Goes F, Blockhuys S, Janssens M
Janssen Research Foundation, Beerse, Belgium.
Doc Ophthalmol. 1994;87(3):271-81. doi: 10.1007/BF01203856.
The efficacy and tolerability of levocabastine eye drops in vernal conjunctivitis (VC) were evaluated in a double-blind, placebo-controlled trial involving 46 patients over a period of 4 weeks. After 1 week of treatment, therapeutic efficacy was considered to be excellent or good for 70% of the levocabastine-treated patients compared with only 33% of patients in the placebo group (p < 0.009). Levocabastine patients experienced significantly greater relief of their individually severest symptom than placebo-treated patients both after 1 week and at the end of the trial (p < 0.04). The reduction in symptom severity was significantly greater in the levocabastine group than in the control group for photophobia (p < 0.003) after 1 week, and for photophobia (p < 0.008), irritation (p = 0.05) and itchy eyes (p = 0.05) at the end of the trial. The percentage of days on which patients were completely symptom-free was significantly higher in the levocabastine group than in the placebo group (28% versus 4%; p < 0.02). Eight placebo-treated patients withdrew from the trial due to treatment inefficacy compared with only four levocabastine-treated patients (p = 0.013). Two of the three levocabastine, and all five placebo patients who elected to continue on open-label levocabastine had an excellent or good overall response after 1 to 3 weeks of treatment. All reported adverse reactions were mild and their incidence was equal in the two treatment groups. Levocabastine eye drops are effective and well tolerated in the treatment of VC.
在一项为期4周、涉及46例患者的双盲、安慰剂对照试验中，评估了左卡巴斯汀滴眼液治疗春季结膜炎（VC）的疗效和耐受性。治疗1周后，70%接受左卡巴斯汀治疗的患者治疗效果被认为优秀或良好，而安慰剂组仅为33%（p<0.009）。在治疗1周后及试验结束时，左卡巴斯汀治疗的患者相比安慰剂治疗的患者，其各自最严重症状的缓解程度明显更大（p<0.04）。治疗1周后，左卡巴斯汀组畏光症状严重程度的降低显著大于对照组（p<0.003）；试验结束时，左卡巴斯汀组在畏光（p<0.008）、刺激感（p=0.05）和眼痒（p=0.05）方面症状严重程度的降低也显著大于对照组。左卡巴斯汀组患者完全无症状的天数百分比显著高于安慰剂组（28%对4%；p<0.02）。8例接受安慰剂治疗的患者因治疗无效退出试验，而接受左卡巴斯汀治疗的患者只有4例（p=0.013）。在选择继续接受开放标签左卡巴斯汀治疗的3例左卡巴斯汀治疗患者和所有5例安慰剂患者中，有2例在治疗1至3周后总体反应优秀或良好。所有报告的不良反应均较轻微，且两个治疗组的发生率相同。左卡巴斯汀滴眼液治疗VC有效且耐受性良好。
