摘要目的 探讨0.025%富马酸酮替芬滴眼液治疗季节性变应性结膜炎患者眼痒、结膜充血的临床疗效.方法 采用多中心、双盲、随机、平行组别的研究方法,将诊断为季节性变应性结膜炎的229例(229只眼)患者随机分为试验组114例,给予进口0.025%富马酸酮替芬滴眼液,对照组115例,给予0.05%依美斯汀滴眼液,均为2次/d,每次1滴,疗程14d.在用药前和用药后(7±1)d,(14±1)d对两组患者的眼痒和结膜充血进行观察评分.结果 用药后(7±1)d以及(14±1)d,酮替芬组和依美斯汀组眼痒、结膜充血评分均明显下降,与基线期相比差异有统计学意义(P＜0.05);眼痒和结膜充血下降幅度组间(酮替芬一依美斯汀)差异无统计学意义(P＞0.05).结论 进口0.025%富马酸酮替芬滴眼液治疗季节性变应性结膜炎患者的眼痒、结膜充血疗效非劣效于0.05%依美斯汀滴眼液.

abstractsObjective To evaluate the efficacy of imported ketotifen fumarate 0.025%ophthalmic solution in alleviating ocular itching and conjunctivai hyperemia in patients with seasonal allergic conjunctivitis.Methods A randomized,double-masked,mnlti-centre,parallel.group clinical study was carried out.Two hundred and twenty-nine patients with seasonal allergic con3unctivitis enrolled into the trial were randomly divided intotwogroups:thetreatmentgroup(n=114)andthe control group(n=115).Patients were either given ketotifen furnarate 0.025%or emedasfine 0.05%,administered twice a day for a treatment period of two weeks.The scores for itching and conjanctival hyperemia of both groups were evaluated at baseline,and on treatment days SeVen(primary efficacy endFIoint)and fourteen.ResultsAt day seven and day fourteen.the scores for itching and conjunctival hyperemia in both groups were reduced significantly.All differences from baseline were statistically significant(P＜0.05).And there was no significant difference in efficacy between the ketotifen and the emedastine groups(P＞0.05).Conclusion The efficacy of imported ketotifen fumarate 0.025%in alleviating ocular itching and conjunctival hyperemia in patients with seasonal allergic conjunctivitis is not inferior to that ofemedastine 0.05%.