Gastpar H, Kiehn R, Sieger C, Weibel M A
Schweiz Rundsch Med Prax. 1989 May 16;78(20):585-8.
The efficacy and tolerability of Naaga (the magnesium salt of N-acetyl-aspartyl-glutamate) and of sodium cromoglycate after intranasal application were tested and compared in 100 patients suffering from chronic allergic rhinitis. The study was conducted according to a randomized, double-blind design in four centers. The intensity and frequency of typical allergic symptoms such as nasal obstruction, sneezing, runny and itching nose, conjunctivitis, ocular itching and tear flow were recorded on a 4-point scale (absent, light, moderate and severe). The intensity of nasal and ocular symptoms was found to be marked for patients in two centers. For the patients in the other two centers the drugs' efficacy was difficult to assess because symptoms were not marked (rated either as absent or light) at the beginning of the study. Thus the assessment of efficacy was based on 60 patients (centers 1 and 2), while the assessment of tolerability was based on the whole patient sample (n = 100). There was no statistically significant difference between the two compounds in terms of efficacy. A total of five patients in each of both groups complained of moderate untoward effects (all patients from the same center).
在100例慢性变应性鼻炎患者中测试并比较了鼻内应用纳加（N-乙酰天冬氨酰谷氨酸镁盐）和色甘酸钠的疗效及耐受性。该研究在四个中心按照随机双盲设计进行。典型变应性症状如鼻塞、喷嚏、流涕、鼻痒、结膜炎、眼痒和流泪的强度及频率采用4分制记录（无、轻、中、重）。在两个中心发现患者的鼻和眼症状强度明显。对于另外两个中心的患者，由于在研究开始时症状不明显（评为无或轻），难以评估药物疗效。因此，疗效评估基于60例患者（中心1和2），而耐受性评估基于整个患者样本（n = 100）。两种化合物在疗效方面无统计学显著差异。两组各有5例患者主诉有中度不良反应（所有患者来自同一中心）。
