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左卡巴斯汀滴眼液与色甘酸钠及安慰剂治疗季节性变应性结膜炎的双盲比较

Double-blind comparison of levocabastine eye drops with sodium cromoglycate and placebo in the treatment of seasonal allergic conjunctivitis.

作者信息

Azevedo M, Castel-Branco M G, Oliveira J F, Ramos E, Delgado L, Almeida J

机构信息

Unit of Clinical Immunoallergology, São João Hospital, Porto, Portugal.

出版信息

Clin Exp Allergy. 1991 Nov;21(6):689-94. doi: 10.1111/j.1365-2222.1991.tb03197.x.

DOI:10.1111/j.1365-2222.1991.tb03197.x
PMID:1685691
Abstract

The efficacy and tolerance of topical administration (one drop in each eye q.i.d.) of levocabastine (0.5 mg/ml) was compared with that of sodium cromoglycate (20 mg/ml) and placebo in a 4-week double-blind trial in patients with seasonal allergic conjunctivitis. The investigator rated the treatment as globally good or excellent in significantly more patients treated with levocabastine (89%) than with cromoglycate (67%, P = 0.03) or placebo (48%, P = 0.007). The patients felt that the treatment was more efficacious in 95% (levocabastine), 35% (cromoglycate) and 36% (placebo) of the cases in which they had taken previous antiallergic medication. Total symptom severity according to the patients' diary data was consistently lower with levocabastine than with cromoglycate or placebo for all ocular symptoms. The difference was mainly apparent at the beginning of treatment. The percentage of symptom-free days was higher in the levocabastine group (53%) than in the cromoglycate (31%, P = 0.02) and the placebo group (34%, P = 0.08). Particularly at high-pollen days, levocabastine was superior to cromoglycate in eliminating moderate or severe symptoms. Adverse effects did not occur more frequently with levocabastine or cromoglycate than with placebo. It is concluded that levocabastine is an efficacious, fast-acting and well-tolerated drug in the management of seasonal allergic conjunctivitis.

摘要

在一项针对季节性过敏性结膜炎患者的为期4周的双盲试验中,对比了左卡巴斯汀(0.5毫克/毫升)局部给药(每只眼每日4次,每次一滴)与色甘酸钠(20毫克/毫升)及安慰剂的疗效和耐受性。研究者评定,接受左卡巴斯汀治疗的患者中,认为治疗总体良好或优秀的比例(89%)显著高于接受色甘酸钠治疗的患者(67%,P = 0.03)及接受安慰剂治疗的患者(48%,P = 0.007)。在曾服用过抗过敏药物的病例中,患者感觉治疗有效的比例分别为:左卡巴斯汀95%、色甘酸钠35%、安慰剂36%。根据患者日记数据,对于所有眼部症状,左卡巴斯汀治疗后总的症状严重程度始终低于色甘酸钠或安慰剂。这种差异在治疗开始时尤为明显。左卡巴斯汀组无症状天数的百分比(53%)高于色甘酸钠组(31%,P = 0.02)和安慰剂组(34%,P = 0.08)。特别是在花粉浓度高的日子,左卡巴斯汀在消除中度或重度症状方面优于色甘酸钠。左卡巴斯汀或色甘酸钠出现不良反应的频率并不高于安慰剂。结论是,左卡巴斯汀在治疗季节性过敏性结膜炎方面是一种有效、起效迅速且耐受性良好的药物。

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