0.0015％他氟前列素滴眼液与0.005％拉坦前列素滴眼液治疗原发性开角型青光眼和高眼压症的多中心随机单盲平行对照试验

Randomized parallel group study of 0.0015% tafluprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension （comparison with 0.005% latanoprost ophthalmic solution）

目的 对比0.0015％他氟前列素滴眼液与0.005％拉坦前列素滴眼液治疗POAG及高眼压症的降眼压效果及安全性.方法 多中心随机单盲平行对照试验研究.从2008年8月至2009年12月在我国5个临床研究中心,对POAG和高眼压症患者进行治疗,按评价者盲法1∶1的比例,随机分为0.0015％他氟前列素滴眼液组和0.005％拉坦前列素滴眼液组.经洗脱后对治疗前0周（基线）、治疗后2周和4周进行Goldmann眼压测量,裂隙灯显微镜检查,房角、眼底、视力、视野、血压、脉搏检查,并询问用药后相关症状,对比两个不同用药组间的差异.对于主要有效性评价指标采用非劣效性评价,安全性评价指标采用Fisher确切概率法进行检验.结果 共入组患者246例（246只眼）,其中他氟前列素组和拉坦前列素组分别为122例（122只眼）和124例（124只眼）.他氟前列素组和拉坦前列素组研究眼17：00的眼压,治疗2周后分别下降（8.8 ±3.8） mmHg和（8.9±4.4） mmHg（1 mmHg =0.133 kPa）,眼压下降率分别为33.2％±12.8％和34.4％±14.1％;治疗4周后或治疗终止时,分别下降了（9.8±4.0） mmHg和（9.2±4.1）mmHg,眼压下降率分别为37.2％±13.4％和35.7％±13.0％.眼压下降率≥30％的受试者中,他氟前列素组为72.5％略高于拉坦前列素组的63.8％.主要不良反应包括结膜充血、眼刺激、眼痛和异物感,发生率他氟前列素组为31.7％,拉坦前列素组为20.8％,组间差异无统计学意义（Fisher确切概率法,P=0.078）.结论 对于POAG和高眼压症患者,0.0015％他氟前列素滴眼液的降眼压效果、治疗安全性均与0.005％拉坦前列素相当.

Objective To confirm the non-inferiority of the IOP-lowering effect of the 0.0015% Tafluprost ophthalmic solution to the 0.005% Latanoprost ophthalmic solution in patients with primary openangle glaucoma or ocular hypertension.Safety was also compared between two groups.Methods This study was conducted from August 2008 to December 2009,at five clinical trial sites in China.Patients of this study population was diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes.Subjects were randomized into 0.0015% Tafluprost group or 0.005% Latanoprost group.Intraocular pressure（IOP）measurement by Goldmann applanation tonometer,slit-lamp microscopy,Gonioscopy,Fundascopy,Visual acuity test,Perimetry,Blood pressure and pulse rate,Subjective symptoms were compered between two groups at Week 0,Week 2 and Week 4.For main effectiveness evaluation index adopt the bad effect evaluation,safety evaluation index by Fisher＇s exact test probability method.Results The 246 subjects/246 eyes were randomized （Tafluprost group：122 subjects/122 eyes,Latanoprost group：124 subjects/124 eyes）.Change in the IOP at 17：00 of Week 2 is （8.8 ± 3.8） mmHg and （8.9 ± 4.4）mmHg （1 mmHg =O.133 kPa）in Tafluprost group and Latanoprost group.Percent change in the IOP at 17：00 of Week 2 is （33.2 ±12.8）% and （34.4 ± 14.1）% in Tafluprost group and Latanoprost group.Change in the IOP at 17：00 at the end of treatment is （9.8 ± 4.0） mmHg and （9.2 ± 4.1） mmHg in Tafluprost group and Latanoprost group.Percent change in the IOP at 17：00 at the end of treatment is 37.2% ± 13.4% group and 35.7% ±13.0% in Tafluprost and Latanoprost group.In addition,distribution of subjects with percentage decrease of IOP 〉 30% was 72.5% in Tafluprost group higher than 63.8% in Latanoprost group.The major adverse reactions were conjunctival hyperemia,eye irritation,eye pain and foreign body sensation.The incidence of adverse reactions is 31.7% in Tafluprost group and 20.8% in Latanoprost group.The inter-group difference had no statistical significance.Conclusion Efficacy and safety of Tafluprost ophthalmic solution are no less than Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.