Palma-Carlos A G, Chieira C, Conde T A, Cordeiro J A
Immunology Institute, Santa Maria Hospital, University of Lisbon, Portugal.
Ann Allergy. 1991 Oct;67(4):394-8.
Nasal levocabastine (0.5 mg/mL) was evaluated for efficacy and tolerance against sodium cromoglycate (20 mg/mL) in a 2-week double-blind trial in 27 and 29 patients with seasonal allergic rhinitis. Globally at 2 weeks, the investigators found a 74% response rate in the levocabastine patients versus a 50% response rate in the cromoglycate patients (P less than .10). Sneezing responded better to levocabastine than to cromoglycate according to three efficacy indicators derived from patient diary ratings of symptom severity: sum of severity scores over the total treatment period as a percentage of the theoretical maximum sum of severity scores (median: 19% versus 41%, P = .01); percentage of symptom-free days (median: 46% versus 22%, P less than .07); percentage of days with moderate or severe symptoms (median: 0% versus 29%, P = .004). Further, the percentage of days with moderate or severe runny nose was lower than in cromoglycate patients (median: 0% versus 25%, P = .09). Although no significant differences were found for itchy nose, blocked nose, and ocular symptoms, severities tended to be generally less under levocabastine than under sodium cromoglycate. Adverse experiences were low level and of similar incidence in the two groups. It is concluded that in a q.i.d. schedule, levocabastine nasal spray is more efficacious than sodium cromoglycate in relieving sneezing and that it is equally well tolerated.
在一项为期2周的双盲试验中，对27例和29例季节性变应性鼻炎患者评估了鼻用左卡巴斯汀（0.5mg/mL）相对于色甘酸钠（20mg/mL）的疗效和耐受性。在2周时，研究人员发现左卡巴斯汀组的有效率为74%，而色甘酸钠组为50%（P<0.10）。根据患者症状严重程度日记评分得出的三个疗效指标，打喷嚏对左卡巴斯汀的反应比对色甘酸钠更好：整个治疗期间严重程度评分总和占理论最大严重程度评分总和的百分比（中位数：19%对41%，P=0.01）；无症状天数的百分比（中位数：46%对22%，P<0.07）；有中度或重度症状天数的百分比（中位数：0%对29%，P=0.004）。此外，有中度或重度流涕天数的百分比低于色甘酸钠组患者（中位数：0%对25%，P=0.09）。虽然在鼻痒、鼻塞和眼部症状方面未发现显著差异，但左卡巴斯汀治疗下的严重程度总体上往往低于色甘酸钠。两组的不良事件发生率较低且相似。得出结论，按每日四次给药方案，左卡巴斯汀鼻喷雾剂在缓解打喷嚏方面比色甘酸钠更有效，且耐受性相同。
