Bertrand B, Dab R, Daele J, van Cauwenberge P, van den Broeck R
Cliniques Universitaires, Saint Luc, Yvoir, Belgium.
Rhinology. 1995 Sep;33(3):132-4.
A double-blind, four-centre study was carried out in 66 children to compare the clinical efficacy and safety of N-acetyl-aspartyl-glutamic acid (NAAGA) and disodium cromoglycate (DSCG) nasal sprays. At similar dosage conditions (one puff per nostril, four times daily, for 3 weeks), no significant differences between the treatments were discernible in the primary efficacy parameters (scores, patients' and physicians' opinion). Both products induced statistically significant improvements in the nasal, ocular and total scores, but not in the respiratory (breathing) score. The hay-fever symptoms improved clinically in > 50% of the children after only two weeks with both treatments. The exact figures depended on the parameters considered. Thirteen out of 25 patients (52%) in the NAAGA group found the efficacy "good" or "excellent" at the end of the treatment period; the corresponding opinion in the DSCG group was expressed by 10 out of 24 patients (41.7%). Of the 28 patients that used the rescue medication, 12 (42.8%) were from the NAAGA group and 16 (57.1%) from the DSCG group. One patient on NAAGA treatment reported side effects, i.e. pruritus in the nose and sneezing.
一项针对66名儿童的双盲、四中心研究开展,以比较N-乙酰天冬氨酰谷氨酸(NAAGA)鼻喷雾剂和色甘酸钠(DSCG)鼻喷雾剂的临床疗效和安全性。在相似剂量条件下(每侧鼻孔喷一下,每日4次,持续3周),在主要疗效参数(评分、患者及医生的意见)方面,两种治疗方法之间没有明显差异。两种产品均在鼻腔、眼部和总分上诱导出具有统计学意义的改善,但在呼吸(呼吸)评分上没有。仅经过两周的两种治疗,超过50%的儿童的花粉症症状在临床上得到改善。确切数字取决于所考虑的参数。NAAGA组25名患者中有13名(52%)在治疗期结束时认为疗效“好”或“极好”;DSCG组24名患者中有10名(41.7%)表达了相应意见。在使用急救药物的28名患者中,12名(42.8%)来自NAAGA组,16名(57.1%)来自DSCG组。一名接受NAAGA治疗的患者报告了副作用,即鼻子瘙痒和打喷嚏。