Allergy. 1994 Sep;49(8):611-5. doi: 10.1111/j.1398-9995.1994.tb00127.x.
This multicenter, double-blind, double-dummy, parallel-group trial was initiated to compare the efficacy and tolerability of two antihistamines, topical levocabastine (eye-drops and nasal spray) and oral loratadine, for the treatment of seasonal allergic rhinoconjunctivitis in the primary care setting. A total of 95 adult patients participated in the study with a treatment duration of 5 weeks. Forty-seven patients were randomized to receive twice daily levocabastine eye-drops and nasal spray plus an oral placebo, and 48 to receive once daily oral loratadine with placebo eye-drops and nasal spray. Naphazoline eye-drops and xylometazoline nasal spray were permitted as rescue medication. No statistically significant intergroup differences in therapeutic efficacy were observed. Symptom severity was comparable in the two treatment groups throughout the trial period. At the end of the study, 86% of levocabastine-treated patients considered global therapeutic efficacy to be excellent or good, as compared with 77% of those who received loratadine. This difference was not statistically significant. There were no significant differences in the use of rescue medication or in the incidence or severity of adverse events in the two treatment groups. In conclusion, levocabastine eye-drops and nasal spray appear to be as effective and well tolerated as oral loratadine for the treatment of seasonal allergic rhinoconjunctivitis.
这项多中心、双盲、双模拟、平行组试验旨在比较两种抗组胺药(局部用左卡巴斯汀,即滴眼液和鼻喷雾剂,以及口服氯雷他定)在基层医疗环境中治疗季节性变应性鼻结膜炎的疗效和耐受性。共有95名成年患者参与了该研究,治疗持续时间为5周。47名患者被随机分配接受每日两次的左卡巴斯汀滴眼液和鼻喷雾剂加口服安慰剂,48名患者接受每日一次的口服氯雷他定加安慰剂滴眼液和鼻喷雾剂。允许使用萘甲唑啉滴眼液和赛洛唑啉鼻喷雾剂作为急救药物。未观察到组间治疗疗效有统计学显著差异。在整个试验期间,两个治疗组的症状严重程度相当。在研究结束时,接受左卡巴斯汀治疗的患者中有86%认为总体治疗效果为优或良,而接受氯雷他定治疗的患者中这一比例为77%。这一差异无统计学显著性。两个治疗组在急救药物使用、不良事件发生率或严重程度方面均无显著差异。总之,左卡巴斯汀滴眼液和鼻喷雾剂在治疗季节性变应性鼻结膜炎方面似乎与口服氯雷他定一样有效且耐受性良好。