Schata M, Jorde W, Richarz-Barthauer U
Department of Internal Medicine, Asthmakrankenhaus der Kamillianer, Mönchengladbach, Germany.
J Allergy Clin Immunol. 1991 Apr;87(4):873-8. doi: 10.1016/0091-6749(91)90136-c.
The efficacy and safety of the nasal administration (twice in each nostril, four times a day) of levocabastine (0.5 mg/ml) were compared with those of sodium cromoglycate (20 mg/ml) and placebo in a 2-week, parallel, double-blind trial in patients with seasonal allergic rhinitis. At the end of treatment, 89% of patients in the levocabastine-treated group rated their treatment as globally good or excellent as compared with 32% (p = 0.003) of sodium cromoglycate-treated and 35% (p = 0.002) of placebo-treated patients. According to the investigators' ratings, the severest nasal symptom and ocular complaints responded better to levocabastine than to cromoglycate (p = 0.05 and p = 0.03) or placebo treatment (p = 0.03 and p = 0.001). Visual analogue scale ratings in patients' diaries indicated that at the end of therapy, nasal symptoms were less severe in the levocabastine-treated group than in the sodium cromoglycate-treated (p = 0.03) or placebo-treated group (p = 0.001). Total symptom severity as a percentage of the theoretical maximum symptom severity during the treatment period was lower for levocabastine than for sodium cromoglycate (p = 0.06) or placebo (p = 0.004) for the severest nasal symptom (35% versus 47% and 76%), sneezing (the most frequent symptom) (27% versus 42% and 67%), and itchy nose (18% versus 37% and 67%). The percentage of days at which nasal symptoms were entirely absent was markedly higher in the levocabastine-treated (33%) than in the sodium cromoglycate-treated (9%; p = 0.006) or placebo-treated (3%; p = 0.001) group.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项为期2周的季节性变应性鼻炎患者平行双盲试验中,比较了左卡巴斯汀(0.5mg/ml)经鼻给药(每侧鼻孔两次,每日四次)与色甘酸钠(20mg/ml)及安慰剂的疗效和安全性。治疗结束时,左卡巴斯汀治疗组89%的患者对其治疗总体评价为良好或优秀,相比之下,色甘酸钠治疗组为32%(p = 0.003),安慰剂治疗组为35%(p = 0.002)。根据研究者的评级,最严重的鼻部症状和眼部不适对左卡巴斯汀的反应比对色甘酸钠(p = 0.05和p = 0.03)或安慰剂治疗(p = 0.03和p = 0.001)更好。患者日记中的视觉模拟量表评分表明,治疗结束时,左卡巴斯汀治疗组的鼻部症状比色甘酸钠治疗组(p = 0.03)或安慰剂治疗组(p = 0.001)轻。在治疗期间,就最严重的鼻部症状(35%对47%和76%)、打喷嚏(最常见症状)(27%对42%和67%)以及鼻痒(18%对37%和67%)而言,左卡巴斯汀的总症状严重程度占理论最大症状严重程度的百分比低于色甘酸钠(p = 0.06)或安慰剂(p = 0.004)。左卡巴斯汀治疗组完全无鼻部症状的天数百分比(33%)显著高于色甘酸钠治疗组(9%;p = 0.006)或安慰剂治疗组(3%;p = 0.001)。(摘要截选于250词)