double-blind, parallel-group study to evaluate a new medication, nedocromil sodium, 1%, in comparison with placebo and cromolyn sodium, 4%, for treatment of ragweed seasonal allergic rhinitis. Two hundred thirty-three patients (aged 12 to 65 years) from eight centers were randomized to treatment, one spray per nostril, four times daily, with nedocromil sodium, cromolyn sodium, or matched placebo (80, 76, and 77 patients, respectively). All patients had at least a 2-year history of ragweed seasonal allergic rhinitis. Treatment was for 8 weeks during the ragweed season, and daily pollen counts were used to identify the peak 3-week period. Clinic examinations were made before and after the 1-week baseline and after 1, 3, 5, and 8 weeks of treatment. Rhinitis symptoms were recorded each day by the patients. Nedocromil sodium was more effective than placebo (p less than 0.05) in relieving symptoms as recorded by the patients. Cromolyn sodium was also more effective than placebo, but the difference was not usually significant. Similarly, the active treatments were both better than placebo for clinical parameters measured at visits and for global opinions of treatment, and more rescue therapy was used by the placebo-treated group. There was no significant difference between the two active treatments, but the trend throughout was in favor of nedocromil sodium. Our findings demonstrated nedocromil sodium to be at least as effective as an established therapy (cromolyn sodium) in reducing symptoms of rhinitis during the peak ragweed pollen season.
本研究是一项双盲、平行组研究，旨在评估1%的奈多罗米钠这种新药，与安慰剂和4%的色甘酸钠相比，用于治疗豚草季节性变应性鼻炎的效果。来自八个中心的233名患者（年龄在12至65岁之间）被随机分配接受治疗，每天每侧鼻孔喷一次，每天四次，分别使用奈多罗米钠、色甘酸钠或匹配的安慰剂（分别为80、76和77名患者）。所有患者都有至少2年的豚草季节性变应性鼻炎病史。在豚草季节进行为期8周的治疗，并使用每日花粉计数来确定花粉高峰期的3周时间段。在1周基线期前后以及治疗1、3、5和8周后进行临床检查。患者每天记录鼻炎症状。奈多罗米钠在缓解患者记录的症状方面比安慰剂更有效（p<0.05）。色甘酸钠也比安慰剂更有效，但差异通常不显著。同样，两种活性治疗在就诊时测量的临床参数和对治疗的总体评价方面都比安慰剂更好，并且安慰剂治疗组使用了更多的急救治疗。两种活性治疗之间没有显著差异，但总体趋势有利于奈多罗米钠。我们的研究结果表明，在豚草花粉高峰期，奈多罗米钠在减轻鼻炎症状方面至少与已确立的疗法（色甘酸钠）一样有效。
